NCT02252172 · OUTCOME

Overall Survival (OS)

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: MEDIAN
Unit: Months
Interval / dispersion: 95% Confidence Interval
Time frame: From randomization (Day -3) up to 8.7 years

What was measured

OS was measured from the date of randomization to the date of the death. Median OS was estimated by using the Kaplan-Meier method.

Analysis population: ITT population included all randomized participants.

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

Group	Source count
Lenalidomide + Dexamethasone (Rd)	369
Daratumumab + Lenalidomide + Dexamethasone (DRd)	368

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide + Dexamethasone (Rd)	64.07	Not reported	55.98	70.80	Not reported
Daratumumab + Lenalidomide + Dexamethasone (DRd)	90.25	Not reported	80.76	NA	Here, 'NA' signifies that upper limit of 95% CI was not estimable due to an insufficient number of participants with events.

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
0.55
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.82
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.0001
param Type
Hazard Ratio (HR)
param Value
0.67
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.55
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.82
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.0001
param Type
Hazard Ratio (HR)
param Value
0.67
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
lower Limit
55.98
upper Limit
70.80
value
64.07
comment
Here, 'NA' signifies that upper limit of 95% CI was not estimable due to an insufficient number of participants with events.
group Id
OG001
lower Limit
80.76
upper Limit
NA
value
90.25

denoms

counts
group Id
OG000
value
369
group Id
OG001
value
368
units
Participants

description

OS was measured from the date of randomization to the date of the death. Median OS was estimated by using the Kaplan-Meier method.

dispersion Type

95% Confidence Interval

groups

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)
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

MEDIAN

population Description

ITT population included all randomized participants.

reporting Status

POSTED

time Frame

From randomization (Day -3) up to 8.7 years

title

Overall Survival (OS)

type

SECONDARY

unit Of Measure

Months

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Preserved source evidence · Not medical advice