Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00833833 · OUTCOME

Phase 2: Kaplan-Meier Estimates of Progression-free Survival (PFS) 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 67 weeks

What was measured

Progression free survival (PFS) is the time from randomization to the first documentation of disease progression or death from any cause during study, whichever occurs earlier. Disease progression was assessed by the Independent Response Adjudication Committee (IRAC). For the primary PFS analysis, participants who withdrew for any reason or received another antimyeloma therapy (except adding dexamethasone to the Phase 2: Pomalidomide arm) without documented PD (as determined by the IRAC review) were censored on the date of their last adequate response assessment, prior to receiving any other anti-myeloma therapy. Subjects who were still active at the time of the data cut-off date without PD (as determined by the IRAC) were censored on the date of their last adequate response assessment. Data collection is ongoing and future data results will be included as available.

Analysis population: Intent to treat 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 + Dexamethasone16.6Not reported14.121.1Not reported
Phase 2: Pomalidomide10.7Not reported8.316.1Not 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
    0.99
    group Description
    With a 12-month accrual period and 12-month follow-up after the study closed to accrual, assuming a 10% drop out rate, 96 participants in each treatment arm would have had 85% power to detect a hazard rate ratio of 1.67 using a one-sided log rank test with an overall significance level of 0.025 adjusted for one interim analysis) and a significance level of 0.0245 for the final analysis.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Cox Proportional Hazard
    param Value
    0.73
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    0.54
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.99
    group Description
    With a 12-month accrual period and 12-month follow-up after the study closed to accrual, assuming a 10% drop out rate, 96 participants in each treatment arm would have had 85% power to detect a hazard rate ratio of 1.67 using a one-sided log rank test with an overall significance level of 0.025 adjusted for one interim analysis) and a significance level of 0.0245 for the final analysis.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    Cox Proportional Hazard
    param Value
    0.73
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        14.1
        upper Limit
        21.1
        value
        16.6
      2. group Id
        OG001
        lower Limit
        8.3
        upper Limit
        16.1
        value
        10.7
denoms
  1. counts
    1. group Id
      OG000
      value
      113
    2. group Id
      OG001
      value
      108
    units
    Participants
description
Progression free survival (PFS) is the time from randomization to the first documentation of disease progression or death from any cause during study, whichever occurs earlier. Disease progression was assessed by the Independent Response Adjudication Committee (IRAC). For the primary PFS analysis, participants who withdrew for any reason or received another antimyeloma therapy (except adding dexamethasone to the Phase 2: Pomalidomide arm) without documented PD (as determined by the IRAC review) were censored on the date of their last adequate response assessment, prior to receiving any other anti-myeloma therapy. Subjects who were still active at the time of the data cut-off date without PD (as determined by the IRAC) were censored on the date of their last adequate response assessment. 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
Intent to treat population. Data collection is ongoing and future data results will be included as available.
reporting Status
POSTED
time Frame
up to 67 weeks
title
Phase 2: Kaplan-Meier Estimates of Progression-free Survival (PFS) as of the 01 April 2011 Cut-off
type
PRIMARY
unit Of Measure
weeks

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

Preserved source evidence · Not medical advice