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NCT05405166 · OUTCOME

Duration of Response (DOR)

SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM · Source last updated 2026-09-02

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 first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months

What was measured

DOR: Time from the date of first response to the date of first occurrence of progressive disease (PD) determined by IRC or death from any cause, whichever occurred first.DOR was determined only for participants who achieved a response (PR or better).If PD/death not observed, participant was censored at date of last valid disease assessment performed prior to initiating further anti-myeloma treatment or analysis cut-off date, whichever occurred first. As per IMWG criteria: PD: increase of \>=25% from lowest confirmed value in any 1 of following: serum M-protein (absolute increase\>=0.5 gram/deciliter\[g/dL\]),serum M-protein increase\>=1g/dL if lowest M-component \>=5g/dL, urine M-component (absolute increase \>=200mg/24h), appearance of new lesion(s),\>=50% increase from nadir in SPD of \>1 lesion or \>=50% increase in longest diameter of a previous lesion \>1 centimeter (cm) in short axis. PR: as defined in OM1.

Analysis population: The ITT population included all randomized population. Only responders (participants who achieved a response of PR or better subsequently confirmed based on disease assessment by IRC) were included in the analysis.

Groups in this outcome

Isa-IV + Pd

Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.

Isa-SC + Pd

Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.

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

Analysis denominator · Participants

GroupSource count
Isa-IV + Pd194
Isa-SC + Pd188

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Isa-IV + Pd29.04Not reported25.791NANA indicates that upper limit of CI was not estimable due to insufficient number of participants with events at DCO date.
Isa-SC + PdNANot reported22.177NANA indicates that median and upper limit of CI was not estimable due to insufficient number of participants with events at DCO date.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        NA indicates that upper limit of CI was not estimable due to insufficient number of participants with events at DCO date.
        group Id
        OG000
        lower Limit
        25.791
        upper Limit
        NA
        value
        29.04
      2. comment
        NA indicates that median and upper limit of CI was not estimable due to insufficient number of participants with events at DCO date.
        group Id
        OG001
        lower Limit
        22.177
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      194
    2. group Id
      OG001
      value
      188
    units
    Participants
description
DOR: Time from the date of first response to the date of first occurrence of progressive disease (PD) determined by IRC or death from any cause, whichever occurred first.DOR was determined only for participants who achieved a response (PR or better).If PD/death not observed, participant was censored at date of last valid disease assessment performed prior to initiating further anti-myeloma treatment or analysis cut-off date, whichever occurred first. As per IMWG criteria: PD: increase of \>=25% from lowest confirmed value in any 1 of following: serum M-protein (absolute increase\>=0.5 gram/deciliter\[g/dL\]),serum M-protein increase\>=1g/dL if lowest M-component \>=5g/dL, urine M-component (absolute increase \>=200mg/24h), appearance of new lesion(s),\>=50% increase from nadir in SPD of \>1 lesion or \>=50% increase in longest diameter of a previous lesion \>1 centimeter (cm) in short axis. PR: as defined in OM1.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received isatuximab 10 mg/kg IV infusion QW (i.e. on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 10 mg/kg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
    id
    OG000
    title
    Isa-IV + Pd
  2. description
    Participants received isatuximab 1400 mg SC injection administered via an OBDS which is an investigational device injector QW (i.e on Days 1, 8, 15 and 22) in Cycle 1 (28 days) and then 1400 mg Q2W (i.e. on Days 1 and 15) of each subsequent 28-day cycle along with pomalidomide 4 mg orally on Days 1 to 21 of each 28-day cycle and dexamethasone 40 mg (or 20 mg for participant \>=75 years) orally on Days 1, 8, 15, and 22 of each cycle until disease progression, unacceptable AEs, participant request to discontinue treatment, or any other reason, whichever came first.
    id
    OG001
    title
    Isa-SC + Pd
param Type
MEDIAN
population Description
The ITT population included all randomized population. Only responders (participants who achieved a response of PR or better subsequently confirmed based on disease assessment by IRC) were included in the analysis.
reporting Status
POSTED
time Frame
From first dose of study medication administration (Day 1) up to DCO date (29-Aug-2025), approximately 38 months
title
Duration of Response (DOR)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice