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NCT03499808 · OUTCOME

To Evaluate Toxicities in the Treatment of Relapsed/Refractory AL Amyloidosis With Isatuximab.

S1702 Isatuximab in Treating Patients With Relapsed or Refractory Primary Amyloidosis · Source last updated 2025-09-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
From date of enrollment until progression or death due to any cause, whichever occurs first, assessed up to 4 years

What was measured

Only adverse events that are possibly, probably or definitely related to study drug are reported.

Analysis population: Participants who completed at least one day of treatment.

Groups in this outcome

Isatuximab

Patients receive isatuximab intravenously (IV) on days 1, 8, 15, and 22 of course 1 and on days 1 and 15 of subsequent courses. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Isatuximab35

Reported measurements

Atrial fibrillation
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Isatuximab1Not reportedNot reportedNot reportedNot reported
Fatigue
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Isatuximab1Not reportedNot reportedNot reportedNot reported
Infections and infestations - Other, specify
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Isatuximab1Not reportedNot reportedNot reportedNot reported
Infusion related reaction
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Isatuximab1Not reportedNot reportedNot reportedNot reported
Lung infection
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Isatuximab2Not reportedNot reportedNot reportedNot reported
Lymphocyte count decreased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Isatuximab3Not reportedNot reportedNot reportedNot reported
Pancreatitis
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Isatuximab1Not reportedNot reportedNot reportedNot reported
Pruritus
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Isatuximab1Not reportedNot reportedNot reportedNot reported
Skin infection
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Isatuximab1Not reportedNot reportedNot reportedNot reported
Syncope
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Isatuximab1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Atrial fibrillation
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Fatigue
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Infections and infestations - Other, specify
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Infusion related reaction
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Lung infection
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Lymphocyte count decreased
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Pancreatitis
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Pruritus
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Skin infection
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Syncope
denoms
  1. counts
    1. group Id
      OG000
      value
      35
    units
    Participants
description
Only adverse events that are possibly, probably or definitely related to study drug are reported.
groups
  1. description
    Patients receive isatuximab intravenously (IV) on days 1, 8, 15, and 22 of course 1 and on days 1 and 15 of subsequent courses. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Isatuximab
param Type
NUMBER
population Description
Participants who completed at least one day of treatment.
reporting Status
POSTED
time Frame
From date of enrollment until progression or death due to any cause, whichever occurs first, assessed up to 4 years
title
To Evaluate Toxicities in the Treatment of Relapsed/Refractory AL Amyloidosis With Isatuximab.
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice