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NCT02990338 · OUTCOME

Overall Survival (OS): Final Analysis

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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From the date of randomization to date of death from any cause or data cut-off date, whichever was earlier (maximum duration 245.6 weeks)

What was measured

OS was defined as the time from the date of randomization to death from any cause. In the absence of confirmation of death, survival time was censored at the last date participant was known to be alive or at the cut-off date, whichever comes first. This pre-specified final analysis was performed when the 220 OS events were met.

Analysis population: Analysis was performed on ITT population.

Groups in this outcome

Pd (Pomalidomide + Dexamethasone)

Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 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: 241.6 weeks).

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: 245.6 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
Pd (Pomalidomide + Dexamethasone)153
IPd (Isatuximab + Pomalidomide + Dexamethasone)154

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pd (Pomalidomide + Dexamethasone)17.71Not reported14.39026.218Not reported
IPd (Isatuximab + Pomalidomide + Dexamethasone)24.57Not reported20.30431.310Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.594
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.015
    estimate Comment
    Stratified on age (\<75 years versus \>=75 years) and number of previous lines of therapy (2 or 3 versus \> 3) according to IRT.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    A closed test procedure was used to control the type I error rate meaning no further testing would be performed unless the significance level had been reached on PFS.
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0319
    p Value Comment
    One-sided significance level was 0.02 using the O'Brien-Fleming alpha spending function.
    param Type
    Hazard Ratio (HR)
    param Value
    0.776
    statistical Comment
    Stratified on age (\<75 years versus \>=75 years) and number of previous lines of therapy (2 or 3 versus \> 3) according to IRT.
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.594
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.015
    estimate Comment
    Stratified on age (\<75 years versus \>=75 years) and number of previous lines of therapy (2 or 3 versus \> 3) according to IRT.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    A closed test procedure was used to control the type I error rate meaning no further testing would be performed unless the significance level had been reached on PFS.
    non Inferiority Type
    SUPERIORITY
    p Value
    0.0319
    p Value Comment
    One-sided significance level was 0.02 using the O'Brien-Fleming alpha spending function.
    param Type
    Hazard Ratio (HR)
    param Value
    0.776
    statistical Comment
    Stratified on age (\<75 years versus \>=75 years) and number of previous lines of therapy (2 or 3 versus \> 3) according to IRT.
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        14.390
        upper Limit
        26.218
        value
        17.71
      2. group Id
        OG001
        lower Limit
        20.304
        upper Limit
        31.310
        value
        24.57
denoms
  1. counts
    1. group Id
      OG000
      value
      153
    2. group Id
      OG001
      value
      154
    units
    Participants
description
OS was defined as the time from the date of randomization to death from any cause. In the absence of confirmation of death, survival time was censored at the last date participant was known to be alive or at the cut-off date, whichever comes first. This pre-specified final analysis was performed when the 220 OS events were met.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received pomalidomide 4 mg PO on Days 1 to 21 of each 28-day treatment cycle plus dexamethasone 40 mg (participants \>= 75 years of age received 20 mg dexamethasone) PO on Days 1, 8, 15 and 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: 241.6 weeks).
    id
    OG000
    title
    Pd (Pomalidomide + Dexamethasone)
  2. 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: 245.6 weeks).
    id
    OG001
    title
    IPd (Isatuximab + Pomalidomide + Dexamethasone)
param Type
MEDIAN
population Description
Analysis was performed on ITT population.
reporting Status
POSTED
time Frame
From the date of randomization to date of death from any cause or data cut-off date, whichever was earlier (maximum duration 245.6 weeks)
title
Overall Survival (OS): Final Analysis
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice