Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03170882 · OUTCOME

Percentage of Participants With Overall Response

A Study of Ixazomib, Given With Dexamethasone in Adults With Multiple Myeloma · Source last updated 2022-12-20

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
95% Confidence Interval
Time frame
From date of randomization until first documentation of CR, VGPR or PR (Up to approximately 3 years)

What was measured

Overall Response Rate (ORR) was defined as the percentage of participants who achieved partial response (PR), very good partial response (VGPR), or complete response (CR) based on laboratory results and IRC assessment using modified IMWG criteria. PR: \>=50% reduction of serum M protein + reduction in 24-hour urinary M protein by \>=90% or to \<200 mg/24-hour; if M protein is not measurable, \>=50% decrease in difference between involved and uninvolved FLC levels is required; if not measurable by FLC, \>=50% reduction in bone marrow plasma cells, when baseline value \>=30% and; if present at baseline, \>=50% reduction in size of soft tissue plasmacytomas is required. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>=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: ITT Population included all participants who were randomized.

Groups in this outcome

Pomalidomide 4 mg + Dexamethasone 40 mg

Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.

Ixazomib 4 mg + Dexamethasone 20 mg

Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.

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

Analysis denominator · Participants

GroupSource count
Pomalidomide 4 mg + Dexamethasone 40 mg49
Ixazomib 4 mg + Dexamethasone 20 mg73

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pomalidomide 4 mg + Dexamethasone 40 mg41Not reported2756Not reported
Ixazomib 4 mg + Dexamethasone 20 mg38Not reported2750Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.43
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.90
    estimate Comment
    OR was based on logistic regression model with treatment group as categorical predictor variable and age, ISS and prior lines of therapy. OR \>1 was deemed to indicate better response in Ixazomib+Dexamethasone arm over Pomalidomide+Dexamethasone arm.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.634
    param Type
    Odds Ratio (OR)
    param Value
    0.90
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    0.43
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.90
    estimate Comment
    OR was based on logistic regression model with treatment group as categorical predictor variable and age, ISS and prior lines of therapy. OR \>1 was deemed to indicate better response in Ixazomib+Dexamethasone arm over Pomalidomide+Dexamethasone arm.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.634
    param Type
    Odds Ratio (OR)
    param Value
    0.90
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        27
        upper Limit
        56
        value
        41
      2. group Id
        OG001
        lower Limit
        27
        upper Limit
        50
        value
        38
denoms
  1. counts
    1. group Id
      OG000
      value
      49
    2. group Id
      OG001
      value
      73
    units
    Participants
description
Overall Response Rate (ORR) was defined as the percentage of participants who achieved partial response (PR), very good partial response (VGPR), or complete response (CR) based on laboratory results and IRC assessment using modified IMWG criteria. PR: \>=50% reduction of serum M protein + reduction in 24-hour urinary M protein by \>=90% or to \<200 mg/24-hour; if M protein is not measurable, \>=50% decrease in difference between involved and uninvolved FLC levels is required; if not measurable by FLC, \>=50% reduction in bone marrow plasma cells, when baseline value \>=30% and; if present at baseline, \>=50% reduction in size of soft tissue plasmacytomas is required. VGPR: serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>=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.
dispersion Type
95% Confidence Interval
groups
  1. description
    Pomalidomide 4 mg, capsules, orally, once daily on Days 1 to 21 of each 28-day cycle, plus dexamethasone 40 mg, (or 20 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
    id
    OG000
    title
    Pomalidomide 4 mg + Dexamethasone 40 mg
  2. description
    Ixazomib 4 mg as starting dose, capsules, orally, once daily on Days 1, 8, and 15 of each 28-day cycle, with escalation to 5.5 mg at the start of Cycle 2 for participants who tolerated the 4 mg dose in Cycle 1, plus dexamethasone 20 mg (or 10 mg if participant is aged \>=75 years), tablets, orally, once daily on Days 1, 2, 8, 9, 15, 16, 22, and 23 of every 28-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or sponsor termination of study up to 2 years.
    id
    OG001
    title
    Ixazomib 4 mg + Dexamethasone 20 mg
param Type
NUMBER
population Description
ITT Population included all participants who were randomized.
reporting Status
POSTED
time Frame
From date of randomization until first documentation of CR, VGPR or PR (Up to approximately 3 years)
title
Percentage of Participants With Overall Response
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice