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NCT01564537 · OUTCOME

Overall Survival (OS)

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 death (up to approximately 97 months)

What was measured

Overall survival is defined as the time from the date of randomization to the date of death. Participants without documentation of death at the time of the analysis were censored at the date when they were last known to be alive.

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 + Dexamethasone53.6Not reported49.2562.95Not reported
Placebo + Lenalidomide + Dexamethasone51.6Not reported44.7859.14Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.784
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.125
    estimate Comment
    HR:estimated from Cox Regression with stratification factors: prior therapies, proteasome inhibitor, and ISS Stage at Screening with treatment as factor in model. \<1 hazard ratio for treatment=better prevention of death in drug arm vs control.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.495
    param Type
    Hazard Ratio (HR)
    param Value
    0.939
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.784
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.125
    estimate Comment
    HR:estimated from Cox Regression with stratification factors: prior therapies, proteasome inhibitor, and ISS Stage at Screening with treatment as factor in model. \<1 hazard ratio for treatment=better prevention of death in drug arm vs control.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.495
    param Type
    Hazard Ratio (HR)
    param Value
    0.939
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        49.25
        upper Limit
        62.95
        value
        53.6
      2. group Id
        OG001
        lower Limit
        44.78
        upper Limit
        59.14
        value
        51.6
denoms
  1. counts
    1. group Id
      OG000
      value
      360
    2. group Id
      OG001
      value
      362
    units
    Participants
description
Overall survival is defined as the time from the date of randomization to the date of death. Participants without documentation of death at the time of the analysis were censored at the date when they were last known to be alive.
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 death (up to approximately 97 months)
title
Overall Survival (OS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice