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NCT02990338 · OUTCOME

Number of Participants With Minimal Residual Disease (MRD)

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 76.7 weeks

What was measured

MRD was assessed by next-generation sequencing in bone marrow samples from participants who achieved CR, to determine the depth of response at the molecular level. IMWG criteria for CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow aspirates. MRD was classified as positive or negative at the minimum sensitivity of 1 in 10\^5 nucleated cells. MRD negativity was defined as the absence of the dominant clonotype sequence(s) identified in the bone marrow aspirate collected at screening. MRD positivity was defined as the presence of the dominant clonotype sequence(s) identified in the bone marrow aspirate collected at screening.

Analysis population: Analysis was performed on ITT population who were evaluable for MRD.

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)2
IPd (Isatuximab + Pomalidomide + Dexamethasone)14

Reported measurements

MRD negative:1 in 10^4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pd (Pomalidomide + Dexamethasone)0Not reportedNot reportedNot reportedNot reported
IPd (Isatuximab + Pomalidomide + Dexamethasone)10Not reportedNot reportedNot reportedNot reported
MRD negative:1 in 10^5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pd (Pomalidomide + Dexamethasone)0Not reportedNot reportedNot reportedNot reported
IPd (Isatuximab + Pomalidomide + Dexamethasone)8Not reportedNot reportedNot reportedNot reported
MRD negative:1 in 10^6
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pd (Pomalidomide + Dexamethasone)0Not reportedNot reportedNot reportedNot reported
IPd (Isatuximab + Pomalidomide + Dexamethasone)2Not reportedNot reportedNot reportedNot reported
MRD positive:1 in 10^4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pd (Pomalidomide + Dexamethasone)2Not reportedNot reportedNot reportedNot reported
IPd (Isatuximab + Pomalidomide + Dexamethasone)4Not reportedNot reportedNot reportedNot reported
MRD positive:1 in 10^5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pd (Pomalidomide + Dexamethasone)2Not reportedNot reportedNot reportedNot reported
IPd (Isatuximab + Pomalidomide + Dexamethasone)6Not reportedNot reportedNot reportedNot reported
MRD positive:1 in 10^6
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Pd (Pomalidomide + Dexamethasone)2Not reportedNot reportedNot reportedNot reported
IPd (Isatuximab + Pomalidomide + Dexamethasone)9Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        10
    title
    MRD negative:1 in 10^4
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        8
    title
    MRD negative:1 in 10^5
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
    title
    MRD negative:1 in 10^6
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        4
    title
    MRD positive:1 in 10^4
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        6
    title
    MRD positive:1 in 10^5
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        9
    title
    MRD positive:1 in 10^6
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      14
    units
    Participants
description
MRD was assessed by next-generation sequencing in bone marrow samples from participants who achieved CR, to determine the depth of response at the molecular level. IMWG criteria for CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow aspirates. MRD was classified as positive or negative at the minimum sensitivity of 1 in 10\^5 nucleated cells. MRD negativity was defined as the absence of the dominant clonotype sequence(s) identified in the bone marrow aspirate collected at screening. MRD positivity was defined as the presence of the dominant clonotype sequence(s) identified in the bone marrow aspirate collected at screening.
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
COUNT_OF_PARTICIPANTS
population Description
Analysis was performed on ITT population who were evaluable for MRD.
reporting Status
POSTED
time Frame
Up to 76.7 weeks
title
Number of Participants With Minimal Residual Disease (MRD)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice