Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03499808 · OUTCOME

Duration of Response (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
Up to 2 years

What was measured

Duration of response is measure as time between hematologic response and hematologic progression. Hematologic progression is defined as 50% increase from nadir. While duration of response was assessed up to 4 years, 4 year estimates were not reached. We are reporting the 24 month estimate (how many participants achieved 24 month duration of response)

Analysis population: 27 participants with response to study 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
Isatuximab27

Reported measurements

Source class 1
Values in Percent of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Isatuximab81Not reported6796Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        67
        upper Limit
        96
        value
        81
denoms
  1. counts
    1. group Id
      OG000
      value
      27
    units
    Participants
description
Duration of response is measure as time between hematologic response and hematologic progression. Hematologic progression is defined as 50% increase from nadir. While duration of response was assessed up to 4 years, 4 year estimates were not reached. We are reporting the 24 month estimate (how many participants achieved 24 month duration of response)
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
27 participants with response to study treatment
reporting Status
POSTED
time Frame
Up to 2 years
title
Duration of Response (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