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NCT03275285 · OUTCOME

Number of Participants With Anti-Drug Antibodies (ADA): Primary Analysis

Multinational Clinical Study Comparing Isatuximab, Carfilzomib And Dexamethasone To Carfilzomib And Dexamethasone In Relapse And/Or Refractory Multiple Myeloma Patients · Source last updated 2026-02-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: 111 weeks)

What was measured

ADA were categorized as: pre-existing, treatment induced, and treatment boosted response. Pre-existing ADA was defined as ADA that were present in samples drawn during the pretreatment period (i.e., before the first isatuximab administration). Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period in participants without pre-existing ADA, including participants without pretreatment samples. Treatment boosted ADA was defined as pre-existing ADA with an increase in titer during the ADA on-study observation period.

Analysis population: Analysis was performed on ADA evaluable population which included participants who received at least one dose of study drug from the IKd arm with at least one ADA assessment during the ADA on-study observation period with a reportable result. Data for this outcome measure was not planned to be collected and analyzed for Kd arm.

Groups in this outcome

Isatuximab + Carfilzomib + Dexamethasone (IKd)

Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Isatuximab + Carfilzomib + Dexamethasone (IKd)168

Reported measurements

Pre-existing ADA
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Isatuximab + Carfilzomib + Dexamethasone (IKd)0Not reportedNot reportedNot reportedNot reported
Treatment induced ADA
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Isatuximab + Carfilzomib + Dexamethasone (IKd)0Not reportedNot reportedNot reportedNot reported
Treatment boosted ADA
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Isatuximab + Carfilzomib + Dexamethasone (IKd)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Pre-existing ADA
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Treatment induced ADA
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Treatment boosted ADA
denoms
  1. counts
    1. group Id
      OG000
      value
      168
    units
    Participants
description
ADA were categorized as: pre-existing, treatment induced, and treatment boosted response. Pre-existing ADA was defined as ADA that were present in samples drawn during the pretreatment period (i.e., before the first isatuximab administration). Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period in participants without pre-existing ADA, including participants without pretreatment samples. Treatment boosted ADA was defined as pre-existing ADA with an increase in titer during the ADA on-study observation period.
groups
  1. description
    Participants received isatuximab 10 mg/kg, IV infusion on Days 1, 8, 15 and 22 in Cycle 1, and then on Days 1 and Day 15 of each 28-day treatment cycle plus carfilzomib 20 mg/m\^2, IV on Days 1, and 2 in Cycle 1, and then escalated to 56 mg/m\^2 on Days 8, 9, 15 and 16 of Cycle 1 and then on Days 1, 2, 8, 9, 15 and 16 of each subsequent 28-day treatment cycle and dexamethasone 20 mg, PO or IV on Day 1, 2, 8, 9, 15, 16, 22 and 23 of each 28-day treatment cycle until disease progression or unacceptable adverse event or participant's decision to discontinue the study treatment or any other reason, whichever comes first (maximum exposure: 111 weeks).
    id
    OG000
    title
    Isatuximab + Carfilzomib + Dexamethasone (IKd)
param Type
COUNT_OF_PARTICIPANTS
population Description
Analysis was performed on ADA evaluable population which included participants who received at least one dose of study drug from the IKd arm with at least one ADA assessment during the ADA on-study observation period with a reportable result. Data for this outcome measure was not planned to be collected and analyzed for Kd arm.
reporting Status
POSTED
time Frame
From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: 111 weeks)
title
Number of Participants With Anti-Drug Antibodies (ADA): Primary Analysis
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice