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NCT01311687 · OUTCOME

Time to Response

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
Full Range
Time frame
From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.

What was measured

Time to response is calculated as the time from randomization to the initial documented response (partial response or better) based on IMWG criteria. SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level \< 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to \< 200 mg/24 hours. If present at baseline a ≥ 50% reduction in size of soft tissue plasmacytomas is also required.

Analysis population: Intent-to-treat responder population

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 Dexamethasone71
High-Dose Dexamethasone6

Reported measurements

Source class 1
Values in weeks · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Pomalidomide Plus Low-Dose Dexamethasone8.1Not reported4.048.0Not reported
High-Dose Dexamethasone10.5Not reported4.142.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.0
        upper Limit
        48.0
        value
        8.1
      2. group Id
        OG001
        lower Limit
        4.1
        upper Limit
        42.1
        value
        10.5
denoms
  1. counts
    1. group Id
      OG000
      value
      71
    2. group Id
      OG001
      value
      6
    units
    Participants
description
Time to response is calculated as the time from randomization to the initial documented response (partial response or better) based on IMWG criteria. SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level \< 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to \< 200 mg/24 hours. If present at baseline a ≥ 50% reduction in size of soft tissue plasmacytomas is also required.
dispersion Type
Full Range
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 responder population
reporting Status
POSTED
time Frame
From randomization until the data cut-off date of 01 March 2013. Maximum time on follow-up was 93 weeks.
title
Time to Response
type
SECONDARY
unit Of Measure
weeks

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

Preserved source evidence · Not medical advice