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NCT03433001 · OUTCOME

Percentage of Participants Who Achieve or Maintain Any Best Response

A Study in Relapsed and/or Refractory Multiple Myeloma Patients Treated With Ixazomib Plus Lenalidomide and Dexamethasone · Source last updated 2023-12-07

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
Up to 36 months as a maximum

What was measured

Best response is defined as the cumulative numbers of participants who achieve each level of best response including partial response (PR), very good PR (VGPR) and complete response (CR) assessed with IMWG Criteria after each cycle of treatment. Per IMWG criteria, PR: ≥50% reduction of serum M protein+reduction in 24-hour urinary M protein by ≥90%/ to \<200 mg/24-hour or ≥50% decrease in difference between involved and uninvolved free light chain (FLC) levels/ ≥50% reduction in bone marrow plasma cells, if ≥30% at baseline/ ≥50% reduction in size of soft tissue plasmacytomas. VGPR: serum+urine M-protein detectable by immunofixation but not on electrophoresis/ ≥90% reduction in serum M-protein+urine M-protein level \<100 mg/24-hour. CR: negative immunofixation on serum+urine +disappearance of soft tissue plasmacytomas+\<5% plasma cells in bone marrow.

Analysis population: Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib.

Groups in this outcome

Ixazomib + Lenalidomide + Dexamethasone

Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug.

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

Analysis denominator · Participants

GroupSource count
Ixazomib + Lenalidomide + Dexamethasone295

Reported measurements

CR
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixazomib + Lenalidomide + Dexamethasone20.0Not reportedNot reportedNot reportedNot reported
VGPR
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixazomib + Lenalidomide + Dexamethasone8.5Not reportedNot reportedNot reportedNot reported
PR
Values in Percentage of Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ixazomib + Lenalidomide + Dexamethasone22.0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        20.0
    title
    CR
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        8.5
    title
    VGPR
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        22.0
    title
    PR
denoms
  1. counts
    1. group Id
      OG000
      value
      295
    units
    Participants
description
Best response is defined as the cumulative numbers of participants who achieve each level of best response including partial response (PR), very good PR (VGPR) and complete response (CR) assessed with IMWG Criteria after each cycle of treatment. Per IMWG criteria, PR: ≥50% reduction of serum M protein+reduction in 24-hour urinary M protein by ≥90%/ to \<200 mg/24-hour or ≥50% decrease in difference between involved and uninvolved free light chain (FLC) levels/ ≥50% reduction in bone marrow plasma cells, if ≥30% at baseline/ ≥50% reduction in size of soft tissue plasmacytomas. VGPR: serum+urine M-protein detectable by immunofixation but not on electrophoresis/ ≥90% reduction in serum M-protein+urine M-protein level \<100 mg/24-hour. CR: negative immunofixation on serum+urine +disappearance of soft tissue plasmacytomas+\<5% plasma cells in bone marrow.
groups
  1. description
    Participants took ixazomib, lenalidomide, and dexamethasone under conditions of standard medical care in this study. The dosage and administration of ixazomib, lenalidomide, and dexamethasone were not defined by the protocol but according to the package insert of each drug.
    id
    OG000
    title
    Ixazomib + Lenalidomide + Dexamethasone
param Type
NUMBER
population Description
Full Analysis Set, defined as all participants who were enrolled into the study and who receive at least one dose of ixazomib.
reporting Status
POSTED
time Frame
Up to 36 months as a maximum
title
Percentage of Participants Who Achieve or Maintain Any Best Response
type
SECONDARY
unit Of Measure
Percentage of Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice