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NCT01615029 · OUTCOME

Phase 2: Duration of Response

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

Duration of response was calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria (2011).

Analysis population: Responders in Intent-to-Treat (ITT) population analysis set included. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure.

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 Dexamethasone26

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 2: 16 mg/kg Daratumumab + Lenalidomide and DexamethasoneNANot reported26.5NAMedian and the upper bound of the 95% confidence interval (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% confidence interval (CI) were not estimable due to insufficient number of participants and/or events.
        group Id
        OG000
        lower Limit
        26.5
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    units
    Participants
description
Duration of response was calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria (2011).
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
Responders in Intent-to-Treat (ITT) population analysis set included. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure.
reporting Status
POSTED
time Frame
Up to 5 years
title
Phase 2: Duration of Response
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice