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WO2025170969A1 - Methods of treating al amyloidosis - Google Patents

Methods of treating al amyloidosis

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Publication number
WO2025170969A1
WO2025170969A1 PCT/US2025/014544 US2025014544W WO2025170969A1 WO 2025170969 A1 WO2025170969 A1 WO 2025170969A1 US 2025014544 W US2025014544 W US 2025014544W WO 2025170969 A1 WO2025170969 A1 WO 2025170969A1
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WO
WIPO (PCT)
Prior art keywords
slowing
decline
physical
points
antibody
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/014544
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French (fr)
Inventor
Katherine Ingrid SPRINZ
Cheng-Yow Timothy LIN
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Prothena Biosciences Ltd
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Prothena Biosciences Ltd
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Application filed by Prothena Biosciences Ltd filed Critical Prothena Biosciences Ltd
Publication of WO2025170969A1 publication Critical patent/WO2025170969A1/en
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/42—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins
    • C07K16/4283—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins against an allotypic or isotypic determinant on Ig
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/55—Medicinal preparations containing antigens or antibodies characterised by the host/recipient, e.g. newborn with maternal antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered

Definitions

  • BACKGROUND Light chain (AL) amyloidosis is a rare, progressive, and typically fatal disease caused by circulating toxic light chain aggregates and insoluble amyloid that deposits in vital organs, leading to organ dysfunction and failure.
  • AL amyloidosis and cardiac involvement have high symptom burden and poor physical function, resulting in reduced health-related quality of life (HRQoL).
  • HRQoL health-related quality of life
  • treatment side effects also have negative impacts on patients’ lives.
  • the outcome of the disease for patients with AL amyloidosis can be predicted based on the Mayo four stage prognostic staging system discussed in Kumar et al., 2012 (Kumar et al., Revised Prognostic Staging System for Light Chain Amyloidosis Incorporating Cardiac Biomarkers and Serum Free Light Chain Measurements, J Clin Oncol.30:989-995 (2012)), with the outcome for Mayo Stage IV patients being quite dire.
  • Current treatment of patients with AL amyloidosis is aimed at reducing or eliminating the bone marrow disorder, i.e., the plasma cells that are responsible for producing the light chains, thereby limiting or halting the production of amyloid.
  • the most aggressive treatment Attorney Docket No.50887-0050WO1 options include stem cell transplant and high-dose chemotherapy for those patients who can tolerate it.
  • Other treatment regimens include combinations of drugs often used to treat hematological malignancies, such as melphalan, prednisone, dexamethasone and proteosome inhibitors such as bortezomib, in an attempt to reduce light chain production.
  • drugs often used to treat hematological malignancies, such as melphalan, prednisone, dexamethasone and proteosome inhibitors such as bortezomib, in an attempt to reduce light chain production.
  • the present disclosure provides a method of slowing a decline in social functioning in a subject having Mayo Stage IV AL amyloidosis, comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105).
  • the present disclosure provides a method of slowing a decline in Health-Related Quality of Life (HRQoL) in a subject having AL amyloidosis, comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105), wherein the slowing of the decline in HRQoL comprises a slowing of a decline in at least one of the following: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), mental health (MH), and mental component score (MCS).
  • PF physical functioning
  • RP role physical
  • BP bodily pain
  • GH general health
  • the slowing of the decline in HRQoL further comprises a slowing of a decline in physical component score (PCS).
  • PCS physical component score
  • the slowing of the decline in physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, mental component score and/or physical component score is assessed using the 36- Item Short Form Survey (SF-36) or the 36-Item Short Form Survey Version 2 (SF-36v2).
  • the present disclosure provides a method of treating Mayo Stage IV AL amyloidosis in a subject, comprising administering to the subject an effective dosage of Attorney Docket No.50887-0050WO1 an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105); wherein treating comprises a slowing of a decline in social functioning in the subject. In some embodiments, the method comprises a slowing of a decline in social functioning in the subject.
  • the slowing of the decline in social functioning is assessed using the SF-36 or the SF-36v2.
  • the slowing of the decline in social functioning comprises a higher score on a social functioning domain of an SF-36 or SF-36v2 relative to a different patient at the same time point who has not been administered the antibody.
  • the slowing of the decline in social functioning comprises a decrease of less than about 20 points on the social functioning domain of the SF-36v2 compared to baseline.
  • the slowing of the decline in social functioning comprises a decrease of less than about 10 points on the social functioning domain of the SF- 36v2 compared to baseline.
  • the light chain variable region comprises the amino acid sequence set forth as SEQ ID NO: 1 or 14, and the heavy chain variable region comprises the amino acid sequence set forth as SEQ ID NO: 2 or 15.
  • the antibody comprises a light chain comprising the amino acid sequence set forth as SEQ ID NO:10, and a heavy chain comprising the amino acid sequence set forth as SEQ ID NO: 11, 12 or 13.
  • the antibody comprises a light chain comprising the amino acid sequence set forth as SEQ ID NO:10, and a heavy chain comprising the amino acid sequence set forth as SEQ ID NO:12.
  • the antibody is a Fab, Fab’, F(ab’)2, F(ab)c, Dab, nanobody, or Fv.
  • the slowing of the decline in HRQoL includes a higher score on at least one of the following domains of an SF-36 or SF-36v2 relative to a different patient at the same time point who has not been administered the antibody: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, mental component score and/or physical component score.
  • the slowing of the decline in HRQoL is assessed by comparing a score on at least one of the following domains of an SF-36 or SF-36v2 to a baseline score: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, mental component score and/or physical component score.
  • the slowing of the decline in reported value for the role physical domain includes a decrease of less than about 5 points on the role physical domain of the SF-36v2 compared to baseline.
  • the method includes a slowing of a decline in a reported value for a bodily pain domain of the SF-36 or SF-36v2.
  • the reported value for the bodily pain domain is higher relative to a different patient at the same time point who has not been administered the antibody.
  • the slowing of the decline in reported value for the bodily pain domain includes a decrease of less than about 5 points on the bodily pain domain of the SF-36v2 compared to baseline.
  • the method includes a slowing of a decline in vitality in the subject. In some embodiments, the method includes a slowing of a decline in role emotional in the subject. In some embodiments, the method Attorney Docket No.50887-0050WO1 includes a slowing of a decline in mental health in the subject. In some embodiments, the method includes a slowing of a decline in mental component score in the subject. In some embodiments, the method includes a slowing of a decline in at least two of the following: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, and mental component score.
  • the method includes a slowing of a decline in at least three of the following: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, and mental component score.
  • the antibody includes a light chain variable region including three complementarity determining regions of 2A4, 7D8 or 11-1F4, and a heavy chain variable region including three complementarity determining regions of 2A4, 7D8 or 11-1F4, respectively.
  • the antibody is a humanized version of 2A4. In some embodiments, the antibody is a humanized or chimeric version of 11-1F4.
  • the antibody includes a light chain variable region including three complementarity determining regions set forth as SEQ ID NOs: 3, 4 and 5, or SEQ ID NOs: 16, 17, and 18, and a heavy chain variable region including three complementarity determining regions set forth as SEQ ID NOs: 6, 7 and 8, or SEQ ID NOs: 19, 20, and 21.
  • the light chain variable region includes the amino acid sequence set forth as SEQ ID NO: 1 or 14.
  • the heavy chain variable region includes the amino acid sequence set forth as SEQ ID NO: 2 or 15.
  • the light chain variable region includes the amino acid sequence set forth as SEQ ID NO: 1 or 14, and the heavy chain variable region includes the amino acid sequence set forth as SEQ ID NO: 2 or 15.
  • the antibody includes a light chain including the amino acid sequence set forth as SEQ ID NO:10, and a heavy chain including the amino acid sequence set forth as SEQ ID NO: 11, 12 or 13. In some embodiments, the antibody includes a light chain including the amino acid sequence set forth as SEQ ID NO:10, and a heavy chain including the amino acid sequence set forth as SEQ ID NO:12. In some embodiments, the antibody is a Fab, Fab’, F(ab’)2, F(ab)c, Dab, nanobody, or Fv. In some embodiments, the antibody is birtamimab.
  • the effective dosage of the antibody is administered from a pharmaceutical formulation including the antibody at a concentration within the range from about 1 mg/mL to about 100 mg/mL. In some embodiments, the dosage is from about 0.5 Attorney Docket No.50887-0050WO1 mg/kg to about 30 mg/kg and the antibody is administered intravenously or subcutaneously at a frequency of from about weekly to about quarterly. In some embodiments, the antibody is present at a concentration of about 50 mg/mL. In some embodiments, the dosage is administered intravenously following the transfer of an amount of the formulation required for the dosage from a vial to an intravenous bag containing a liquid. In some embodiments, the dosage is about 24 mg/kg and the antibody is administered intravenously every 28 days.
  • Figure 1 shows the change from baseline to month 9 in reported values for the eight domains of the SF-36v2 questionnaire for Mayo Stage IV patients treated with birtamimab plus standard of care compared to placebo plus standard of care and demonstrates a slowing of decline in reported values for social functioning, role physical, and bodily pain domains.
  • the present disclosure provides methods of slowing a decline in Health-Related Quality of Life (HRQoL) in a subject having AL amyloidosis, including administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105), where the slowing of the decline in HRQoL includes a slowing of a decline in at least one of the following: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), mental health (MH), and mental component score (MCS).
  • PF physical functioning
  • RP role physical
  • BP bodily pain
  • GH general health
  • VT vitality
  • this disclosure provides methods of treating AL amyloidosis in a subject, including administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11- 1F4 (ATCC Accession Number PTA-105); where treating includes a slowing of a decline in HRQoL including a slowing of a decline in at least one of the following: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, and mental component score.
  • the present disclosure also provides methods for reducing a decline in life quality for Mayo Stage IV AL amyloidosis, as demonstrated by a slowing of a decline in reported values (e.g., on an SF-36 and/or SF-36v2 questionnaire) relative to Health Related Quality of Life (“HRQoL”).
  • HRQoL Health Related Quality of Life
  • the present disclosure provides methods of slowing of a decline in reported value for at least one of the following domains: social function, physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, and mental component score in patients with Mayo Stage IV AL amyloidosis.
  • the present disclosure provides methods of slowing of a decline in reported value for a social function domain in patients with Mayo Stage IV AL amyloidosis.
  • the disclosure further provides treating certain AL amyloidosis patients namely patients with Mayo Stage IV AL amyloidosis, wherein treating comprises a slowing of a decline in reported value for a social function domain.
  • the slowing of the decline in HRQoL comprises an increase in a reported domain value of at least about 5 points (e.g., at least about 6 points, at least about 7 points, at least about 8 points, or at least about 9 points) relative to a different patient at the same time point who has not been administered the antibody; wherein the domain value is at least one of the following: a physical functioning value, a role physical value, a bodily pain value, a general health value, a vitality value, a social functioning value, a role emotional value, a mental health value, and/or a mental component score value.
  • the slowing of the decline in HRQoL comprises an increase in a reported domain value of at least about 10 points (e.g., at least about 11 points, at least about 12 points, at least about 13 points, or at least about 14 points) relative to a different patient at the same time point who has not been administered the antibody; wherein the domain value is at least one of the following: a physical functioning Attorney Docket No.50887-0050WO1 value, a role physical value, a bodily pain value, a general health value, a vitality value, a social functioning value, a role emotional value, a mental health value, and/or a mental component score value.
  • a physical functioning Attorney Docket No.50887-0050WO1 value e.g., a role physical value, a bodily pain value, a general health value, a vitality value, a social functioning value, a role emotional value, a mental health value, and/or a mental component score value.
  • the slowing of the decline in HRQoL comprises an increase in a reported domain value of about 5 points to about 15 points (e.g., about 6 points to about 15 points, about 7 points to about 15 points, about 8 points to about 15 points, about, or 9 points to about 15 points) relative to a different patient at the same time point who has not been administered the antibody; wherein the domain value is at least one of the following: a physical functioning value, a role physical value, a bodily pain value, a general health value, a vitality value, a social functioning value, a role emotional value, a mental health value, and/or a mental component score value.
  • the slowing of the decline in HRQoL comprises an increase in a reported domain value of about 10 points to about 15 points (e.g., about 11 points to about 15 points, about 12 points to about 15 points, about 11 points to about 14 points, about, or 12 points to about 14 points) relative to a different patient at the same time point who has not been administered the antibody; wherein the domain value is at least one of the following: a physical functioning value, a role physical value, a bodily pain value, a general health value, a vitality value, a social functioning value, a role emotional value, a mental health value, and/or a mental component score value.
  • the present disclosure provides a method of treating Mayo Stage IV AL amyloidosis in a subject, comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105); wherein treating comprises a slowing of a decline in social functioning in the subject.
  • this disclosure provides methods of treating AL amyloidosis in a subject, including administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11- 1F4 (ATCC Accession Number PTA-105); where treating includes a slowing of a decline in HRQoL including a slowing of a decline in at least one of the following: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, and mental component score.
  • This disclosure further provides methods of slowing a decline in Health-Related Quality of Life (HRQoL) in a subject having AL amyloidosis with cardiac involvement, including administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA- 9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105), where the slowing of the decline in HRQoL includes a Attorney Docket No.50887-0050WO1 slowing of a decline in at least one of the following: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), mental health (MH), and mental component score (MCS).
  • PF physical functioning
  • RP role physical
  • this disclosure provides methods of treating AL amyloidosis with cardiac involvement in a subject, including administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105); where treating includes a slowing of a decline in HRQoL including a slowing of a decline in at least one of the following: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, and mental component score.
  • the slowing the decline in social functioning comprises a decrease of about 1 point to about 15 points (e.g., 1 point to about 12 points, 1 point to about 10 points, 1 point to about 8 points) on the social functioning domain compared to baseline. In some embodiments, the slowing the decline in social functioning comprises a decrease of about 3 points to about 15 points (e.g., 3 points to about 12 points, 3 points to about 10 points, 3 points to about 8 points) on the social functioning domain compared to baseline. In some embodiments, the slowing the decline in social functioning comprises a decrease of about 5 points to about 15 points (e.g., 5 points to about 12 points, 5 points to about 10 points, 5 points to about 8 points) on the social functioning domain compared to baseline.
  • the slowing the decline in social functioning comprises a decrease of about 4 points to about 8 points on the social functioning domain compared to baseline. In some embodiments, the slowing the decline in social functioning comprises a decrease of about 5 points to about 7 points on the social functioning domain compared to baseline. In some embodiments, the slowing the decline in social functioning comprises a decrease of about 3 points, about 4 points, about 5 points, about 6 points, about 7 points, about 8 points, about 9 points, or about 10 points on the social functioning domain compared to baseline.
  • the slowing the decline in social functioning comprises a higher score on a social functioning domain of an SF-36 or SF-36v2 relative to a different patient having Mayo Stage IV AL amyloidosis at the same time point who has not been administered the antibody.
  • the slowing of the decline in social functioning comprises a higher score on a social functioning domain of an SF-36 relative to a different patient at the same time point who has not been administered the antibody.
  • the slowing of the decline in social functioning comprises a higher score on a social functioning domain of an SF-36v2 relative to a different patient at the same time point who has not been administered the antibody.
  • the slowing of the decline in social functioning comprises a increase of about 20 points to about 25 points (e.g., 21 points to about 24 points, 22 points to about 24 points, 21 points to about 23 points, or 22 points to about 23 points) on the social functioning domain relative to a different patient at the same time point who has not been administered the antibody.
  • the slowing of the decline in social functioning comprises a increase of about 18 points, about 19 points, about 20 points, about 21 points, about 22 points, about 23 points, about 24 points, about 25 points, about 26 points, or about 27 points on the social functioning domain relative to a different patient at the same time point who has not been administered the antibody.
  • the slowing of the decline in social functioning comprises an increase of about 23 points on the social functioning domain relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in social functioning is assessed after at least about 6 months (e.g., at least about 7 months or at least about 8 months) following a first administration of the antibody. In some embodiments, the slowing of the decline in social functioning is assessed after at least about 9 months (e.g., at least about 10 months or at least about 11 months) following a first administration of the antibody.
  • the slowing of the decline in social functioning is assessed after about 12 months (e.g., about 13 months, about 14 months, or about 15 months) following a first administration of the antibody.
  • the method further comprises assessing the HRQoL in the subject in at least one of the following domains (e.g., using the SF-36 or the SF-36v2) is assessed: role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, mental component score and/or physical component score.
  • the method comprises a slowing of a decline in bodily pain in the subject, and the first and second HRQoL values comprise a first bodily pain value and a second bodily pain value, respectively.
  • the method comprises a slowing of a decline in general health in the subject, and the first and second HRQoL values comprise a first general health value and a second general health value, respectively.
  • the method comprises a slowing of a decline in vitality in the subject, and the first and second HRQoL values comprise a first vitality value and a second vitality value, respectively.
  • the first value comprises a first score on a domain of the SF-36 or the SF-36v2 and the second value comprises a second score on a domain of the SF-36 or Attorney Docket No.50887-0050WO1 the SF-36v2.
  • the first value comprises a first score on a domain of the SF-36 and the second value comprises a second score on a domain of the SF-36.
  • the first value comprises a first score on a domain of the SF-36v2 and the second value comprises a second score on a domain of the SF-36v2.
  • the domain is at least one of the following: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, and mental component score.
  • the first HRQoL value is a baseline HRQoL value.
  • the first HRQoL value comprises a at least one of the following a baseline physical functioning value, a baseline role physical value, a baseline bodily pain value, a baseline general health value, a baseline vitality value, a baseline social functioning value, a baseline role emotional value, a baseline mental health value, and a baseline mental component score value.
  • the present disclosure provides a method of slowing a decline in social functioning in a subject having AL (including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement) amyloidosis, the method comprising: (d) assessing social functioning in the subject thereby obtaining a first social functioning value; (e) administering to the subject an effective dosage of an antibody, wherein the antibody competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for Attorney Docket No.50887-0050WO1 binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105); and (f) assessing social functioning in the subject thereby obtaining a second social functioning value.
  • AL Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement
  • the second score on the social functioning domain is less than about 20 points (e.g., less than about 19 points, less than about 18 points, less than about 17 points, or less than about 16 points) lower than the first score on the social functioning domain. In some embodiments, the second score on the social functioning domain is less than about 15 points (e.g., less than about 14 points, less than about 13 points, less than about 12 points, or less than about 11 points) lower than the first score on the social functioning domain. In some embodiments, the second score on the social functioning domain is less than about 10 points (e.g., less than about 9 points, less than about 8 points, less than about 7 points, or less than about 6 points) lower than the first score on the social functioning domain.
  • the second score on the social functioning domain is about 3 points, about 4 points, about 5 points, about 6 points, about 7 points, about 8 points, about 9 points, or about 10 points lower than the first score on the social functioning domain.
  • the second social function value is assessed after at least about 6 months (e.g., at least about 7 months or at least about 8 months) following a first administration of the antibody.
  • the second social function value is assessed after at least about 9 months (e.g., at least about 10 months or at least about 11 months) following a first administration of the antibody.
  • the second social function value is assessed after at least about 12 months (e.g., at least about 13 months, at least about 14 months, or at least about 15 months) following a first administration of the antibody. In some embodiments, the second social function value is assessed after about 6 months (e.g., about 7 months or about 8 months) following a first administration of the antibody. In some embodiments, the second social function value is assessed after about 9 months (e.g., about 10 months or about 11 months) following a first administration of the antibody. In some embodiments, the second social function value is assessed after about 12 months (e.g., about 13 months, about 14 months, or about 15 months) following a first administration of the antibody.
  • the method further comprises a slowing of a decline in at least one value for the following domains of the SF-36 or SF-36v2: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and mental component score.
  • the method further comprises a slowing of a decline in at least one value for the following domains of the SF-36 or SF-36v2: physical functioning, role physical, bodily pain, role-emotional, mental health, physical component score, and mental component score.
  • the method further comprises a slowing of a decline in at least one value for the following domains of the SF-36 or SF-36v2: physical functioning, role physical, bodily pain, physical component score, and mental component score. In some embodiments, the method further comprises a slowing of a decline in at least one value for the following domains of the SF-36 or SF-36v2: role physical, bodily pain, and physical component score.
  • the present disclosure provides a method of slowing a decline in a reported value for at least one of the following domains in a subject having AL amyloidosis(including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement): physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and mental component score (e.g., reported value of one or more domain of the SF-36 or SF-36v2); the method comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11- 1F4 (ATCC Accession Number PTA-105
  • the present disclosure provides a method of treating AL amyloidosis (including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement) in a subject, comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105); wherein treating comprises a slowing of a decline in a reported value for at least one of the following domains in the subject: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and mental component score (e.g., reported value of one or more domain of the SF-36 or SF-36v2).
  • AL amyloidosis including May
  • the method further comprises a slowing of a decline in role physical and/or bodily pain domains of the SF-36 or SF-36v2. In some embodiments, the method further comprises a slowing of a decline in role physical and/or bodily pain domains of the SF-36. In some embodiments, the method further comprises a slowing of a decline in role physical and/or bodily pain domains of the SF-36v2. In some embodiments, the method further comprises a slowing of a decline in role physical and/or bodily pain domains of the SF-36v2 compared to baseline.
  • the reported value for the role physical domain is higher relative to a different patient at the same time point who has not been administered the antibody.
  • the present disclosure provides a method of slowing a decline in role physical (e.g., reported value of role physical domain) in a subject having AL Attorney Docket No.50887-0050WO1 amyloidosis (including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement), comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105).
  • the present disclosure provides a method of treating AL amyloidosis (including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement) in a subject, comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105); wherein treating comprises a slowing of a decline in role physical (e.g., reported value of role physical domain) in the subject.
  • AL amyloidosis including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement
  • an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4
  • the slowing of the decline in reported value for the role physical domain comprises a decrease of less than about 10 points (e.g., less than about 9 points, less than about 8 points, less than about 7 points, or less than about 6 points) on the role physical domain (e.g., of the SF-36 or SF-36v2) compared to baseline. In some embodiments, the slowing of the decline in reported value for the role physical domain comprises a decrease of less than about 5 points (e.g., less than about 4 points, less than about 3 points, or less than about 2 points) on the role physical domain compared to baseline.
  • the slowing of the decline in reported value for the role physical domain comprises a decrease of about 1 point to about 5 points (e.g., about 1 point to about 4 points, about 1 point to about 3 points, or about 1 point to about 2 points) on the role physical domain (e.g., of the SF-36 or SF-36v2) compared to baseline.
  • the slowing of the decline in reported value for the role physical domain comprises a decrease of about 2 points to about 3 points on the role physical domain compared to baseline.
  • the slowing of the decline in reported value for the role physical domain comprises a decrease of about 1 point, about 2 points, about 3 points, about 4 points, or about 5 points on the role physical domain compared to baseline.
  • the slowing of the decline in reported value for the role physical domain comprises a decrease of about 2 points on the role physical domain compared to baseline.
  • Attorney Docket No.50887-0050WO1 the slowing of the decline in reported value for the role physical domain comprises an increase of at least about 1 point (e.g., at least about 2 points, at least about 3 points, or at least about 4 points) on the role physical domain relative to a different patient at the same time point who has not been administered the antibody.
  • the slowing of the decline in reported value for the role physical domain comprises an increase of at least about 5 points (e.g., at least about 6 points, at least about 7 points, at least about 8 points, or at least about 9 points) on the role physical domain relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in reported value for the role physical domain comprises an increase of at least about 10 points (e.g., at least about 11 points, at least about 12 points, at least about 13 points, or at least about 14 points) on the role physical domain relative to a different patient at the same time point who has not been administered the antibody.
  • the slowing of the decline in reported value for the role physical domain comprises an increase of about 11 points to about 12 points on the role physical domain relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in reported value for the role physical domain comprises an increase of about 8 points, about 9 points, about 10 points, about 11 points, about 12 points, about 13 points, or about 14 points on the role physical domain relative to a different patient at the same time point who has not been administered the antibody.
  • the slowing of the decline in reported value for the role physical domain comprises an increase of about 11 points on the role physical domain Attorney Docket No.50887-0050WO1 relative to a different patient at the same time point who has not been administered the antibody.
  • the method further comprises a slowing of the decline in bodily pain of the SF-36 or SF-36v2.
  • the method further comprises a slowing of the decline in a bodily pain domain of the SF-36.
  • the method further comprises a slowing of the decline in a bodily pain domain of the SF-36v2.
  • the reported value for the bodily pain domain is lower than baseline.
  • the slowing of the decline in bodily pain comprises a decrease of less than about 10 points (e.g., less than about 9 points, less than about 8 points, less than about 7 points, or less than about 6 points) on the bodily pain domain compared to baseline. In some embodiments, the slowing of the decline in bodily pain comprises a decrease of less than about 5 points (e.g., less than about 4 points, less than about 3 points, or less than about 2 points) on the bodily pain domain compared to baseline.
  • the slowing of the decline in bodily pain comprises a decrease of about 1 point to about 10 points (e.g., 1 point to about 9 points, 1 point to about 8 points, 1 point to about 6 points, 1 point to about 5 points, or 1 point to about 4 points) on the bodily pain domain compared to baseline.
  • the slowing of the decline in bodily pain comprises a decrease of about 2 points to about 8 points (e.g., 2 points to about 7 points, 2 points to about 6 points, 2 points to about 5 points, 2 points to about 4 points, or 2 points to about 3 points) on the bodily pain domain compared to baseline.
  • the slowing of the decline in bodily pain comprises a decrease of about 2 points to about 4 points on the bodily pain domain compared to baseline. In some embodiments, the slowing of the decline in bodily pain comprises a decrease of about 1 point, about 2 points, about 3 points, about 4 points, about 5 points, about 6 points, about 7 points, at least 8 points, at least 9 points, or at least 10 points on the bodily pain domain compared to baseline. In some embodiments, the slowing of the decline in bodily pain domain comprises a decrease of about 3 points on the bodily pain domain compared to baseline.
  • the slowing of the decline in reported value for the bodily pain domain comprises an increase of at least about 1 point (e.g., at least about 2 points, at least about 3 points, or at least about 4 points) on the bodily pain domain relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in reported value for the bodily pain domain comprises an increase of at least about 5 points (e.g., at least about 6 points, at least about 7 points, at least about 8 points, or at least about 9 points) on the bodily pain domain relative to a different patient at the same time point who has not been administered the antibody.
  • the slowing of the decline in reported value for the bodily pain domain comprises an increase of at least about 10 points (e.g., at least about 11 points, at least about 12 points, at least about 13 points, or at least about 14 points) on the bodily pain domain relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in reported value for the bodily pain domain comprises an increase of at least about 15 points (e.g., at least about 16 points, at least about 17 points, at least about 18 points, or at least about 19 points) on the bodily pain domain relative to a different patient at the same time point who has not been administered the antibody.
  • the slowing of the decline in reported value for the bodily pain domain comprises an increase of about 15 points to about 18 points (e.g., about 15 points to about 17 points, about 15 points to about 16 points, about 16 points to about 18 points, or about 16 points to about 17 points) on the bodily pain domain relative to a different patient at the same time point who has not been administered the antibody.
  • the slowing of the decline in reported value for the bodily pain domain comprises an increase of about 12 points, about 13 points, about 14 points, about 15 points, about 16 points, about 17 points, about 18 points, about 19 points, or about 20 points on the bodily pain domain relative to a different patient at the same time point who has not been administered the antibody.
  • the present disclosure provides a method of treating AL amyloidosis (including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement) in a subject, comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105); wherein treating comprises a slowing of a decline in physical functioning (e.g., reported value of physical functioning domain) in the subject.
  • AL amyloidosis including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement
  • an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4
  • the present disclosure provides a method of slowing a decline in vitality (e.g., reported value of vitality domain) in a subject having AL amyloidosis (including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement), comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11- 1F4 (ATCC Accession Number PTA-105).
  • AL amyloidosis including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement
  • the present disclosure provides a method of treating AL amyloidosis (including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement) in a subject, comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105); wherein treating comprises a slowing of a decline in vitality (e.g., reported value of vitality domain) in the subject.
  • an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding
  • the present disclosure provides a method of treating AL amyloidosis (including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement) in a subject, comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Attorney Docket No.50887-0050WO1 Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105); wherein treating comprises a slowing of a decline in mental component score (e.g., reported value of mental component score domain) in the subject.
  • AL amyloidosis including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement
  • an antibody which competes for binding to human amyloid A peptide or human k
  • the method comprises a slowing of the decline in value for any of the following domains of the SF-36 compared to baseline: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score.
  • the method comprises a slowing of a decline in value for any of the following domains of the SF-36v2 compared to baseline: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score.
  • the slowing of the decline in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score comprises a decrease of less than about 5 points (e.g., less than about 4 points, less than about 3 points, less than about 2 points, or less than about 1 point) on the domain compared to baseline.
  • the slowing of the decline in in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score comprises a decrease of about 5 points to about 15 points (e.g., 5 points to about 12 points, 5 points to about 10 points, 5 points to about 8 points) on the domain compared to baseline.
  • the slowing of the decline in in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score comprises a decrease of about 4 points to about 8 points on the domain compared to baseline.
  • the slowing of the decline in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score comprises an increase of at least about 1 point (e.g., at least about 2 points, at least about 3 points, or at least about 4 points) on the domain (e.g., of the SF-36 or SF- 36v2) relative to a different patient at the same time point who has not been administered the antibody.
  • the slowing of the decline in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental Attorney Docket No.50887-0050WO1 component score comprises an increase of at least about 20 points (e.g., at least about 21 points, at least about 22 points, or at least about 23 points) on the domain relative to a different patient at the same time point who has not been administered the antibody.
  • the slowing of the decline in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score comprises a increase of about 5 points to about 15 points (e.g., 5 points to about 14 points, 5 points to about 12 points, 5 points to about 10 points, 6 points to about 14 points, 6 points to about 12 points, 6 points to about 10 points, or 6 points to about 8 points) on the domain relative to a different patient at the same time point who has not been administered the antibody.
  • the slowing of the decline in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score comprises an increase of about 1 point, about 2 points, about 3 points, about 4 points, about 5 points, about 6 points, about 7 points, about 8 points, about 9 points, about 10 points, about 11 points, about 12 points, about 13 points, about 14 points, about 15 points, about 16 points, or about 17 points, about 18 points, about 19 points, about 20 points, about 21 points, about 22 points, about 23 points, about 24 points, or about 25 points, on the domain relative to a different patient at the same time point who has not been administered the antibody.
  • the slowing of the decline in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, Attorney Docket No.50887-0050WO1 physical component score, and/or mental component score is assessed after about 9 months (e.g., about 10 months or about 11 months) following a first administration of the antibody.
  • treatment with an antibody disclosed herein results in an increase of a subject’s score on the SF-36 and/or SF36v2, of at least 1, at least 2, at least 3, at least 4, at least 5, at least 6, at least 7, at least 8, at least 9, at least 10, at least 11, at least 12, at least 13, at least 14, at least 15, at least 16, at least 17, at least 18, at least 19, at least 20, at least 21, at least 22, at least 23, at least 24, at least 25, at least 26, at least 27, at least 28, at least 29, at least 30, at least 31, at least 32, at least 33, at least 34, at least 35, at least 36, at least 37, at least 38, at least 39, at least 40, at least 41, at least 42, at least 43, at least 44, at least 45, at least 46, at least 47, at least 48, at least 49, at least 50, at least 51, at least 52, at least 53, at least 54, at least 55, at least 56, at least 57, at least 58, at least 59, at least 60, at least 61,
  • treatment with an antibody disclosed herein results in an increase of a subject’s SF-36 or SF36v2, of about 1, about 2, about 3, about 4, about 5, about 6, about 7, about 8, about 9, about 10, about 11, about 12, about 13, about 14, about 15, about 16, about 17, about 18, about 19, about 20, about 21, about 22, about 23, about 24, about 25, about 26, about 27, about 28, about 29, about 30, about 31, about 32, about 33, about 34, about 35, about 36, about 37, about 38, about 39, about 40, about 41, about 42, about 43, about 44, about 45, about 46, about 47, Attorney Docket No.50887-0050WO1 about 48, about 49, about 50, about 51, about 52, about 53, about 54, about 55, about 56, about 57, about 58, about 59, about 60, about 61, about 62, about 63, about 64, about 65, about 66, about 67, about 68, about 69, about 70, about 71, about 72, about 73, about 74, about 75, about
  • the response of patients with AL amyloidosis to treatment can be monitored by assessing cardiac markers, such as NT-proBNP and/or troponin-T, serum creatine, and/or alkaline phosphatase; by performing serum free light chain (SFLC) assays, quantitative immunoglobulin assays, Attorney Docket No.50887-0050WO1 biopsies, serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP), serum, urine immunofixation electrophoresis (IFE), and/or organ imaging techniques.
  • An exemplary complete response (CR) can be determined from response criteria including negative IFE of serum and urine, normal ⁇ ration and/or ⁇ 5 % plasma cells in bone marrow.
  • An exemplary very good partial response can be determined from a dFLC of ⁇ 40 mg/L.
  • An exemplary partial response (PR) can be determined from a dFLC decrease of ⁇ 50%.
  • a response to treatment can be determined, for example, from a ⁇ 50% reduction (e.g., > 0.5g/24 hours) in 24 hour urine protein excretion in the absence of either a reduction in eGFR of ⁇ 25% or an increase in serum creatine of ⁇ 0.5 mg/dL.
  • a response to treatment can be determined, for example, from a ⁇ 50% reduction in initially elevated alkaline phosphatase or a ⁇ 2 cm reduction in liver size on CT scan or MRI.
  • the birtamimab formulation transferred to the intravenous bag was first reconstituted from a lyophilized formulation to a formulation having a pH of about 6.5 and comprising about 50 mg/ml birtamimab, about 25 mM histidine buffer, about 230 mM trehalose and about 0.2 g/L polysorbate 20.
  • the desired dosage can be administered subcutaneously without dilution from a vial containing any of the formulations disclosed herein.
  • the antibody is administered to the patient for at least 8 months, at least 9 months, at least 10 months, at least 11 months, at least 12 months, or for a longer period of time.
  • the subject has been previously determined diagnosed, identified, or selected as having decreased score for at least one (e.g., at least two, at least three, or at least four) of the following domains: social functioning, physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score (e.g., as compared to a subject of similar age and not having AL amyloidosis or any neurological disorder or compared to a prior measurement taken from the same subject).
  • subjects may be selected for treatment based on their reported value for a social functioning score (e.g., as measured by the SF-36 or SF- 36v2).
  • the subject has been previously determined diagnosed, identified, or selected Attorney Docket No.50887-0050WO1 as having decreased general health perceptions score (e.g., as compared to a subject of similar age and not having AL amyloidosis or any neurological disorder or compared to a prior measurement taken from the same subject).
  • subjects may be selected for treatment based on their reported value for a vitality score (e.g., as measured by the SF-36 or SF-36v2).
  • subject has been determined, diagnosed, identified, or selected for treatment as having baseline role physical score (e.g., as measured using the SF-36 or SF- 36v2) of about 20 to about 50 (e.g., about 25 to about 50, about 30 to about 50, about 35 to about 50, or about 40 to about 50).
  • baseline role physical score e.g., as measured using the SF-36 or SF- 36v2
  • the subject has been determined, diagnosed, identified, or selected for treatment as having baseline role physical score of about 20 to about 40 (e.g., about 25 to about 40, about 30 to about 40, or about 35 to about 40).
  • Such patients may, or may not, have experienced cardiac and/or renal improvement as a result of such treatment.
  • the methods of the disclosure include administering to a patient an antibody that specifically bind to immunoglobulin light chain.
  • examples include antibodies that compete with 11-1F4 for binding to immunoglobulin light chain, and antibodies that compete with 2A4 or 7D8 for binding to human amyloid A peptide, or specifically bind to the same epitope as 11-1F4 (U.S. Patent No.8,105,594), 2A4 or 7D8 (U.S. Patent No.7,928,203).
  • the antibody is a humanized version of 2A4.
  • the light chain variable region comprises the amino acid sequence set forth as SEQ ID NO: 1.
  • the heavy chain variable region comprises the amino acid sequence set forth as SEQ ID NO: 2.
  • the antibody comprises light chain and heavy chain variable regions of a murine, chimeric, or humanized 2A4 antibody, or of a murine, chimeric, or humanized 7D8 antibody, as described in U.S. Patent No.7,928,203 and PCT International Publication No. WO 2009/086539, each of which is incorporated herein by reference in its entirety, and the light chain and heavy chain variable region sequences described in the referenced patent and publication are specifically incorporated by reference herein.
  • Antibodies used in the disclosed formulations also include modified forms of murine, chimeric or humanized 2A4 antibodies, or murine, chimeric or humanized 7D8 antibodies, which have increased in vivo half-lives relative to the corresponding unmodified antibodies.
  • modified forms may be prepared, for example, by glycosylation, acetylation, pegylation, phosphorylation, amidation, derivatization by known protecting/blocking groups, proteolytic cleavage, linkage to a cellular ligand or other protein, etc.
  • representative methods for antibody half-life extension are described in PCT International Publication No. WO 02/060919.
  • polysorbate 20 is present at a concentration within the range of about from about 0.005% to about 0.05% by weight, for example, 0.005%, 0.01%, 0.015%, 0.02%, 0.025%, 0.03%, 0.035%, 0.04%, 0.045%, or 0.05%.
  • polysorbate 20 is present at a concentration within the range of about from about 0.05 g/L, 0.1 g/L, 0.15 g/L, 0.2 g/L, 0.25 g/L, 0.3 g/L, 0.35 g/L, 0.4 g/L, 0.45 g/L, or 0.5 g/L.
  • Some formulations include polysorbate 20 at a concentration of 0.2 g/L. Some formulations are characterized by a pH within the range of about 6-7, for example, a pH of 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, or 7.0. Some formulations have a pH of about 6.5. Some formulations are characterized by an osmolality of about 300 mOsm/kg. A bulking agent may also be included some formulations. Typically, the formulations are sterile, for example, as accomplished by sterile filtration using a 0.2 ⁇ m or a 0.22 ⁇ m filter. The formulations disclosed herein are also generally stable upon freezing and thawing.
  • formulations disclosed herein may further comprise other excipients, such as saccharides, polyols, and amino acids (e.g., arginine, lysine, and methionine).
  • excipients such as saccharides, polyols, and amino acids (e.g., arginine, lysine, and methionine).
  • the present disclosure also provides formulations substantially free of surfactant, inorganic salts, additional sugars, and/or other excipients, i.e., less than about less than 0.0005%, less than 0.0003%, or less than 0.0001% of such compounds.
  • An exemplary formulation comprises an antibody comprising a light chain comprising an amino acid sequence set forth as SEQ ID NO: 10 and a heavy chain comprising an amino acid sequence set forth as any one of SEQ ID NOs: 11, 12, or 13, which is present at a concentration of about 50 mg/mL, a histidine buffer present at a concentration of about 25 mM, trehalose present at a concentration of about 230 mM, polysorbate 20 present at a concentration of about 0.2 g/L, and a pH of about 6.5.
  • Some formulations comprise an antibody comprising a light chain comprising an amino acid sequence set forth as SEQ ID NO: 10 and a heavy chain comprising an amino acid sequence set forth as SEQ ID NO: 12, which is present at a concentration of about 50 mg/mL, a histidine buffer present at a concentration of about 25 mM, trehalose present at a concentration of about 230 mM, polysorbate 20 present at a concentration of about 0.2 g/L, and a pH of about 6.5.
  • Some formulations comprise birtamimab, which is present at a concentration of about 50 mg/mL, a histidine buffer present at a concentration of about 25 mM, trehalose present at a concentration of about 230 mM, polysorbate 20 present at a concentration of about 0.2 g/L, and a pH of about 6.5.
  • the methods disclosed herein involve pharmaceutical products comprising lyophilized antibody drug substance and instructions for reconstitution and use.
  • a representative pharmaceutical product can comprise: (a) a vial comprising about 100 mg antibody in powder form; (b) instructions for reconstitution of the antibody; and (c) instructions for preparing the reconstituted antibody for infusion, wherein (i) the antibody comprises a light chain comprising an amino acid sequence set forth as SEQ ID NO: 10 and a heavy chain comprising an amino acid sequence set forth as any one of SEQ ID NOs: 12-15; and (ii) the reconstitution instructions require reconstitution with water for injection to an extractable volume of 10 mL.
  • Example 1 Phase 2b Clinical Assessment of NEOD001, also known as birtamimab (Humanized 2A4) A Phase 2b global, multi-center, randomized, double-blind, placebo-controlled clinical study of NEOD001 vs.
  • Example 2 Phase 3 Clinical Assessment of NEOD001 A Phase 3 global, multi-center, randomized, double-blind, placebo-controlled clinical study of NEOD001 vs. placebo was conducted in newly diagnosed, treatment-na ⁇ ve patients with AL amyloidosis and cardiac dysfunction, with both arms of the study receiving standard of care (VITAL Study; The VITAL Amyloidosis Study, a Global Phase 3, Efficacy and Safety Study of NEOD001 in Patients With AL Amyloidosis (VITAL), ClinicalTrials.gov Identifier: NCT02312206). The study enrolled 260 patients (see Table 1). Table 1.
  • NEOD001 placebo-based chemotherapy
  • Placebo was administered as a 250 mL bag of normal saline once every 28 days.
  • the primary outcome measures were time to composite of all-cause mortality or cardiac hospitalization. Secondary outcome measures included NT-proBNP best response, time to cardiac mortality or cardiac hospitalization, change in the 6 minute walk test, change in the Short Form-36 questionnaire, change in the Kansas City Cardiomyopathy questionnaire, renal best response as assessed using Palladini et al, 2014 criteria and hepatic best response as assessed using Comenzo et al, 2012 criteria.
  • Example 3 Improvements in Health-Related Quality of Life Metrics for Stage IV AL Amyloidosis Patients – Surprising Results in Certain Patients from the VITAL Study Patients with AL amyloidosis have reduced HRQoL, particularly those with advanced cardiac involvement who have a high symptom burden and poor physical function.
  • we Attorney Docket No.50887-0050WO1 assessed longitudinal HRQoL changes in the VITAL trial among patients with Mayo Stage IV (MSIV) AL amyloidosis.
  • VITAL newly diagnosed treatment-na ⁇ ve patients received birtamimab in combination with standard of care or placebo with standard of care.
  • Short Form-36 questionnaire, version 2 (SF-36v2) was completed at baseline and months 3, 6, and 9 (i.e., after 3, 6, and 9 months of treatment. Lower scores on the SF-36v2 and domains and component scores therein indicate worse HRQoL.
  • a mixed model for repeated measures was used to estimate least squares mean (LSM), standard error (SE), and 95% CI for each treatment group and LSM difference between groups.
  • LSM least squares mean
  • SE standard error
  • 95% CI 95% CI for each treatment group and LSM difference between groups.
  • LSM least squares mean
  • SE standard error
  • 95% CI 95% CI for each treatment group and LSM difference between groups.
  • Tables 2A-2C provide values for HRQoL values reported by the Mayo Stage IV Amyloidosis patients at baseline, month 3, month 6, and month 9.
  • n 7 5 7 0 0 0 7 H a e e c 30 . 3 a 8 . l , 7 . 7 . 5 , 0 . 0 . 4 , 5 . 0 . N 3 3 5 2 3 3 2 5 1 0 5 0 3 02 3 5 2 1 7 6 . . 5 y ( 3 ( 6 6 ( 5 ( d m ) P . 0 u 7 . 0 2 .
  • the MMRM included fixed effects for treatment group, categorical time point (all postbaseline visits), treatment group by visit interaction, IWRS stratification factors (Renal Stage: I, II/III and baseline 6MWT distance: ⁇ 300 meters, ⁇ 300 meters), the associated baseline value as a covariate, and an unstructured covariance structure to model the within- subject errors.
  • Secondary objectives are to evaluate birtamimab plus standard of care on the following: (1) change from baseline to month 9 in health related quality of life using the SF-36v2, including but not limited to, the social functioning, role physical, and bodily pain domains; and (2) change from baseline to month 9 in the 6 Minute Walk Test (6MWT) distance (meters).
  • 6MWT 6 Minute Walk Test
  • Newly diagnosed Mayo Stage IV subjects with AL amyloidosis receive birtamimab plus local standard of care chemotherapy.
  • the initial first-line chemotherapy regimen must include bortezomib. Subjects remain on study until study completion, which occurs when approximately 16 primary endpoint events (all-cause mortality) have been reached or 62 subjects have completed 9 months of treatment.
  • ETD Early Treatment Discontinuation
  • Subject screening will occur during the 28 days prior to the first administration of study drug on Month 1-Day 1. The screening period may be extended upon approval by the Medical Monitor. Screening assessments are listed in Table 3, herein. Two screening 6MWTs are required before the first administration of study drug.
  • the first screening 6MWT is required to be performed between Days -28 and 5, at least 4 days prior to the second Screening 6MWT, which should be performed within 2 days prior to Month 1 Day 1.
  • the postbaseline 6MWTs may be performed on the same day as study drug administration and must be completed prior to study drug infusion. If all eligibility requirements are met, Month 1-Day 1 assessments are completed, and treatment is initiated. Each visit is denoted by its “month” and “day” such that the first study drug infusion day is denoted as Month 1-Day 1; subsequent months use sequential numbers (e.g., the second dose is administered on Month 2-Day 1). “Cycle” is reserved to denote administration of chemotherapy.
  • ⁇ Is over 75 years of age with concurrent monoclonal gammopathy. ⁇ Has a history of familial amyloidosis and has concurrent monoclonal gammopathy. OR ⁇ If the subject meets any of the above 3 conditions and has echocardiographic evidence of amyloidosis, biopsy-proven amyloidosis with a monoclonal gammopathy and no tissue is available for mass spectrometry or immunoelectron microscopy, the subject must have gene sequencing consistent with transthyretin (TTR) wild type (e.g., no TTR mutation present) AND must score 0 in technetium-99m-3,3-diphosphono-1,2 propanodicarboxylic acid (99mTc DPD; Rapezzi 2011), hydroxymethylenediphosphonate (99mTc HMDP; Galat 2015), or pyrophosphate (99mTc PYP; Bokhari 2013) scintigraphy.
  • TTR transthyretin
  • AST Aspartate aminotransferase
  • SGOT Aspartate aminotransferase
  • ALT Alanine aminotransferase
  • SGPT Serum glutamic pyruvic transaminase
  • ALP Alkaline phosphatase
  • eGFR Estimated glomerular filtration rate
  • Non-AL amyloidosis 2.
  • NT-proBNP > 8,500 pg/mL.
  • IMWG International Myeloma Working Group
  • Subject is eligible for and plans to undergo ASCT or organ transplant during the study. 5.
  • Symptomatic orthostatic hypotension that in the medical judgment of the Investigator would interfere with subject’s ability to safely receive treatment or complete study assessments. 6.
  • ECG evidence of acute ischemia within 6 months prior to the Month 1-Day 1 Visit. 7. Severe valvular stenosis (e.g., aortic or mitral stenosis with a valve area ⁇ 1.0 cm2) or severe congenital heart disease. 8. ECG evidence of acute ischemia or active conduction system abnormalities with the exception of any of the following: ⁇ First degree AV-block. ⁇ Second degree AV-block Type 1 (Mobitz Type 1 / Wenckebach type). ⁇ Right or left bundle branch block.
  • Atrial fibrillation with a controlled ventricular rate (uncontrolled [>110 bpm] ventricular rate is not allowed [determined by an average of three beats in Lead II or three representative beats if Lead II is not representative of the overall EKG]).
  • Attorney Docket No.50887-0050WO1 9.
  • Subject is receiving oral or IV antibiotics, antifungals or antivirals within 1 week of Month 1-Day 1 with the exception of prophylactic oral agents.
  • birtamimab such as histidine/L histidine hydrochloride monohydrate, trehalose dehydrate, or polysorbate 20 or history of Grade ⁇ 3 infusion-related AEs or hypersensitivity to another monoclonal antibody, or known hypersensitivity to diphenhydramine (or an equivalent H1 antihistamine) or acetaminophen (or its equivalent, paracetamol).
  • Study drug consists of birtamimab (24 mg/kg) supplied as a sterile, lyophilized dosage form in a 20/25 mL vial containing 500 mg birtamimab. Each vial is reconstituted with 9.6 mL sterile water for injection (WFI) to a concentration of 50 mg/mL resulting in a buffered, isotonic, preservative-free solution. Study drug is administered once every 28 days as an initial 120 ( ⁇ 10)-minute IV infusion. If the subject tolerates the initial infusion, subsequent infusions may be administered over 60 ( ⁇ 10) minutes.
  • WFI sterile water for injection
  • the length of the infusion may be extended over a longer period of time if and when it is clinically indicated. A minimum of 21 days between doses is required.
  • Premedication All subjects are premedicated for each dose of study drug with 25 mg diphenhydramine (or an equivalent dose of a H1 antihistamine) and 650 mg acetaminophen (or an equivalent paracetamol dose) within 30-90 minutes prior to study drug administration.
  • Standard of Care Chemotherapy All subjects receive concomitant standard of care chemotherapy, which must include bortezomib administered subcutaneously on a weekly basis for the initial, first-line chemotherapy regimen. Subsequent chemotherapy regimens may be prescribed as per standard of care at the Investigator’s discretion. Antiviral prophylaxis is required.
  • the Intent-to-Treat (ITT) Population includes all subjects with Mayo Stage IV AL amyloidosis who receive any amount of study drug.
  • the ITT Population is the primary population used for efficacy and safety analyses. Efficacy Analyses. Primary Analysis - The primary endpoint is time to all-cause mortality. For all-cause mortality, all deaths occurring after the first infusion of study drug (Study Day 1) through the study’s last subject last visit (LSLV) are included. Using an exponential survival model, the estimated survival percentage at 9 months is estimated. Using an exact binomial test, the estimated survival percentage is compared to the historical control value of 49%.
  • the 28-day Screening period may be extended upon approval by the Medical Monitor. Individual test results that do not meet eligibility requirements may be repeated, with the exception of 6MWT; full rescreening is allowed once per subject.
  • Cycle 2-Days 8 and 22 and Cycle 3-Days 8, 15 and 22 bortezomib-containing chemotherapy should be administered by the Investigator at the study site if subject had significant toxicity; otherwise, it may be administered by local physician at Investigator’s discretion.
  • Results from mass spectrometry tissue typing, immunoelectron microscopy, gene sequencing, and/or 99mTc scintigraphy must be obtained prior to randomization to assess eligibility for subjects identified in Inclusion Criterion #5. 6.
  • the SF-36v2 (Appendix 4) is to be administered, the SF-36v2 needs to be administered prior to the performance of any other study assessments on that day. 7. If an echocardiogram has been conducted within 90 days prior to Screening Day -28, it does not need to be repeated during Screening and the previous result can be used for eligibility. After Screening, perform echocardiograms every 6 months within 10 days prior to Day 1; repeat at EOT/ETD if not performed within 60 days prior to visit.
  • ECG to be performed in triplicate as follows: Month 1-Day 1: within 30 minutes before dosing and 1 hour ( ⁇ 15 min) post-EOI; All Other Visits (Months 1, 2, 3 and every 3 months starting at Month 6): within 30 minutes before dosing or any time on non-infusion days. Medications given for prophylaxis chemotherapy-induced side effects should not be administered prior to completion of the post infusion ECG. 9.
  • Complete PE includes height (Screening only), weight, and examination of the following: general appearance; head, ears, eyes, nose, and throat; neck; skin; cardiovascular Attorney Docket No.50887-0050WO1 system; respiratory system; gastrointestinal system; and nervous system. Assess macroglossia, submandibular nodes/fullness, adenopathy, ecchymoses, liver/spleen size (palpable +/-), ascites (+/-), and edema (which should be quantified on a scale of 0-4). 10.
  • Symptom-directed PE should be as clinically indicated and also include weight, and assessment of macroglossia, submandibular nodes/fullness, adenopathy, ecchymoses, liver/spleen size (palpable +/-), ascites (+/-), and edema (which should be quantified on a scale of 0-4).
  • Local laboratory results for hematology and chemistry will be used for subject management and should be reviewed for safety assessment prior to administration of chemotherapy but will not be collected in the electronic case report forms or the clinical database. 12. Perform only if subject returns to study site for this visit.
  • 14. Obtain local urine pregnancy test prior to study drug administration. 15.
  • the postbaseline 6MWT may be administered on the same calendar day that study drug is administered (i.e., Months 3, 6, 9, etc.) as long as the NT- proBNP sample is drawn before conducting the 6MWT and the 6MWT is completed before initiation of the study drug infusion.
  • Collect BP and HR pre- and post-6MWT administration 20.
  • the first Screening 6MWT must be performed between Days -28 and -5, at least 4 days prior to the second Screening 6MWT, which should be performed within 2 days prior to the Month 1-Day 1 visit (i.e., on Day -2 or Day -1).
  • Attorney Docket No.50887-0050WO1 21.
  • Archive serum samples will only be collected from those subjects who have consented to the collection and archiving of their samples for future correlative testing. 22. All subjects are to receive 25 mg diphenhydramine (or an equivalent dose of a H1 antihistamine) and 650 mg acetaminophen (or an equivalent paracetamol dose) within 3090 minutes prior to the start of infusion.
  • First-line chemotherapy must be a bortezomib-containing regimen, with bortezomib administered weekly, SC, according to the approved prescribing information and local institutional practices. Antiviral prophylaxis is required. When chemotherapy is administered on same day as study drug, the chemotherapy must be administered AFTER the post-study drug infusion observation period. Number of first-line chemotherapy cycles and subsequent chemotherapy regimens will be administered per standard of care at the Investigator’s discretion. 26.
  • Cycle 2-Days 8 and 22, and Cycle 3-Days 8, 15, and 22 chemotherapy may be administered by local physician with a Homecare visit by a Prothena-sponsored healthcare professional to the subject within 1 day prior to or pre-dose on the day of each bortezomib administration to obtain vital signs, blood samples for central laboratory testing, and bioanalytical samples (if applicable).

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Abstract

Antibody formulations and methods useful for treatment of patients with AL amyloidosis are disclosed herein.

Description

Attorney Docket No.50887-0050WO1 METHODS OF TREATING AL AMYLOIDOSIS CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application Serial No. 63/550,372, filed February 6, 2024, U.S. Provisional Patent Application Serial No. 63/556,569, filed February 22, 2024, and U.S. Provisional Patent Application Serial No. 63/743,803, filed January 10, 2025; the entire contents of which are herein incorporated by reference. SEQUENCE LISTING This application contains a Sequence Listing that has been submitted electronically as an XML file named 50887-0050WO1_SL_ST26.xml. The XML file, created on January 28, 2025 is 22,885 bytes in size. The material in the XML file is hereby incorporated by reference in its entirety. FIELD The disclosure relates to the technical fields of immunology and medicine. BACKGROUND Light chain (AL) amyloidosis is a rare, progressive, and typically fatal disease caused by circulating toxic light chain aggregates and insoluble amyloid that deposits in vital organs, leading to organ dysfunction and failure.1 Patients with AL amyloidosis and cardiac involvement have high symptom burden and poor physical function, resulting in reduced health-related quality of life (HRQoL).1-5 In addition to disease pathology, treatment side effects also have negative impacts on patients’ lives. The outcome of the disease for patients with AL amyloidosis can be predicted based on the Mayo four stage prognostic staging system discussed in Kumar et al., 2012 (Kumar et al., Revised Prognostic Staging System for Light Chain Amyloidosis Incorporating Cardiac Biomarkers and Serum Free Light Chain Measurements, J Clin Oncol.30:989-995 (2012)), with the outcome for Mayo Stage IV patients being quite dire. Current treatment of patients with AL amyloidosis is aimed at reducing or eliminating the bone marrow disorder, i.e., the plasma cells that are responsible for producing the light chains, thereby limiting or halting the production of amyloid. The most aggressive treatment Attorney Docket No.50887-0050WO1 options include stem cell transplant and high-dose chemotherapy for those patients who can tolerate it. Other treatment regimens include combinations of drugs often used to treat hematological malignancies, such as melphalan, prednisone, dexamethasone and proteosome inhibitors such as bortezomib, in an attempt to reduce light chain production. There are no currently approved treatments for AL amyloidosis that directly target potentially toxic forms of the amyloidogenic proteins. While some treatment options may ameliorate some of the morbidity associated with AL amyloidosis, few if any have been demonstrated to improve the prognosis in patients. Furthermore, Mayo Stage IV patients with AL amyloidosis represent a patient subset with a very high burden of morbidity and mortality, with no currently approved treatments. Thus, there is an unmet need for therapies that improve health status and enhance the quality of life in patients with Mayo Stage IV AL amyloidosis. SUMMARY The present disclosure relates to methods of treating AL amyloidosis patients (including patients with Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement). In one aspect, the present disclosure provides a method of slowing a decline in social functioning in a subject having Mayo Stage IV AL amyloidosis, comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105). In one aspect, the present disclosure provides a method of slowing a decline in Health-Related Quality of Life (HRQoL) in a subject having AL amyloidosis, comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105), wherein the slowing of the decline in HRQoL comprises a slowing of a decline in at least one of the following: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), mental health (MH), and mental component score (MCS). Attorney Docket No.50887-0050WO1 In another aspect, the present disclosure provides a method of treating AL amyloidosis in a subject, comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105); wherein treating comprises a slowing of a decline in HRQoL comprising a slowing of a decline in at least one of the following: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, and mental component score. In some embodiments, the slowing of the decline in HRQoL further comprises a slowing of a decline in physical component score (PCS). In some embodiments, the slowing of the decline in physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, mental component score and/or physical component score is assessed using the 36- Item Short Form Survey (SF-36) or the 36-Item Short Form Survey Version 2 (SF-36v2). In some embodiments, the slowing of the decline in HRQoL comprises a higher score on at least one of the following domains of an SF-36 or SF-36v2 relative to a different patient at the same time point who has not been administered the antibody: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, mental component score and/or physical component score. In some embodiments, the slowing of the decline in HRQoL is assessed by comparing a score on at least one of the following domains of an SF-36 or SF-36v2 relative to a baseline score: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, mental component score and/or physical component score. In some embodiments, the slowing of the decline in HRQoL is assessed after at least about 9 months following a first administration of the antibody. In some embodiments, the slowing of the decline in HRQoL is assessed after about 9 months following a first administration of the antibody. In some embodiments, the method comprises a slowing of a decline in social functioning in the subject. In another aspect, the present disclosure provides a method of treating Mayo Stage IV AL amyloidosis in a subject, comprising administering to the subject an effective dosage of Attorney Docket No.50887-0050WO1 an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105); wherein treating comprises a slowing of a decline in social functioning in the subject. In some embodiments, the method comprises a slowing of a decline in social functioning in the subject. In some embodiments, the slowing of the decline in social functioning is assessed using the SF-36 or the SF-36v2. In some embodiments, the slowing of the decline in social functioning comprises a higher score on a social functioning domain of an SF-36 or SF-36v2 relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in social functioning comprises a decrease of less than about 20 points on the social functioning domain of the SF-36v2 compared to baseline. In some embodiments, the slowing of the decline in social functioning comprises a decrease of less than about 10 points on the social functioning domain of the SF- 36v2 compared to baseline. In some embodiments, the slowing of the decline in social functioning is assessed after at least about 9 months following a first administration of the antibody. In some embodiments, the slowing of the decline in social functioning is assessed after about 9 months following a first administration of the antibody. In some embodiments, the method further comprises a slowing of a decline in at least one value for the following domains of the SF-36 or SF-36v2: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and mental component score. In some embodiments, the method comprises a slowing of a decline in a reported value for a role physical domain of the SF-36 or SF-36v2. In some embodiments, the reported value for the role physical domain is higher relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in reported value for the role physical domain comprises a decrease of less than about 5 points on the role physical domain of the SF-36v2 compared to baseline. In some embodiments, the method comprises a slowing of a decline in a reported value for a bodily pain domain of the SF-36 or SF-36v2. In some embodiments, the reported value for the bodily pain domain is higher relative to a different patient at the same time point Attorney Docket No.50887-0050WO1 who has not been administered the antibody. In some embodiments, the slowing of the decline in reported value for the bodily pain domain comprises a decrease of less than about 5 points on the bodily pain domain of the SF-36v2 compared to baseline. In some embodiments, the slowing of the decline in the reported value for the role physical domain and/or the reported value for the bodily pain domain is assessed after at least about 9 months following a first administration of the antibody. In some embodiments, the slowing of the decline in the reported value for the role physical domain and/or the reported value for the bodily pain domain is assessed after about 9 months following a first administration of the antibody. In some embodiments, the method comprises a slowing of a decline in physical functioning in the subject. In some embodiments, the method comprises a slowing of a decline in role physical in the subject. In some embodiments, the method comprises a slowing of a decline in bodily pain in the subject. In some embodiments, the method comprises a slowing of a decline in general health in the subject. In some embodiments, the method comprises a slowing of a decline in vitality in the subject. In some embodiments, the method comprises a slowing of a decline in role emotional in the subject. In some embodiments, the method comprises a slowing of a decline in mental health in the subject. In some embodiments, the method comprises a slowing of a decline in mental component score in the subject. In some embodiments, the method comprises a slowing of a decline in at least two of the following: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, and mental component score. In some embodiments, the method comprises a slowing of a decline in at least three of the following: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, and mental component score. In some embodiments, the antibody comprises a light chain variable region comprising three complementarity determining regions of 2A4, 7D8 or 11-1F4, and a heavy chain variable region comprising three complementarity determining regions of 2A4, 7D8 or 11-1F4, respectively. In some embodiments, the antibody is a humanized version of 2A4. In some embodiments, the antibody is a humanized or chimeric version of 11-1F4. In some embodiments, the antibody comprises a light chain variable region comprising three complementarity determining regions set forth as SEQ ID NOs: 3, 4 and 5, or SEQ ID NOs: 16, 17, and 18, and a heavy chain variable region comprising three complementarity Attorney Docket No.50887-0050WO1 determining regions set forth as SEQ ID NOs: 6, 7 and 8, or SEQ ID NOs: 19, 20, and 21. In some embodiments, the light chain variable region comprises the amino acid sequence set forth as SEQ ID NO: 1 or 14. In some embodiments, the heavy chain variable region comprises the amino acid sequence set forth as SEQ ID NO: 2 or 15. In some embodiments, the light chain variable region comprises the amino acid sequence set forth as SEQ ID NO: 1 or 14, and the heavy chain variable region comprises the amino acid sequence set forth as SEQ ID NO: 2 or 15. In some embodiments, the antibody comprises a light chain comprising the amino acid sequence set forth as SEQ ID NO:10, and a heavy chain comprising the amino acid sequence set forth as SEQ ID NO: 11, 12 or 13. In some embodiments, the antibody comprises a light chain comprising the amino acid sequence set forth as SEQ ID NO:10, and a heavy chain comprising the amino acid sequence set forth as SEQ ID NO:12. In some embodiments, the antibody is a Fab, Fab’, F(ab’)2, F(ab)c, Dab, nanobody, or Fv. In some embodiments, the antibody is birtamimab. In some embodiments, the effective dosage of the antibody is administered from a pharmaceutical formulation comprising the antibody at a concentration within the range from about 1mg/mL to about 100 mg/mL. In some embodiments, the dosage is from about 0.5 mg/kg to about 30 mg/kg and the antibody is administered intravenously or subcutaneously at a frequency of from about weekly to about quarterly. In some embodiments, the antibody is present at a concentration of about 50 mg/mL. In some embodiments, the dosage is administered intravenously following the transfer of an amount of the formulation required for the dosage from a vial to an intravenous bag containing a liquid. In some embodiments, the dosage is about 24 mg/kg and the antibody is administered intravenously every 28 days. In some embodiments, the duration of the treatment is at least 9 months. In some embodiments, the duration of the treatment is at least 12 months. In some embodiments, the AL amyloidosis is AL amyloidosis with cardiac involvement. In some embodiments, the AL amyloidosis is Mayo Stage IV amyloidosis. Also provided herein are methods of slowing a decline in Health-Related Quality of Life (HRQoL) in a subject having AL amyloidosis with cardiac involvement, including administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105), where the slowing of the decline in HRQoL includes a slowing of a Attorney Docket No.50887-0050WO1 decline in at least one of the following: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), mental health (MH), and mental component score (MCS). Also provided herein are methods of treating AL amyloidosis with cardiac involvement in a subject, including administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105); where treating includes a slowing of a decline in HRQoL including a slowing of a decline in at least one of the following: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, and mental component score. In some embodiments, the slowing of the decline in HRQoL includes a slowing of a decline in physical component score (PCS). In some embodiments, the slowing of the decline in physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, mental component score and/or physical component score is assessed using a 36-Item Short Form Survey (SF-36) or a 36-Item Short Form Survey Version 2 (SF-36v2). In some embodiments, the slowing of the decline in HRQoL includes a higher score on at least one of the following domains of an SF-36 or SF-36v2 relative to a different patient at the same time point who has not been administered the antibody: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, mental component score and/or physical component score. In some embodiments, the slowing of the decline in HRQoL is assessed by comparing a score on at least one of the following domains of an SF-36 or SF-36v2 to a baseline score: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, mental component score and/or physical component score. In some embodiments, the slowing of the decline in HRQoL is assessed after at least about 9 months following a first administration of the antibody. In some embodiments, the slowing of the decline in HRQoL is assessed after about 9 months following a first administration of the antibody. In some embodiments, the method includes a slowing of a decline in social functioning in the subject. In some embodiments, the slowing of the decline in social Attorney Docket No.50887-0050WO1 functioning includes a decrease of less than about 20 points on the social functioning domain of the SF-36v2 compared to baseline. In some embodiments, the decline in social functioning includes a decrease of less than about 10 points on the social functioning domain of the SF-36v2 compared to baseline. In some embodiments, the method includes a slowing of a decline in at least one value for the following domains of the SF-36 or SF-36v2: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and mental component score. In some embodiments, the method includes a slowing of a decline in a reported value for a role physical domain of the SF-36 or SF-36v2. In some embodiments, the reported value for the role physical domain is higher relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in reported value for the role physical domain includes a decrease of less than about 5 points on the role physical domain of the SF-36v2 compared to baseline. In some embodiments, the method includes a slowing of a decline in a reported value for a bodily pain domain of the SF-36 or SF-36v2. In some embodiments, the reported value for the bodily pain domain is higher relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in reported value for the bodily pain domain includes a decrease of less than about 5 points on the bodily pain domain of the SF-36v2 compared to baseline. In some embodiments, the slowing of the decline in the reported value for the role physical domain and/or the reported value for the bodily pain domain is assessed after at least about 9 months following a first administration of the antibody. In some embodiments, the slowing of the decline in the reported value for the role physical domain and/or the reported value for the bodily pain domain is assessed after about 9 months following a first administration of the antibody. In some embodiments, the method includes a slowing of a decline in physical functioning in the subject. In some embodiments, the method includes a slowing of a decline in role physical in the subject. In some embodiments, the method includes a slowing of a decline in bodily pain in the subject. In some embodiments, the method includes a slowing of a decline in general health in the subject. In some embodiments, the method includes a slowing of a decline in vitality in the subject. In some embodiments, the method includes a slowing of a decline in role emotional in the subject. In some embodiments, the method Attorney Docket No.50887-0050WO1 includes a slowing of a decline in mental health in the subject. In some embodiments, the method includes a slowing of a decline in mental component score in the subject. In some embodiments, the method includes a slowing of a decline in at least two of the following: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, and mental component score. In some embodiments, the method includes a slowing of a decline in at least three of the following: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, and mental component score. In some embodiments, the antibody includes a light chain variable region including three complementarity determining regions of 2A4, 7D8 or 11-1F4, and a heavy chain variable region including three complementarity determining regions of 2A4, 7D8 or 11-1F4, respectively. In some embodiments, the antibody is a humanized version of 2A4. In some embodiments, the antibody is a humanized or chimeric version of 11-1F4. In some embodiments, the antibody includes a light chain variable region including three complementarity determining regions set forth as SEQ ID NOs: 3, 4 and 5, or SEQ ID NOs: 16, 17, and 18, and a heavy chain variable region including three complementarity determining regions set forth as SEQ ID NOs: 6, 7 and 8, or SEQ ID NOs: 19, 20, and 21. In some embodiments, the light chain variable region includes the amino acid sequence set forth as SEQ ID NO: 1 or 14. In some embodiments, the heavy chain variable region includes the amino acid sequence set forth as SEQ ID NO: 2 or 15. In some embodiments, the light chain variable region includes the amino acid sequence set forth as SEQ ID NO: 1 or 14, and the heavy chain variable region includes the amino acid sequence set forth as SEQ ID NO: 2 or 15. In some embodiments, the antibody includes a light chain including the amino acid sequence set forth as SEQ ID NO:10, and a heavy chain including the amino acid sequence set forth as SEQ ID NO: 11, 12 or 13. In some embodiments, the antibody includes a light chain including the amino acid sequence set forth as SEQ ID NO:10, and a heavy chain including the amino acid sequence set forth as SEQ ID NO:12. In some embodiments, the antibody is a Fab, Fab’, F(ab’)2, F(ab)c, Dab, nanobody, or Fv. In some embodiments, the antibody is birtamimab. In some embodiments, the effective dosage of the antibody is administered from a pharmaceutical formulation including the antibody at a concentration within the range from about 1 mg/mL to about 100 mg/mL. In some embodiments, the dosage is from about 0.5 Attorney Docket No.50887-0050WO1 mg/kg to about 30 mg/kg and the antibody is administered intravenously or subcutaneously at a frequency of from about weekly to about quarterly. In some embodiments, the antibody is present at a concentration of about 50 mg/mL. In some embodiments, the dosage is administered intravenously following the transfer of an amount of the formulation required for the dosage from a vial to an intravenous bag containing a liquid. In some embodiments, the dosage is about 24 mg/kg and the antibody is administered intravenously every 28 days. In some embodiments, the duration of the treatment is at least 9 months. In some embodiments, the duration of the treatment is at least 12 months. In some embodiments, the AL amyloidosis is Mayo Stage IV amyloidosis. Some antibodies provided herein are formulated as a pharmaceutical formulation comprising the antibody at a concentration within the range from about 1mg/mL to about 100 mg/mL, histidine buffer at a concentration within the range from about 20 mM to about 30 mM, trehalose at a concentration within the range from about 210 mM to about 250 mM, polysorbate 20 at a concentration within the range from about 0.005% to about 0.05% by weight, and the pharmaceutical formulation is characterized by a pH within the range from about 6 to about 7. Some uses of the antibody comprise a dosage from about 0.5 mg/kg to about 30 mg/kg and wherein the antibody is administered intravenously or subcutaneously at a frequency of from about weekly to about quarterly. For some uses, the antibody is present at a concentration of about 50 mg/mL, the histidine buffer is present at a concentration of about 25 mM, the trehalose is present at a concentration of about 230 mM, the polysorbate 20 is present at a concentration of about 0.2 g/L, and the pH is about 6.5. BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 shows the change from baseline to month 9 in reported values for the eight domains of the SF-36v2 questionnaire for Mayo Stage IV patients treated with birtamimab plus standard of care compared to placebo plus standard of care and demonstrates a slowing of decline in reported values for social functioning, role physical, and bodily pain domains. Attorney Docket No.50887-0050WO1 DETAILED DESCRIPTION The present disclosure provides methods of slowing a decline in Health-Related Quality of Life (HRQoL) in a subject having AL amyloidosis, including administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105), where the slowing of the decline in HRQoL includes a slowing of a decline in at least one of the following: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), mental health (MH), and mental component score (MCS). In another aspect this disclosure provides methods of treating AL amyloidosis in a subject, including administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11- 1F4 (ATCC Accession Number PTA-105); where treating includes a slowing of a decline in HRQoL including a slowing of a decline in at least one of the following: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, and mental component score. This disclosure further provides methods of slowing a decline in Health-Related Quality of Life (HRQoL) in a subject having AL amyloidosis with cardiac involvement, including administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA- 9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105), where the slowing of the decline in HRQoL includes a slowing of a decline in at least one of the following: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), mental health (MH), and mental component score (MCS). In another aspect this disclosure provides methods of treating AL amyloidosis with cardiac involvement in a subject, including administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or Attorney Docket No.50887-0050WO1 lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105); where treating includes a slowing of a decline in HRQoL including a slowing of a decline in at least one of the following: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, and mental component score. The present disclosure also provides methods for reducing a decline in life quality for Mayo Stage IV AL amyloidosis, as demonstrated by a slowing of a decline in reported values (e.g., on an SF-36 and/or SF-36v2 questionnaire) relative to Health Related Quality of Life (“HRQoL”). Thus, the present disclosure provides methods of slowing of a decline in reported value for at least one of the following domains: social function, physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, and mental component score in patients with Mayo Stage IV AL amyloidosis. In particular, the present disclosure provides methods of slowing of a decline in reported value for a social function domain in patients with Mayo Stage IV AL amyloidosis. The disclosure further provides treating certain AL amyloidosis patients namely patients with Mayo Stage IV AL amyloidosis, wherein treating comprises a slowing of a decline in reported value for a social function domain. Such Mayo Stage IV AL amyloidosis patients include those with a baseline six minute walk distance (“6MWD”; sometimes referred to as the six minute walk test (“6MWT”) distance) greater than or equal to 150 meters and ejection fraction (EF) greater than 50%, Mayo Stage IV patients with a baseline EF greater than 50%, and Mayo Stage IV patients with a baseline 6MWD greater than or equal to 150 meters and ejection fraction (EF) greater than 50%. The methods involve administering to such patients an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with antibody 2A4 (ATCC Accession Number PTA-9662) or antibody 7D8 (ATCC Accession Number PTA-9468) or which competes for binding to kappa immunoglobulin light chain with antibody 11-1F4 (ATCC Accession Number PTA-150). In some embodiments, the antibody is birtamimab. I. Definitions The term “antibody” includes intact antibodies and antigen-binding fragments thereof. Typically, fragments compete with the intact antibody from which they were derived for Attorney Docket No.50887-0050WO1 specific binding to the target including separate heavy chains, light chains Fab, Fab', F(ab')2, F(ab)c, Dabs, nanobodies, and Fv. Fragments can be produced by recombinant DNA techniques, or by enzymatic or chemical separation of intact immunoglobulins. The term “antibody” also includes a bispecific or multispecific antibody and/or a humanized antibody. A bispecific or bifunctional or multifunctional antibody is an artificial hybrid antibody having two or more different heavy/light chain pairs and two or more different binding sites (see, e.g., Songsivilai and Lachmann, Clin. Exp. Immunol., 79:315-321 (1990); Kostelny et al., J. Immunol., 148:1547-53 (1992)). The term “baseline” includes an initial measurement of a condition that is taken at an early time point and used for comparison over time to look for changes and which is used for comparison with later data (e.g., such as response to treatment as measured by scores, tests, or other described measurement techniques described herein). For example, in some embodiments, “baseline” refers to measurements of a condition that is taken prior to treatment with antibodies of the present disclosure. The term “cardiac involvement” refers to: (1) past documented or presently noted clinical signs and symptoms supportive of a diagnosis of heart failure in the setting of a confirmed diagnosis of AL amyloidosis in the absence of an alternative explanation for heart failure; and (2) (a) either an endomyocardial biopsy demonstrating AL amyloidosis or an echocardiogram demonstrating a mean left ventricular wall thickness at diastole > 12 mm in the absence of other causes (e.g., severe hypertension, aortic stenosis), which would adequately explain the degree of wall thickening, or (b) cardiovascular magnetic resonance imaging findings reported as characteristic of amyloidosis. The term “censoring” refers to a situation in which the value of a measurement or observation is only partially known. For example, if a study is conducted to measure the impact of a drug on mortality rate, survival will be assumed for the period of the study in the absence of data indicating death, such that patients who withdrew from the study are considered to be alive through the duration of the study regardless of their unknown disposition (i.e., alive or dead). The term “control population” or “control group” includes a population or group of patients that can receive a placebo, another treatment, or do not receive a drug or treatment at all (e.g., treatment with any of the antibodies described herein). The patients receiving treatment can be compared to the control population or control group. Attorney Docket No.50887-0050WO1 The term “ejection fraction” or “EF” refers to the measurement of how much blood the left ventricle pumps out with each contraction. An ejection fraction of 50 percent means that 50 percent of the total amount of blood in the left ventricle is pushed out with each heartbeat. Ejection fraction is used as a measure of heart failure. The EF of a normal heart is typically between 50-70 percent. 41-49 percent may be considered borderline and an EF under 40 percent may be evidence of heart failure or cardiomyopathy. The term “hazard ratio” or “HR” reflects the instantaneous probability (i.e., hazard rate) of an event (death or progression) in the experimental arm as a ratio to the probability in the comparator arm. If the HR is 1.0, there is no clear advantage for either arm. The lower the HR value, the greater the reduction in risk of death or progression for the experimental treatment arm of the study, which is calculated as 1-HR. For example, an HR of 0.84 equals a 16% relative reduction in event risk in comparison with the control arm of the study. The term “humanized immunoglobulin” or “humanized antibody” refers to an immunoglobulin or antibody that includes at least one humanized immunoglobulin or antibody chain (i.e., at least one humanized light or heavy chain). The term “humanized immunoglobulin chain” or “humanized antibody chain” (i.e., a “humanized immunoglobulin light chain” or “humanized immunoglobulin heavy chain”) refers to an immunoglobulin or antibody chain (i.e., a light or heavy chain, respectively) having a variable region that includes a variable framework region substantially from a human immunoglobulin or antibody and complementarity determining regions (CDRs) (e.g., at least one CDR, preferably two CDRs, more preferably three CDRs) substantially from a non-human immunoglobulin or antibody, and further includes constant regions (e.g., at least one constant region or portion thereof, in the case of a light chain, and preferably three constant regions in the case of a heavy chain). The term “humanized variable region” (e.g., “humanized light chain variable region” or “humanized heavy chain variable region”) refers to a variable region that includes a variable framework region substantially from a human immunoglobulin or antibody and complementarity determining regions (CDRs) substantially from a non- human immunoglobulin or antibody. The term “Mayo Stage IV patients” or “Stage IV” refers to patients with stage IV disease according to the prognostic staging system established by the Mayo Clinic (Kumar et al., Revised Prognostic Staging System for Light Chain Amyloidosis Incorporating Cardiac Biomarkers and Serum Free Light Chain Measurements, J Clin Oncol 30:989-995 (2012)), which incorporates both cardiac biomarkers and level of amyloidogenic light chain synthesis. Attorney Docket No.50887-0050WO1 Collectively, patients with stage I, stage II or stage III disease are referred to herein as “Mayo Stage I-III patients” or “Stage I-III patients”. In some embodiments, a patient is identified as having Stage IV AL amyloidosis if they meet the criteria for the following three prognostic variables: troponin-T (cTnT) ^ 0.025 ng/mL, N-terminal pro-B-type natriuretic peptide (NT- ProBNP) ^ 1,800 pg/mL, and difference between involved and uninvolved light chain (FLC- diff or dFLC) ^ 18 mg/dL). In certain embodiments, a patient can be confirmed as Mayo Stage IV as defined by: (1) NT-proBNP ≥ 1800 pg/mL, (2) Troponin-T > 0.03 ng/mL, and (3) dFLC ≥ 18 mg/dL. The term “p-value” or “p” refers to a number between 0 and 1 relating to the significance of results obtained. A small p-value indicates strong evidence against the null hypothesis (i.e., the hypothesis that there is no effect), for example ^0.1, indicates statistical significance, with p ^0.001 being statistically highly significant (less than one in a thousand chance of being wrong). The phrase “substantially from a human immunoglobulin or antibody” means that, when aligned to a human immunoglobulin or antibody amino sequence for comparison purposes, the region shares at least 80-90%, preferably 90-95%, more preferably 95-99% identity (i.e., local sequence identity) with the human framework or constant region sequence, allowing, for example, for conservative substitutions, consensus sequence substitutions, germline substitutions, backmutations, and the like. The introduction of conservative substitutions, consensus sequence substitutions, germline substitutions, backmutations, and the like, is often referred to as “optimization” of a humanized antibody or chain. The phrase “substantially from a non-human immunoglobulin or antibody” or “substantially non-human” means having an immunoglobulin or antibody sequence at least 80-95%, preferably 90-95%, more preferably, 96%, 97%, 98%, or 99% identical to that of a non-human organism, e.g., a non-human mammal. Accordingly, all regions or residues of a humanized immunoglobulin or antibody, or of a humanized immunoglobulin or antibody chain, except possibly the CDRs, are substantially identical to the corresponding regions or residues of one or more native human immunoglobulin sequences. The term “corresponding region” or “corresponding residue” refers to a region or residue on a second amino acid or nucleotide sequence which occupies the same (i.e., equivalent) position as a region or residue on a first amino acid or nucleotide sequence, when the first and second sequences are optimally aligned for comparison purposes. Attorney Docket No.50887-0050WO1 The phrases “risk reduction” and “risk of” refer to the relative risk unless specified to mean absolute risk. As used herein, the terms "treat" and "treatment" refer to the alleviation or amelioration of one or more symptoms or effects associated with the disease, prevention, inhibition or delay of the onset of one or more symptoms or effects of the disease, lessening of the severity or frequency of one or more symptoms or effects of the disease, and/or increasing or trending toward desired outcomes as described herein. II. Treatment Regimens Desired outcomes of the treatments disclosed herein vary according to the amyloid disease and patient profile and are readily determinable to those skilled in the art. Desired outcomes include an improvement in the patient’s health status. Generally, desired outcomes include measurable indices such as reduction or clearance of pathologic amyloid fibrils, decreased or inhibited amyloid aggregation and/or deposition of amyloid fibrils, and increased immune response to pathologic and/or aggregated amyloid fibrils. Desired outcomes also include amelioration of amyloid disease-specific symptoms. For example, desired outcomes for the treatment of AL amyloidosis include a decrease in the incidence or severity of known symptoms, including organ dysfunction, peripheral and autonomic neuropathy, carpal tunnel syndrome, macroglossia, restrictive cardiomyopathy, arthropathy of large joints, immune dyscrasias, myelomas, as well as occult dyscrasias. A slowing of decline in health-related quality of life (“HRQoL”) is also a desired outcome of the disclosed therapies, including, for example, as measured by the SF-36 Health Survey (White et al., Psychometric validation of the SF-36 Health Survey in light chain amyloidosis: results from community-based and clinic-based samples, Patient Related Outcome Measures 2017:8157-167) and/or the SF-36 Health Survey version 2. The SF-36 involves scores that represent eight dimensions of function and well-being: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and mental health, and summary scores, such as physical component summary and mental component summary. Higher SF-36 scores represent better health. Desired outcomes of the disclosed therapies are generally quantifiable measures as compared to a control or baseline measurement. Attorney Docket No.50887-0050WO1 As used herein, relative terms such as "improve,” "increase," or "reduce" include references to values relative to a control, such as a measurement in the same individual prior to initiation of treatment described herein, or a measurement in a control individual or group. A control individual can be an individual afflicted with the same amyloid disease as the individual being treated, who is about the same age as the individual being treated (to ensure that the stages of the disease in the treated individual and the control individual are comparable), but who has not received treatment using the disclosed antibody formulations. In this case, efficacy of the disclosed antibody formulations is assessed by a shift or trend away from measurable indices in the untreated control. Alternatively, in some embodiments, relative terms such as "improve,” "increase," or "reduce" include comparisons to a control individual that is a healthy individual, who is about the same age as the individual being treated. In this case, efficacy of the disclosed antibody formulations is assessed by a shift or trend toward from measurable indices in the healthy control. In some embodiments, relative terms such as "improve,” "increase," or "reduce" can alternatively include comparisons to values reported by the individual receiving treatment with antibodies described herein. In some such embodiments, these terms refer to comparisons to the individual’s reported values at baseline (e.g., prior to receiving treatment). For example, in some embodiments, relative terms include comparisons of the individual’s baseline values and the individual’s reported values at, e.g., 3, 6, 9, or 12 months of treatment. Changes or improvements in response to therapy may be statistically significant and described by a p-value less than or equal to 0.1, less than 0.05, less than 0.01, less than 0.005, or less than 0.001 may be regarded as significant. The present disclosure provides methods of slowing a decline in Health-Related Quality of Life (HRQoL) in a subject having AL amyloidosis, including administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105), where the slowing of the decline in HRQoL includes a slowing of a decline in at least one of the following: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), mental health (MH), and mental component score (MCS). Attorney Docket No.50887-0050WO1 In another aspect this disclosure provides methods of treating AL amyloidosis in a subject, including administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11- 1F4 (ATCC Accession Number PTA-105); where treating includes a slowing of a decline in HRQoL including a slowing of a decline in at least one of the following: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, and mental component score. This disclosure further provides methods of slowing a decline in Health-Related Quality of Life (HRQoL) in a subject having AL amyloidosis with cardiac involvement, including administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA- 9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105), where the slowing of the decline in HRQoL includes a slowing of a decline in at least one of the following: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), mental health (MH), and mental component score (MCS). In another aspect this disclosure provides methods of treating AL amyloidosis with cardiac involvement in a subject, including administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105); where treating includes a slowing of a decline in HRQoL including a slowing of a decline in at least one of the following: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, and mental component score. In another aspect, the present disclosure provides a method of slowing of a decline in HRQoL in a subject (also referred herein as a “patient”) having Mayo Stage IV AL amyloidosis, comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Attorney Docket No.50887-0050WO1 Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105), wherein the slowing of the decline in HRQoL comprises a slowing of a decline in at least one of the following: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, and mental component score. In another aspect, the present disclosure provides a method of treating Mayo Stage IV AL amyloidosis in a subject, comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105); wherein treating comprises a slowing of a decline in HRQoL comprising a slowing of a decline in at least one of the following: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, and mental component score. In some embodiments, the slowing of the decline in HRQoL further comprises a slowing of a decline in physical component score. In some embodiments, the slowing of the decline in HRQoL is assessed using the SF- 36 or the SF-36v2. In some embodiments, the slowing of the decline in HRQoL is assessed using the SF-36 or the SF-36v2. In some embodiments, the slowing of the decline in HRQoL is assessed using the SF-36v2. In some embodiments, the slowing of the decline in physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, mental component score and/or physical component score is assessed using the SF-36 or the SF-36v2. In some embodiments, the slowing of the decline in physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, mental component score and/or physical component score is assessed using the SF-36 or the SF-36v2. In some embodiments, the slowing of the decline in physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, mental component score and/or physical component score is assessed using the SF- 36v2. In some embodiments, the slowing of the decline in HRQoL comprises a higher score on at least one of the following domains of an SF-36 or SF-36v2 relative to a different patient at the same time point who has not been administered the antibody: physical functioning, role Attorney Docket No.50887-0050WO1 physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, mental component score and/or physical component score. In some embodiments, the slowing of the decline in HRQoL is assessed by comparing a score on at least one of the following domains of an SF-36 or SF-36v2 relative to a baseline score: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, mental component score and/or physical component score. In some embodiments, the slowing or decline in HRQoL is assessed after at least about 3 months (e.g., at least about 4 months or at least about 5 months) following a first administration of the antibody. In some embodiments, the slowing or decline in HRQoL is assessed after at least about 6 months (e.g., at least about 7 months or at least about 8 months) following a first administration of the antibody. In some embodiments, the slowing or decline in HRQoL is assessed after at least about 6 months (e.g., at least about 7 months or at least about 8 months) following a first administration of the antibody. In some embodiments, the slowing of the decline in HRQoL is assessed after at least about 9 months (e.g., at least about 10 months or at least about 11 months) following a first administration of the antibody. In some embodiments, the slowing of the decline in HRQoL is assessed after at least about 12 months (e.g., at least about 13 months, at least about 14 months, or at least about 15 months) following a first administration of the antibody. In some embodiments, the slowing of the decline in HRQoL is assessed after about 3 months (e.g., about 4 months or about 5 months) following a first administration of the antibody. In some embodiments, the slowing of the decline in HRQoL is assessed after about 6 months (e.g., about 7 months or about 8 months) following a first administration of the antibody. In some embodiments, the slowing of the decline in HRQoL is assessed after about 9 months (e.g., about 10 months or about 11 months) following a first administration of the antibody. In some embodiments, the slowing of the decline in HRQoL is assessed after about 12 months (e.g., about 13 months, about 14 months, or about 15 months) following a first administration of the antibody. In some embodiments, the method comprises a slowing of a decline in social functioning in the subject. In some embodiments, the method comprises a slowing of a decline in physical functioning in the subject. In some embodiments, the method comprises a slowing of a decline in role physical in the subject. In some embodiments, the method comprises a slowing of a decline in bodily pain in the subject. In some embodiments, the Attorney Docket No.50887-0050WO1 method comprises a slowing of a decline in general health in the subject. In some embodiments, the method comprises a slowing of a decline in vitality in the subject. In some embodiments, the method comprises a slowing of a decline in role emotional in the subject. In some embodiments, the method comprises a slowing of a decline in mental health in the subject. In some embodiments, the method comprises a slowing of a decline in mental component score in the subject. In some embodiments, the slowing of the decline in HRQoL comprises a decrease in a reported domain value (e.g., of the SF-36 or SF-36v2) that is less than about 25 points (e.g., less than about 24 points, less than about 23 points, less than about 22 points, or less than about 21 points) compared to baseline; wherein the domain value is at least one of the following: a physical functioning value, a role physical value, a bodily pain value, a general health value, a vitality value, a social functioning value, a role emotional value, a mental health value, and/or a mental component score value. In some embodiments, the slowing of the decline in HRQoL comprises a decrease in a reported domain value that is less than about 20 points (e.g., less than about 19 points, less than about 18 points, less than about 17 points, or less than about 16 points) compared to baseline; wherein the domain value is at least one of the following: a physical functioning value, a role physical value, a bodily pain value, a general health value, a vitality value, a social functioning value, a role emotional value, a mental health value, and/or a mental component score value. In some embodiments, the slowing of the decline in HRQoL comprises a decrease in a reported domain value that is less than about 15 points (e.g., less than about 14 points, less than about 13 points, less than about 12 points, or less than about 11 points) compared to baseline; wherein the domain value is at least one of the following: a physical functioning value, a role physical value, a bodily pain value, a general health value, a vitality value, a social functioning value, a role emotional value, a mental health value, and/or a mental component score value. In some embodiments, the slowing of the decline in HRQoL comprises a decrease in a reported domain value that is less than about 10 points (e.g., less than about 9 points, less than about 8 points, less than about 7 points, or less than about 6 points) compared to baseline; wherein the domain value is at least one of the following: a physical functioning value, a role physical value, a bodily pain value, a general health value, a vitality value, a social functioning value, a role emotional value, a mental health value, and/or a mental component score value. In some embodiments, the slowing of the decline in HRQoL comprises a decrease in a reported domain value that is less than about 5 points (e.g., less than about 4 points, less than about 3 points, less than Attorney Docket No.50887-0050WO1 about 2 points, or less than about 1 point) compared to baseline; wherein the domain value is at least one of the following: a physical functioning value, a role physical value, a bodily pain value, a general health value, a vitality value, a social functioning value, a role emotional value, a mental health value, and/or a mental component score value. In some embodiments, the slowing of the decline in HRQoL comprises a decrease in a reported domain value that is about 1 point to about 25 points (e.g., 1 point to about 22 points, 1 point to about 20 points, 1 point to about 18 points) compared to baseline; wherein the domain value is at least one of the following: a physical functioning value, a role physical value, a bodily pain value, a general health value, a vitality value, a social functioning value, a role emotional value, a mental health value, and/or a mental component score value. In some embodiments, the slowing of the decline in HRQoL comprises a decrease in a reported domain value that is about 1 point to about 15 points (e.g., 1 point to about 12 points, 1 point to about 10 points, 1 point to about 8 points) compared to baseline; wherein the domain value is at least one of the following: a physical functioning value, a role physical value, a bodily pain value, a general health value, a vitality value, a social functioning value, a role emotional value, a mental health value, and/or a mental component score value. In some embodiments, the slowing of the decline in HRQoL comprises a decrease in a reported domain value that is about 3 points to about 15 points (e.g., 3 points to about 12 points, 3 points to about 10 points, 3 points to about 8 points) compared to baseline; wherein the domain value is at least one of the following: a physical functioning value, a role physical value, a bodily pain value, a general health value, a vitality value, a social functioning value, a role emotional value, a mental health value, and/or a mental component score value. In some embodiments, the slowing of the decline in HRQoL comprises a decrease in a reported domain value that is about 5 points to about 15 points (e.g., 5 points to about 12 points, 5 points to about 10 points, 5 points to about 8 points) compared to baseline; wherein the domain value is at least one of the following: a physical functioning value, a role physical value, a bodily pain value, a general health value, a vitality value, a social functioning value, a role emotional value, a mental health value, and/or a mental component score value. In some embodiments, the slowing of the decline in HRQoL comprises a decrease in a reported domain value that is about 1 point to about 10 points (e.g., 1 point to about 9 points, 1 point to about 8 points, 1 point to about 7 points, or 1 point to about 6 points) compared to baseline; wherein the domain value is at least one of the following: a physical functioning value, a role physical value, a bodily pain value, a general health value, a vitality value, a Attorney Docket No.50887-0050WO1 social functioning value, a role emotional value, a mental health value, and/or a mental component score value. In some embodiments, the slowing of the decline in HRQoL comprises a decrease in a reported domain value that is about 1 point to about 5 points (e.g., 1 point to about 4 points, 1 point to about 3 points, or 1 point to about 2 points) compared to baseline; wherein the domain value is at least one of the following: a physical functioning value, a role physical value, a bodily pain value, a general health value, a vitality value, a social functioning value, a role emotional value, a mental health value, and/or a mental component score value. In some embodiments, the slowing of the decline in HRQoL comprises an increase in a reported domain value of at least about 1 point (e.g., at least about 2 points, at least about 3 points, or at least about 4 points) relative to a different patient at the same time point who has not been administered the antibody; wherein the domain value is at least one of the following: a physical functioning value, a role physical value, a bodily pain value, a general health value, a vitality value, a social functioning value, a role emotional value, a mental health value, and/or a mental component score value. In some embodiments, the slowing of the decline in HRQoL comprises an increase in a reported domain value of at least about 1 point (e.g., at least about 2 points, at least about 3 points, or at least about 4 points) relative to a different patient at the same time point who has not been administered the antibody; wherein the domain value is at least one of the following: a physical functioning value, a role physical value, a bodily pain value, a general health value, a vitality value, a social functioning value, a role emotional value, a mental health value, and/or a mental component score value. In some embodiments, the slowing of the decline in HRQoL comprises an increase in a reported domain value of at least about 5 points (e.g., at least about 6 points, at least about 7 points, at least about 8 points, or at least about 9 points) relative to a different patient at the same time point who has not been administered the antibody; wherein the domain value is at least one of the following: a physical functioning value, a role physical value, a bodily pain value, a general health value, a vitality value, a social functioning value, a role emotional value, a mental health value, and/or a mental component score value. In some embodiments, the slowing of the decline in HRQoL comprises an increase in a reported domain value of at least about 10 points (e.g., at least about 11 points, at least about 12 points, at least about 13 points, or at least about 14 points) relative to a different patient at the same time point who has not been administered the antibody; wherein the domain value is at least one of the following: a physical functioning Attorney Docket No.50887-0050WO1 value, a role physical value, a bodily pain value, a general health value, a vitality value, a social functioning value, a role emotional value, a mental health value, and/or a mental component score value. In some embodiments, the slowing of the decline in HRQoL comprises an increase in a reported domain value of about 5 points to about 15 points (e.g., about 6 points to about 15 points, about 7 points to about 15 points, about 8 points to about 15 points, about, or 9 points to about 15 points) relative to a different patient at the same time point who has not been administered the antibody; wherein the domain value is at least one of the following: a physical functioning value, a role physical value, a bodily pain value, a general health value, a vitality value, a social functioning value, a role emotional value, a mental health value, and/or a mental component score value. In some embodiments, the slowing of the decline in HRQoL comprises an increase in a reported domain value of about 10 points to about 15 points (e.g., about 11 points to about 15 points, about 12 points to about 15 points, about 11 points to about 14 points, about, or 12 points to about 14 points) relative to a different patient at the same time point who has not been administered the antibody; wherein the domain value is at least one of the following: a physical functioning value, a role physical value, a bodily pain value, a general health value, a vitality value, a social functioning value, a role emotional value, a mental health value, and/or a mental component score value. In some embodiments, the slowing of the decline in HRQoL comprises an increase in a reported domain value of about 1 points to about 25 points (e.g., about 1 point to about 20 points, about 1 point to about 15 points, about 1 point to about 12 points, about, or about 1 points to about 10 points) relative to a different patient at the same time point who has not been administered the antibody; wherein the domain value is at least one of the following: a physical functioning value, a role physical value, a bodily pain value, a general health value, a vitality value, a social functioning value, a role emotional value, a mental health value, and/or a mental component score value. For example, in one aspect, the present disclosure provides a method of slowing a decline in social functioning in a subject having Mayo Stage IV AL amyloidosis, comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105). Attorney Docket No.50887-0050WO1 In another aspect, the present disclosure provides a method of treating Mayo Stage IV AL amyloidosis in a subject, comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105); wherein treating comprises a slowing of a decline in social functioning in the subject. The present disclosure provides methods of slowing a decline in Health-Related Quality of Life (HRQoL) in a subject having AL amyloidosis, including administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105), where the slowing of the decline in HRQoL includes a slowing of a decline in at least one of the following: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), mental health (MH), and mental component score (MCS). In another aspect this disclosure provides methods of treating AL amyloidosis in a subject, including administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11- 1F4 (ATCC Accession Number PTA-105); where treating includes a slowing of a decline in HRQoL including a slowing of a decline in at least one of the following: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, and mental component score. This disclosure further provides methods of slowing a decline in Health-Related Quality of Life (HRQoL) in a subject having AL amyloidosis with cardiac involvement, including administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA- 9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105), where the slowing of the decline in HRQoL includes a Attorney Docket No.50887-0050WO1 slowing of a decline in at least one of the following: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), mental health (MH), and mental component score (MCS). In another aspect this disclosure provides methods of treating AL amyloidosis with cardiac involvement in a subject, including administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105); where treating includes a slowing of a decline in HRQoL including a slowing of a decline in at least one of the following: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, and mental component score. In some embodiments, the slowing the decline in social functioning is assessed using the SF-36 or the SF-36v2. In some embodiments, the slowing the decline in social functioning is assessed using the SF-36 or the SF-36v2. In some embodiments, the slowing the decline in social functioning is assessed using the SF-36v2. In some embodiments, the method comprises a slowing of a decline in social function domain of the SF-36 or SF-36v2 compared to baseline. In some embodiments, the method comprises a slowing of a decline in social function domain of the SF-36 compared to baseline. In some embodiments, the method comprises a slowing of a decline in social function domain of the SF-36v2 compared to baseline. In some embodiments, the slowing the decline in social functioning comprises a decrease of less than about 25 points (e.g., less than about 24 points, less than about 23 points, less than about 22 points, or less than about 21 points) on the social functioning domain (e.g., of the SF-36 or SF-36v2) compared to baseline. In some embodiments, the slowing the decline in social functioning comprises a decrease of less than about 20 points (e.g., less than about 19 points, less than about 18 points, less than about 17 points, or less than about 16 points) on the social functioning domain compared to baseline. In some embodiments, the slowing the decline in social functioning comprises a decrease of less than about 15 points (e.g., less than about 14 points, less than about 13 points, less than about 12 points, or less than about 11 points) on the social functioning domain compared to baseline. In some embodiments, the slowing the decline in social functioning comprises a decrease of less than about 10 points (e.g., less than about 9 points, less than about 8 points, less than Attorney Docket No.50887-0050WO1 about 7 points, or less than about 6 points) on the social functioning domain compared to baseline. In some embodiments, the slowing the decline in social functioning comprises a decrease of about 1 point to about 15 points (e.g., 1 point to about 12 points, 1 point to about 10 points, 1 point to about 8 points) on the social functioning domain compared to baseline. In some embodiments, the slowing the decline in social functioning comprises a decrease of about 3 points to about 15 points (e.g., 3 points to about 12 points, 3 points to about 10 points, 3 points to about 8 points) on the social functioning domain compared to baseline. In some embodiments, the slowing the decline in social functioning comprises a decrease of about 5 points to about 15 points (e.g., 5 points to about 12 points, 5 points to about 10 points, 5 points to about 8 points) on the social functioning domain compared to baseline. In some embodiments, the slowing the decline in social functioning comprises a decrease of about 4 points to about 8 points on the social functioning domain compared to baseline. In some embodiments, the slowing the decline in social functioning comprises a decrease of about 5 points to about 7 points on the social functioning domain compared to baseline. In some embodiments, the slowing the decline in social functioning comprises a decrease of about 3 points, about 4 points, about 5 points, about 6 points, about 7 points, about 8 points, about 9 points, or about 10 points on the social functioning domain compared to baseline. In some embodiments, the slowing the decline in social functioning comprises a higher score on a social functioning domain of an SF-36 or SF-36v2 relative to a different patient having Mayo Stage IV AL amyloidosis at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in social functioning comprises a higher score on a social functioning domain of an SF-36 relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in social functioning comprises a higher score on a social functioning domain of an SF-36v2 relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in social functioning comprises a increase of at least about 15 points (e.g., at least about 16 points, at least about 17 points, at least about 18 points, or at least about 19 points) on the social functioning domain (e.g., of the SF-36 or SF-36v2) relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in social Attorney Docket No.50887-0050WO1 functioning comprises an increase of at least about 20 points (e.g., at least about 21 points, at least about 22 points, or at least about 23 points) on the social functioning domain relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in social functioning comprises a increase of about 15 points to about 30 points (e.g., 15 points to about 28 points, 15 points to about 25 points, or 15 points to about 23 points) on the social functioning domain relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in social functioning comprises a increase of about 20 points to about 30 points (e.g., 20 points to about 28 points, 20 points to about 25 points, or 20 points to about 23 points) on the social functioning domain relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in social functioning comprises a increase of about 20 points to about 25 points (e.g., 21 points to about 24 points, 22 points to about 24 points, 21 points to about 23 points, or 22 points to about 23 points) on the social functioning domain relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in social functioning comprises a increase of about 18 points, about 19 points, about 20 points, about 21 points, about 22 points, about 23 points, about 24 points, about 25 points, about 26 points, or about 27 points on the social functioning domain relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in social functioning comprises an increase of about 23 points on the social functioning domain relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in social functioning is assessed after at least about 6 months (e.g., at least about 7 months or at least about 8 months) following a first administration of the antibody. In some embodiments, the slowing of the decline in social functioning is assessed after at least about 9 months (e.g., at least about 10 months or at least about 11 months) following a first administration of the antibody. In some embodiments, the slowing of the decline in social functioning is assessed after at least about 12 months (e.g., at least about 13 months, at least about 14 months, or at least about 15 months) following a first administration of the antibody. In some embodiments, the slowing of the decline in social functioning is assessed after about 6 months (e.g., about 7 months or about 8 months) following a first administration Attorney Docket No.50887-0050WO1 of the antibody. In some embodiments, the slowing of the decline in social functioning is assessed after about 9 months (e.g., about 10 months or about 11 months) following a first administration of the antibody. In some embodiments, the slowing of the decline in social functioning is assessed after about 12 months (e.g., about 13 months, about 14 months, or about 15 months) following a first administration of the antibody. In some embodiments, the method further comprises assessing the HRQoL in the subject in at least one of the following domains (e.g., using the SF-36 or the SF-36v2) is assessed: role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, mental component score and/or physical component score. In some embodiments, the method further comprises assessing a baseline value of HRQoL in the subject in at least one of the following domains is assessed: role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, mental component score and/or physical component score. In some embodiments, the method further comprises assessing a post-treatment value of HRQoL in the subject (e.g., after 3-months, 6 months, 9 months, or 12 months of treatment with antibodies disclosed herein) in at least one of the following domains is assessed: role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, mental component score and/or physical component score. In some embodiments, the method further comprises comparing the baseline value of HRQoL in the subject to the post-treatment value of HRQoL in the subject thereby demonstrating a slowing of the decline in HRQoL; wherein the baseline HRQoL value and the post-treatment HRQoL value each comprise a value for at least one of the following domains (e.g., the same domain): role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, mental component score and/or physical component score. For example, in another aspect, the present disclosure provides a method of slowing a decline in HRQoL in a subject having AL amyloidosis (including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement), the method comprising: (a) assessing the HRQoL in the subject thereby obtaining a first HRQoL value, the first HRQoL value comprising a first value for at least one of the following: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, and mental component score; Attorney Docket No.50887-0050WO1 (b) administering to the subject an effective dosage of an antibody, wherein the antibody competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105); and (c) assessing the HRQoL of the subject thereby obtaining a second HRQoL value, the second HRQoL value comprising a second value for at least one of the following: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, and mental component score; wherein the slowing of the decline in HRQoL comprises a slowing of a decline in at least one of the following: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, and mental component score. In another aspect, the present disclosure provides a method of treating AL amyloidosis (including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement) in a subject, the method comprising: (a) assessing HRQoL in the subject thereby a first HRQoL value, the first HRQoL value comprising a first value for at least one of the following: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, and mental component score; (b) administering to the subject an effective dosage of an antibody, wherein the antibody competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105); and (c) assessing HRQoL in the subject thereby obtaining a second HRQoL value, the second HRQoL value comprising a second value for at least one of the following: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, and mental component score; Attorney Docket No.50887-0050WO1 wherein treating comprises a slowing of a decline in HRQoL comprising a slowing of a decline in at least one of the following: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, and mental component score. In some embodiments, the method comprises a slowing of a decline in social functioning in the subject, and the first and second HRQoL values comprise a first social functioning value and a second social functioning value, respectively. In some embodiments, the method comprises a slowing of a decline in physical functioning in the subject, and the first and second HRQoL values comprise a first physical functioning value and a second physical functioning, respectively. In some embodiments, the method comprises a slowing of a decline in role physical in the subject, and the first and second HRQoL values comprise a first role physical value and a second role physical value, respectively. In some embodiments, the method comprises a slowing of a decline in bodily pain in the subject, and the first and second HRQoL values comprise a first bodily pain value and a second bodily pain value, respectively. In some embodiments, the method comprises a slowing of a decline in general health in the subject, and the first and second HRQoL values comprise a first general health value and a second general health value, respectively. In some embodiments, the method comprises a slowing of a decline in vitality in the subject, and the first and second HRQoL values comprise a first vitality value and a second vitality value, respectively. In some embodiments, the method comprises a slowing of a decline in role emotional in the subject, and the first and second HRQoL values comprise a first role emotional value and a second role emotional value, respectively. In some embodiments, the method comprises a slowing of a decline in mental health in the subject, and the first and second HRQoL values comprise a first mental health value and a second mental health value, respectively. In some embodiments, the method comprises a slowing of a decline in mental component score in the subject, and the first and second HRQoL values comprise a first mental component score value and a second mental component score value, respectively. In some embodiments, the method comprises a slowing of a decline in social functioning in the subject, and the first and second HRQoL values are a first social functioning value and a second social functioning value, respectively. In some embodiments, the method comprises a slowing of a decline in physical functioning in the subject, and the first and second HRQoL values are a first physical functioning value and a second physical functioning, respectively. In some embodiments, the method comprises a slowing of a decline Attorney Docket No.50887-0050WO1 in role physical in the subject, and the first and second HRQoL values are a first role physical value and a second role physical value, respectively. In some embodiments, the method comprises a slowing of a decline in bodily pain in the subject, and the first and second HRQoL values are a first bodily pain value and a second bodily pain value, respectively. In some embodiments, the method comprises a slowing of a decline in general health in the subject, and the first and second HRQoL values are a first general health value and a second general health value, respectively. In some embodiments, the method comprises a slowing of a decline in vitality in the subject, and the first and second HRQoL values are a first vitality value and a second vitality value, respectively. In some embodiments, the method comprises a slowing of a decline in role emotional in the subject, and the first and second HRQoL values are a first role emotional value and a second role emotional value, respectively. In some embodiments, the method comprises a slowing of a decline in mental health in the subject, and the first and second HRQoL values are a first mental health value and a second mental health value, respectively. In some embodiments, the method comprises a slowing of a decline in mental component score in the subject, and the first and second HRQoL values are a first mental component score value and a second mental component score value, respectively. In some embodiments, the first HRQoL value and/or the second HRQoL value is assessed using a SF-36 or a SF-36v2. In some embodiments, the first HRQoL value and/or the second HRQoL value is assessed using a SF-36. In some embodiments, the first HRQoL value and/or the second HRQoL value is assessed using a SF-36v2. In some embodiments, the second HRQoL value comprises a higher score on a domain of an SF-36 or SF-36v2 relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the second HRQoL value comprises a higher score on a domain of an SF-36 relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the second HRQoL value comprises a higher score on a domain of an SF-36v2 relative to a different patient at the same time point who has not been administered the antibody. In various embodiments, the domain is at least one of the following: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, and mental component score. In some embodiments, the first value comprises a first score on a domain of the SF-36 or the SF-36v2 and the second value comprises a second score on a domain of the SF-36 or Attorney Docket No.50887-0050WO1 the SF-36v2. In some embodiments, the first value comprises a first score on a domain of the SF-36 and the second value comprises a second score on a domain of the SF-36. In some embodiments, the first value comprises a first score on a domain of the SF-36v2 and the second value comprises a second score on a domain of the SF-36v2. In various embodiments, the domain is at least one of the following: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, and mental component score. In various embodiments throughout the present disclosure, the first HRQoL value is a baseline HRQoL value. In some such embodiments, the first HRQoL value comprises a at least one of the following a baseline physical functioning value, a baseline role physical value, a baseline bodily pain value, a baseline general health value, a baseline vitality value, a baseline social functioning value, a baseline role emotional value, a baseline mental health value, and a baseline mental component score value. In some such embodiments, the first HRQoL value comprises a baseline value for at least one of the following domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, and mental component score. In some embodiments, the second HRQoL score (e.g., of the SF-36 or SF-36v2) is less than about 25 points (e.g., less than about 24 points, less than about 23 points, less than about 22 points, or less than about 21 points) lower than the first HRQoL score. In some embodiments, the second HRQoL score is less than about 20 points (e.g., less than about 19 points, less than about 18 points, less than about 17 points, or less than about 16 points) lower than the first HRQoL score. In some embodiments, the second HRQoL score is less than about 15 points (e.g., less than about 14 points, less than about 13 points, less than about 12 points, or less than about 11 points) lower than the first HRQoL score. In some embodiments, the second HRQoL score is less than about 10 points (e.g., less than about 9 points, less than about 8 points, less than about 7 points, or less than about 6 points) lower than the first HRQoL score. In some embodiments, the second HRQoL score is less than about 5 points (e.g., less than about 4 points, less than about 3 points, less than about 2 points, or less than about 1 point) lower than the first HRQoL score. In some embodiments, the HRQoL second score (e.g., of the SF-36 or SF-36v2) is about 1 point to about 25 points (e.g., 1 point to about 22 points, 1 point to about 20 points, 1 point to about 18 points) lower than the first HRQoL score. In some embodiments, the HRQoL second score (e.g., of the SF-36 or SF-36v2) is about 1 point to about 15 points (e.g., Attorney Docket No.50887-0050WO1 1 point to about 12 points, 1 point to about 10 points, 1 point to about 8 points) lower than the first HRQoL score. In some embodiments, the second HRQoL score is about 3 points to about 15 points (e.g., 3 points to about 12 points, 3 points to about 10 points, 3 points to about 8 points) lower than the first HRQoL score. In some embodiments, the second HRQoL score is about 5 points to about 15 points (e.g., 5 points to about 12 points, 5 points to about 10 points, 5 points to about 8 points) lower than the HRQoL first score. In some embodiments, the second HRQoL score is about 4 points to about 8 points lower than the first HRQoL score. In some embodiments, the second HRQoL score is about 2 points to about 10 points lower than the first HRQoL score. In some embodiments, the second HRQoL score is about 5 points to about 7 points lower than the first HRQoL score. In some embodiments, the second HRQoL value is assessed after at least about 6 months (e.g., at least about 7 months or at least about 8 months) following a first administration of the antibody. In some embodiments, the second HRQoL value is assessed after at least about 9 months (e.g., at least about 10 months or at least about 11 months) following a first administration of the antibody. In some embodiments, the second HRQoL value is assessed after at least about 12 months (e.g., at least about 13 months, at least about 14 months, or at least about 15 months) following a first administration of the antibody. In some embodiments, the second HRQoL value is assessed after about 6 months (e.g., about 7 months or about 8 months) following a first administration of the antibody. In some embodiments, the second HRQoL value is assessed after about 9 months (e.g., about 10 months or about 11 months) following a first administration of the antibody. In some embodiments, the second HRQoL value is assessed after about 12 months (e.g., about 13 months, about 14 months, or about 15 months) following a first administration of the antibody. In another aspect, the present disclosure provides a method of slowing a decline in social functioning in a subject having AL (including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement) amyloidosis, the method comprising: (d) assessing social functioning in the subject thereby obtaining a first social functioning value; (e) administering to the subject an effective dosage of an antibody, wherein the antibody competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for Attorney Docket No.50887-0050WO1 binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105); and (f) assessing social functioning in the subject thereby obtaining a second social functioning value. In another aspect, the present disclosure provides a method of treating AL amyloidosis (including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement) in a subject, the method comprising: (d) assessing social functioning in the subject thereby obtaining a first social functioning value; (e) administering to the subject an effective dosage of an antibody, wherein the antibody competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105); and (f) assessing social functioning in the subject thereby obtaining a second social functioning value; wherein treating comprises a slowing of a decline in social functioning in the subject. In some embodiments, the first social functioning value and/or the second social functioning value is assessed using a SF-36 or a SF-36v2. In some embodiments, the first social functioning value and/or the second social functioning value is assessed using a SF-36. In some embodiments, the first social functioning value and/or the second social functioning value is assessed using a SF-36v2. In some embodiments, the second social function value comprises a higher score on a social functioning domain of an SF-36 or SF-36v2 relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the second social function value comprises a higher score on a social functioning domain of an SF-36 relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the second social function value comprises a higher score on a social functioning domain of an SF-36v2 relative to a different patient at the same time point who has not been administered the antibody. Attorney Docket No.50887-0050WO1 In some embodiments, the first social function value comprises a first score on a social functioning domain of the SF-36 or the SF-36v2 and the second social function value comprises a second score on a social functioning domain of the SF-36 or the SF-36v2. In some embodiments, the first social function value comprises a first score on a social functioning domain of the SF-36 and the second social function value comprises a second score on a social functioning domain of the SF-36. In some embodiments, the first social function value comprises a first score on a social functioning domain of the SF-36v2 and the second social function value comprises a second score on a social functioning domain of the SF-36v2. In some embodiments, the second score on the social functioning domain (e.g., of the SF-36 or SF-36v2) is less than about 25 points (e.g., less than about 24 points, less than about 23 points, less than about 22 points, or less than about 21 points) lower than the first score on the social functioning domain. In some embodiments, the second score on the social functioning domain is less than about 20 points (e.g., less than about 19 points, less than about 18 points, less than about 17 points, or less than about 16 points) lower than the first score on the social functioning domain. In some embodiments, the second score on the social functioning domain is less than about 15 points (e.g., less than about 14 points, less than about 13 points, less than about 12 points, or less than about 11 points) lower than the first score on the social functioning domain. In some embodiments, the second score on the social functioning domain is less than about 10 points (e.g., less than about 9 points, less than about 8 points, less than about 7 points, or less than about 6 points) lower than the first score on the social functioning domain. In some embodiments, the second score on the social functioning domain (e.g., of the SF-36 or SF-36v2) is about 1 point to about 15 points (e.g., 1 point to about 12 points, 1 point to about 10 points, 1 point to about 8 points) lower than the first score on the social functioning domain. In some embodiments, the second score on the social functioning domain is about 3 points to about 15 points (e.g., 3 points to about 12 points, 3 points to about 10 points, 3 points to about 8 points) lower than the first score on the social functioning domain. In some embodiments, the second score on the social functioning domain is 5 points to about 15 points (e.g., 5 points to about 12 points, 5 points to about 10 points, 5 points to about 8 points) lower than the first score on the social functioning domain. In some embodiments, the second score on the social functioning domain is about 4 points to about 8 points lower than the first score on the social functioning domain. In some embodiments, the Attorney Docket No.50887-0050WO1 second score on the social functioning domain is about 5 points to about 7 points lower than the first score on the social functioning domain. In some embodiments, the second score on the social functioning domain is about 3 points, about 4 points, about 5 points, about 6 points, about 7 points, about 8 points, about 9 points, or about 10 points lower than the first score on the social functioning domain. In some embodiments, the second social function value is assessed after at least about 6 months (e.g., at least about 7 months or at least about 8 months) following a first administration of the antibody. In some embodiments, the second social function value is assessed after at least about 9 months (e.g., at least about 10 months or at least about 11 months) following a first administration of the antibody. In some embodiments, the second social function value is assessed after at least about 12 months (e.g., at least about 13 months, at least about 14 months, or at least about 15 months) following a first administration of the antibody. In some embodiments, the second social function value is assessed after about 6 months (e.g., about 7 months or about 8 months) following a first administration of the antibody. In some embodiments, the second social function value is assessed after about 9 months (e.g., about 10 months or about 11 months) following a first administration of the antibody. In some embodiments, the second social function value is assessed after about 12 months (e.g., about 13 months, about 14 months, or about 15 months) following a first administration of the antibody. In some embodiments, the method further comprises a slowing of a decline in at least one value for the following domains of the SF-36 or SF-36v2: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and mental component score. In some embodiments, the method further comprises a slowing of a decline in at least one value for the following domains of the SF-36 or SF-36v2: physical functioning, role physical, bodily pain, role-emotional, mental health, physical component score, and mental component score. In some embodiments, the method further comprises a slowing of a decline in at least one value for the following domains of the SF-36 or SF-36v2: physical functioning, role physical, bodily pain, physical component score, and mental component score. In some embodiments, the method further comprises a slowing of a decline in at least one value for the following domains of the SF-36 or SF-36v2: role physical, bodily pain, and physical component score. Attorney Docket No.50887-0050WO1 Thus, in another aspect, the present disclosure provides a method of slowing a decline in a reported value for at least one of the following domains in a subject having AL amyloidosis(including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement): physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and mental component score (e.g., reported value of one or more domain of the SF-36 or SF-36v2); the method comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11- 1F4 (ATCC Accession Number PTA-105). In another aspect, the present disclosure provides a method of treating AL amyloidosis (including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement) in a subject, comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105); wherein treating comprises a slowing of a decline in a reported value for at least one of the following domains in the subject: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and mental component score (e.g., reported value of one or more domain of the SF-36 or SF-36v2). In some embodiments, the method further comprises a slowing of a decline in role physical and/or bodily pain domains of the SF-36 or SF-36v2. In some embodiments, the method further comprises a slowing of a decline in role physical and/or bodily pain domains of the SF-36. In some embodiments, the method further comprises a slowing of a decline in role physical and/or bodily pain domains of the SF-36v2. In some embodiments, the method further comprises a slowing of a decline in role physical and/or bodily pain domains of the SF-36v2 compared to baseline. In some embodiments, the reported value for the role physical domain (e.g., of the SF-36 or SF-36v2) is higher relative to a different patient at the same time point who has not been administered the antibody. Thus, in some aspects, the present disclosure provides a method of slowing a decline in role physical (e.g., reported value of role physical domain) in a subject having AL Attorney Docket No.50887-0050WO1 amyloidosis (including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement), comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105). In another aspect, the present disclosure provides a method of treating AL amyloidosis (including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement) in a subject, comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105); wherein treating comprises a slowing of a decline in role physical (e.g., reported value of role physical domain) in the subject. In some embodiments, the slowing of the decline in reported value for the role physical domain comprises a decrease of less than about 10 points (e.g., less than about 9 points, less than about 8 points, less than about 7 points, or less than about 6 points) on the role physical domain (e.g., of the SF-36 or SF-36v2) compared to baseline. In some embodiments, the slowing of the decline in reported value for the role physical domain comprises a decrease of less than about 5 points (e.g., less than about 4 points, less than about 3 points, or less than about 2 points) on the role physical domain compared to baseline. In some embodiments, the slowing of the decline in reported value for the role physical domain comprises a decrease of about 1 point to about 5 points (e.g., about 1 point to about 4 points, about 1 point to about 3 points, or about 1 point to about 2 points) on the role physical domain (e.g., of the SF-36 or SF-36v2) compared to baseline. In some embodiments, the slowing of the decline in reported value for the role physical domain comprises a decrease of about 2 points to about 3 points on the role physical domain compared to baseline. In some embodiments, the slowing of the decline in reported value for the role physical domain comprises a decrease of about 1 point, about 2 points, about 3 points, about 4 points, or about 5 points on the role physical domain compared to baseline. In some embodiments, the slowing of the decline in reported value for the role physical domain comprises a decrease of about 2 points on the role physical domain compared to baseline. Attorney Docket No.50887-0050WO1 In some embodiments, the slowing of the decline in reported value for the role physical domain comprises an increase of at least about 1 point (e.g., at least about 2 points, at least about 3 points, or at least about 4 points) on the role physical domain relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in reported value for the role physical domain comprises an increase of at least about 5 points (e.g., at least about 6 points, at least about 7 points, at least about 8 points, or at least about 9 points) on the role physical domain relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in reported value for the role physical domain comprises an increase of at least about 10 points (e.g., at least about 11 points, at least about 12 points, at least about 13 points, or at least about 14 points) on the role physical domain relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in reported value for the role physical domain comprises an increase of about 5 points to about 15 points (e.g., about 6 points to about 15 points, about 7 points to about 15 points, about 8 points to about 15 points, about, or 9 points to about 15 points) on the role physical domain relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in reported value for the role physical domain comprises an increase of about 10 points to about 15 points (e.g., about 11 points to about 15 points, about 12 points to about 15 points, about 11 points to about 14 points, about, or 12 points to about 14 points) on the role physical domain relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in reported value for the role physical domain comprises an increase of about 11 points to about 12 points on the role physical domain relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in reported value for the role physical domain comprises an increase of about 8 points, about 9 points, about 10 points, about 11 points, about 12 points, about 13 points, or about 14 points on the role physical domain relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in reported value for the role physical domain comprises an increase of about 11 points on the role physical domain Attorney Docket No.50887-0050WO1 relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the method further comprises a slowing of the decline in bodily pain of the SF-36 or SF-36v2. In some embodiments, the method further comprises a slowing of the decline in a bodily pain domain of the SF-36. In some embodiments, the method further comprises a slowing of the decline in a bodily pain domain of the SF-36v2. In some embodiments, the reported value for the bodily pain domain is lower than baseline. In some embodiments, the reported value for the bodily pain domain (e.g., of the SF-36 or SF- 36v2) is higher relative to a different patient at the same time point who has not been administered the antibody. Thus, in some aspects, the present disclosure provides a method of slowing a decline in bodily pain (e.g., reported value of bodily pain domain) in a subject having AL amyloidosis (including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement), comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105). In another aspect, the present disclosure provides a method of treating AL amyloidosis (including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement) in a subject, comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105); wherein treating comprises a slowing of a decline in bodily pain (e.g., reported value of bodily pain domain) in the subject. In some embodiments, the slowing of the decline in bodily pain comprises a decrease of less than about 10 points (e.g., less than about 9 points, less than about 8 points, less than about 7 points, or less than about 6 points) on the bodily pain domain compared to baseline. In some embodiments, the slowing of the decline in bodily pain comprises a decrease of less than about 5 points (e.g., less than about 4 points, less than about 3 points, or less than about 2 points) on the bodily pain domain compared to baseline. Attorney Docket No.50887-0050WO1 In some embodiments, the slowing of the decline in bodily pain comprises a decrease of about 1 point to about 10 points (e.g., 1 point to about 9 points, 1 point to about 8 points, 1 point to about 6 points, 1 point to about 5 points, or 1 point to about 4 points) on the bodily pain domain compared to baseline. In some embodiments, the slowing of the decline in bodily pain comprises a decrease of about 2 points to about 8 points (e.g., 2 points to about 7 points, 2 points to about 6 points, 2 points to about 5 points, 2 points to about 4 points, or 2 points to about 3 points) on the bodily pain domain compared to baseline. In some embodiments, the slowing of the decline in bodily pain comprises a decrease of about 2 points to about 4 points on the bodily pain domain compared to baseline. In some embodiments, the slowing of the decline in bodily pain comprises a decrease of about 1 point, about 2 points, about 3 points, about 4 points, about 5 points, about 6 points, about 7 points, at least 8 points, at least 9 points, or at least 10 points on the bodily pain domain compared to baseline. In some embodiments, the slowing of the decline in bodily pain domain comprises a decrease of about 3 points on the bodily pain domain compared to baseline. In some embodiments, the slowing of the decline in reported value for the bodily pain domain comprises an increase of at least about 1 point (e.g., at least about 2 points, at least about 3 points, or at least about 4 points) on the bodily pain domain relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in reported value for the bodily pain domain comprises an increase of at least about 5 points (e.g., at least about 6 points, at least about 7 points, at least about 8 points, or at least about 9 points) on the bodily pain domain relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in reported value for the bodily pain domain comprises an increase of at least about 10 points (e.g., at least about 11 points, at least about 12 points, at least about 13 points, or at least about 14 points) on the bodily pain domain relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in reported value for the bodily pain domain comprises an increase of at least about 15 points (e.g., at least about 16 points, at least about 17 points, at least about 18 points, or at least about 19 points) on the bodily pain domain relative to a different patient at the same time point who has not been administered the antibody. Attorney Docket No.50887-0050WO1 In some embodiments, the slowing of the decline in reported value for the bodily pain domain comprises an increase of about 10 points to about 20 points (e.g., about 12 points to about 20 points, about 14 points to about 20 points, about 15 points to about 20 points, or about 16 points to about 20 points) on the bodily pain domain relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in reported value for the bodily pain domain comprises an increase of about 15 points to about 18 points (e.g., about 15 points to about 17 points, about 15 points to about 16 points, about 16 points to about 18 points, or about 16 points to about 17 points) on the bodily pain domain relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in reported value for the bodily pain domain comprises an increase of about 12 points, about 13 points, about 14 points, about 15 points, about 16 points, about 17 points, about 18 points, about 19 points, or about 20 points on the bodily pain domain relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in reported value for the bodily pain domain comprises an increase of about 16 points on the bodily pain domain relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in role physical and/or bodily pain (e.g., the slowing of the decline in the reported value for the role physical domain and/or the reported value for the bodily pain domain) is assessed after at least about 6 months (e.g., at least about 7 months or at least about 8 months) following a first administration of the antibody. In some embodiments, the slowing of the decline in role physical and/or bodily pain is assessed after at least about 9 months (e.g., at least about 10 months or at least about 11 months) following a first administration of the antibody. In some embodiments, the slowing of the decline in role physical and/or bodily pain is assessed after at least about 12 months (e.g., at least about 13 months, at least about 14 months, or at least about 15 months) following a first administration of the antibody. In some embodiments, the slowing of the decline in role physical and/or bodily pain (e.g., the slowing of the decline in the reported value for the role physical domain and/or the reported value for the bodily pain domain) is assessed after about 6 months (e.g., about 7months or about 8 months) following a first administration of the antibody. In some embodiments, the slowing of the decline in role physical and/or bodily pain is assessed after Attorney Docket No.50887-0050WO1 about 9 months (e.g., about 10 months or about 11 months) following a first administration of the antibody. In some embodiments, the slowing of the decline in role physical and/or bodily pain is assessed after about 12 months (e.g., about 13 months, about 14 months, or about 15 months) following a first administration of the antibody. In another aspect, the present disclosure provides a method of slowing a decline in physical functioning (e.g., reported value of physical functioning domain) in a subject having AL amyloidosis (including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement), comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105). In another aspect, the present disclosure provides a method of treating AL amyloidosis (including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement) in a subject, comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105); wherein treating comprises a slowing of a decline in physical functioning (e.g., reported value of physical functioning domain) in the subject. In another aspect, the present disclosure provides a method of slowing a decline in general health perceptions (e.g., reported value of general health perceptions domain) in a subject having AL amyloidosis (including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement), comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105). In another aspect, the present disclosure provides a method of treating AL amyloidosis (including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement) in a subject, comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda Attorney Docket No.50887-0050WO1 light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105); wherein treating comprises a slowing of a decline in general health perceptions (e.g., reported value of general health perceptions domain) in the subject. In another aspect, the present disclosure provides a method of slowing a decline in vitality (e.g., reported value of vitality domain) in a subject having AL amyloidosis (including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement), comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11- 1F4 (ATCC Accession Number PTA-105). In another aspect, the present disclosure provides a method of treating AL amyloidosis (including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement) in a subject, comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105); wherein treating comprises a slowing of a decline in vitality (e.g., reported value of vitality domain) in the subject. In another aspect, the present disclosure provides a method of slowing a decline in role-emotional (e.g., reported value of role-emotional domain) in a subject having AL amyloidosis (including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement), comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105). In another aspect, the present disclosure provides a method of treating AL amyloidosis (including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement) in a subject, comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda Attorney Docket No.50887-0050WO1 light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105); wherein treating comprises a slowing of a decline in role-emotional (e.g., reported value of role-emotional domain) in the subject. In another aspect, the present disclosure provides a method of slowing a decline in mental health (e.g., reported value of mental health domain) in a subject having AL amyloidosis (including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement), comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105). In another aspect, the present disclosure provides a method of treating AL amyloidosis (including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement) in a subject, comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105); wherein treating comprises a slowing of a decline in mental health (e.g., reported value of mental health domain) in the subject. In another aspect, the present disclosure provides a method of slowing a decline in mental component score (e.g., reported value of mental component score domain) in a subject having AL amyloidosis (including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement), comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105). In another aspect, the present disclosure provides a method of treating AL amyloidosis (including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement) in a subject, comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Attorney Docket No.50887-0050WO1 Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105); wherein treating comprises a slowing of a decline in mental component score (e.g., reported value of mental component score domain) in the subject. In some embodiments, the AL amyloidosis is Mayo Stage IV amyloidosis or AL amyloidosis with cardiac involvement. In some embodiments, the slowing of the decline in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score is measured by the SF-36 or SF-36v2. In some embodiments, the slowing of the decline in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score is measured by the SF-36. In some embodiments, the slowing of the decline in value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score is measured by the SF-36v2. In some embodiments, the method comprises a slowing of the decline in value for any of the following domains of the SF-36 or SF-36v2 compared to baseline: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score. In some embodiments, the method comprises a slowing of the decline in value for any of the following domains of the SF-36 compared to baseline: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score. In some embodiments, the method comprises a slowing of a decline in value for any of the following domains of the SF-36v2 compared to baseline: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score. In some embodiments, the slowing of the decline in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score comprises a decrease of less than about 25 points (e.g., less than about 24 Attorney Docket No.50887-0050WO1 points, less than about 23 points, less than about 22 points, or less than about 21 points) on the domain (e.g., of the SF-36 or SF-36v2) compared to baseline. In some embodiments, the slowing of the decline in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score comprises a decrease of less than about 20 points (e.g., less than about 19 points, less than about 18 points, less than about 17 points, or less than about 16 points) on the domain compared to baseline. In some embodiments, the slowing of the decline in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score comprises a decrease of less than about 15 points (e.g., less than about 14 points, less than about 13 points, less than about 12 points, or less than about 11 points) on the domain compared to baseline. In some embodiments, the slowing of the decline in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score comprises a decrease of less than about 10 points (e.g., less than about 9 points, less than about 8 points, less than about 7 points, or less than about 6 points) on the domain compared to baseline. In some embodiments, the slowing of the decline in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score comprises a decrease of less than about 5 points (e.g., less than about 4 points, less than about 3 points, less than about 2 points, or less than about 1 point) on the domain compared to baseline. In some embodiments, the slowing of the decline in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score comprises a decrease of about 1 point to about 15 points (e.g., 1 point to about 12 points, 1 point to about 10 points, 1 point to about 8 points) on the domain compared to baseline. In some embodiments, the slowing of the decline in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score comprises a decrease of about 3 points to about 15 points (e.g., 3 points to about 12 points, 3 points to about 10 points, 3 points to about 8 points) on the domain Attorney Docket No.50887-0050WO1 compared to baseline. In some embodiments, the slowing of the decline in in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score comprises a decrease of about 5 points to about 15 points (e.g., 5 points to about 12 points, 5 points to about 10 points, 5 points to about 8 points) on the domain compared to baseline. In some embodiments, the slowing of the decline in in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score comprises a decrease of about 4 points to about 8 points on the domain compared to baseline. In some embodiments, the slowing of the decline in in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score comprises a decrease of about 5 points to about 7 points on the domain compared to baseline. In some embodiments, the slowing of the decline in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score comprises a decrease of about 1 point, about 2 points, about 3 points, about 4 points, about 5 points, about 6 points, about 7 points, about 8 points, about 9 points, about 10 points, about 11 points, about 12 points, about 13 points, about 14 points, about 15 points, about 16 points, about 17 points, about 18 points, about 19 points, about 20 points, about 21 points, about 22 points, about 23 points, about 24 points, or about 25 points on the domain compared to baseline. In some embodiments, the slowing of the decline in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score comprises a higher score on that domain of an SF-36 or SF-36v2 relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score comprises a higher score on that domain of an SF-36 relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of Attorney Docket No.50887-0050WO1 the decline in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score comprises a higher score on that domain of an SF-36v2 relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score comprises an increase of at least about 1 point (e.g., at least about 2 points, at least about 3 points, or at least about 4 points) on the domain (e.g., of the SF-36 or SF- 36v2) relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score comprises an increase of at least about 5 points (e.g., at least about 6 points, at least about 7 points, at least about 8 points, or at least about 9 points) on the domain relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score comprises an increase of at least about 10 points (e.g., at least about 11 points, at least about 12 points, at least about 13 points, or at least about 14 points) on the domain relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score comprises an increase of at least about 15 points (e.g., at least about 16 points, at least about 17 points, at least about 18 points, or at least about 19 points) on the domain relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental Attorney Docket No.50887-0050WO1 component score comprises an increase of at least about 20 points (e.g., at least about 21 points, at least about 22 points, or at least about 23 points) on the domain relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score comprises a increase of about 5 points to about 20 points (e.g., 5 points to about 18 points, 5 points to about 15 points, or 5 points to about 13 points) on the domain relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score comprises a increase of about 10 points to about 20 points (e.g., 10 points to about 18 points, 10 points to about 15 points, or 10 points to about 13 points) on the domain relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score comprises a increase of about 5 points to about 15 points (e.g., 5 points to about 14 points, 5 points to about 12 points, 5 points to about 10 points, 6 points to about 14 points, 6 points to about 12 points, 6 points to about 10 points, or 6 points to about 8 points) on the domain relative to a different patient at the same time point who has not been administered the antibody. In some embodiments, the slowing of the decline in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score comprises an increase of about 1 point, about 2 points, about 3 points, about 4 points, about 5 points, about 6 points, about 7 points, about 8 points, about 9 points, about 10 points, about 11 points, about 12 points, about 13 points, about 14 points, about 15 points, about 16 points, or about 17 points, about 18 points, about 19 points, about 20 points, about 21 points, about 22 points, about 23 points, about 24 points, or about 25 points, on the domain relative to a different patient at the same time point who has not been administered the antibody. Attorney Docket No.50887-0050WO1 In some embodiments, the slowing of the decline in reported value is for the physical functioning domain. In some embodiments, the slowing of the decline in reported value is for the role physical domain. In some embodiments, the slowing of the decline in reported value is for the bodily pain domain. In some embodiments, the slowing of the decline in reported value is for the general health perceptions domain. In some embodiments, the slowing of the decline in reported value is for vitality domain. In some embodiments, the slowing of the decline in reported value is for the role-emotional domain. In some embodiments, the slowing of the decline in reported value is for the mental health domain. In some embodiments, the slowing of the decline in reported value is for the mental component score domain. In some embodiments, the slowing of the decline in reported value is for the physical component score domain. In some embodiments, the slowing of the decline in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score is assessed after at least about 6 months (e.g., at least about 7 months or at least about 8 months) following a first administration of the antibody. In some embodiments, the slowing of the decline in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score is assessed after at least about 9 months (e.g., at least about 10 months or at least about 11 months) following a first administration of the antibody. In some embodiments, the slowing of the decline in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score is assessed after at least about 12 months (e.g., at least about 13 months, at least about 14 months, or at least about 15 months) following a first administration of the antibody. In some embodiments, the slowing of the decline in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score is assessed after about 6 months (e.g., about 7 months or about 8 months) following a first administration of the antibody. In some embodiments, the slowing of the decline in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, Attorney Docket No.50887-0050WO1 physical component score, and/or mental component score is assessed after about 9 months (e.g., about 10 months or about 11 months) following a first administration of the antibody. In some embodiments, the slowing of the decline in reported value for any of the following domains: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score is assessed after about 12 months (e.g., about 13 months, about 14 months, or about 15 months) following a first administration of the antibody. Furthermore, an improvement in the overall score for the SF-36 and/or SF-36v2 can also indicate an improvement in health status of the patient. For example, a patient treated with an antibody who scores higher on the SF-36 and/or SF-36v2 questionnaire than a different patient at the same time point who has not received the antibody has achieved an improvement in health status. In some embodiments, treatment with an antibody disclosed herein results in an increase of a subject’s score on the SF-36 and/or SF36v2, of at least 1, at least 2, at least 3, at least 4, at least 5, at least 6, at least 7, at least 8, at least 9, at least 10, at least 11, at least 12, at least 13, at least 14, at least 15, at least 16, at least 17, at least 18, at least 19, at least 20, at least 21, at least 22, at least 23, at least 24, at least 25, at least 26, at least 27, at least 28, at least 29, at least 30, at least 31, at least 32, at least 33, at least 34, at least 35, at least 36, at least 37, at least 38, at least 39, at least 40, at least 41, at least 42, at least 43, at least 44, at least 45, at least 46, at least 47, at least 48, at least 49, at least 50, at least 51, at least 52, at least 53, at least 54, at least 55, at least 56, at least 57, at least 58, at least 59, at least 60, at least 61, at least 62, at least 63, at least 64, at least 65, at least 66, at least 67, at least 68, at least 69, at least 70, at least 71, at least 72, at least 73, at least 74, at least 75, at least 76, at least 77, at least 78, at least 79, at least 80, at least 81, at least 82, at least 83, at least 84, at least 85, at least 86, at least 87, at least 88, at least 89, at least 90, at least 91, at least 92, at least 93, at least 94, at least 95, at least 96, at least 97, at least 98, or at least 99 compared to a different patient at the same time point who has not received the antibody has achieved an improvement in health status. In some embodiments, treatment with an antibody disclosed herein results in an increase of a subject’s SF-36 or SF36v2, of about 1, about 2, about 3, about 4, about 5, about 6, about 7, about 8, about 9, about 10, about 11, about 12, about 13, about 14, about 15, about 16, about 17, about 18, about 19, about 20, about 21, about 22, about 23, about 24, about 25, about 26, about 27, about 28, about 29, about 30, about 31, about 32, about 33, about 34, about 35, about 36, about 37, about 38, about 39, about 40, about 41, about 42, about 43, about 44, about 45, about 46, about 47, Attorney Docket No.50887-0050WO1 about 48, about 49, about 50, about 51, about 52, about 53, about 54, about 55, about 56, about 57, about 58, about 59, about 60, about 61, about 62, about 63, about 64, about 65, about 66, about 67, about 68, about 69, about 70, about 71, about 72, about 73, about 74, about 75, about 76, about 77, about 78, about 79, about 80, about 81, about 82, about 83, about 84, about 85, about 86, about 87, about 88, about 89, about 90, about 91, about 92, about 93, about 94, about 95, about 96, about 97, about 98, about 99, or about 100, compared to a different patient at the same time point who has not received the antibody has achieved an improvement in health status. Additional endpoints for assessing the efficacy of the methods of the present disclosure include one or more of the following: mortality (e.g., all causes or cardiovascular related); relative risk of mortality (e.g., all-cause mortality, cardiac mortality); risk of hospitalization; number of days alive out of hospital (DAOH); NT-proBNP; cardiac response rate; improving a six minute walk test (6MWT); a Kansas City Cardiomyopathy Questionnaire (KCCQ) score; and/or Major Organ Deterioration Progression Free Survival (MOD-PFS). Thus, in some embodiments, methods of the present disclosure further comprises one or more of the following: an improvement and/or slowing of mortality (e.g., all causes or cardiovascular related); a reduction in a relative risk of mortality (e.g., all-cause mortality, cardiac mortality); a reduction of the risk of hospitalization; an increase in the number of days alive out of hospital (DAOH); a reduction in NT-proBNP; an improvement in cardiac response rate; an improvement a six minute walk test (6MWT); an increase and/or slowing of decline in a Kansas City Cardiomyopathy Questionnaire (KCCQ) score; and/or an increase in Major Organ Deterioration Progression Free Survival (MOD-PFS). In some embodiments, methods of the present disclosure include achieving, during treatment, values for these endpoints disclosed in Int’l Pat. App. No. WO2020/178638A1, which is incorporated herein by reference in its entirety. Treatment typically entails multiple dosages over a period of time. Treatment can be monitored by assaying antibody or employing radiolabeled SAP Scintigraphy over time. If the response falls, a booster dosage may be indicated. Changes in the health status of the patients can be monitored based on outcome measures such as 6MWD, SF-36 PCS (SF- 36v2), hospitalizations and survival as discussed in greater detail above. In addition, the response of patients with AL amyloidosis to treatment can be monitored by assessing cardiac markers, such as NT-proBNP and/or troponin-T, serum creatine, and/or alkaline phosphatase; by performing serum free light chain (SFLC) assays, quantitative immunoglobulin assays, Attorney Docket No.50887-0050WO1 biopsies, serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP), serum, urine immunofixation electrophoresis (IFE), and/or organ imaging techniques. An exemplary complete response (CR) can be determined from response criteria including negative IFE of serum and urine, normal ^^^ ration and/or <5 % plasma cells in bone marrow. An exemplary very good partial response (VGPR) can be determined from a dFLC of < 40 mg/L. An exemplary partial response (PR) can be determined from a dFLC decrease of ≥ 50%. In the kidney, a response to treatment can be determined, for example, from a ≥ 50% reduction (e.g., > 0.5g/24 hours) in 24 hour urine protein excretion in the absence of either a reduction in eGFR of ≥ 25% or an increase in serum creatine of ≥ 0.5 mg/dL. In the liver, a response to treatment can be determined, for example, from a ≥ 50% reduction in initially elevated alkaline phosphatase or a ≥ 2 cm reduction in liver size on CT scan or MRI. In the heart, a response to treatment can be determined, for example, from a >30% and > 300 ng/L reduction in NT-proBNP in patients with baseline of NT-proBNP of > 650 ng/L. In the kidney, a response to treatment can be determined, for example, from a > 30% decrease in proteinuria or a decrease in proteinuria to < 0.5 g/24 hours in the absence of renal progression. Neuropathy responders are generally characterized by < 2 point increase in NIS- LL from baseline. Improvement in neuropathy (e.g., improved nerve function) is determined from a decrease in the NIS-LL from baseline. Improvement in health status can also be determined from a decrease in the frequency of hospitalizations, a decrease in hospitalizations of greater than ninety days, or from longer survival relative to an untreated different patient with a similar prognosis upon diagnosis, for example, AL amyloidosis patients with cardiac involvement. The antibody formulation can be administered intravenously or subcutaneously in dosage ranges from about 0.5 mg/kg to about 30 mg/kg of the host body weight. For example, dosages can be about 0.5 mg/kg body weight, about 1.0 mg/kg, about 1.5 mg/kg, about 2.0 mg/kg, about 4.0 mg/kg, about 5.0 mg/kg, about 8.0 mg/kg, about 10 mg/kg, about 15 mg/kg, about 16 mg/kg, about 20 mg/kg, about 24 mg/kg, about 25 mg/kg, or about 30 mg/kg body weight. The dosages can also be administered according to body surface area from about 0.5 mg/m2 to about 500 mg/m2, for example, 0.5, 5, 10, 50, 100, 250 or 500 mg/m2. For intravenous dosing, an amount of the antibody formulation sufficient to achieve the desired dosage for the individual patient is transferred from one or more vials to one or more intravenous bags containing a liquid (e.g., saline) and administered to the patient. Attorney Docket No.50887-0050WO1 Antibody is usually administered on multiple occasions. An exemplary treatment regimen entails administration once per every two weeks, once a month, or once every 3 to 6 months. For example, patients can receive the antibody formulation once every four weeks as a cycle, for example every twenty-eight days. The dosing frequency can be adjusted depending on the pharmacokinetic profile of the antibody formulation in the patient. For example, the half-life of the antibody may warrant a two week frequency of dosing. In some embodiments, the pharmaceutical formulation is administered intravenously every 28 days with an antibody dosage of about 24 mg/kg. For example, some patients may receive an intravenous dose of about 24 mg/kg birtamimab every 28 days. For example, some patients may receive an intravenous dose of about 24 mg/kg birtamimab every 28 days (±5 days). In certain embodiments, a minimum of 21 days is required between doses. For some such patients, the birtamimab formulation transferred to the intravenous bag was first reconstituted from a lyophilized formulation to a formulation having a pH of about 6.5 and comprising about 50 mg/ml birtamimab, about 25 mM histidine buffer, about 230 mM trehalose and about 0.2 g/L polysorbate 20. For some patients the desired dosage can be administered subcutaneously without dilution from a vial containing any of the formulations disclosed herein. In some embodiments disclosed herein, the antibody is administered to the patient for at least 8 months, at least 9 months, at least 10 months, at least 11 months, at least 12 months, or for a longer period of time. For example, the pharmaceutical formulation is administered to the patient for a duration effective to achieve or maintain an improvement in health status as indicated by an increase in 6MWD or SF-36 PCS score, or long enough to achieve or maintain a lower risk of mortality relative to an untreated patient. For some patients, the lower risk can be established after at least 8 months of treatment. For some patients, the lower risk can be established after at least 9 months of treatment. For some patients, the lower risk can be established after at least 12 months of treatment or after at least 18 months of treatment or after twenty-four months of treatment. For these patients, a lower risk of mortality correlates with longer survival times relative to untreated patients. Also disclosed herein are combination therapies for treatment or prophylaxis of AL amyloidosis (including Mayo Stage IV amyloidosis or AL amyloidosis with cardiac involvement). Such combination therapies are performed by administering an antibody formulation disclosed herein in conjunction with one or more second therapeutic agents, such as another therapy to treat or effect prophylaxis of AL amyloidosis. Combination therapies as Attorney Docket No.50887-0050WO1 disclosed herein may also be performed in conjunction with a second therapy is used to treat or effect prophylaxis of a disease or condition associated with amyloid disease, such as an inflammatory disease, a chronic microbial infection, a neoplasm (including malignant neoplasms), an inherited inflammatory disease, and/or a lymphoproliferative disorder. Numerous treatments are available in commercial use, in clinical evaluation, and in pre- clinical development, any of which could be selected for use in combination with the disclosed antibody formulations. Such treatments can be one or more compounds or treatments selected from, but not limited to several major categories, namely, (i) non- steroidal anti-inflammatory drugs (NSAIDs; e.g., detoprofen, diclofenac, diflunisal, etodolac, fenoprofen, flurbiprofen, ibuprofen, indomethacin, ketoprofen, meclofenameate, mefenamic acid, meloxicam, nabumeone, naproxen sodium, oxaprozin, piroxicam, sulindac, tolmetin, celecoxib, rofecoxib, aspirin, choline salicylate, salsalte, and sodium and magnesium salicylate); (ii) steroids (e.g., cortisone, dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone, triamcinolone); (iii) DMARDs, i.e., disease modifying antirheumatic drugs (e.g., cyclosporine, azathioprine, methotrexate, leflunomide, cyclophosphamide, hydroxychloroquine, sulfasalazine, D-penicillamine, minocycline, and gold); (iv) recombinant proteins (e.g., ENBREL® (etanercept, a soluble TNF receptor) and REMICADE® (infliximab) a chimeric monoclonal anti-TNF antibody); (v) stem cell transplantation; and/or (vi) chemotherapy. Patients with AL amyloidosis may also receive treatment regimens that include drugs or combinations of drugs often used to treat hematological malignancies, such as melphalan, prednisone, dexamethasone, lenalidomide (REVLIMID®), proteosome inhibitors such as bortezomib (VELCADE®) and carfilzomib (KYPROLIS®), and CD38 agents such as daratumumab (DARZALEX®), at dosages in the range of the standard of care. When performing a combination therapy, the two or more drug substances are administered simultaneously or sequentially in any order, i.e., a formulation disclosed herein is administered prior to administering a second drug substance, concurrently with a second drug substance, or subsequent to administration of a second drug substance. For example, a combination therapy may be performed by administering a first therapy prior to (e.g., 1 minute, 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 8 weeks, or 12 weeks before), concomitantly with, or subsequent to (e.g., 1 minute, 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 Attorney Docket No.50887-0050WO1 hours, 48 hours, 72 hours, 96 hours, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 8 weeks, or 12 weeks after) administering a second agent/therapy. The dosage, frequency and mode of administration of each component of the combination can be controlled independently. For example, one therapeutic agent/therapy may be administered orally three times per day, while the second therapeutic agent/therapy may be administered intramuscularly once per day. Combination therapy may be given in on-and-off cycles that include rest periods. The compounds may also be admixed or otherwise formulated together such that one administration delivers both compounds. In this case, each therapeutic agent is generally present in an amount of 1-95% by weight of the total weight of the composition. Alternatively, an antibody formulation disclosed herein and a second therapeutic agent can be formulated separately and in individual dosage amounts. Drug combinations for treatment can be provided as components of a pharmaceutical pack. Preferably, the disclosed combination therapies elicit a synergistic therapeutic effect, i.e., an effect greater than the sum of their individual effects or therapeutic outcomes. Measurable therapeutic outcomes are described herein. For example, a synergistic therapeutic effect may be an effect of at least about two-fold greater than sum of the therapeutic effects elicited by the single agents of a given combination, or at least about five-fold greater, or at least about ten-fold greater, or at least about twenty-fold greater, or at least about fifty-fold greater, or at least about one hundred-fold greater. A synergistic therapeutic effect may also be observed as an increase in therapeutic effect of at least 10% compared to the sum of the therapeutic effects elicited by the single agents of a given combination, or at least 20%, or at least 30%, or at least 40%, or at least 50%, or at least 60%, or at least 70%, or at least 80%, or at least 90%, or at least 100%, or more. A synergistic effect is also an effect that permits reduced dosing of therapeutic agents when they are used in combination. Some methods of the disclosure include treating a subject having AL amyloidosis by determining one or more of the following prognostic indicators: (1) the Mayo Stage of the patient’s AL amyloidosis, (2) the 6 minute walk distance (6MWD) and ejection fraction (EF) of the patient, and/or the Mayo Stage and the EF of the patient. Once the prognostic indicator(s) has been determined, a patient is selected the patient for treatment if the patient meets one of the following treatment criteria: (1) has Mayo Stage IV AL amyloidosis; (2) has a 6MWD ^ 150 meters and an EF > 50% at baseline; (3) has Mayo Stage IV and EF > 50% at baseline; or (4) has Mayo Stage IV, a 6MWD ^ 150 meters and an EF > 50% at baseline. Treatment includes administering an effective dosage of an antibody disclosed herein. Attorney Docket No.50887-0050WO1 In one method of the disclosure, a patient meeting or more of the prognostic indicators is treated with birtamimab (24 mg/kg) supplied as a sterile, lyophilized dosage form in a 20/25 mL vial containing 500 mg birtamimab. Each vial may be reconstituted with 9.6 mL sterile water for injection (WFI) to a concentration of 50 mg/mL resulting in a buffered, isotonic, preservative-free solution. Birtamimab is administered once every 28 days as an initial 120 (±10)-minute IV infusion. If the subject tolerates the initial infusion, subsequent infusions may be administered over 60 (±10) minutes. Dose are administered at intervals of at least 21 days. Patients may also be treated with concomitant standard of care chemotherapy, which may include, for example, bortezomib administered subcutaneously on a weekly basis. III. Methods of Treatment and Amenable Subjects Subjects amenable to treatments and methods disclosed herein are those with AL amyloidosis (including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement). Thus, provided herein are methods of treating a human subject showing symptoms of or diagnosed with AL amyloidosis (including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement) and a human subject having a baseline 6MWD of ^ 150 meters and a baseline EF of >50%, comprising administering to the patient a regimen of any of the antibodies or antibody formulations described herein effective to improve the health status of the subject. Some of the subjects have Mayo Stage IV AL amyloidosis and a baseline 6MWD of ^ 150 meters and a baseline EF of > 50%. Some subjects have Mayo Stage IV AL amyloidosis and a baseline EF of > 50%. Some patients have systemic organ dysfunction attributed to AL amyloidosis, including dysfunction of the heart, kidney, liver, peripheral nervous system, gastrointestinal system, autonomic nervous system, lung, and/or soft tissue or lymphatic system. In addition to selecting subjects having AL amyloidosis (including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement), some methods herein may involve determining the baseline level of troponin-T, NT-proBNP and relative levels of involved and uninvolved light chain in a subject, selecting the patient for treatment if the subject has a baseline level of cTnT ^ 0.025 ng/mL or > 0.03 ng/mL, NT-ProBNP ^ 1,800 pg/mL (and < 8500 pg/mL) and FLC-diff ^ 18 mg/dL, and administering an effective dosage of any of the antibodies disclosed herein. Some methods also may involve determining the 6MWD and EF Attorney Docket No.50887-0050WO1 of a subject at baseline and selecting the patient for treatment if the subject has a 6MWD of ^ 150 meters and an EF of > 50%. In such instances, subjects having Mayo Stage IV with baseline 6MWD of ^ 150 meters and/or baseline EF of > 50% are selected for treatment. Some methods involve determining the Mayo Stage and EF of the subject and in some instances Mayo Stage IV subjects with a baseline EF of > 50% are selected for treatment. In addition to selecting subjects having AL amyloidosis (including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement), subjects can also be selected for treatment based on their responses on SF-36 and/or SF-36v2. For example, in some embodiments, subjects may be selected for treatment based on their reported value for a HRQoL (e.g., as measured by the SF-36 or SF-36v2). For example, in some embodiments, the subject is selected for treatment after being determined, diagnosed, identified, or selected as having decreased HRQoL (e.g., as compared to a subject of similar age and not having AL amyloidosis or any neurological disorder or compared to a prior measurement taken from the same subject). In some embodiments, the subject has been previously determined diagnosed, identified, or selected as having decreased HRQoL (e.g., as compared to a subject of similar age and not having AL amyloidosis or any neurological disorder, or compared to a prior measurement taken from the same subject). In some embodiments, subjects may be selected for treatment based on their reported value for any of the following domains: social functioning, physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score (e.g., as measured by the SF-36 or SF-36v2). For example, in some embodiments, the subject is selected for treatment after being determined, diagnosed, identified, or selected as having decreased score for any of the following domains: social functioning, physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score (e.g., as compared to a subject of similar age and not having AL amyloidosis or any neurological disorder or compared to a prior measurement taken from the same subject). For example, in some embodiments, the subject has been previously determined diagnosed, identified, or selected as having decreased score for any of the following domains: social functioning, physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score (e.g., as compared to a subject of similar age and not having Attorney Docket No.50887-0050WO1 AL amyloidosis or any neurological disorder or compared to a prior measurement taken from the same subject). In some embodiments, subjects may be selected for treatment based on their reported value for at least one (e.g., at least two, at least three, or at least four) of the following domains: social functioning, physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score (e.g., as measured by the SF-36 or SF-36v2). For example, in some embodiments, the subject is selected for treatment after being determined, diagnosed, identified, or selected as having decreased score for at least one (e.g., at least two, at least three, or at least four) of the following domains: social functioning, physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score (e.g., as compared to a subject of similar age and not having AL amyloidosis or any neurological disorder or compared to a prior measurement taken from the same subject). For example, in some embodiments, the subject has been previously determined diagnosed, identified, or selected as having decreased score for at least one (e.g., at least two, at least three, or at least four) of the following domains: social functioning, physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score (e.g., as compared to a subject of similar age and not having AL amyloidosis or any neurological disorder or compared to a prior measurement taken from the same subject). For example, in some embodiments, subjects may be selected for treatment based on their reported value for a social functioning score (e.g., as measured by the SF-36 or SF- 36v2). For example, in some embodiments, the subject is selected for treatment after being determined, diagnosed, identified, or selected as having decreased social functioning score (e.g., as compared to a subject of similar age and not having AL amyloidosis or any neurological disorder or compared to a prior measurement taken from the same subject). In some embodiments, the subject has been previously determined diagnosed, identified, or selected as having decreased social functioning score (e.g., as compared to a subject of similar age and not having AL amyloidosis or any neurological disorder or compared to a prior measurement taken from the same subject). In some embodiments, subjects may be selected for treatment based on their reported value for a role physical score (e.g., as measured by the SF-36 or SF-36v2). For example, in Attorney Docket No.50887-0050WO1 some embodiments, the subject is selected for treatment after being determined, diagnosed, identified, or selected as having decreased role physical score (e.g., as compared to a subject of similar age and not having AL amyloidosis or any neurological disorder or compared to a prior measurement taken from the same subject). In some embodiments, the subject has been previously determined, diagnosed, identified, or selected as having decreased role physical score (e.g., as compared to a subject of similar age and not having AL amyloidosis or any neurological disorder or compared to a prior measurement taken from the same subject). In some embodiments, subjects may be selected for treatment based on their reported value for a bodily pain score (e.g., as measured by the SF-36 or SF-36v2). For example, in some embodiments, the subject is selected for treatment after being determined, diagnosed, identified, or selected as having decreased bodily pain score (e.g., as compared to a subject of similar age and not having AL amyloidosis or any neurological disorder or compared to a prior measurement taken from the same subject). In some embodiments, the subject has been previously determined, diagnosed, identified, or selected as having decreased bodily pain score (e.g., as compared to a subject of similar age and not having AL amyloidosis or any neurological disorder or compared to a prior measurement taken from the same subject). In some embodiments, subjects may be selected for treatment based on their reported value for a physical functioning score (e.g., as measured by the SF-36 or SF-36v2). For example, in some embodiments, the subject is selected for treatment after being determined, diagnosed, identified, or selected as having decreased physical functioning score (e.g., as compared to a subject of similar age and not having AL amyloidosis or any neurological disorder or compared to a prior measurement taken from the same subject). In some embodiments, the subject has been previously determined, diagnosed, identified, or selected as having decreased physical functioning score (e.g., as compared to a subject of similar age and not having AL amyloidosis or any neurological disorder or compared to a prior measurement taken from the same subject). In some embodiments, subjects may be selected for treatment based on their reported value for a general health perceptions score (e.g., as measured by the SF-36 or SF-36v2). For example, in some embodiments, the subject is selected for treatment after being determined, diagnosed, identified, or selected as having decreased general health perceptions score (e.g., as compared to a subject of similar age and not having AL amyloidosis or any neurological disorder or compared to a prior measurement taken from the same subject). In some embodiments, the subject has been previously determined diagnosed, identified, or selected Attorney Docket No.50887-0050WO1 as having decreased general health perceptions score (e.g., as compared to a subject of similar age and not having AL amyloidosis or any neurological disorder or compared to a prior measurement taken from the same subject). In some embodiments, subjects may be selected for treatment based on their reported value for a vitality score (e.g., as measured by the SF-36 or SF-36v2). For example, in some embodiments, the subject is selected for treatment after being determined, diagnosed, identified, or selected as having decreased vitality score (e.g., as compared to a subject of similar age and not having AL amyloidosis or any neurological disorder or compared to a prior measurement taken from the same subject). In some embodiments, the subject has been previously determined, diagnosed, identified, or selected as having decreased vitality score (e.g., as compared to a subject of similar age and not having AL amyloidosis or any neurological disorder or compared to a prior measurement taken from the same subject). In some embodiments, subjects may be selected for treatment based on their reported value for a role-emotional score (e.g., as measured by the SF-36 or SF-36v2). For example, in some embodiments, the subject is selected for treatment after being determined, diagnosed, identified, or selected as having decreased role-emotional score (e.g., as compared to a subject of similar age and not having AL amyloidosis or any neurological disorder or compared to a prior measurement taken from the same subject). In some embodiments, the subject has been previously determined, diagnosed, identified, or selected as having decreased role-emotional score (e.g., as compared to a subject of similar age and not having AL amyloidosis or any neurological disorder or compared to a prior measurement taken from the same subject). In some embodiments, subjects may be selected for treatment based on their reported value for a mental health score (e.g., as measured by the SF-36 or SF-36v2). For example, in some embodiments, the subject is selected for treatment after being determined, diagnosed, identified, or selected as having decreased mental health score (e.g., as compared to a subject of similar age and not having AL amyloidosis or any neurological disorder or compared to a prior measurement taken from the same subject). In some embodiments, the subject has been previously determined, diagnosed, identified, or selected as having decreased mental health score (e.g., as compared to a subject of similar age and not having AL amyloidosis or any neurological disorder or compared to a prior measurement taken from the same subject). In some embodiments, subjects may be selected for treatment based on their reported value for a physical component score (e.g., as measured by the SF-36 or SF-36v2). For Attorney Docket No.50887-0050WO1 example, in some embodiments, the subject is selected for treatment after being determined, diagnosed, identified, or selected as having decreased physical component score (e.g., as compared to a subject of similar age and not having AL amyloidosis or any neurological disorder or compared to a prior measurement taken from the same subject). In some embodiments, the subject has been previously determined, diagnosed, identified, or selected as having decreased physical component score (e.g., as compared to a subject of similar age and not having AL amyloidosis or any neurological disorder or compared to a prior measurement taken from the same subject). In some embodiments, subjects may be selected for treatment based on their reported value for a mental component score (e.g., as measured by the SF-36 or SF-36v2). For example, in some embodiments, the subject is selected for treatment after being determined, diagnosed, identified, or selected as having decreased mental component score (e.g., as compared to a subject of similar age and not having AL amyloidosis or any neurological disorder or compared to a prior measurement taken from the same subject). In some embodiments, the subject has been previously determined, diagnosed, identified, or selected as having decreased mental component score (e.g., as compared to a subject of similar age and not having AL amyloidosis or any neurological disorder or compared to a prior measurement taken from the same subject). For example, in another aspect, the present disclosure provides a method of slowing a decline in social functioning in a subject having AL amyloidosis (including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement), the method comprising: (a) selecting a subject for treatment based on the subject having a low HRQoL (e.g., as compared to a subject of similar age and not having AL amyloidosis or any neurological disorder); and (b) administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468) or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105). In another aspect, the present disclosure provides a method of treating AL amyloidosis (including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement) in a subject, the method comprising: Attorney Docket No.50887-0050WO1 (a) selecting a subject for treatment based on the subject having a low baseline HRQoL (e.g., as compared to a subject of similar age and not having AL amyloidosis or any neurological disorder or compared to a prior measurement taken from the same subject) and (b) administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105); wherein treating comprises a slowing of a decline in HRQoL in the subject. In some embodiments, the low baseline HRQoL score comprises a low score in any of the following domains: social functioning, physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and/or mental component score (e.g., as measured by the SF-36 or SF-36v2). In some embodiments, the low baseline HRQoL score comprises a low score in at least one (e.g., at least two, at least three, or at least four) of the following domains: social functioning, physical functioning, role physical, bodily pain, general health perceptions, vitality, role- emotional, mental health, physical component score, and/or mental component score (e.g., as measured by the SF-36 or SF-36v2). In various embodiments, the low baseline HRQoL score comprises a reported baseline value within any of the ranges of baseline values provided in Tables 2A-2C. In various embodiments, the low baseline HRQoL score comprises a reported baseline value at about the same value as any of the baseline values provided in Tables 2A- 2C (e.g., median value, Q1 value, or Q3 value). In another aspect, the present disclosure provides a method of slowing a decline in social functioning in a subject having AL amyloidosis (including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement), the method comprising: (a) selecting a subject for treatment based on the subject having a low baseline social functioning score, role physical score, or bodily pain score (e.g., as compared to a subject of similar age and not having AL amyloidosis or any neurological disorder); and (b) administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Attorney Docket No.50887-0050WO1 Accession Number PTA-9468) or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105). In another aspect, the present disclosure provides a method of treating AL amyloidosis (including Mayo Stage IV AL amyloidosis or AL amyloidosis with cardiac involvement) in a subject, the method comprising: (a) selecting a subject for treatment based on the subject having a baseline social functioning score, role physical score, or bodily pain score (e.g., as compared to a subject of similar age and not having AL amyloidosis or any neurological disorder); and (b) administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105); wherein treating comprises a slowing of a decline in social functioning in the subject. In some embodiments, the baseline social functioning score (or baseline role physical score or baseline bodily pain score) is assessed using the SF-36 or the SF-36v2. In some embodiments, the baseline social functioning score (or baseline role physical score or baseline bodily pain score) is assessed using the SF-36 or the SF-36v2. In some embodiments, the baseline social functioning score (or baseline role physical score or baseline bodily pain score) is assessed using the SF-36v2. In some embodiments, the subject has been determined, diagnosed, identified, or selected for treatment as having baseline social functioning score (e.g., as measured using the SF-36 or SF-36v2) of less than about 85 (e.g., less than about 83, less than about 81, less than about 79, or less than about 77). In some embodiments, the subject has been determined, diagnosed, identified, or selected for treatment as having baseline social functioning score of less than about 75 (e.g., less than about 73, less than about 71, less than about 69, or less than about 67). In some embodiments, the subject has been determined, diagnosed, identified, or selected for treatment as having baseline social functioning score of less than about 65 (e.g., less than about 63, less than about 61, less than about 59, or less than about 57). In some embodiments, the subject has been determined, diagnosed, identified, or selected for treatment as having baseline social functioning score (e.g., as measured using the SF-36 or SF-36v2) of about 45 to about 85 (e.g., about 50 to about 85, about 55 to about 85, Attorney Docket No.50887-0050WO1 about 60 to about 85, about 65 to about 85, or about 70 to about 85). In some embodiments, the subject has been determined, diagnosed, identified, or selected for treatment as having baseline social functioning score of about 45 to about 80 (e.g., about 50 to about 80, about 55 to about 80, about 60 to about 80, about 65 to about 80, or about 70 to about 80). In some embodiments, the subject has been determined, diagnosed, identified, or selected for treatment as having baseline social functioning score of about 45 to about 75 (e.g., about 50 to about 75, about 55 to about 75, about 60 to about 75, about 65 to about 75, or about 70 to about 75). In some embodiments, the subject has been determined, diagnosed, identified, or selected for treatment as having baseline social functioning score of about 45 to about 70 (e.g., about 50 to about 70, about 55 to about 70, about 60 to about 70, or about 65 to about 70). In some embodiments, the subject has been determined, diagnosed, identified, or selected for treatment as having baseline social functioning score of about 50 to about 65. In some embodiments, the subject has been determined, diagnosed, identified, or selected for treatment as having baseline role physical score (e.g., as measured using the SF- 36 or SF-36v2) of less than about 55 (e.g., less than about 53, less than about 51, less than about 49, or less than about 47). In some embodiments, the subject has been determined, diagnosed, identified, or selected for treatment as having baseline role physical score of less than about 45 (e.g., less than about 43, less than about 41, less than about 39, or less than about 37). In some embodiments, the subject has been determined, diagnosed, identified, or selected for treatment as having baseline role physical score of less than about 35 (e.g., less than about 34, less than about 33, less than about 32, or less than about 31). In some embodiments, subject has been determined, diagnosed, identified, or selected for treatment as having baseline role physical score (e.g., as measured using the SF-36 or SF- 36v2) of about 20 to about 50 (e.g., about 25 to about 50, about 30 to about 50, about 35 to about 50, or about 40 to about 50). In some embodiments, the subject has been determined, diagnosed, identified, or selected for treatment as having baseline role physical score of about 20 to about 40 (e.g., about 25 to about 40, about 30 to about 40, or about 35 to about 40). In some embodiments, the subject has been determined, diagnosed, identified, or selected for treatment as having baseline role physical score of about 25 to about 35 (e.g., about 27 to about 35, about 29 to about 35, or about 31 to about 35). In some embodiments, the subject has been determined, diagnosed, identified, or selected for treatment as having baseline bodily pain score (e.g., as measured using the SF-36 or SF-36v2) of less than about 85 (e.g., less than about 83, less than about 81, less than about Attorney Docket No.50887-0050WO1 79, or less than about 77). In some embodiments, the subject has been determined, diagnosed, identified, or selected for treatment as having baseline bodily pain score of less than about 75 (e.g., less than about 73, less than about 71, less than about 69, or less than about 67). In some embodiments, the subject has been determined, diagnosed, identified, or selected for treatment as having baseline bodily pain score (e.g., as measured using the SF-36 or SF-36v2) of about 45 to about 85 (e.g., about 50 to about 85, about 55 to about 85, about 60 to about 85, about 65 to about 85, or about 70 to about 85). In some embodiments, the subject has been determined, diagnosed, identified, or selected for treatment as having baseline bodily pain score of about 45 to about 80 (e.g., about 50 to about 80, about 55 to about 80, about 60 to about 80, about 65 to about 80, or about 70 to about 80). In some embodiments, the subject has been determined, diagnosed, identified, or selected for treatment as having baseline bodily pain score of about 45 to about 75 (e.g., about 50 to about 75, about 55 to about 75, about 60 to about 75, about 65 to about 75, or about 70 to about 75). In some embodiments, the subject has been determined, diagnosed, identified, or selected for treatment as having baseline bodily pain score of about 45 to about 70 (e.g., about 50 to about 70, about 55 to about 70, about 60 to about 70, or about 65 to about 70). In some embodiments, the subject has been determined, diagnosed, identified, or selected for treatment as having baseline bodily pain score of about 60 to about 70. In some embodiments, the subject (also referred herein as a “patient”) is treatment naïve, meaning that the patient has not previously received any treatment for AL amyloidosis. Patients amenable to treatment also include those patients who have received, are currently receiving, or will later receive an alternate therapy for treatment of AL amyloidosis or an associated condition, such as, inflammatory diseases, chronic microbial infections, malignant neoplasms, inherited inflammatory diseases, and lymphoproliferative disorders. For example, patients may also receive or have received one or more of the therapeutic agents identified herein with respect to combination therapies. As an example, patients suffering from AL amyloidosis may also receive or have received or may later receive bortezomib, melphalan, lenalidomide, prednisone, dexamethasone, cyclophosphamide, pomalidomide, carfilzomib, doxorubicin, doxycycline, daratumumab, autologous transplant or combinations thereof. For those patients who have previously received alternate therapies for the treatment of amyloid disease, such therapies may or may not have been successful by the relevant clinical measures, and likely did not improve health status. Additional examples of such therapies include (1) CyBorD, which is a combination therapy comprising Attorney Docket No.50887-0050WO1 cyclophosphamide, bortezomib and dexamethasone, (2) BMDex, which is a combination of bortezomib, melphalan and dexamethasone, (3) MDex, which is a combination of melphalan and dexamethasone, (4) LDex, which is a combination of lenalidomide and dexamethasone, (5) CLD, which is a combination of cyclophosphamide, lenalidomide and dexamethasone, (6) PomDex, which is a combination of pomalidomide and dexamethasone, and (7) CRd, which is a combination of lenalidomide, cyclophosphamide and dexamethasone. Such patients may, or may not, have experienced cardiac and/or renal improvement as a result of such treatment. IV. Antibodies The methods of the disclosure include administering to a patient an antibody that specifically bind to immunoglobulin light chain. Examples include antibodies that compete with 11-1F4 for binding to immunoglobulin light chain, and antibodies that compete with 2A4 or 7D8 for binding to human amyloid A peptide, or specifically bind to the same epitope as 11-1F4 (U.S. Patent No.8,105,594), 2A4 or 7D8 (U.S. Patent No.7,928,203). In some embodiments, the antibody is a humanized version of 2A4. In some embodiments, the antibody is a chimeric or humanized version of 11-1F4, such as, for example, Ch mAb 11- 1F4, CAEL-101, anselamimab. In some embodiments, the antibody is one that is disclosed in U.S. Patent Publication No.20190038745A1, U.S. Patent Publication No.20200002410A1, and U.S. Patent No.10,046,050. In some embodiments, the antibody comprises a light chain variable region comprising three complementarity determining regions set forth as SEQ ID NOs: 3, 4 and 5, and a heavy chain variable region comprising three complementarity determining regions set forth as SEQ ID NOs: 6, 7 and 8. In some embodiments, the light chain variable region comprises the amino acid sequence set forth as SEQ ID NO: 1. In some embodiments, the heavy chain variable region comprises the amino acid sequence set forth as SEQ ID NO: 2. In other methods, the antibody comprises light chain and heavy chain variable regions of a murine, chimeric, or humanized 2A4 antibody, or of a murine, chimeric, or humanized 7D8 antibody, as described in U.S. Patent No.7,928,203 and PCT International Publication No. WO 2009/086539, each of which is incorporated herein by reference in its entirety, and the light chain and heavy chain variable region sequences described in the referenced patent and publication are specifically incorporated by reference herein. Some formulations for the methods disclosed herein are described in U.S. Patent No.9,089,529 and PCT International Publication No. WO 2013/063284. Attorney Docket No.50887-0050WO1 In some embodiments, the antibody comprises a light chain comprising an amino acid sequence set forth as SEQ ID NO: 10 and a heavy chain comprising an amino acid sequence set forth as any one of SEQ ID NOs: 11-13. For example, the antibody can comprise a light chain comprising an amino acid sequence set forth as SEQ ID NO:10 and a heavy chain comprising an amino acid sequence set forth as SEQ ID NO:12. The antibody can include, or not include, the leader sequences of the above-noted light chain and heavy chain amino acid sequences. In some embodiments, the antibody is birtamimab (CAS Registry No. 1608108-91-3). In other methods, the antibody is a fragment of a 2A4 or 7D8 antibody, including chimeric and humanized versions thereof, such as a Fab fragment, a Fab’ fragment, a F(ab’)2 fragment, F(ab)c, Dab, nanobody or Fv. As discussed in greater detail below, the antibody can be administered as a pharmaceutical formulation. In some embodiments, the length of treatment using an antibody disclosed herein for at least 1 month, at least 2 months, at least 3 months, at least 4 months, at least 5 months, at least 6 months, at least 7 months, at least 8 months, at least 9 months, at least 10 months, at least 11 months, at least 12 months, at least 13 months, at least 14 months, at least 15 months, at least 16 months, at least 17 months, at least 18 months, at least 19 months, at least 20 months, at least 21 months, at least 22 months, at least 23 months, or at least 24 months. In some embodiments, the length of treatment using an antibody disclosed herein for about 1 month, about 2 months, about 3 months, about 4 months, about 5 months, about 6 months, about 7 months, about 8 months, about 9 months, about 10 months, about 11 months, about 12 months, about 13 months, about 14 months, about 15 months, about 16 months, about 17 months, about 18 months, about 19 months, about 20 months, about 21 months, about 22 months, about 23 months, about 24 months. V. Pharmaceutical Formulations and Products In some embodiments disclosed herein, the antibody can be administered to a patient as a pharmaceutical formulation, for example, comprising in addition to the antibody, a histidine buffer, trehalose, and polysorbate 20. In some such formulations used in the methods described above, the antibody is present at a concentration within the range from about 1 mg/mL to about 100 mg/mL; the histidine buffer is present at a concentration within the range from about 20 mM to about 30 mM; the trehalose is present at a concentration within the range from about 210 mM to about 250 mM; the polysorbate 20 present at a Attorney Docket No.50887-0050WO1 concentration within the range from about 0.005% to about 0.05% by weight; and the pH is within the range from about 6 to about 7. Some suitable formulations for the methods disclosed herein are described in greater detail below. In some formulations, the antibody is present at a concentration within the range from about 5 mg/mL to about 100 mg/mL. In some formulations, the antibody is present at a concentration within the range from about 5 mg/mL to about 15 mg/mL. In some formulations, the antibody is present at a concentration within the range from about 25 mg/mL to about 75 mg/mL. For example, the antibody may be present at a concentration of about 10 mg/mL, or present at a concentration of about 50 mg/mL. The antibody may be present in a sterile liquid dosage form of about 50 mg/vial to about 500 mg/vial, or greater. For example, the antibody may be present in a sterile liquid dosage form of about 100 mg/vial. In another, non-limiting example, the antibody may be present as a sterile, lyophilized dosage form that may be reconstituted with sterile liquid dosage form of about 500 mg/vial. In another, non-limiting example, the antibody may be present as a sterile, lyophilized dosage form that may be reconstituted with sterile liquid of about 10 mL for a dosage form of about 50 mg/mL or about 500 mg/vial. Antibodies used in the disclosed formulations can be coupled with a therapeutic moiety, such as a cytotoxic agent, a radiotherapeutic agent, an immunomodulator, a second antibody (e.g., to form an antibody heteroconjugate), or any other biologically active agent that facilitates or enhances the activity of a chimeric or humanized 2A4 or a chimeric or humanized 7D8 antibody. Representative therapeutic moieties include agent known to be useful for treatment, management, or amelioration of amyloid disease or symptoms of amyloid disease. Therapeutic moieties and/or detectable substances may be coupled or conjugated directly to a murine, chimeric or humanized 2A4 antibody or a murine, chimeric or humanized 7D8 antibody, or indirectly, through an intermediate (e.g., a linker) using techniques known in the art. See e.g., Arnon et al., "Monoclonal Antibodies For Immunotargeting Of Drugs In Cancer Therapy", in Monoclonal Antibodies And Cancer Therapy, Reisfeld et al. (eds.), pp.243-56 (Alan R. Liss, Inc.1985); Hellstrom et al., "Antibodies For Drug Delivery", in Controlled Drug Delivery (2nd Ed.), Robinson et al. (eds.), pp.623-53 (Marcel Dekker, Inc.1987); Thorpe, "Antibody Carriers Of Cytotoxic Agents In Cancer Therapy: A Review", in Monoclonal Antibodies 84: Biological And Clinical Applications, Pinchera et al. (eds.), pp.475-506 (1985); "Analysis, Results, And Attorney Docket No.50887-0050WO1 Future Prospective Of The Therapeutic Use Of Radiolabeled Antibody In Cancer Therapy", in Monoclonal Antibodies For Cancer Detection And Therapy, Baldwin et al. (eds.), pp.303- 16 (Academic Press 1985), and Thorpe et al., Immunol. Rev., 1982, 62:119-58. Antibodies used in the disclosed formulations also include modified forms of murine, chimeric or humanized 2A4 antibodies, or murine, chimeric or humanized 7D8 antibodies, which have increased in vivo half-lives relative to the corresponding unmodified antibodies. Such modified forms may be prepared, for example, by glycosylation, acetylation, pegylation, phosphorylation, amidation, derivatization by known protecting/blocking groups, proteolytic cleavage, linkage to a cellular ligand or other protein, etc. As one example, representative methods for antibody half-life extension are described in PCT International Publication No. WO 02/060919. The histidine buffer may be present in some formulations at a concentration of about 25 mM. In some formulations, the histidine buffer comprises L-histidine and L-histidine HCl monohydrate. For example, in some formulations, L-histidine is present at a concentration within the range from about 16 mM to about 22 mM and L-histidine HCl monohydrate is present at a concentration within the range from about 4 mM to about 8 mM. In some formulations, trehalose is present at a concentration from about 210 mM to about 250 mM, for example, about 230 mM. In some formulations, a different non-reducing sugar is used, such as sucrose, mannitol, or sorbitol. In some formulations, polysorbate 20 is present at a concentration within the range of about from about 0.005% to about 0.05% by weight, for example, 0.005%, 0.01%, 0.015%, 0.02%, 0.025%, 0.03%, 0.035%, 0.04%, 0.045%, or 0.05%. Alternatively, in some formulations, polysorbate 20 is present at a concentration within the range of about from about 0.05 g/L, 0.1 g/L, 0.15 g/L, 0.2 g/L, 0.25 g/L, 0.3 g/L, 0.35 g/L, 0.4 g/L, 0.45 g/L, or 0.5 g/L. Some formulations include polysorbate 20 at a concentration of 0.2 g/L. Some formulations are characterized by a pH within the range of about 6-7, for example, a pH of 6.0, 6.1, 6.2, 6.3, 6.4, 6.5, 6.6, 6.7, 6.8, 6.9, or 7.0. Some formulations have a pH of about 6.5. Some formulations are characterized by an osmolality of about 300 mOsm/kg. A bulking agent may also be included some formulations. Typically, the formulations are sterile, for example, as accomplished by sterile filtration using a 0.2 ^m or a 0.22 ^m filter. The formulations disclosed herein are also generally stable upon freezing and thawing. Attorney Docket No.50887-0050WO1 Optionally, formulations disclosed herein may further comprise other excipients, such as saccharides, polyols, and amino acids (e.g., arginine, lysine, and methionine). The present disclosure also provides formulations substantially free of surfactant, inorganic salts, additional sugars, and/or other excipients, i.e., less than about less than 0.0005%, less than 0.0003%, or less than 0.0001% of such compounds. An exemplary formulation comprises an antibody comprising a light chain comprising an amino acid sequence set forth as SEQ ID NO: 10 and a heavy chain comprising an amino acid sequence set forth as any one of SEQ ID NOs: 11, 12, or 13, which is present at a concentration of about 50 mg/mL, a histidine buffer present at a concentration of about 25 mM, trehalose present at a concentration of about 230 mM, polysorbate 20 present at a concentration of about 0.2 g/L, and a pH of about 6.5. Some formulations comprise an antibody comprising a light chain comprising an amino acid sequence set forth as SEQ ID NO: 10 and a heavy chain comprising an amino acid sequence set forth as SEQ ID NO: 12, which is present at a concentration of about 50 mg/mL, a histidine buffer present at a concentration of about 25 mM, trehalose present at a concentration of about 230 mM, polysorbate 20 present at a concentration of about 0.2 g/L, and a pH of about 6.5. Some formulations comprise birtamimab, which is present at a concentration of about 50 mg/mL, a histidine buffer present at a concentration of about 25 mM, trehalose present at a concentration of about 230 mM, polysorbate 20 present at a concentration of about 0.2 g/L, and a pH of about 6.5. The methods disclosed herein involve pharmaceutical products comprising lyophilized antibody drug substance and instructions for reconstitution and use. For example, a representative pharmaceutical product can comprise: (a) a vial comprising about 100 mg antibody in powder form; (b) instructions for reconstitution of the antibody; and (c) instructions for preparing the reconstituted antibody for infusion, wherein (i) the antibody comprises a light chain comprising an amino acid sequence set forth as SEQ ID NO: 10 and a heavy chain comprising an amino acid sequence set forth as any one of SEQ ID NOs: 12-15; and (ii) the reconstitution instructions require reconstitution with water for injection to an extractable volume of 10 mL. EXAMPLES The following examples have been included to illustrate modes disclosed herein. Certain aspects of the following examples are described in terms of techniques and Attorney Docket No.50887-0050WO1 procedures found or contemplated by the present co-inventors to work well in the practice disclosed herein. In light of the present disclosure and the general level of skill in the art, those of skill appreciate that the following examples are intended to be exemplary only and that numerous changes, modifications, and alterations may be employed without departing from the scope of the disclosure. Example 1. Phase 2b Clinical Assessment of NEOD001, also known as birtamimab (Humanized 2A4) A Phase 2b global, multi-center, randomized, double-blind, placebo-controlled clinical study of NEOD001 vs. placebo was conducted in previously-treated patients with AL amyloidosis and persistent cardiac dysfunction (PRONTO Study). The study enrolled 129 patients. Patients were randomized on a 1:1 basis to receive 24 mg/kg of NEOD001 (n=66) or placebo (n=63) via intravenous infusion every 28 days. The primary outcome measure was cardiac best response as measured by NT-proBNP through 12 months of treatment. Secondary outcome measures included change in Short Form-36 (SF-36 Questionnaire, change in 6 minute walk test (6MWT), renal best response as measured by proteinuria, change in Neuropathy Impairment Score – Lower Limb (NIS-LL) score and NT-proBNP slope. Additional information regarding the clinical study design is available on https://clinicaltrials.gov. The PRONTO Study did not meet its primary or secondary endpoints. Example 2. Phase 3 Clinical Assessment of NEOD001 A Phase 3 global, multi-center, randomized, double-blind, placebo-controlled clinical study of NEOD001 vs. placebo was conducted in newly diagnosed, treatment-naïve patients with AL amyloidosis and cardiac dysfunction, with both arms of the study receiving standard of care (VITAL Study; The VITAL Amyloidosis Study, a Global Phase 3, Efficacy and Safety Study of NEOD001 in Patients With AL Amyloidosis (VITAL), ClinicalTrials.gov Identifier: NCT02312206). The study enrolled 260 patients (see Table 1). Table 1. Demographics and Clinical Characteristics All Subjects (n=260) Mayo Stage IV Subjects Attorney Docket No.50887-0050WO1 NEOD001 + Placebo + NEOD001 + Placebo + SOC SOC SOC (n=38) SOC ) ) ) 1) ) 6, Attorney Docket No.50887-0050WO1 (13.83, (18.00, (25.13, (35.52, 53.05) 63.06) 56.17) 106.28) a dFLC, difference between involved minus uninvolved serum free light chains; FLC, free light chain; NT-proBNP, N-terminal pro-brain natriuretic peptide; SOC, standard of care. Patients were randomized on a 1:1 basis to receive 24 mg/kg of NEOD001 or placebo via intravenous infusion every 28 days. All patients received bortezomib based chemotherapy concurrently with NEOD001 or placebo. Placebo was administered as a 250 mL bag of normal saline once every 28 days. The primary outcome measures were time to composite of all-cause mortality or cardiac hospitalization. Secondary outcome measures included NT-proBNP best response, time to cardiac mortality or cardiac hospitalization, change in the 6 minute walk test, change in the Short Form-36 questionnaire, change in the Kansas City Cardiomyopathy questionnaire, renal best response as assessed using Palladini et al, 2014 criteria and hepatic best response as assessed using Comenzo et al, 2012 criteria. Additional information regarding the clinical study design is available on https://clinicaltrials.gov. Based on the results from the PRONTO Study, a futility analysis was performed on the ongoing VITAL Study. The futility analysis, based on 103 adjudicated events of the 156 events specified to complete the study, was not statistically significant. The hazard ratio (HR) was 0.84 favoring NEOD001 vs. control arm (HR, 0.84, 95% confidence interval [CI], 0.57–1.204; P=0.386). Based on the results from the PRONTO Study and the futility analysis of the VITAL Study, clinical development of NEOD001 was discontinued. Example 3 – Improvements in Health-Related Quality of Life Metrics for Stage IV AL Amyloidosis Patients – Surprising Results in Certain Patients from the VITAL Study Patients with AL amyloidosis have reduced HRQoL, particularly those with advanced cardiac involvement who have a high symptom burden and poor physical function. Here, we Attorney Docket No.50887-0050WO1 assessed longitudinal HRQoL changes in the VITAL trial among patients with Mayo Stage IV (MSIV) AL amyloidosis. In VITAL, newly diagnosed treatment-naïve patients received birtamimab in combination with standard of care or placebo with standard of care. Short Form-36 questionnaire, version 2 (SF-36v2) was completed at baseline and months 3, 6, and 9 (i.e., after 3, 6, and 9 months of treatment. Lower scores on the SF-36v2 and domains and component scores therein indicate worse HRQoL. A mixed model for repeated measures was used to estimate least squares mean (LSM), standard error (SE), and 95% CI for each treatment group and LSM difference between groups. In Mayo Stage IV Amyloidosis patients, baseline values were similar between birtamimab (n=38) and placebo (n=39) arms for all eight SF-36v2 domains and component summary scores. Tables 2A-2C provide values for HRQoL values reported by the Mayo Stage IV Amyloidosis patients at baseline, month 3, month 6, and month 9.
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( 02 . 9 , 1 7 4 0 . 0 7 . 6 , 0 . 6 . 2 , 0 . 2 . 9. 5 . 0. 1 . 8 2 , 0 . 3 . 4 454 60 6 7 5 . 7 . 0 7 ( 0 1 8 70 . 7 3 ( 3 ( 5 5 ( 6 ( )0 ) 0 ) . 0 ) 0 5 ) 5 0 ) 0 . 2 . 7 0 . 5 0 0 0 . 0 1 0 5 079 565 0 . 35 3 0 3 0 . 78 . 059 754 097 3 0 1 4 085 9 , 4 . 0 , . 2 . 3 , . . , . . , . . , . 7 0 0 . 7 4 0 5 2 . 4 4 5 2 2 4 5 7 0 0 8 6 3 8 07 7 0 8 0 0 4 7 6 7 . 1 . 0 0 . . 0 ( 2 ( 3 ( 5 ( 5 7 ( 7 ( )0 0 ) ) ) ) ) . 0 0 5 0 0 0 . 0 00 . 7 0 7 . 5 0 3 . 0 . . 0 1 3 5 0 . 0 . 5 8 1 5 . 2 . 4 1 2 07 . 0 . 8 6 1 7 6 0 1 7 0 0 0 0 9 3 5 8 , 0 6 2 , 3 1 , 4 4 , . 3 . 1 , . . , . 6 0 . 6 4 0 04 3 5 3 5 0 6 9 78 7 5 7 00 7 1 . 7 5 0 . 5 . 6 0 . ( 3 8 ( 1 7 . ( 3 ( 6 6 5 ( 5 ( ‐ ‐ ‐ ‐ ‐ ‐ ‐ ) ) ) ) 0 0 ) 0 ) 0 0 0 0 0 0. 0 04 . 0 . 0 . . 0 0 . . 8 8 0 02 . 0 . 5 3 6 80 . 3 . 5 5 6 0 0 5 7 9 9 3 3 0 1 0 1 0 0 0 8 8 6 3 , 0 7 , 1 4 , . 6 . 0 , . 0 . , . . , . 6 0 0 . 6 3 0 0 . 4 3 5 7 . 3 5 0 05 3 8 0 0 6 7 0 7 0 0 8 6 1 0 . . . 4 3 8 5 0 0 ( ( 1 ( 2 ( 5 ( 6 ( n i g aP l n i l n a y l a i r h t y t d e i l oi n t o i l a t h o n l a l a a i c c n e l t o n tl a B e Ge t H i V o S u F o R m e E Me H Attorney Docket No.50887-0050WO1 As shown in Tables 2A-2C, after 9 months of treatment, patients in the birtamimab arm had higher scores in the physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health domains as well the summary scores, physical component summary (also referred to herein as physical component score) and mental component summary (also referred to herein as mental component score), compared to those in the placebo arm. Further, as also shown in Tables 2A-2C, after 3 and/or 6 months of treatment, patients in the birtamimab arm had higher scores than placebo for many, if not all, of the following domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, physical component score, and mental component score. Least mean squares (LSM) change from baseline to month 9 in birtamimab and placebo arms are provided in Figure 1, as are standard error values (SE) for each measurement. Birtamimab-treated patients at month 9, n=24; placebo patients at month 9, n=18. MMRM was used to estimate LSM and 95% CI for each treatment group and the LSM difference between treatment groups. The MMRM included fixed effects for treatment group, categorical time point (all postbaseline visits), treatment group by visit interaction, IWRS stratification factors (Renal Stage: I, II/III and baseline 6MWT distance: <300 meters, ≥300 meters), the associated baseline value as a covariate, and an unstructured covariance structure to model the within- subject errors. LSM (SE) change from baseline to month 9 in the social functioning (SF) domain of the SF-36v2 for birtamimab and placebo arms, respectively, was −5.73 (5.460) vs −28.52 (5.099). LSM (SE) change from baseline to month 9 in the role physical (RP) domain of the SF-36v2 for birtamimab and placebo arms, respectively, was −2.07 (3.824) vs −13.52 (3.433). LSM (SE) change from baseline to month 9 in the bodily pain (BP) domain of the SF-36v2 for birtamimab and placebo arms, respectively, was −3.03 (5.496) vs −19.37 (5.038). LSM (SE) change from baseline to month 9 in the physical component summary (PCS) domain of the SF- 36v2 for birtamimab and placebo arms, respectively, was −0.75 (1.749) vs −5.40 (1.597). LSM differences, 95% CI, and P-values for all domains are also shown in Figure 1. Thus, as shown by Figure 1, birtamimab plus standard of care in Mayo Stage IV AL amyloidosis patients was associated with significantly less decline in HRQoL compared to placebo plus standard of care in several SF-36v2 domains. Thus, these results exemplify the ability for method of the present disclosure to achieve improvement in reported values for Health-Related Quality of Life, including but not limited to, social functioning, role physical, and bodily pain. Attorney Docket No.50887-0050WO1 EXAMPLE 4 – A Phase 3, Multicenter, Open-Label, Single-Arm, Efficacy and Safety Study of Birtamimab (NEOD001) Plus Standard of Care in Mayo Stage IV Subjects with Light Chain (AL) Amyloidosis. The primary objective of the study (NEOD001-301) is to evaluate the efficacy of birtamimab plus standard of care when administered intravenously in Mayo Stage IV subjects with AL amyloidosis by assessing time to all-cause mortality. Secondary objectives are to evaluate birtamimab plus standard of care on the following: (1) change from baseline to month 9 in health related quality of life using the SF-36v2, including but not limited to, the social functioning, role physical, and bodily pain domains; and (2) change from baseline to month 9 in the 6 Minute Walk Test (6MWT) distance (meters). Newly diagnosed Mayo Stage IV subjects with AL amyloidosis receive birtamimab plus local standard of care chemotherapy. The initial first-line chemotherapy regimen must include bortezomib. Subjects remain on study until study completion, which occurs when approximately 16 primary endpoint events (all-cause mortality) have been reached or 62 subjects have completed 9 months of treatment. If the subject discontinues study drug prior to the end of the study but is willing to continue to participate in study visits, the subject should have an Early Treatment Discontinuation (ETD) visit within 28-35 days after the last study drug administration and then have assessments every third month. All visits after the ETD Visit should occur on schedule, that is, at the time when the visit would have occurred had the subject remained on study drug. Subject screening will occur during the 28 days prior to the first administration of study drug on Month 1-Day 1. The screening period may be extended upon approval by the Medical Monitor. Screening assessments are listed in Table 3, herein. Two screening 6MWTs are required before the first administration of study drug. The first screening 6MWT is required to be performed between Days -28 and 5, at least 4 days prior to the second Screening 6MWT, which should be performed within 2 days prior to Month 1 Day 1. The postbaseline 6MWTs may be performed on the same day as study drug administration and must be completed prior to study drug infusion. If all eligibility requirements are met, Month 1-Day 1 assessments are completed, and treatment is initiated. Each visit is denoted by its “month” and “day” such that the first study drug infusion day is denoted as Month 1-Day 1; subsequent months use sequential numbers (e.g., the second dose is administered on Month 2-Day 1). “Cycle” is reserved to denote administration of chemotherapy. Assessment and visit windows are described in the Schedule of Events (Table Attorney Docket No.50887-0050WO1 3). Each month, subjects receive their study drug infusion on Day 1 at the study site. For Months 1 through 3, subjects are assessed weekly, although not all visits are required to be at the study site. For Month 3 and all subsequent months until the end of the study, subjects are only required to return to the study site every 28 days for Day 1 dosing of study drug. First-line chemotherapy must be a bortezomib-containing regimen, with bortezomib administered subcutaneously (SC), weekly. The first administration of chemotherapy, including bortezomib, is administered after Month 1 Day 1 study drug administration (following the post-study drug infusion observation period) such that Month 1-Day 1 of the study is equivalent to Cycle 1 Day 1 of chemotherapy. In addition to the visits outlined above, during the first cycle of chemotherapy, the subject must return to the study site for each weekly administration of bortezomib and for assessments prior to the administrations. During the second and third cycles of chemotherapy, bortezomib must be administered at the study site during the Month 2-Day 1, Month 2-Day 15, and Month 3-Day 1 visits (i.e., Cycle 2 Day 1, Cycle 2-Day 15, and Cycle 3-Day 1, respectively). If, for any reason in the opinion of the Investigator, the subject should continue to be seen weekly at the study site (e.g., toxicity that appears to exceed the anticipated side effects of the chemotherapy), then the other Cycle 2 and Cycle 3 weekly bortezomib administrations may be performed at the study site, as well. At the Investigator’s discretion, if the subject is not experiencing any unanticipated or significant toxicity, the subject may be administered the Cycle 2-Days 8 and 22 and the Cycle 3 Days 8, 15 and 22 bortezomib by their local physician, rather than by the Investigator. Within 1 day prior to or on the day of each administration of bortezomib by the local physician, a healthcare professional must obtain pre-dose vital signs and central laboratory samples. However, if bortezomib is administered on a Monday (or there is an intervening holiday), then it is acceptable for the Homecare visit to take place on the previous Friday. In the event that bortezomib doses are missed, the chemotherapy cycles may become misaligned with the monthly study drug dosing. In this case, the weekly visits during Months 1 through 3 should continue as described above in order to closely monitor subjects’ health during the initial months of concomitant chemotherapy. Throughout the study, monthly doses of study drug should not be delayed or skipped due to adjustments that are made to chemotherapy dosing. Safety and efficacy assessments are performed at each visit. Attorney Docket No.50887-0050WO1 Inclusion Criteria (subjects must meet all of the following criteria): 1. Aged ≥ 18 years. 2. Newly diagnosed and AL amyloidosis treatment naïve. 3. Bone marrow demonstrating clonal plasma cells. 4. Confirmed diagnosis of AL amyloidosis by the following: ^ Histochemical diagnosis of amyloidosis determined by polarizing light microscopy of green birefringent material in Congo red-stained tissue specimens OR characteristic electron microscopy appearance, AND ^ Confirmatory immunohistochemistry OR mass spectroscopy of AL amyloidosis. 5. Confirmed diagnosis of AL amyloidosis by mass spectrometry or immunoelectron microscopy of amyloid material in tissue biopsy if the subject meets any of the following: ^ Is black or African American. ^ Is over 75 years of age with concurrent monoclonal gammopathy. ^ Has a history of familial amyloidosis and has concurrent monoclonal gammopathy. OR ^ If the subject meets any of the above 3 conditions and has echocardiographic evidence of amyloidosis, biopsy-proven amyloidosis with a monoclonal gammopathy and no tissue is available for mass spectrometry or immunoelectron microscopy, the subject must have gene sequencing consistent with transthyretin (TTR) wild type (e.g., no TTR mutation present) AND must score 0 in technetium-99m-3,3-diphosphono-1,2 propanodicarboxylic acid (99mTc DPD; Rapezzi 2011), hydroxymethylenediphosphonate (99mTc HMDP; Galat 2015), or pyrophosphate (99mTc PYP; Bokhari 2013) scintigraphy. 6. Cardiac involvement as defined by all of the following: ^ Past documented or presently noted clinical signs and symptoms supportive of a diagnosis of heart failure in the setting of a confirmed diagnosis of AL amyloidosis in the absence of an alternative explanation for heart failure. Attorney Docket No.50887-0050WO1 ^ Either an endomyocardial biopsy demonstrating AL amyloidosis or an echocardiogram demonstrating a mean left ventricular wall thickness at diastole > 12 mm in the absence of other causes (e.g., severe hypertension, aortic stenosis), which would adequately explain the degree of wall thickening. 7. Confirmed Mayo Stage IV as defined by: ^ NT-proBNP ≥ 1800 pg/mL, and ^ Troponin-T > 0.03 ng/mL, and ^ dFLC ≥ 18 mg/dL. 8. Planned first-line chemotherapy contains bortezomib administered subcutaneously (SC) weekly. 9. Adequate bone marrow reserve, hepatic function, and renal function, as demonstrated by: ^ Absolute neutrophil count (ANC) ≥ 1.0 × 109/L. ^ Platelet count ≥ 75 × 109/L. ^ Hemoglobin ≥ 9 g/dL. ^ Total bilirubin ≤ 2 times the upper limit of normal (× ULN). ^ Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) ≤ 3 × ULN. ^ Alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) ≤ 3 × ULN. ^ Alkaline phosphatase (ALP) ≤ 5 × ULN (except for subjects with hepatomegaly and isozymes specific to liver, rather than bone). ^ Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2 as estimated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. 10. Seated systolic blood pressure 90-180 mmHg. 11. Distance walked during each Screening 6MWT is ≥ 30 meters and ≤ 550 meters. 12. Women of childbearing potential (WOCBP) must have two negative pregnancy tests during Screening, the second within 24 hours prior to the first administration of study drug, and must agree to use highly effective physician-approved contraception from Screening to 90 days following the last study drug administration. Attorney Docket No.50887-0050WO1 13. Male subjects must be surgically sterile or must agree to use highly effective physician-approved contraception from Screening to 90 days following the last study drug administration. 14. Ability to understand and willingness to sign an informed consent form prior to initiation of any study procedures. Exclusion Criteria (subjects must meet none of the following criteria): 1. Non-AL amyloidosis. 2. NT-proBNP > 8,500 pg/mL. 3. Meets the International Myeloma Working Group (IMWG) definition of Multiple Myeloma. *Note that subjects who meet the IMWG definition of symptomatic multiple myeloma with signs and/or symptoms attributable only to associated amyloidosis are potentially eligible upon approval of the Sponsor. 4. Subject is eligible for and plans to undergo ASCT or organ transplant during the study. 5. Symptomatic orthostatic hypotension that in the medical judgment of the Investigator would interfere with subject’s ability to safely receive treatment or complete study assessments. 6. Myocardial infarction, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic (ECG) evidence of acute ischemia, within 6 months prior to the Month 1-Day 1 Visit. 7. Severe valvular stenosis (e.g., aortic or mitral stenosis with a valve area <1.0 cm2) or severe congenital heart disease. 8. ECG evidence of acute ischemia or active conduction system abnormalities with the exception of any of the following: ^ First degree AV-block. ^ Second degree AV-block Type 1 (Mobitz Type 1 / Wenckebach type). ^ Right or left bundle branch block. ^ Atrial fibrillation with a controlled ventricular rate (uncontrolled [>110 bpm] ventricular rate is not allowed [determined by an average of three beats in Lead II or three representative beats if Lead II is not representative of the overall EKG]). Attorney Docket No.50887-0050WO1 9. Peripheral neuropathy assessed as National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade 2 with pain, Grade 3, or Grade 4. 10. Subject is receiving oral or IV antibiotics, antifungals or antivirals within 1 week of Month 1-Day 1 with the exception of prophylactic oral agents. 11. Prior treatment with hematopoietic growth factors, transfusions of blood or blood products within 1 week of Month 1-Day 1. 12. Prior radiotherapy within 4 weeks of Month 1-Day 1. 13. Major surgery within 4 weeks of Month 1-Day 1 or planned major surgery during the study. 14. Active malignancy with the exception of any of the following: ^ Adequately treated basal cell carcinoma, squamous cell carcinoma, or in situ cervical cancer. ^ Adequately treated Stage I cancer from which the subject is currently in remission and has been in remission for 2 years. ^ Low-risk prostate cancer with Gleason score < 7 and prostate-specific antigen < 10 mg/mL. ^ Any other cancer from which the subject has been disease-free for ≥ 2 years. 15. History of severe allergy to any of the components of birtamimab such as histidine/L histidine hydrochloride monohydrate, trehalose dehydrate, or polysorbate 20 or history of Grade ≥ 3 infusion-related AEs or hypersensitivity to another monoclonal antibody, or known hypersensitivity to diphenhydramine (or an equivalent H1 antihistamine) or acetaminophen (or its equivalent, paracetamol). 16. Known or history of uncontrolled, active HIV, hepatitis B or hepatitis C infection. 17. Prior treatment with plasma cell-directed chemotherapy, birtamimab, daratumumab, 11-1F4, anti-serum amyloid P antibody, doxycycline for amyloid, or other investigational treatment directed at amyloid. 18. Treatment with another investigational agent within 30 days of Month 1-Day 1. 19. Women who are pregnant or lactating. 20. Any condition which could interfere with, or the treatment for which might interfere with, the conduct of the study or which would, in the opinion of the Investigator, unacceptably increase the subject’s risk by participating in the study. Attorney Docket No.50887-0050WO1 21. Subject is under legal custodianship. 22. History of epilepsy or seizure disorder with the exception of childhood febrile seizures. 23. Waldenström's macroglobulinemia and/or immunoglobulin M (IgM) monoclonal gammopathy. Study Drug: Study drug consists of birtamimab (24 mg/kg) supplied as a sterile, lyophilized dosage form in a 20/25 mL vial containing 500 mg birtamimab. Each vial is reconstituted with 9.6 mL sterile water for injection (WFI) to a concentration of 50 mg/mL resulting in a buffered, isotonic, preservative-free solution. Study drug is administered once every 28 days as an initial 120 (±10)-minute IV infusion. If the subject tolerates the initial infusion, subsequent infusions may be administered over 60 (±10) minutes. The length of the infusion may be extended over a longer period of time if and when it is clinically indicated. A minimum of 21 days between doses is required. Premedication: All subjects are premedicated for each dose of study drug with 25 mg diphenhydramine (or an equivalent dose of a H1 antihistamine) and 650 mg acetaminophen (or an equivalent paracetamol dose) within 30-90 minutes prior to study drug administration. Standard of Care Chemotherapy: All subjects receive concomitant standard of care chemotherapy, which must include bortezomib administered subcutaneously on a weekly basis for the initial, first-line chemotherapy regimen. Subsequent chemotherapy regimens may be prescribed as per standard of care at the Investigator’s discretion. Antiviral prophylaxis is required. Statistical Considerations Analysis Populations. The Intent-to-Treat (ITT) Population includes all subjects with Mayo Stage IV AL amyloidosis who receive any amount of study drug. The ITT Population is the primary population used for efficacy and safety analyses. Efficacy Analyses. Primary Analysis - The primary endpoint is time to all-cause mortality. For all-cause mortality, all deaths occurring after the first infusion of study drug (Study Day 1) through the study’s last subject last visit (LSLV) are included. Using an exponential survival model, the estimated survival percentage at 9 months is estimated. Using an exact binomial test, the estimated survival percentage is compared to the historical control value of 49%. Attorney Docket No.50887-0050WO1 Key Secondary Efficacy Analyses – If the primary analysis concludes in favor of birtamimab, then the data for the placebo plus SOC Mayo Stage IV subjects from Study NEOD001 CL0002 [VITAL] is used to compare change from baseline to Month 9 in the social functioning, role physical, and/or bodily pain scores (and/or additional domains listed herein) of the SF-36v2. For each of these variables, change from baseline to Month 9 and 95% confidence intervals are computed. If the lower bounds of the confidence intervals are greater than the observed values from the placebo group in VITAL, then the study concludes that that birtamimab is superior to control.
Attorney Docket No.50887-0050WO1 / T3 D OT X7 X X X X 5 1 X X X X X X X E E X r n ine D er o c t S 81 2- - y y a X X X X 7 X X X X X X X X X a D D s t ) n e v 5 P ) s s E i B s C CLf o o d i 1 O 1 F y W y s ( e l t o u n l e y r t ( y r t s n i d s m6 8 0 1 s i c e n n s i ah o A ye v G E mc r C P e a 6 h n g 1 m 4 h y e h C, Ct S C L de we i 4 A u E S e t d e t y r C e r r o t C C 3 h g i v y r f o h t ma a c c e o t & P e a r & 7 1 s t 8 1 L s m t r o f e o R t s i n l oi a e r g i o l 9 p i E r i P D s a s r y a o g n o i o y r b a g n o o n i t e T P e n N e r : n e n I y t i l H t l a H 2 i d r r T e t - l b l e m C a o t U a / L l l o t e a s a a l l m u e l i B e p n o o r s a F 3 e l m s n b s e e t s t i i b r i a g c i m r i i d f v 6 a c d e n 3 - o a h e l l p o t p A Ll m - m m H a m c e u r a r t m y g H e S n e m a m p o p- t p m y u r H A o o r T r e a l o F c o y Y o e C C T N T S T s A W E M C S E 2 1 C S N L C Attorney Docket No.50887-0050WO1 Table 3 Footnotes 1. The 28-day Screening period may be extended upon approval by the Medical Monitor. Individual test results that do not meet eligibility requirements may be repeated, with the exception of 6MWT; full rescreening is allowed once per subject. 2. Cycle 2-Days 8 and 22 and Cycle 3-Days 8, 15 and 22 bortezomib-containing chemotherapy should be administered by the Investigator at the study site if subject had significant toxicity; otherwise, it may be administered by local physician at Investigator’s discretion. 3. EOT/ETD Visit to occur 28-35 days after the last study drug administration. 4. Obtain comprehensive cardiac, hematologic, and oncologic medical history; additionally, for all other conditions obtain relevant medical history for the past 5 years (including all major hospitalizations and surgeries), as well as the subject’s current medical status. 5. Results from mass spectrometry tissue typing, immunoelectron microscopy, gene sequencing, and/or 99mTc scintigraphy must be obtained prior to randomization to assess eligibility for subjects identified in Inclusion Criterion #5. 6. At visits where the SF-36v2 (Appendix 4) is to be administered, the SF-36v2 needs to be administered prior to the performance of any other study assessments on that day. 7. If an echocardiogram has been conducted within 90 days prior to Screening Day -28, it does not need to be repeated during Screening and the previous result can be used for eligibility. After Screening, perform echocardiograms every 6 months within 10 days prior to Day 1; repeat at EOT/ETD if not performed within 60 days prior to visit. To be eligible for the additional cardiac imaging analysis, the subject must have had a 4-chamber view, 2- dimensional echocardiogram with Doppler. 8. ECG to be performed in triplicate as follows: Month 1-Day 1: within 30 minutes before dosing and 1 hour (±15 min) post-EOI; All Other Visits (Months 1, 2, 3 and every 3 months starting at Month 6): within 30 minutes before dosing or any time on non-infusion days. Medications given for prophylaxis chemotherapy-induced side effects should not be administered prior to completion of the post infusion ECG. 9. Complete PE includes height (Screening only), weight, and examination of the following: general appearance; head, ears, eyes, nose, and throat; neck; skin; cardiovascular Attorney Docket No.50887-0050WO1 system; respiratory system; gastrointestinal system; and nervous system. Assess macroglossia, submandibular nodes/fullness, adenopathy, ecchymoses, liver/spleen size (palpable +/-), ascites (+/-), and edema (which should be quantified on a scale of 0-4). 10. Symptom-directed PE should be as clinically indicated and also include weight, and assessment of macroglossia, submandibular nodes/fullness, adenopathy, ecchymoses, liver/spleen size (palpable +/-), ascites (+/-), and edema (which should be quantified on a scale of 0-4). 11. Local laboratory results for hematology and chemistry will be used for subject management and should be reviewed for safety assessment prior to administration of chemotherapy but will not be collected in the electronic case report forms or the clinical database. 12. Perform only if subject returns to study site for this visit. 13. Use local lab for serum pregnancy test within 24 hours prior to Month 1-Day 1 study drug administration. 14. Obtain local urine pregnancy test prior to study drug administration. 15. Obtain local laboratory serum pregnancy test 90 (±5) days after the last study drug administration. 16. Collect central laboratory samples before 6MWT, if being performed on the same day. 17. Collect PT/INR and PTT at each time point. 18. NT-proBNP should be drawn before conducting 6MWT if being performed on the same calendar day. 19. Subjects should plan to be able to return to the same clinical site for each 6MWT from first Screening through Month 9. The postbaseline 6MWT may be administered on the same calendar day that study drug is administered (i.e., Months 3, 6, 9, etc.) as long as the NT- proBNP sample is drawn before conducting the 6MWT and the 6MWT is completed before initiation of the study drug infusion. Collect BP and HR pre- and post-6MWT administration. 20. The first Screening 6MWT must be performed between Days -28 and -5, at least 4 days prior to the second Screening 6MWT, which should be performed within 2 days prior to the Month 1-Day 1 visit (i.e., on Day -2 or Day -1). Attorney Docket No.50887-0050WO1 21. Archive serum samples will only be collected from those subjects who have consented to the collection and archiving of their samples for future correlative testing. 22. All subjects are to receive 25 mg diphenhydramine (or an equivalent dose of a H1 antihistamine) and 650 mg acetaminophen (or an equivalent paracetamol dose) within 3090 minutes prior to the start of infusion. 23. Vital signs include BP, HR, RR, and temperature; assess in same position for all time points after the subject has been at rest for ≥5 minutes. Pre-dose assessments should be performed after administration of premedication. Screening and non-infusion days: any time; Month 1-Day 1: Within 30 minutes before dosing, halfway through infusion (i.e., approximately 60 minutes after the start of the infusion), immediately at EOI (+10 min), 0.5 hour (±10 min) post-EOI, and 1 hour (±10 min) post-EOI. All Other Months-Day 1: Within 30 minutes before dosing, EOI (+10 min), and 1 hour (±10 min) post-EOI. 24. Subjects should be closely monitored for 90 (±10) minutes following completion of the study drug infusion. The Investigator may increase this standard monitoring time if deemed appropriate or per local standards. In the event of any clinical concerns or suspicious signs or symptoms after the infusion, the subject will remain under observation for as long as the Investigator deems it appropriate. 25. First-line chemotherapy must be a bortezomib-containing regimen, with bortezomib administered weekly, SC, according to the approved prescribing information and local institutional practices. Antiviral prophylaxis is required. When chemotherapy is administered on same day as study drug, the chemotherapy must be administered AFTER the post-study drug infusion observation period. Number of first-line chemotherapy cycles and subsequent chemotherapy regimens will be administered per standard of care at the Investigator’s discretion. 26. Bortezomib must be administered at the study site for Cycle 1-Days 1, 8, 15, and 22; Cycle 2-Days 1 and 15; and on Day 1 of subsequent cycles, after review of local labs, study drug administration, and the post-study drug infusion observation period. 27. Cycle 2-Days 8 and 22, and Cycle 3-Days 8, 15, and 22 chemotherapy may be administered by local physician with a Homecare visit by a Prothena-sponsored healthcare professional to the subject within 1 day prior to or pre-dose on the day of each bortezomib administration to obtain vital signs, blood samples for central laboratory testing, and bioanalytical samples (if applicable). If bortezomib is administered on a Monday, the Attorney Docket No.50887-0050WO1 Homecare visit may occur on the previous Friday. If significant toxicity occurs during Cycle 1, subject should return to the study site for Cycle 2 and Cycle 3 visits until Investigator deems it appropriate for local administration. 28. New SAEs occurring beyond the EOT/ETD Visit or >28 days after the last administration of study drug, whichever is later, will be reported to the Sponsor or its designee only if, in the judgement of the Investigator, the SAE is associated with any protocol intervention (i.e., related to study procedure or previous study drug exposure). 29. For all subjects who received a dose of study drug: Conduct vital status assessment approximately 3 months after the subject’s last visit and approximately every 3 months thereafter. Analysis of SF-36v2 data from Mayo Stage IV subjects enrolled in the present study will demonstrate slowing of decline in the physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health domains as well the summary scores, physical component summary and/or mental component summary. In some embodiments, these observed values will be consistent with those values disclosed herein from the Study NEOD001 CL0002 [VITAL]. The disclosure of every patent, patent application, and publication cited herein is hereby incorporated herein by reference in its entirety. While this invention has been disclosed with reference to specific embodiments, other embodiments and variations of this disclosure can be devised by others skilled in the art without departing from the true spirit and scope of the disclosure. The appended claims include all such embodiments and equivalent variations.
Attorney Docket No.50887-0050WO1 SEQUENCES SEQ ID NO: 1 Humanized antibody sequence containing murine and human residues (humanized 2A4 light chain variable region version 3) DVVMTQSPLSLPVTPGEPASISCRSSQSLVHSTGNTYLHWYLQKPGQSPQLLI YKVSNRFSGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCSQSTHVPFTFGGG TKVEIK SEQ ID NO: 2 Humanized antibody sequence containing murine and human residues (humanized 2A4 heavy chain variable region version 3) EVQLVESGGGLVQPGGSLRLSCAASGFTFNTYAMYWIRQAPGKGLEWVARIRS KSNNYAIYYADSVKDRFTISRDDSKNSLYLQMNSLKTEDTAVYYCARPYSDSF AYWGQGTLVTVSS SEQ ID NO: 32A4 VL CDR1 RSSQSLVHSTGNTYLH SEQ ID NO: 42A4 VL CDR2 KVSNRFS SEQ ID NO: 52A4 VL CDR3 SQSTHVPFT SEQ ID NO: 62A4 VH CDR1 GFTFNTYAMY SEQ ID NO: 72A4 VH CDR2 RIRSKSNNYAIYYADSVKD SEQ ID NO: 82A4 VH CDR3 PYSDSFAY Attorney Docket No.50887-0050WO1 SEQ ID NO: 97D8 VL CDR1 RSSLSLVHSTGNTYLH SEQ ID NO: 10 Humanized antibody sequence containing murine and human residues (humanized 2A4 kappa light chain) DVVMTQSPLSLPVTPGEPASISCRSSQSLVHSTGNTYLHWYLQKPGQSPQLLI YKVSNRFSGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCSQSTHVPFTFGGG TKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNAL QSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTK SFNRGEC SEQ ID NO: 11 Humanized antibody sequence containing murine and human residues (humanized 2A4 IgG1 heavy chain variant 1 (G1m1 allotype)) EVQLVESGGGLVQPGGSLRLSCAASGFTFNTYAMYWIRQAPGKGLEWVARIRS KSNNYAIYYADSVKDRFTISRDDSKNSLYLQMNSLKTEDTAVYYCARPYSDSF AYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVS WNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTK VDKRVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVV VDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNG KEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLV KGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNV FSCSVMHEALHNHYTQKSLSLSPGK SEQ ID NO: 12 Humanized antibody sequence containing murine and human residues (humanized 2A4 IgG1 heavy chain variant 2 (G1m3 allotype)) EVQLVESGGGLVQPGGSLRLSCAASGFTFNTYAMYWIRQAPGKGLEWVARIRS KSNNYAIYYADSVKDRFTISRDDSKNSLYLQMNSLKTEDTAVYYCARPYSDSF AYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVS WNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTK VDKRVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVV VDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNG KEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLV KGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNV FSCSVMHEALHNHYTQKSLSLSPGK Attorney Docket No.50887-0050WO1 SEQ ID NO: 13 Humanized antibody sequence containing murine and human residues (humanized 2A4 IgG2 heavy chain) EVQLVESGGGLVQPGGSLRLSCAASGFTFNTYAMYWIRQAPGKGLEWVARIRS KSNNYAIYYADSVKDRFTISRDDSKNSLYLQMNSLKTEDTAVYYCARPYSDSF AYWGQGTLVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVS WNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSNFGTQTYTCNVDHKPSNTK VDKTVERKCCVECPPCPAPPVAGPSVFLFPPKPKDTLMISRTPEVTCVVVDVS HEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTFRVVSVLTVVHQDWLNGKEYK CKVSNKGLPAPIEKTISKTKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFY PSDIAVEWESNGQPENNYKTTPPMLDSDGSFFLYSKLTVDKSRWQQGNVFSCS VMHEALHNHYTQKSLSLSPGK SEQ ID NO: 14 11-1F4 monoclonal antibody variable light [kappa] DVVMTQTPLSLPVSLGDQASISCRSSQSLVHRNGNTYLHWYLQKPGQSPKLLI YKVSNRFSGVPDRFSGSGSGTDFTLKISRVEAEDLGLYFCFQTTYVPNTFGGG TKLEIK SEQ ID NO: 15 11-1F4 monoclonal antibody variable heavy QVQLKESGPGLVAPSQSLSITCTVSGFSLSSYGVSWVRQPPGKGLEWLGVIWG DGSTNYKPNLMSRLSISKDISKSQVLFKLNSLQTDDTATYYCVTLDYWGQGTS VTVSS SEQ ID NO: 16 11-1F4 monoclonal antibody CDR1 light chain RSSQSLVHRNGNYTLH SEQ ID NO: 17 11-1F4 monoclonal antibody CDR2 light chain LVSNRFS SEQ ID NO: 18 11-1F4 monoclonal antibody CDR3 light chain FNTTYVPNT Attorney Docket No.50887-0050WO1 SEQ ID NO: 19 11-1F4 monoclonal antibody CDR1 heavy chain SYGVSW SEQ ID NO: 20 11-1F4 monoclonal antibody CDR2 heavy chain VIWGDGSTNYHPNLMSRLSIS SEQ ID NO: 21 11-1F4 monoclonal antibody CDR3 heavy chain LDY SEQ ID NO: 22 11-1F4 monoclonal antibody variable light [kappa] gatgttgtga tgacccaaac tccactctcc ctgcctgtca gtcttggaga tcaagcctcc atctcttgca gatctagtca gagccttgta catagaaatg gaaacaccta tttacattgg tacctgcaga agccaggcca gtctccaaag ctcctgatct acaaagtttc caaccgattt tctggggtcc cagacaggtt cagtggcagt ggatcaggga cagatttcac actcaagatc agcagagtgg aggctgagga tttgggactt tatttctgtt ttcaaactac atatgttccg aacacgttcg gaggggggac caagctggaa ataaaa SEQ ID NO: 23 11-1F4 monoclonal antibody variable heavy caggtgcagc tgaaggagtc aggacctggc ctggtggcgc cctcacagag cctgtccatc acatgcactg tctcagggtt ctcattaagc agctatggtg taagctgggt tcgccagcct ccaggaaagg gtctggagtg gctgggagta atatggggtg acgggagcac aaattatcat ccaaatctca tgtccagact gagtatcagc aaggatattt ccaagagcca agttctcttc aaactgaata gtctgcaaac tgatgacaca gccacgtact actgtgtcac cttcgactac tggggtcaag gaacctcagt caccgtctcc tca

Claims

Attorney Docket No.50887-0050WO1 WHAT IS CLAIMED IS: 1. A method of slowing a decline in Health-Related Quality of Life (HRQoL) in a subject having AL amyloidosis, comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105), wherein the slowing of the decline in HRQoL comprises a slowing of a decline in at least one of the following: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), mental health (MH), and mental component score (MCS). 2. A method of treating AL amyloidosis in a subject, comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105); wherein treating comprises a slowing of a decline in HRQoL comprising a slowing of a decline in at least one of the following: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, and mental component score. 3. The method of claim 1 or claim 2, wherein the slowing of the decline in HRQoL further comprises a slowing of a decline in physical component score (PCS). 4. The method of any one of claims 1 to 3, wherein the slowing of the decline in physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, mental component score and/or physical component score is assessed using a 36-Item Short Form Survey (SF-36) or a 36-Item Short Form Survey Version 2 (SF-36v2). Attorney Docket No.50887-0050WO1 5. The method of any one of claims 1 to 4, wherein the slowing of the decline in HRQoL comprises a higher score on at least one of the following domains of an SF-36 or SF-36v2 relative to a different patient at the same time point who has not been administered the antibody: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, mental component score and/or physical component score. 6. The method of any one of claims 1 to 4, wherein the slowing of the decline in HRQoL is assessed by comparing a score on at least one of the following domains of an SF-36 or SF- 36v2 to a baseline score: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, mental component score and/or physical component score. 7. The method of any one of claims 1 to 6, wherein the slowing of the decline in HRQoL is assessed after at least about 9 months following a first administration of the antibody. 8. The method of any one of claims 1 to 6, wherein the slowing of the decline in HRQoL is assessed after about 9 months following a first administration of the antibody. 9. The method of any of the preceding claims, wherein the method comprises a slowing of a decline in social functioning in the subject. 10. The method of claim 9, wherein the slowing of the decline in social functioning comprises a decrease of less than about 20 points on the social functioning domain of the SF-36v2 compared to baseline. 11. The method of claim 9, wherein the slowing of the decline in social functioning comprises a decrease of less than about 10 points on the social functioning domain of the SF-36v2 compared to baseline. Attorney Docket No.50887-0050WO1 12. The method of any one of claims 1 to 11, wherein the method further comprises a slowing of a decline in at least one value for the following domains of the SF-36 or SF-36v2: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and mental component score. 13. The method of any one of claims 1 to 12, wherein the method comprises a slowing of a decline in a reported value for a role physical domain of the SF-36 or SF-36v2. 14. The method of claim 13, wherein the reported value for the role physical domain is higher relative to a different patient at the same time point who has not been administered the antibody. 15. The method of claim 13, wherein the slowing of the decline in reported value for the role physical domain comprises a decrease of less than about 5 points on the role physical domain of the SF-36v2 compared to baseline. 16. The method of any one of claims 1 to 15, wherein the method comprises a slowing of a decline in a reported value for a bodily pain domain of the SF-36 or SF-36v2. 17. The method of claim 16, wherein the reported value for the bodily pain domain is higher relative to a different patient at the same time point who has not been administered the antibody. 18. The method of claim 17, wherein the slowing of the decline in reported value for the bodily pain domain comprises a decrease of less than about 5 points on the bodily pain domain of the SF-36v2 compared to baseline. 19. The method of any one of claims 13 to 18, wherein the slowing of the decline in the reported value for the role physical domain and/or the reported value for the bodily pain domain is assessed after at least about 9 months following a first administration of the antibody. Attorney Docket No.50887-0050WO1 20. The method of any one of claims 13 to 18, wherein the slowing of the decline in the reported value for the role physical domain and/or the reported value for the bodily pain domain is assessed after about 9 months following a first administration of the antibody. 21. The method of any of the preceding claims, wherein the method comprises a slowing of a decline in physical functioning in the subject. 22. The method of any of the preceding claims, wherein the method comprises a slowing of a decline in role physical in the subject. 23. The method of any of the preceding claims, wherein the method comprises a slowing of a decline in bodily pain in the subject. 24. The method of any of the preceding claims, wherein the method comprises a slowing of a decline in general health in the subject. 25. The method of any of the preceding claims, wherein the method comprises a slowing of a decline in vitality in the subject. 26. The method of any of the preceding claims, wherein the method comprises a slowing of a decline in role emotional in the subject. 27. The method of any of the preceding claims, wherein the method comprises a slowing of a decline in mental health in the subject. 28. The method of any of the preceding claims, wherein the method comprises a slowing of a decline in mental component score in the subject. 29. The method of any of the preceding claims, wherein the method comprises a slowing of a decline in at least two of the following: physical functioning, role physical, bodily pain, Attorney Docket No.50887-0050WO1 general health, vitality, social functioning, role emotional, mental health, and mental component score. 30. The method of any of the preceding claims, wherein the method comprises a slowing of a decline in at least three of the following: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, and mental component score. 31. The method of any of the preceding claims, wherein the antibody comprises a light chain variable region comprising three complementarity determining regions of 2A4, 7D8 or 11- 1F4, and a heavy chain variable region comprising three complementarity determining regions of 2A4, 7D8 or 11-1F4, respectively. 32. The method of any of the preceding claims, wherein the antibody is a humanized version of 2A4. 33. The method of any of the preceding claims, wherein the antibody is a humanized or chimeric version of 11-1F4. 34. The method of any of the preceding claims, wherein the antibody comprises a light chain variable region comprising three complementarity determining regions set forth as SEQ ID NOs: 3, 4 and 5, or SEQ ID NOs: 16, 17, and 18, and a heavy chain variable region comprising three complementarity determining regions set forth as SEQ ID NOs: 6, 7 and 8, or SEQ ID NOs: 19, 20, and 21. 35. The method of any of the preceding claims, wherein the light chain variable region comprises the amino acid sequence set forth as SEQ ID NO: 1 or 14. 36. The method of any of the preceding claims, wherein the heavy chain variable region comprises the amino acid sequence set forth as SEQ ID NO: 2 or 15. Attorney Docket No.50887-0050WO1 37. The method of any of the preceding claims, wherein the light chain variable region comprises the amino acid sequence set forth as SEQ ID NO: 1 or 14, and the heavy chain variable region comprises the amino acid sequence set forth as SEQ ID NO: 2 or 15. 38. The method of any of the preceding claims, wherein the antibody comprises a light chain comprising the amino acid sequence set forth as SEQ ID NO:10, and a heavy chain comprising the amino acid sequence set forth as SEQ ID NO: 11, 12 or 13. 39. The method of any of the preceding claims, wherein the antibody comprises a light chain comprising the amino acid sequence set forth as SEQ ID NO:10, and a heavy chain comprising the amino acid sequence set forth as SEQ ID NO:12. 40. The method of any of the preceding claims, wherein the antibody is a Fab, Fab’, F(ab’)2, F(ab)c, Dab, nanobody, or Fv. 41. The method of any of the preceding claims, wherein the antibody is birtamimab. 42. The method of any of the preceding claims, wherein the effective dosage of the antibody is administered from a pharmaceutical formulation comprising the antibody at a concentration within the range from about 1mg/mL to about 100 mg/mL. 43. The method of any of the preceding claims, wherein the dosage is from about 0.5 mg/kg to about 30 mg/kg and the antibody is administered intravenously or subcutaneously at a frequency of from about weekly to about quarterly. 44. The method of any of the preceding claims, wherein the antibody is present at a concentration of about 50 mg/mL. 45. The method of any of the preceding claims, wherein the dosage is administered intravenously following the transfer of an amount of the formulation required for the dosage from a vial to an intravenous bag containing a liquid. Attorney Docket No.50887-0050WO1 46. The method of any of the preceding claims, wherein the dosage is about 24 mg/kg and the antibody is administered intravenously every 28 days. 47. The method of any of the preceding claims, wherein the duration of the treatment is at least 9 months. 48. The method of any of the preceding claims, wherein the duration of the treatment is at least 12 months. 49. The method of any one of claims 1-48, wherein the AL amyloidosis is AL amyloidosis with cardiac involvement. 50. The method of any one of claims 1-49, wherein the AL amyloidosis is Mayo Stage IV amyloidosis. 51. A method of slowing a decline in Health-Related Quality of Life (HRQoL) in a subject having AL amyloidosis with cardiac involvement, comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105), wherein the slowing of the decline in HRQoL comprises a slowing of a decline in at least one of the following: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), mental health (MH), and mental component score (MCS). 52. A method of treating AL amyloidosis with cardiac involvement in a subject, comprising administering to the subject an effective dosage of an antibody which competes for binding to human amyloid A peptide or human kappa or lambda light chain immunoglobulin with 2A4 (ATCC Accession Number PTA-9662) or 7D8 (ATCC Accession Number PTA-9468), or competes for binding to kappa light chain immunoglobulin with 11-1F4 (ATCC Accession Number PTA-105); wherein treating comprises a slowing of a decline in HRQoL comprising Attorney Docket No.50887-0050WO1 a slowing of a decline in at least one of the following: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, and mental component score. 53. The method of claim 51 or claim 52, wherein the slowing of the decline in HRQoL further comprises a slowing of a decline in physical component score (PCS). 54. The method of any one of claims 51 to 53, wherein the slowing of the decline in physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, mental component score and/or physical component score is assessed using a 36-Item Short Form Survey (SF-36) or a 36-Item Short Form Survey Version 2 (SF-36v2). 55. The method of any one of claims 51 to 54, wherein the slowing of the decline in HRQoL comprises a higher score on at least one of the following domains of an SF-36 or SF-36v2 relative to a different patient at the same time point who has not been administered the antibody: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, mental component score and/or physical component score. 56. The method of any one of claims 51 to 54, wherein the slowing of the decline in HRQoL is assessed by comparing a score on at least one of the following domains of an SF-36 or SF- 36v2 to a baseline score: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, mental component score and/or physical component score. 57. The method of any one of claims 51 to 56, wherein the slowing of the decline in HRQoL is assessed after at least about 9 months following a first administration of the antibody. 58. The method of any one of claims 51 to 56, wherein the slowing of the decline in HRQoL is assessed after about 9 months following a first administration of the antibody. Attorney Docket No.50887-0050WO1 59. The method of any one of claims 51-58, wherein the method comprises a slowing of a decline in social functioning in the subject. 60. The method of claim 59, wherein the slowing of the decline in social functioning comprises a decrease of less than about 20 points on the social functioning domain of the SF-36v2 compared to baseline. 61. The method of claim 59, wherein the slowing of the decline in social functioning comprises a decrease of less than about 10 points on the social functioning domain of the SF-36v2 compared to baseline. 62. The method of any one of claims 51 to 61, wherein the method further comprises a slowing of a decline in at least one value for the following domains of the SF-36 or SF-36v2: physical functioning, role physical, bodily pain, general health perceptions, vitality, role-emotional, mental health, physical component score, and mental component score. 63. The method of any one of claims 51 to 62, wherein the method comprises a slowing of a decline in a reported value for a role physical domain of the SF-36 or SF-36v2. 64. The method of claim 63, wherein the reported value for the role physical domain is higher relative to a different patient at the same time point who has not been administered the antibody. 65. The method of claim 63, wherein the slowing of the decline in reported value for the role physical domain comprises a decrease of less than about 5 points on the role physical domain of the SF-36v2 compared to baseline. 66. The method of any one of claims 51 to 65, wherein the method comprises a slowing of a decline in a reported value for a bodily pain domain of the SF-36 or SF-36v2. Attorney Docket No.50887-0050WO1 67. The method of claim 66, wherein the reported value for the bodily pain domain is higher relative to a different patient at the same time point who has not been administered the antibody. 68. The method of claim 67, wherein the slowing of the decline in reported value for the bodily pain domain comprises a decrease of less than about 5 points on the bodily pain domain of the SF-36v2 compared to baseline. 69. The method of any one of claims 63 to 68, wherein the slowing of the decline in the reported value for the role physical domain and/or the reported value for the bodily pain domain is assessed after at least about 9 months following a first administration of the antibody. 70. The method of any one of claims 63 to 68, wherein the slowing of the decline in the reported value for the role physical domain and/or the reported value for the bodily pain domain is assessed after about 9 months following a first administration of the antibody. 71. The method of any one of claims 51-70, wherein the method comprises a slowing of a decline in physical functioning in the subject. 72. The method of any one of claims 51-71, wherein the method comprises a slowing of a decline in role physical in the subject. 73. The method of any one of claims 51-72, wherein the method comprises a slowing of a decline in bodily pain in the subject. 74. The method of any one of claims 51-73, wherein the method comprises a slowing of a decline in general health in the subject. 75. The method of any one of claims 51-74, wherein the method comprises a slowing of a decline in vitality in the subject. Attorney Docket No.50887-0050WO1 76. The method of any one of claims 51-75, wherein the method comprises a slowing of a decline in role emotional in the subject. 77. The method of any one of claims 51-76, wherein the method comprises a slowing of a decline in mental health in the subject. 78. The method of any one of claims 51-77, wherein the method comprises a slowing of a decline in mental component score in the subject. 79. The method of any one of claims 51-78, wherein the method comprises a slowing of a decline in at least two of the following: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, and mental component score. 80. The method of any one of claims 51-79, wherein the method comprises a slowing of a decline in at least three of the following: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health, and mental component score. 81. The method of any one of claims 51-80, wherein the antibody comprises a light chain variable region comprising three complementarity determining regions of 2A4, 7D8 or 11- 1F4, and a heavy chain variable region comprising three complementarity determining regions of 2A4, 7D8 or 11-1F4, respectively. 82. The method of any one of claims 51-81, wherein the antibody is a humanized version of 2A4. 83. The method of any one of claims 51-82, wherein the antibody is a humanized or chimeric version of 11-1F4. 84. The method of any one of claims 51-83, wherein the antibody comprises a light chain variable region comprising three complementarity determining regions set forth as SEQ ID Attorney Docket No.50887-0050WO1 NOs: 3, 4 and 5, or SEQ ID NOs: 16, 17, and 18, and a heavy chain variable region comprising three complementarity determining regions set forth as SEQ ID NOs: 6, 7 and 8, or SEQ ID NOs: 19, 20, and 21. 85. The method of any one of claims 51-84, wherein the light chain variable region comprises the amino acid sequence set forth as SEQ ID NO: 1 or 14. 86. The method of any one of claims 51-85, wherein the heavy chain variable region comprises the amino acid sequence set forth as SEQ ID NO: 2 or 15. 87. The method of any one of claims 51-86, wherein the light chain variable region comprises the amino acid sequence set forth as SEQ ID NO: 1 or 14, and the heavy chain variable region comprises the amino acid sequence set forth as SEQ ID NO: 2 or 15. 88. The method of any one of claims 51-87, wherein the antibody comprises a light chain comprising the amino acid sequence set forth as SEQ ID NO:10, and a heavy chain comprising the amino acid sequence set forth as SEQ ID NO: 11, 12 or 13. 89. The method of one of claims 51-88, wherein the antibody comprises a light chain comprising the amino acid sequence set forth as SEQ ID NO:10, and a heavy chain comprising the amino acid sequence set forth as SEQ ID NO:12. 90. The method of any one of claims 51-89, wherein the antibody is a Fab, Fab’, F(ab’)2, F(ab)c, Dab, nanobody, or Fv. 91. The method of any one of claims 51-90, wherein the antibody is birtamimab. 92. The method of any one of claims 51-91, wherein the effective dosage of the antibody is administered from a pharmaceutical formulation comprising the antibody at a concentration within the range from about 1mg/mL to about 100 mg/mL. Attorney Docket No.50887-0050WO1 93. The method of any one of claims 51-92, wherein the dosage is from about 0.5 mg/kg to about 30 mg/kg and the antibody is administered intravenously or subcutaneously at a frequency of from about weekly to about quarterly. 94. The method of one of claims 51-93, wherein the antibody is present at a concentration of about 50 mg/mL. 95. The method of any one of claims 51-94, wherein the dosage is administered intravenously following the transfer of an amount of the formulation required for the dosage from a vial to an intravenous bag containing a liquid. 96. The method of any one of claims 51-95, wherein the dosage is about 24 mg/kg and the antibody is administered intravenously every 28 days. 97. The method of any one of claims 51-96, wherein the duration of the treatment is at least 9 months. 98. The method of any one of claims 51-97, wherein the duration of the treatment is at least 12 months 99. The method of any one of claims 51-98, wherein the AL amyloidosis is Mayo Stage IV amyloidosis.
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