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NCT02312258 · OUTCOME

Percentage of Participants Who Achieve or Maintain Any Best Response Category During the Treatment Period

A Study of Oral Ixazomib Maintenance Therapy in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Not Treated With Stem Cell Transplantation (SCT) · Source last updated 2023-09-21

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 27 months

What was measured

Response was assessed according to IMWG criteria based on IRC assessment. Best response included PR, VGPR and CR. PR= \>=50% reduction of serum M protein and \>=90% or \<200 mg reduction urinary M protein in 24-hour, or \>50% decrease in difference between involved and uninvolved FLC levels, or \>50% reduction in bone marrow plasma cells, if bone marrow plasma cells \>30% and \>50% reduction in size of soft tissue plasmacytomas at baseline. VGPR= \>90% reduction (\<100 mg/24-hour) in serum M-protein + urine M-protein detectable by immunofixation but not on electrophoresis. Complete response= \>5% plasma cells in myelogram with absence of paraprotein in serum and urine according to immunofixation.

Analysis population: ITT Population included all participants who were randomized and had post-randomization data. The percentages are rounded off to the single nearest decimal point.

Groups in this outcome

Placebo

Ixazomib placebo-matching capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.

Ixazomib

Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.

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

Analysis denominator · Participants

GroupSource count
Placebo281
Ixazomib425

Reported measurements

PR
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo29Not reportedNot reportedNot reportedNot reported
Ixazomib25Not reportedNot reportedNot reportedNot reported
VGPR
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo37Not reportedNot reportedNot reportedNot reported
Ixazomib34Not reportedNot reportedNot reportedNot reported
CR
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo28Not reportedNot reportedNot reportedNot reported
Ixazomib31Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        29
      2. group Id
        OG001
        value
        25
    title
    PR
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        37
      2. group Id
        OG001
        value
        34
    title
    VGPR
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        28
      2. group Id
        OG001
        value
        31
    title
    CR
denoms
  1. counts
    1. group Id
      OG000
      value
      281
    2. group Id
      OG001
      value
      425
    units
    Participants
description
Response was assessed according to IMWG criteria based on IRC assessment. Best response included PR, VGPR and CR. PR= \>=50% reduction of serum M protein and \>=90% or \<200 mg reduction urinary M protein in 24-hour, or \>50% decrease in difference between involved and uninvolved FLC levels, or \>50% reduction in bone marrow plasma cells, if bone marrow plasma cells \>30% and \>50% reduction in size of soft tissue plasmacytomas at baseline. VGPR= \>90% reduction (\<100 mg/24-hour) in serum M-protein + urine M-protein detectable by immunofixation but not on electrophoresis. Complete response= \>5% plasma cells in myelogram with absence of paraprotein in serum and urine according to immunofixation.
groups
  1. description
    Ixazomib placebo-matching capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 through 26.
    id
    OG000
    title
    Placebo
  2. description
    Ixazomib 3 mg, capsule, orally, once on Days 1, 8, and 15 of each 28-day cycle from Cycles 1 to 4 that may have been escalated to 4 mg thereafter up to Cycle 26.
    id
    OG001
    title
    Ixazomib
param Type
NUMBER
population Description
ITT Population included all participants who were randomized and had post-randomization data. The percentages are rounded off to the single nearest decimal point.
reporting Status
POSTED
time Frame
Up to 27 months
title
Percentage of Participants Who Achieve or Maintain Any Best Response Category During the Treatment Period
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice