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NCT03499808 · OUTCOME

Progression-free Survival (24 Month Estimate)

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 registration to time of confirmed hematologic progression

What was measured

To evaluate progression-free survival (24 month estimate) Hematologic progression is defined as 50% increase from nadir, or from baseline (if there was no response) in any ONE OR MORE of the following: 1. Serum M-protein: 50% increase in Serum M protein to a value greater than 0.5 g/dL. 2. Urine M protein: 50% increase in Urine M protein to a value greater than 200 mg/day (a visible peak must be present) 3. Free light chain increase of 50% to a value greater than 10 mg/dL

Analysis population: 35 participants were 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
Isatuximab74Not reported5988Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        59
        upper Limit
        88
        value
        74
denoms
  1. counts
    1. group Id
      OG000
      value
      35
    units
    Participants
description
To evaluate progression-free survival (24 month estimate) Hematologic progression is defined as 50% increase from nadir, or from baseline (if there was no response) in any ONE OR MORE of the following: 1. Serum M-protein: 50% increase in Serum M protein to a value greater than 0.5 g/dL. 2. Urine M protein: 50% increase in Urine M protein to a value greater than 200 mg/day (a visible peak must be present) 3. Free light chain increase of 50% to a value greater than 10 mg/dL
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 were analyzable
reporting Status
POSTED
time Frame
From registration to time of confirmed hematologic progression
title
Progression-free Survival (24 Month Estimate)
type
SECONDARY
unit Of Measure
percentage of paticipants

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

Preserved source evidence · Not medical advice