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NCT03180736 · OUTCOME

Overall Survival

Comparison of Pom and Dex in Subjects With RRMM Previously Treated With Len and a PI Dara/Pom/Dex vs Pom/Dex · Source last updated 2025-12-19

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 randomization until death from any cause (up to 5 years)

What was measured

Overall survival is defined as the time, in months, from randomization to the date of death from any cause.

Analysis population: Final OS analysis with the CCO of 31 May 2022 and a median (range) follow-up of 39.6 (0.1-56.9) months

Groups in this outcome

Daratumumab+Pomalidomide+Dexamethasone

Patients received Daratumumab subcutaneously (fixed dose of 1800 mg) or intravenously (16 mg/kg) weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter. Pomalidomide was administered at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone at 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles.. Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle. Dexamethasone: Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.

Pomalidomide + Dexamethasone

Patients received Pomalidomide at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles

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

Analysis denominator · Participants

GroupSource count
Daratumumab+Pomalidomide+Dexamethasone151
Pomalidomide + Dexamethasone153

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Daratumumab+Pomalidomide+Dexamethasone34.40Not reported23.6940.25Not reported
Pomalidomide + Dexamethasone23.72Not reported19.6129.37Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        23.69
        upper Limit
        40.25
        value
        34.40
      2. group Id
        OG001
        lower Limit
        19.61
        upper Limit
        29.37
        value
        23.72
denoms
  1. counts
    1. group Id
      OG000
      value
      151
    2. group Id
      OG001
      value
      153
    units
    Participants
description
Overall survival is defined as the time, in months, from randomization to the date of death from any cause.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients received Daratumumab subcutaneously (fixed dose of 1800 mg) or intravenously (16 mg/kg) weekly for cycles 1-2, every 2 weeks for cycles 3-6, and every 4 weeks thereafter. Pomalidomide was administered at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone at 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles.. Pomalidomide: Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle. Dexamethasone: Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
    id
    OG000
    title
    Daratumumab+Pomalidomide+Dexamethasone
  2. description
    Patients received Pomalidomide at a dose of 4 mg orally every day on days 1 through 21, and dexamethasone 40 mg (or 20 mg for patients ≥75 years of age) orally weekly, in 28-day cycles
    id
    OG001
    title
    Pomalidomide + Dexamethasone
param Type
MEDIAN
population Description
Final OS analysis with the CCO of 31 May 2022 and a median (range) follow-up of 39.6 (0.1-56.9) months
reporting Status
POSTED
time Frame
From randomization until death from any cause (up to 5 years)
title
Overall Survival
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice