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NCT01564537 · OUTCOME

Progression Free Survival (PFS) as Assessed by the Independent Review Committee (IRC)

A Phase 3 Study Comparing Oral Ixazomib Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma · Source last updated 2023-03-10

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 date of randomization until disease progression or death up to approximately 27 months (approximate median follow-up 15 months)

What was measured

Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of first documentation of disease progression (PD) or death due to any cause, whichever occurs first. Response including PD was assessed by independent review committee (IRC) using the International Myeloma Working Group (IMWG) response criteria. PD requires 1 of the following: Increase of ≥ 25% from nadir in: Serum M-component (absolute increase ≥ 0.5 g/dl); Urine M-component (absolute increase ≥ 200 mg/24 hours); In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase \> 10 mg/dl); Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium \> 11.5 mg/dl) attributed solely to plasma cell proliferative disease. Status evaluated every 4 weeks until disease progression (PD) was confirmed.

Analysis population: ITT population was defined as all randomized participants.

Groups in this outcome

Ixazomib+ Lenalidomide + Dexamethasone

Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first up to EOT (up to approximately 42.9 months).

Placebo + Lenalidomide + Dexamethasone

Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first (up to approximately 41 months).

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 + Dexamethasone360
Placebo + Lenalidomide + Dexamethasone362

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Ixazomib+ Lenalidomide + Dexamethasone20.6Not reported17.02NAThe upper limit of 95% confidence interval was not estimable due to low number of participants with events.
Placebo + Lenalidomide + Dexamethasone14.7Not reported12.9117.58Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.587
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.939
    estimate Comment
    HR is estimated from Cox Regression.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.012
    param Type
    Hazard Ratio (HR)
    param Value
    0.742
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.587
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.939
    estimate Comment
    HR is estimated from Cox Regression.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.012
    param Type
    Hazard Ratio (HR)
    param Value
    0.742
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        The upper limit of 95% confidence interval was not estimable due to low number of participants with events.
        group Id
        OG000
        lower Limit
        17.02
        upper Limit
        NA
        value
        20.6
      2. group Id
        OG001
        lower Limit
        12.91
        upper Limit
        17.58
        value
        14.7
denoms
  1. counts
    1. group Id
      OG000
      value
      360
    2. group Id
      OG001
      value
      362
    units
    Participants
description
Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of first documentation of disease progression (PD) or death due to any cause, whichever occurs first. Response including PD was assessed by independent review committee (IRC) using the International Myeloma Working Group (IMWG) response criteria. PD requires 1 of the following: Increase of ≥ 25% from nadir in: Serum M-component (absolute increase ≥ 0.5 g/dl); Urine M-component (absolute increase ≥ 200 mg/24 hours); In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase \> 10 mg/dl); Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium \> 11.5 mg/dl) attributed solely to plasma cell proliferative disease. Status evaluated every 4 weeks until disease progression (PD) was confirmed.
dispersion Type
95% Confidence Interval
groups
  1. description
    Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first up to EOT (up to approximately 42.9 months).
    id
    OG000
    title
    Ixazomib+ Lenalidomide + Dexamethasone
  2. description
    Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until PD or unacceptable toxicity, whichever occurred first (up to approximately 41 months).
    id
    OG001
    title
    Placebo + Lenalidomide + Dexamethasone
param Type
MEDIAN
population Description
ITT population was defined as all randomized participants.
reporting Status
POSTED
time Frame
From date of randomization until disease progression or death up to approximately 27 months (approximate median follow-up 15 months)
title
Progression Free Survival (PFS) as Assessed by the Independent Review Committee (IRC)
type
PRIMARY
unit Of Measure
months

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Preserved source evidence · Not medical advice