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NCT02252172 · OUTCOME

Sub-group Analysis: Overall Response Rate (ORR)

Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Participants With Previously Untreated Multiple Myeloma · Source last updated 2025-10-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
Not reported
Time frame
From randomization (Day -3) up to 6.6 years

What was measured

ORR for participants with cytogenic high risk was reported. ORR: percentage of participants who achieved PR/better per IMWG criteria. PR: \>=50% reduction of serum M-protein, reduction in 24h urinary M-protein by \>=90% or \<200mg/24h. If serum/urine M-protein were not measurable, decrease of \>=50% in difference between involved and uninvolved FLC levels was required in place of M-protein criteria. If present at baseline, \>=50% reduction in size of soft tissue plasmacytomas was required. VGPR: serum/urine M-component detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum and urine M-protein \<100mg/24h. CR: negative immunofixation on serum/urine, disappearance of soft tissue plasmacytomas, \<5% PCs in bone marrow; sCR: CR in addition to normal FLC ratio, absence of clonal cells in bone marrow by IHC, immunofluorescence, 2-4 color FC. High risk: positive for any of del17p, t(14;16) or t(4;14) by FISH/Karyotype.

Analysis population: Intent-to-treat (ITT) population included all randomized participants. Here, 'N' signifies number of participants evaluable for this outcome measure.

Groups in this outcome

Lenalidomide + Dexamethasone (Rd)

Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity up to 77.5 months. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group \[IMWG\] criteria).

Daratumumab + Lenalidomide + Dexamethasone (DRd)

Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity up to 77.3 months. After implementation of Amendment 8, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab subcutaneous (SC) injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria).

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 + Dexamethasone (Rd)44
Daratumumab + Lenalidomide + Dexamethasone (DRd)48

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide + Dexamethasone (Rd)75.0Not reportedNot reportedNot reportedNot reported
Daratumumab + Lenalidomide + Dexamethasone (DRd)91.7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        75.0
      2. group Id
        OG001
        value
        91.7
denoms
  1. counts
    1. group Id
      OG000
      value
      44
    2. group Id
      OG001
      value
      48
    units
    Participants
description
ORR for participants with cytogenic high risk was reported. ORR: percentage of participants who achieved PR/better per IMWG criteria. PR: \>=50% reduction of serum M-protein, reduction in 24h urinary M-protein by \>=90% or \<200mg/24h. If serum/urine M-protein were not measurable, decrease of \>=50% in difference between involved and uninvolved FLC levels was required in place of M-protein criteria. If present at baseline, \>=50% reduction in size of soft tissue plasmacytomas was required. VGPR: serum/urine M-component detectable by immunofixation but not on electrophoresis or \>=90% reduction in serum and urine M-protein \<100mg/24h. CR: negative immunofixation on serum/urine, disappearance of soft tissue plasmacytomas, \<5% PCs in bone marrow; sCR: CR in addition to normal FLC ratio, absence of clonal cells in bone marrow by IHC, immunofluorescence, 2-4 color FC. High risk: positive for any of del17p, t(14;16) or t(4;14) by FISH/Karyotype.
groups
  1. description
    Participants received Lenalidomide 25 milligrams (mg) capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or intravenously (IV) once a week (QW) until disease progression or unacceptable toxicity up to 77.5 months. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by the International Myeloma Working Group \[IMWG\] criteria).
    id
    OG000
    title
    Lenalidomide + Dexamethasone (Rd)
  2. description
    Participants received Daratumumab 16 milligrams per kilograms (mg/kg) IV QW for the first 8 weeks (cycles 1-2) and then every 2 weeks (Q2W) for 16 weeks (Cycle 3-6), then every 4 weeks (Q4W) (from Cycle 7 and beyond) (each cycle of 28 days), Lenalidomide 25 mg capsule orally daily on Day 1 through Day 21 of each 28-day cycle, Dexamethasone 40 mg orally or IV QW until disease progression or unacceptable toxicity up to 77.3 months. After implementation of Amendment 8, participants who were ongoing with daratumumab IV treatment were given an option to switch to daratumumab subcutaneous (SC) injection on Day 1 of any cycle, as per investigator's discretion. After completion of treatment, participants entered follow-up phase and were not started on subsequent anti-myeloma therapy without confirmed disease progression (assessed by IMWG criteria).
    id
    OG001
    title
    Daratumumab + Lenalidomide + Dexamethasone (DRd)
param Type
NUMBER
population Description
Intent-to-treat (ITT) population included all randomized participants. Here, 'N' signifies number of participants evaluable for this outcome measure.
reporting Status
POSTED
time Frame
From randomization (Day -3) up to 6.6 years
title
Sub-group Analysis: Overall Response Rate (ORR)
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice