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NCT03180736 · OUTCOME

Health-related Quality of Life-Time to Worsening in EQ-5D-5L Utility Score

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
MEAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Approximately up to 3 years (assessed on Day 1 of each treatment cycle, at the end of treatment, and every 4 weeks post treatment until PD).

What was measured

Worsening is defined as a decrease in score that is at least half of standard deviation from baseline values, where standard deviation is calculated from the scores at baseline combining both treatment groups. The EQ-5D-5L is a 5 item questionnaire that assesses 5 domains including mobility, self care, usual activities, pain/discomfort, and anxiety/depression plus a visual analog scale rating "health today"

Analysis population: Intent-to-treat (ITT) analysis set: total of 304 randomized subjects (151 in the Daratumumab/Pomalidomide/Dexamethasone group and 153 in the Pomalidomide/Dexamethasone group).

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+Dexamethasone7.39Not reported5.3219.52Not reported
Pomalidomide + Dexamethasone6.14Not reported3.8813.14Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.32
        upper Limit
        19.52
        value
        7.39
      2. group Id
        OG001
        lower Limit
        3.88
        upper Limit
        13.14
        value
        6.14
denoms
  1. counts
    1. group Id
      OG000
      value
      151
    2. group Id
      OG001
      value
      153
    units
    Participants
description
Worsening is defined as a decrease in score that is at least half of standard deviation from baseline values, where standard deviation is calculated from the scores at baseline combining both treatment groups. The EQ-5D-5L is a 5 item questionnaire that assesses 5 domains including mobility, self care, usual activities, pain/discomfort, and anxiety/depression plus a visual analog scale rating "health today"
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
MEAN
population Description
Intent-to-treat (ITT) analysis set: total of 304 randomized subjects (151 in the Daratumumab/Pomalidomide/Dexamethasone group and 153 in the Pomalidomide/Dexamethasone group).
reporting Status
POSTED
time Frame
Approximately up to 3 years (assessed on Day 1 of each treatment cycle, at the end of treatment, and every 4 weeks post treatment until PD).
title
Health-related Quality of Life-Time to Worsening in EQ-5D-5L Utility Score
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice