Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02990338 · OUTCOME

Number of Participants With Anti-drug Antibodies (ADA)

Multinational Clinical Study Comparing Isatuximab, Pomalidomide, and Dexamethasone to Pomalidomide and Dexamethasone in Refractory or Relapsed and Refractory Multiple Myeloma Patients · Source last updated 2025-01-17

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 randomization up to 60 days after last dose of study drug (maximum duration 76.7 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 preexisting ADA, including participants without pretreatment samples. Treatment boosted ADA was defined as pre-existing ADA that increased at least 2 titer steps between pre-treatment and post-treatment.

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

Groups in this outcome

IPd (Isatuximab + Pomalidomide + Dexamethasone)

Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 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
IPd (Isatuximab + Pomalidomide + Dexamethasone)151

Reported measurements

Pre-existing ADA
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
IPd (Isatuximab + Pomalidomide + Dexamethasone)0Not reportedNot reportedNot reportedNot reported
Treatment induced ADA
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
IPd (Isatuximab + Pomalidomide + Dexamethasone)0Not reportedNot reportedNot reportedNot reported
Treatment boosted ADA
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
IPd (Isatuximab + Pomalidomide + Dexamethasone)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
      151
    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 preexisting ADA, including participants without pretreatment samples. Treatment boosted ADA was defined as pre-existing ADA that increased at least 2 titer steps between pre-treatment and post-treatment.
groups
  1. description
    Participants received isatuximab 10 mg/kg IV infusion on Days 1, 8, 15, and 22 at Cycle 1, and then on Days 1 and 15 of subsequent cycles plus pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle and dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone), PO or IV on Day 1, 8, 15, 22 of each 28-day treatment cycle until disease progression or unacceptable toxicity or participant's wish to discontinue study treatment, or any other reason, whichever comes first (maximum exposure: 76.7 weeks).
    id
    OG000
    title
    IPd (Isatuximab + Pomalidomide + Dexamethasone)
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 IPd arm with at least one ADA assessment during the ADA on-study observation period with a reportable result. Data for this OM was not planned to be collected and analyzed for Pd arm.
reporting Status
POSTED
time Frame
From randomization up to 60 days after last dose of study drug (maximum duration 76.7 weeks)
title
Number of Participants With Anti-drug Antibodies (ADA)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice