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NCT03499808 · OUTCOME

Overall 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
percent of participants
Interval / dispersion
95% Confidence Interval
Time frame
From date of enrollment up to 2 years

What was measured

Overall survival is measured from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. While OS was assessed up to 4 years, 4 year estimates were not reached. We are reporting the 24 month estimate (how many participants reached survival time of at least 24 months).

Analysis population: 35 eligible participants who received at least one dose of study drug.

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 percent of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Isatuximab85Not reported7397Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        73
        upper Limit
        97
        value
        85
denoms
  1. counts
    1. group Id
      OG000
      value
      35
    units
    Participants
description
Overall survival is measured from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact. While OS was assessed up to 4 years, 4 year estimates were not reached. We are reporting the 24 month estimate (how many participants reached survival time of at least 24 months).
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 eligible participants who received at least one dose of study drug.
reporting Status
POSTED
time Frame
From date of enrollment up to 2 years
title
Overall Survival (24 Month Estimate)
type
SECONDARY
unit Of Measure
percent of participants

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

Preserved source evidence · Not medical advice