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NCT02990338 · OUTCOME

Overall Response Rate (ORR): Percentage of Participants With Disease Response as Per Independent Response Committee (IRC)

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
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
From the date of randomization to the date of first documentation of progression or initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)

What was measured

ORR (IMWG criteria): percentage of participants with stringent complete response(sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) as best overall response, assessed by IRC. sCR:negative immunofixation on serum and urine,disappearance of any soft tissue plasmacytomas,\<5% plasma cells in bone marrow aspirates plus normal free light chain(FLC)ratio(0.26-1.65), absence of clonal cells in bone marrow biopsy.CR:negative immunofixation on serum and urine,disappearance of any soft tissue plasmacytomas,\<5% plasma cells in bone marrow aspirates.VGPR: serum and urine M-protein detectable by immunofixation, not on electrophoresis/,\>=90% reduction in serum M-protein plus urine M-protein level \<100mg/24h/,\>=90% decrease in SPD compared to baseline in soft tissue plasmacytoma. PR: \>=50% reduction of serum M-protein and reduction in 24h urinary M-protein by \>=90%/\<200mg/24h,if present at baseline,\>=50% reduction in the size (SPD) of soft tissue plasmacytomas.

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

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pd (Pomalidomide + Dexamethasone)35.3Not reportedNot reportedNot reportedNot reported
IPd (Isatuximab + Pomalidomide + Dexamethasone)60.4Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. 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
    <0.0001
    p Value Comment
    Threshold for statistical significance at 0.025.
    statistical Comment
    One sided p-value was stratified based on age (\<75 years versus \>=75 years) and number of previous lines (2 or 3 versus \>3) according to IRT.
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. 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
    <0.0001
    p Value Comment
    Threshold for statistical significance at 0.025.
    statistical Comment
    One sided p-value was stratified based on age (\<75 years versus \>=75 years) and number of previous lines (2 or 3 versus \>3) according to IRT.
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        35.3
      2. group Id
        OG001
        value
        60.4
denoms
  1. counts
    1. group Id
      OG000
      value
      153
    2. group Id
      OG001
      value
      154
    units
    Participants
description
ORR (IMWG criteria): percentage of participants with stringent complete response(sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) as best overall response, assessed by IRC. sCR:negative immunofixation on serum and urine,disappearance of any soft tissue plasmacytomas,\<5% plasma cells in bone marrow aspirates plus normal free light chain(FLC)ratio(0.26-1.65), absence of clonal cells in bone marrow biopsy.CR:negative immunofixation on serum and urine,disappearance of any soft tissue plasmacytomas,\<5% plasma cells in bone marrow aspirates.VGPR: serum and urine M-protein detectable by immunofixation, not on electrophoresis/,\>=90% reduction in serum M-protein plus urine M-protein level \<100mg/24h/,\>=90% decrease in SPD compared to baseline in soft tissue plasmacytoma. PR: \>=50% reduction of serum M-protein and reduction in 24h urinary M-protein by \>=90%/\<200mg/24h,if present at baseline,\>=50% reduction in the size (SPD) of soft tissue plasmacytomas.
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
NUMBER
population Description
Analysis was performed on ITT population.
reporting Status
POSTED
time Frame
From the date of randomization to the date of first documentation of progression or initiation of further anti-myeloma treatment or data cut-off whichever comes first (maximum duration 76.7 weeks)
title
Overall Response Rate (ORR): Percentage of Participants With Disease Response as Per Independent Response Committee (IRC)
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice