Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03180736 · OUTCOME

Time to Next Therapy

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 the date to next anti-neoplastic therapy or death from any cause, whichever comes first (approximately up to 3 years)

What was measured

Time to next therapy will be defined as the time, in months, from randomization to the date to next anti-neoplastic therapy or death from any cause, whichever comes first.

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+Dexamethasone23.23Not reported13.80NAUpper limit of 95% CI was not estimable due to short follow-up by participants
Pomalidomide + Dexamethasone11.83Not reported8.8715.38Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Upper limit of 95% CI was not estimable due to short follow-up by participants
        group Id
        OG000
        lower Limit
        13.80
        upper Limit
        NA
        value
        23.23
      2. group Id
        OG001
        lower Limit
        8.87
        upper Limit
        15.38
        value
        11.83
denoms
  1. counts
    1. group Id
      OG000
      value
      151
    2. group Id
      OG001
      value
      153
    units
    Participants
description
Time to next therapy will be defined as the time, in months, from randomization to the date to next anti-neoplastic therapy or death from any cause, whichever comes first.
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
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
From randomization until the date to next anti-neoplastic therapy or death from any cause, whichever comes first (approximately up to 3 years)
title
Time to Next Therapy
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice