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NCT03416374 · OUTCOME

Number of Participants With Minimal Residual Disease (MRD) Positive or Negative in Bone Marrow in Participants Who Achieved CR

A Study to Evaluate the Efficacy and Safety of Ixazomib in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma Initially Treated With an Injection of Proteasome Inhibitor-Based Therapy · Source last updated 2022-09-27

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 39 months as a maximum

What was measured

MRD was measured by the flow cytometry method using bone marrow aspiration. Reported data were numbers of participants with MRD positive and negative in bone marrow in participants who achieved CR. MRD positive was categorized into three sensitivity levels with the numbers of cells counted (10\^-4 to - Max; 10\^-5 to 10\^-4; 10\^-6 to 10\^-5). MRD negativity is defined as absence of MRD and MRD positivity is defined as presence of MRD. If a participant is MRD-positive at their first evaluation and MRD-negative after re-examination, the participant will be considered to be MRD-negative. CR will be assessed by IMWG Criteria.

Analysis population: Full Analysis Set (FAS): all participants who were enrolled in Treatment Period I and who receive at least one dose of any therapy during the Treatment Period.

Groups in this outcome

[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy

Bortezomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)

[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy

Carfilzomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)

[Overall]; Combination Therapy + Ixazomib Therapy

Bortezomib + Lenalidomide + Dexamethasone, or Carfilzomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy2
[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy9
[Overall]; Combination Therapy + Ixazomib Therapy11

Reported measurements

Sensitivity Level; 10^-4=< - Max
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy0Not reportedNot reportedNot reportedNot reported
[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy1Not reportedNot reportedNot reportedNot reported
[Overall]; Combination Therapy + Ixazomib Therapy1Not reportedNot reportedNot reportedNot reported
Sensitivity Level; 10^-5=< - <10^-4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy1Not reportedNot reportedNot reportedNot reported
[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy2Not reportedNot reportedNot reportedNot reported
[Overall]; Combination Therapy + Ixazomib Therapy3Not reportedNot reportedNot reportedNot reported
Sensitivity Level; 10^-6=< - <10^-5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy1Not reportedNot reportedNot reportedNot reported
[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy1Not reportedNot reportedNot reportedNot reported
[Overall]; Combination Therapy + Ixazomib Therapy2Not reportedNot reportedNot reportedNot reported
Negative
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy0Not reportedNot reportedNot reportedNot reported
[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy5Not reportedNot reportedNot reportedNot reported
[Overall]; Combination Therapy + Ixazomib Therapy5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        1
    title
    Sensitivity Level; 10^-4=< - Max
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        3
    title
    Sensitivity Level; 10^-5=< - <10^-4
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        2
    title
    Sensitivity Level; 10^-6=< - <10^-5
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        5
    title
    Negative
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      9
    3. group Id
      OG002
      value
      11
    units
    Participants
description
MRD was measured by the flow cytometry method using bone marrow aspiration. Reported data were numbers of participants with MRD positive and negative in bone marrow in participants who achieved CR. MRD positive was categorized into three sensitivity levels with the numbers of cells counted (10\^-4 to - Max; 10\^-5 to 10\^-4; 10\^-6 to 10\^-5). MRD negativity is defined as absence of MRD and MRD positivity is defined as presence of MRD. If a participant is MRD-positive at their first evaluation and MRD-negative after re-examination, the participant will be considered to be MRD-negative. CR will be assessed by IMWG Criteria.
groups
  1. description
    Bortezomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)
    id
    OG000
    title
    [VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy
  2. description
    Carfilzomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)
    id
    OG001
    title
    [KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy
  3. description
    Bortezomib + Lenalidomide + Dexamethasone, or Carfilzomib + Lenalidomide + Dexamethasone, standard recommended dose according to the package insert of each drug (Treatment Period I), followed by Ixazomib (4.0 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 to 21, and Dexamethasone (40 mg) on Days 1, 8, 15 and 22, of a 28-day cycle (Treatment Period II)
    id
    OG002
    title
    [Overall]; Combination Therapy + Ixazomib Therapy
param Type
COUNT_OF_PARTICIPANTS
population Description
Full Analysis Set (FAS): all participants who were enrolled in Treatment Period I and who receive at least one dose of any therapy during the Treatment Period.
reporting Status
POSTED
time Frame
Up to 39 months as a maximum
title
Number of Participants With Minimal Residual Disease (MRD) Positive or Negative in Bone Marrow in Participants Who Achieved CR
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice