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NCT01311687 · OUTCOME

Overall Survival With a Later Cut-off Date

A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide in Combination With Low-Dose Dexamethasone Versus High-Dose Dexamethasone in Subjects With Refractory Multiple Myeloma or Relapsed and Refractory Multiple Myeloma and Companion Study · Source last updated 2018-10-24

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
weeks
Interval / dispersion
95% Confidence Interval
Time frame
From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up for survival was 93 weeks.

What was measured

Overall survival is calculated as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.

Analysis population: Intent-to-treat

Groups in this outcome

Pomalidomide Plus Low-Dose Dexamethasone

Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.

High-Dose Dexamethasone

Participants received 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.

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 Plus Low-Dose Dexamethasone302
High-Dose Dexamethasone153

Reported measurements

Source class 1
Values in weeks · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pomalidomide Plus Low-Dose Dexamethasone54.0Not reported45.366.4Not reported
High-Dose Dexamethasone34.9Not reported29.939.1Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.54
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.92
    estimate Comment
    Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.009
    param Type
    Hazard Ratio (HR)
    param Value
    0.70
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.54
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.92
    estimate Comment
    Hazard ratio is for Pomalidomide Plus Low-Dose Dexamethasone : High Dose Dexamethasone
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.009
    param Type
    Hazard Ratio (HR)
    param Value
    0.70
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        45.3
        upper Limit
        66.4
        value
        54.0
      2. group Id
        OG001
        lower Limit
        29.9
        upper Limit
        39.1
        value
        34.9
denoms
  1. counts
    1. group Id
      OG000
      value
      302
    2. group Id
      OG001
      value
      153
    units
    Participants
description
Overall survival is calculated as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
    id
    OG000
    title
    Pomalidomide Plus Low-Dose Dexamethasone
  2. description
    Participants received 40 mg dexamethasone (participants \> 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
    id
    OG001
    title
    High-Dose Dexamethasone
param Type
MEDIAN
population Description
Intent-to-treat
reporting Status
POSTED
time Frame
From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up for survival was 93 weeks.
title
Overall Survival With a Later Cut-off Date
type
SECONDARY
unit Of Measure
weeks

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

Preserved source evidence · Not medical advice