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NCT01946477 · OUTCOME

Progression Free Survival (PFS)

Pomalidomide in Combination With Low-dose Dexamethasone or Pomalidomide in Combination With Low-dose Dexamethasone and Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Following Lenalidomide-based Therapy in the First or Second Line Setting · Source last updated 2026-06-15

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 first dose until the first documented disease progression, or death whichever occurs first (Up to 130 months)

What was measured

PFS is defined as the time from the first dose to the first documentation of disease progression according to modified International Myeloma Working Group (mIMWG) criteria or death from any cause, whichever occurs first. Disease Progression=Increase or reappearance of monoclonal protein in serum or urine meeting mIMWG progression thresholds; Increase in bone marrow plasma cell percentage consistent with disease progression; Development of new or worsening lytic bone lesions; Progressive or newly enlarging extramedullary plasmacytomas. Based on Kaplan-Meier Estimates.

Analysis population: All treated participants

Groups in this outcome

Cohort A

(Pomalidomide + low dose Dexamethasone) in participants with 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old).

Cohort B

(Pomalidomide + Daratumumab + low dose Dexamethasone) in participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.

Cohort C

(Pomalidomide + Daratumumab + low dose Dexamethasone) in Japanese participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.

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

Analysis denominator · Participants

GroupSource count
Cohort A56
Cohort B112
Cohort C18

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort A9.5Not reported6.215.2Not reported
Cohort B26.4Not reported18.746.5Not reported
Cohort CNANot reported18.6NAinsufficient number of participants with event to calculate upper limit and median per K-M methodology
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.2
        upper Limit
        15.2
        value
        9.5
      2. group Id
        OG001
        lower Limit
        18.7
        upper Limit
        46.5
        value
        26.4
      3. comment
        insufficient number of participants with event to calculate upper limit and median per K-M methodology
        group Id
        OG002
        lower Limit
        18.6
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      56
    2. group Id
      OG001
      value
      112
    3. group Id
      OG002
      value
      18
    units
    Participants
description
PFS is defined as the time from the first dose to the first documentation of disease progression according to modified International Myeloma Working Group (mIMWG) criteria or death from any cause, whichever occurs first. Disease Progression=Increase or reappearance of monoclonal protein in serum or urine meeting mIMWG progression thresholds; Increase in bone marrow plasma cell percentage consistent with disease progression; Development of new or worsening lytic bone lesions; Progressive or newly enlarging extramedullary plasmacytomas. Based on Kaplan-Meier Estimates.
dispersion Type
95% Confidence Interval
groups
  1. description
    (Pomalidomide + low dose Dexamethasone) in participants with 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old).
    id
    OG000
    title
    Cohort A
  2. description
    (Pomalidomide + Daratumumab + low dose Dexamethasone) in participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
    id
    OG001
    title
    Cohort B
  3. description
    (Pomalidomide + Daratumumab + low dose Dexamethasone) in Japanese participants with 1 or 2 prior lines of therapy with the most recent line of therapy containing lenalidomide. The starting dose level of POM was 4 mg. The starting dose level of Dex was 40 mg/day (≤75 years old) or 20 mg/day (\> 75 years old). DARA was administered intravenously (IV) at a starting dose of 16 mg/kg.
    id
    OG002
    title
    Cohort C
param Type
MEDIAN
population Description
All treated participants
reporting Status
POSTED
time Frame
From first dose until the first documented disease progression, or death whichever occurs first (Up to 130 months)
title
Progression Free Survival (PFS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice