Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02990338 · OUTCOME

Progression Free Survival in High Risk Cytogenetic Population

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 the date of first documentation of progression, or the date of death from any cause, or initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)

What was measured

PFS in high risk cytogenetic population was defined as PFS in subgroup of participants carrying high risk cytogenetic changes including del(17p), translocation (t)(4;14) or translocation t(14;16) assessed by fluorescence in situ hybridization (FISH). PFS was defined as the time from date of randomization to date of first documentation of PD (determined by IRC) or date of death from any cause, whichever comes first. PD defined as per IMWG criteria as: increase of \>=25% from lowest confirmed value in any one of following criteria: serum M-protein (absolute increase must be \>=0.5 g/dL), serum M-protein increase \>=1 g/dL if lowest M component was \>=5 g/dL; urine M-component (absolute increase must be \>=200 mg/24hour), appearance of new lesion(s), \>=50% increase from nadir in SPD of \>1 lesion, or \>=50% increase in the longest diameter of previous lesion \>1 centimeter (cm) in short axis.

Analysis population: Analysis was performed in high-risk cytogenetic population which included participants carrying del (17p), t(4;14) or t(14;16) in each arm.

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: 73.7 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: 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
Pd (Pomalidomide + Dexamethasone)36
IPd (Isatuximab + Pomalidomide + Dexamethasone)25

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pd (Pomalidomide + Dexamethasone)3.745Not reported2.7937.885Not reported
IPd (Isatuximab + Pomalidomide + Dexamethasone)7.491Not reported2.628NADue to smaller number of participants with an event, 95% CI could not be calculated.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.793
        upper Limit
        7.885
        value
        3.745
      2. comment
        Due to smaller number of participants with an event, 95% CI could not be calculated.
        group Id
        OG001
        lower Limit
        2.628
        upper Limit
        NA
        value
        7.491
denoms
  1. counts
    1. group Id
      OG000
      value
      36
    2. group Id
      OG001
      value
      25
    units
    Participants
description
PFS in high risk cytogenetic population was defined as PFS in subgroup of participants carrying high risk cytogenetic changes including del(17p), translocation (t)(4;14) or translocation t(14;16) assessed by fluorescence in situ hybridization (FISH). PFS was defined as the time from date of randomization to date of first documentation of PD (determined by IRC) or date of death from any cause, whichever comes first. PD defined as per IMWG criteria as: increase of \>=25% from lowest confirmed value in any one of following criteria: serum M-protein (absolute increase must be \>=0.5 g/dL), serum M-protein increase \>=1 g/dL if lowest M component was \>=5 g/dL; urine M-component (absolute increase must be \>=200 mg/24hour), appearance of new lesion(s), \>=50% increase from nadir in SPD of \>1 lesion, or \>=50% increase in the longest diameter of previous lesion \>1 centimeter (cm) in short axis.
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: 73.7 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: 76.7 weeks).
    id
    OG001
    title
    IPd (Isatuximab + Pomalidomide + Dexamethasone)
param Type
MEDIAN
population Description
Analysis was performed in high-risk cytogenetic population which included participants carrying del (17p), t(4;14) or t(14;16) in each arm.
reporting Status
POSTED
time Frame
From the date of randomization to the date of first documentation of progression, or the date of death from any cause, or initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)
title
Progression Free Survival in High Risk Cytogenetic Population
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice