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← AL Amyloidosis

NCT03154047 · STUDY IN CONTEXT

Study in Subjects With Light Chain (AL) Amyloidosis

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome, or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.

OLE Safety Population

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-al-amyloidosis
nct id
NCT03154047
trial label
Study in Subjects With Light Chain (AL) Amyloidosis
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
1
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-al-amyloidosis
    nct id
    NCT03154047
    outcome key
    om-0000
    source section id
    NCT03154047-om-0000
    source outcome index
    0
    endpoint
    Number of Participants With Adverse Events
    endpoint definition
    AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome, or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
    time origin
    Each subject's study participation may have been up to 36 months or until the study was terminated
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    OLE Safety Population
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-al-amyloidosis
    nct id
    NCT03154047
    outcome key
    om-0000
    arm key
    OG000
    arm label
    NEOD001 24 mg/kg
    regimen
    NEOD001, 24 mg/kg IV every 4 weeks
    analyzed count
    80
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03154047-om-0000#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-al-amyloidosis
    nct id
    NCT03154047
    harm key
    EG000
    source section id
    NCT03154047-ae
    event group key
    EG000
    event group label
    NEOD001 24 mg/kg
    serious affected
    13
    serious at risk
    80
    other affected
    28
    other at risk
    80
    frequency threshold
    5
    collection period
    Initiation of study drug through study completion, up to 11 months
    event definition
    AE that newly appears, increases in frequency, or worsens in severity following initiation of study drug and through the last study visit or up to 30 days after date of last dose, whichever is later.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice