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NCT00833833 · OUTCOME

Phase 2: Kaplan-Meier Estimates of Overall Survival as of the 01 April 2011 Cut-off

MTD, Safety, and Efficacy of Pomalidomide (CC-4047) Alone or With Low-dose Dexamethasone in Patients With Relapsed and Refractory Multiple Myeloma · Source last updated 2016-04-27

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
up to 70 weeks

What was measured

Overall survival was defined as the time between randomization and death. Participants who die, regardless of the cause of the death, were considered to have had an event. All participants who were lost to follow-up prior to the end of the trial or who were withdrawn from the trial were censored at the time of last contact. Participants who were still being treated were censored at the last available date the subject was known to be alive, or clinical cut-off date if it was earlier. Data collection is ongoing and future data results will be included as available.

Analysis population: ITT population. Data collection is ongoing and future data results will be included as available.

Groups in this outcome

Phase 2: Pomalidomide + Dexamethasone

Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.

Phase 2: Pomalidomide

4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide or to discontinue treatment.

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

Analysis denominator · Participants

GroupSource count
Phase 2: Pomalidomide + Dexamethasone113
Phase 2: Pomalidomide108

Reported measurements

Source class 1
Values in weeks · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 2: Pomalidomide + Dexamethasone62.6Not reported53.6NANot estimable due to 69 out of 113 patients were still alive at data cutoff date
Phase 2: Pomalidomide59.3Not reported41.6NANot estimable due to 61 out of 108 patients were still alive at data cutoff date

Source statistical analyses

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

  1. ci Lower Limit
    0.57
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.29
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Cox Proportional Hazard
    param Value
    0.85
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    0.57
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.29
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Cox Proportional Hazard
    param Value
    0.85
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. comment
        Not estimable due to 69 out of 113 patients were still alive at data cutoff date
        group Id
        OG000
        lower Limit
        53.6
        upper Limit
        NA
        value
        62.6
      2. comment
        Not estimable due to 61 out of 108 patients were still alive at data cutoff date
        group Id
        OG001
        lower Limit
        41.6
        upper Limit
        NA
        value
        59.3
denoms
  1. counts
    1. group Id
      OG000
      value
      113
    2. group Id
      OG001
      value
      108
    units
    Participants
description
Overall survival was defined as the time between randomization and death. Participants who die, regardless of the cause of the death, were considered to have had an event. All participants who were lost to follow-up prior to the end of the trial or who were withdrawn from the trial were censored at the time of last contact. Participants who were still being treated were censored at the last available date the subject was known to be alive, or clinical cut-off date if it was earlier. Data collection is ongoing and future data results will be included as available.
dispersion Type
95% Confidence Interval
groups
  1. description
    Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
    id
    OG000
    title
    Phase 2: Pomalidomide + Dexamethasone
  2. description
    4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide or to discontinue treatment.
    id
    OG001
    title
    Phase 2: Pomalidomide
param Type
MEDIAN
population Description
ITT population. Data collection is ongoing and future data results will be included as available.
reporting Status
POSTED
time Frame
up to 70 weeks
title
Phase 2: Kaplan-Meier Estimates of Overall Survival as of the 01 April 2011 Cut-off
type
SECONDARY
unit Of Measure
weeks

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

Preserved source evidence · Not medical advice