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NCT01615029 · OUTCOME

Phase 2: Overall Survival (OS)

Daratumumab in Combination With Lenalidomide and Dexamethasone in Relapsed and Relapsed-refractory Multiple Myeloma · Source last updated 2026-03-16

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
Up to 5 years

What was measured

Overall Survival (OS) was defined as the number of days from administration of the first infusion (Day 1) to date of death. Median Overall Survival was estimated by using the Kaplan Meier method.

Analysis population: ITT population analysis set included all enrolled participants who signed the informed consent during Phase 2.

Groups in this outcome

Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone

Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.

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

Analysis denominator · Participants

GroupSource count
Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone32

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 2: 16 mg/kg Daratumumab + Lenalidomide and DexamethasoneNANot reported32.23NAMedian and the upper bound of the 95% CI were not estimable due to insufficient number of participants and/or events.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Median and the upper bound of the 95% CI were not estimable due to insufficient number of participants and/or events.
        group Id
        OG000
        lower Limit
        32.23
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      32
    units
    Participants
description
Overall Survival (OS) was defined as the number of days from administration of the first infusion (Day 1) to date of death. Median Overall Survival was estimated by using the Kaplan Meier method.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
    id
    OG000
    title
    Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
param Type
MEDIAN
population Description
ITT population analysis set included all enrolled participants who signed the informed consent during Phase 2.
reporting Status
POSTED
time Frame
Up to 5 years
title
Phase 2: Overall Survival (OS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice