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NCT03499808 · OUTCOME

Assess Efficacy by Confirmed Overall Hematologic Response

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
percentage of paticipants
Interval / dispersion
95% Confidence Interval
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

To assess the efficacy as measured by the confirmed overall hematologic response rate (partial response, very good partial response, complete response) of isatuximab in relapsed/ refractory systemic light chain (AL) amyloidosis. Measured as rate of partial response or better. Partial response is defined as a dFLC decrease of ≥ 50%, but remaining \> 4.0 mg/dL. Very good partial response is defined as the difference between involved and uninvolved FLCs \[dFLC\] \< 4.0 mg/dL. Complete response is defined as laboratory values within the normal range free light chain (FLC) ratio (0.25 - 1.65) and negative serum and urine immunofixation.

Analysis population: 35 participants who received treatment and are analyzable.

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

Source class 1
Values in percentage of paticipants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Isatuximab77.1Not reported59.989.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        59.9
        upper Limit
        89.6
        value
        77.1
denoms
  1. counts
    1. group Id
      OG000
      value
      35
    units
    Participants
description
To assess the efficacy as measured by the confirmed overall hematologic response rate (partial response, very good partial response, complete response) of isatuximab in relapsed/ refractory systemic light chain (AL) amyloidosis. Measured as rate of partial response or better. Partial response is defined as a dFLC decrease of ≥ 50%, but remaining \> 4.0 mg/dL. Very good partial response is defined as the difference between involved and uninvolved FLCs \[dFLC\] \< 4.0 mg/dL. Complete response is defined as laboratory values within the normal range free light chain (FLC) ratio (0.25 - 1.65) and negative serum and urine immunofixation.
dispersion Type
95% Confidence Interval
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
35 participants who received treatment and are analyzable.
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
Assess Efficacy by Confirmed Overall Hematologic Response
type
PRIMARY
unit Of Measure
percentage of paticipants

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

Preserved source evidence · Not medical advice