Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03275285 · OUTCOME

Duration of Response (DOR): 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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months)

What was measured

DOR: time (in months) from date of 1st IRC determined response for participants achieving PR/better to date of 1st documented PD determined by IRC/death, whichever happens 1st. If disease progression/death before analysis cut-off date was not observed, DOR was censored at date of last valid disease assessment performed prior to initiation of further anti-myeloma treatment/data cut-off date, whichever was 1st. PD (IMWG criteria): inc of \>=25% from lowest confirmed value in any 1 of following criteria: serum M-protein (absolute inc must be \>=0.5 g/dL), serum M-protein inc \>=1g/dL if lowest M component was \>=5g/dL; urine M-component (absolute inc must be \>=200mg/24 hour),appearance of new lesion(s), \>=50% inc from nadir in SPD of \>1 lesion, or \>=50% inc in the longest diameter of previous lesion \>1 cm in short axis. PR: \>=50% reduction of serum M-protein \& reduction in 24h urinary M-protein by \>=90%/\<200mg/24 h. Estimated by Kaplan Meier method.

Analysis population: Analysis was performed on the subset of participants with PR or better (defined as responders) in ITT population.

Groups in this outcome

Carfilzomib + Dexamethasone (Kd)

Participants received carfilzomib 20 mg/m\^2, IV infusion 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 along with dexamethasone 20 mg, PO or IV on Days 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: 114 weeks).

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
Carfilzomib + Dexamethasone (Kd)102
Isatuximab + Carfilzomib + Dexamethasone (IKd)155

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Carfilzomib + Dexamethasone (Kd)NANot reported14.752NAMedian and upper limit of confidence interval could not be calculated because of less than 50% of the participants reaching PR or better with PFS events (PFS events includes progression and death without progression).
Isatuximab + Carfilzomib + Dexamethasone (IKd)NANot reportedNANAMedian and the upper and lower limit of confidence interval could not be calculated because of less than 50% of the participants reaching PR or better with PFS events (PFS events includes progression and death without progression).

Source statistical analyses

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

  1. ci Lower Limit
    0.269
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.672
    estimate Comment
    Stratification was done on the number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Stratified Hazard Ratio
    param Value
    0.425
Complete source fields
analyses
  1. ci Lower Limit
    0.269
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.672
    estimate Comment
    Stratification was done on the number of prior lines of therapy (1 vs. \>1) and R-ISS stage (I or II vs. III vs. not classified) according to IRT.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Stratified Hazard Ratio
    param Value
    0.425
classes
  1. categories
    1. measurements
      1. comment
        Median and upper limit of confidence interval could not be calculated because of less than 50% of the participants reaching PR or better with PFS events (PFS events includes progression and death without progression).
        group Id
        OG000
        lower Limit
        14.752
        upper Limit
        NA
        value
        NA
      2. comment
        Median and the upper and lower limit of confidence interval could not be calculated because of less than 50% of the participants reaching PR or better with PFS events (PFS events includes progression and death without progression).
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      102
    2. group Id
      OG001
      value
      155
    units
    Participants
description
DOR: time (in months) from date of 1st IRC determined response for participants achieving PR/better to date of 1st documented PD determined by IRC/death, whichever happens 1st. If disease progression/death before analysis cut-off date was not observed, DOR was censored at date of last valid disease assessment performed prior to initiation of further anti-myeloma treatment/data cut-off date, whichever was 1st. PD (IMWG criteria): inc of \>=25% from lowest confirmed value in any 1 of following criteria: serum M-protein (absolute inc must be \>=0.5 g/dL), serum M-protein inc \>=1g/dL if lowest M component was \>=5g/dL; urine M-component (absolute inc must be \>=200mg/24 hour),appearance of new lesion(s), \>=50% inc from nadir in SPD of \>1 lesion, or \>=50% inc in the longest diameter of previous lesion \>1 cm in short axis. PR: \>=50% reduction of serum M-protein \& reduction in 24h urinary M-protein by \>=90%/\<200mg/24 h. Estimated by Kaplan Meier method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received carfilzomib 20 mg/m\^2, IV infusion 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 along with dexamethasone 20 mg, PO or IV on Days 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: 114 weeks).
    id
    OG000
    title
    Carfilzomib + Dexamethasone (Kd)
  2. 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
    OG001
    title
    Isatuximab + Carfilzomib + Dexamethasone (IKd)
param Type
MEDIAN
population Description
Analysis was performed on the subset of participants with PR or better (defined as responders) in ITT population.
reporting Status
POSTED
time Frame
From randomization until the primary analysis data cut-off date of 7 Feb 2020 (the median duration of follow-up was 20.73 months)
title
Duration of Response (DOR): Primary Analysis
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice