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NCT02076009 · OUTCOME

Time to Response

A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma · Source last updated 2025-05-01

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 up to first documented CR or PR (up to 21 months)

What was measured

Time to response was defined as the time between the date of randomization and the first efficacy evaluation that the participant met all criteria for partial response (PR) or better.

Analysis population: Response-evaluable set is defined as participants who have a confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit. In addition, participants must have received at least 1 administration of study treatment and have at least 1 post baseline disease assessment.

Groups in this outcome

Lenalidomide, Low-dose Dexamethasone (Rd)

Participants received lenalidomide at a dose of 25 milligrams (mg) orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone at a total dose of 40 mg weekly (or 20 mg weekly for participants greater than \[\>\] 75 years old or with a body mass index less than \[\<\] 18.5 kilograms per meter square \[kg/m\^2\]).

Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)

Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks, each 28-day cycle); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks, each 28-day cycle); once only on Day 1 during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone was administered at a total dose of 40 mg weekly (or 20 mg weekly for participants \>75 years old or with a body mass index \< 18.5 kg/m\^2).

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

Analysis denominator · Participants

GroupSource count
Lenalidomide, Low-dose Dexamethasone (Rd)276
Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)281

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lenalidomide, Low-dose Dexamethasone (Rd)1.3Not reported1.11.9Not reported
Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)1.0Not reported1.01.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.1
        upper Limit
        1.9
        value
        1.3
      2. group Id
        OG001
        lower Limit
        1.0
        upper Limit
        1.1
        value
        1.0
denoms
  1. counts
    1. group Id
      OG000
      value
      276
    2. group Id
      OG001
      value
      281
    units
    Participants
description
Time to response was defined as the time between the date of randomization and the first efficacy evaluation that the participant met all criteria for partial response (PR) or better.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received lenalidomide at a dose of 25 milligrams (mg) orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone at a total dose of 40 mg weekly (or 20 mg weekly for participants greater than \[\>\] 75 years old or with a body mass index less than \[\<\] 18.5 kilograms per meter square \[kg/m\^2\]).
    id
    OG000
    title
    Lenalidomide, Low-dose Dexamethasone (Rd)
  2. description
    Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks, each 28-day cycle); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks, each 28-day cycle); once only on Day 1 during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone was administered at a total dose of 40 mg weekly (or 20 mg weekly for participants \>75 years old or with a body mass index \< 18.5 kg/m\^2).
    id
    OG001
    title
    Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)
param Type
MEDIAN
population Description
Response-evaluable set is defined as participants who have a confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit. In addition, participants must have received at least 1 administration of study treatment and have at least 1 post baseline disease assessment.
reporting Status
POSTED
time Frame
From randomization up to first documented CR or PR (up to 21 months)
title
Time to Response
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice