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NCT02312258 · OUTCOME

Correlation of MRD Status With PFS and OS

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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From randomization up to 52 months

What was measured

PFS is defined as the time from the date of randomization to the date of first documentation of PD or death from any cause, as evaluated by an IRC according to IMWG criteria, or death due to any cause, whichever occurred first, assessed for up to 52 months in this outcome measure. OS was measured as the time from the date of randomization to the date of death, assessed for up to 52 months in this outcome measure. Participants with various types of known MRD status were pooled together for analysis of overall survival in this outcome measure.

Analysis population: ITT Population included all participants who were randomized and had post-randomization data. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analyses for the specified category.

Groups in this outcome

Placebo

Ixazomib 3 mg, 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
Placebo151
Ixazomib213

Reported measurements

PFS for Participants with Known MRD+ at Study Entry

Analysis denominator · Participants

GroupSource count
Placebo125
Ixazomib169
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo9.3Not reported7.7511.99Not reported
Ixazomib16.9Not reported13.4721.29Not reported
PFS for Participants with Known MRD- at Study Entry

Analysis denominator · Participants

GroupSource count
Placebo26
Ixazomib44
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
PlaceboNANot reported23.69NAMedian and upper limit of confidence interval (CI) were not estimable due to censoring.
Ixazomib40.5Not reported26.94NAUpper limit of CI was not estimable due to censoring.
OS for Participants with Known MRD Status (MRD- Status, MRD+ Status) at Study Entry

Analysis denominator · Participants

GroupSource count
Placebo151
Ixazomib213
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
PlaceboNANot reportedNANAMedian, upper, and lower limit of CI were not estimable due to censoring.
IxazomibNANot reportedNANAMedian, upper, and lower limit of CI were not estimable due to censoring.

Source statistical analyses

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

  1. ci Lower Limit
    0.425
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.796
    group Description
    PFS for Participants with Known MRD+ at Study Entry
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    other Analysis Description
    P-value comparing PFS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR). Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant.
    p Value
    =0.001
    param Type
    Hazard Ratio (HR)
    param Value
    0.582
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.563
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    4.194
    group Description
    PFS for Participants with Known MRD- at Study Entry
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    other Analysis Description
    P-value comparing PFS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR). Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant.
    p Value
    =0.398
    param Type
    Hazard Ratio (HR)
    param Value
    1.537
    statistical Method
    Log Rank
  3. ci Lower Limit
    1.194
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    86.649
    group Description
    OS for Participants with Known MRD Status (MRD- Status, MRD+ Status) at Study Entry
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    other Analysis Description
    P-value comparing OS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR). Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant.
    p Value
    =0.012
    param Type
    Hazard Ratio (HR)
    param Value
    10.173
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.425
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.796
    group Description
    PFS for Participants with Known MRD+ at Study Entry
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    other Analysis Description
    P-value comparing PFS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR). Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant.
    p Value
    =0.001
    param Type
    Hazard Ratio (HR)
    param Value
    0.582
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.563
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    4.194
    group Description
    PFS for Participants with Known MRD- at Study Entry
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    other Analysis Description
    P-value comparing PFS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR). Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant.
    p Value
    =0.398
    param Type
    Hazard Ratio (HR)
    param Value
    1.537
    statistical Method
    Log Rank
  3. ci Lower Limit
    1.194
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    86.649
    group Description
    OS for Participants with Known MRD Status (MRD- Status, MRD+ Status) at Study Entry
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    other Analysis Description
    P-value comparing OS between treatment groups was based on log-rank test stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR). Hazard ratio was based on an unadjusted Cox's proportional hazard regression model stratified by initial therapy (proteasome inhibitor-containing or not), ISS stage before initial therapy (stage I or II vs stage III), age (\<75 vs \>=75 years) at randomization, and best response to initial therapy (CR or VGPR vs PR), comparing the hazard rate of ixazomib arm over the hazard rate of placebo arm. A less than 1 hazard ratio was to be considered statistically significant.
    p Value
    =0.012
    param Type
    Hazard Ratio (HR)
    param Value
    10.173
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.75
        upper Limit
        11.99
        value
        9.3
      2. group Id
        OG001
        lower Limit
        13.47
        upper Limit
        21.29
        value
        16.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        125
      2. group Id
        OG001
        value
        169
      units
      Participants
    title
    PFS for Participants with Known MRD+ at Study Entry
  2. categories
    1. measurements
      1. comment
        Median and upper limit of confidence interval (CI) were not estimable due to censoring.
        group Id
        OG000
        lower Limit
        23.69
        upper Limit
        NA
        value
        NA
      2. comment
        Upper limit of CI was not estimable due to censoring.
        group Id
        OG001
        lower Limit
        26.94
        upper Limit
        NA
        value
        40.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        44
      units
      Participants
    title
    PFS for Participants with Known MRD- at Study Entry
  3. categories
    1. measurements
      1. comment
        Median, upper, and lower limit of CI were not estimable due to censoring.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        Median, upper, and lower limit of CI were not estimable due to censoring.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    denoms
    1. counts
      1. group Id
        OG000
        value
        151
      2. group Id
        OG001
        value
        213
      units
      Participants
    title
    OS for Participants with Known MRD Status (MRD- Status, MRD+ Status) at Study Entry
denoms
  1. counts
    1. group Id
      OG000
      value
      151
    2. group Id
      OG001
      value
      213
    units
    Participants
description
PFS is defined as the time from the date of randomization to the date of first documentation of PD or death from any cause, as evaluated by an IRC according to IMWG criteria, or death due to any cause, whichever occurred first, assessed for up to 52 months in this outcome measure. OS was measured as the time from the date of randomization to the date of death, assessed for up to 52 months in this outcome measure. Participants with various types of known MRD status were pooled together for analysis of overall survival in this outcome measure.
dispersion Type
95% Confidence Interval
groups
  1. description
    Ixazomib 3 mg, 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
MEDIAN
population Description
ITT Population included all participants who were randomized and had post-randomization data. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analyses for the specified category.
reporting Status
POSTED
time Frame
From randomization up to 52 months
title
Correlation of MRD Status With PFS and OS
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice