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NCT02252172 · OUTCOME

Duration of Response (DoR)

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 6.6 years

What was measured

DoR was defined for participants with confirmed response (PR or better) as time between first documentation of response and disease progression per IMWG response criteria, or death due to PD, whichever occurs first. PD per IMWG criteria- Increase of 25 % from lowest response value in one of following: Serum M-component (absolute increase \>=0.5 g/dL); Urine M-component (absolute increase \>=200 mg/24 hours); Only in participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase \>10 milligram per deciliter \[mg/dL\]); Definite development of new bone lesions/soft tissue plasmacytomas or definite increase in size of existing bone lesions/soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to the PC proliferative disorder.

Analysis population: Response evaluable population included all participants with confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit and received at least one administration of study treatment and had adequate postbaseline disease assessments. Here, 'N' (Overall number of participants analyzed) 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)152
Daratumumab + Lenalidomide + Dexamethasone (DRd)119

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lenalidomide + Dexamethasone (Rd)43.7Not reported36.852.6Not reported
Daratumumab + Lenalidomide + Dexamethasone (DRd)NANot reportedNANAHere 'NA' signifies median, upper and lower of 95% CI was not estimable due to an insufficient number of participants with events.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        36.8
        upper Limit
        52.6
        value
        43.7
      2. comment
        Here 'NA' signifies median, upper and lower of 95% CI was not estimable due to an insufficient number of participants with events.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      152
    2. group Id
      OG001
      value
      119
    units
    Participants
description
DoR was defined for participants with confirmed response (PR or better) as time between first documentation of response and disease progression per IMWG response criteria, or death due to PD, whichever occurs first. PD per IMWG criteria- Increase of 25 % from lowest response value in one of following: Serum M-component (absolute increase \>=0.5 g/dL); Urine M-component (absolute increase \>=200 mg/24 hours); Only in participants without measurable serum and urine M-protein levels: difference between involved and uninvolved FLC levels (absolute increase \>10 milligram per deciliter \[mg/dL\]); Definite development of new bone lesions/soft tissue plasmacytomas or definite increase in size of existing bone lesions/soft tissue plasmacytomas and Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to the PC proliferative disorder.
dispersion Type
95% Confidence Interval
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
MEDIAN
population Description
Response evaluable population included all participants with confirmed diagnosis of multiple myeloma and measurable disease at baseline or screening visit and received at least one administration of study treatment and had adequate postbaseline disease assessments. Here, 'N' (Overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
reporting Status
POSTED
time Frame
From randomization (Day -3) up to 6.6 years
title
Duration of Response (DoR)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice