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NCT03499808 · OUTCOME

Time to 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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
From registration to time of confirmed hematologic progression

What was measured

To evaluate time to hematologic response. 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: Of the 35 analyzable participants, 27 achieved a response.

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 Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Isatuximab1.1Not reported13Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1
        upper Limit
        3
        value
        1.1
denoms
  1. counts
    1. group Id
      OG000
      value
      27
    units
    Participants
description
To evaluate time to hematologic response. 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
MEDIAN
population Description
Of the 35 analyzable participants, 27 achieved a response.
reporting Status
POSTED
time Frame
From registration to time of confirmed hematologic progression
title
Time to Hematologic Response
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice