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NCT02076009 · OUTCOME

Duration of Response (DOR)

A Study Comparing Daratumumab, Lenalidomide, and Dexamethasone With Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma · Source last updated 2025-05-01

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 to the date of first documented evidence of PD (up to 21 months)

What was measured

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

Analysis population: Response-evaluable set included participants who have a confirmed diagnosis of multiple myeloma and measurable disease and must have received at least 1 administration of study treatment and have at least 1 post baseline disease assessment. Here 'N' signifies number of participants who had PR or better response.

Groups in this outcome

Lenalidomide, Low-dose Dexamethasone (Rd)

Participants received lenalidomide at a dose of 25 milligrams (mg) orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone at a total dose of 40 mg weekly (or 20 mg weekly for participants greater than \[\>\] 75 years old or with a body mass index less than \[\<\] 18.5 kilograms per meter square \[kg/m\^2\]).

Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)

Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks, each 28-day cycle); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks, each 28-day cycle); once only on Day 1 during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone was administered at a total dose of 40 mg weekly (or 20 mg weekly for participants \>75 years old or with a body mass index \< 18.5 kg/m\^2).

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, Low-dose Dexamethasone (Rd)211
Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)261

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lenalidomide, Low-dose Dexamethasone (Rd)17.4Not reported17.4NAUpper limit of 95% CI was not estimable due to high censoring rate and lesser number of responders who progressed.
Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)NANot reportedNANAMedian and 95% CI was not estimable due to high censoring rate and lesser number of responders who progressed.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Upper limit of 95% CI was not estimable due to high censoring rate and lesser number of responders who progressed.
        group Id
        OG000
        lower Limit
        17.4
        upper Limit
        NA
        value
        17.4
      2. comment
        Median and 95% CI was not estimable due to high censoring rate and lesser number of responders who progressed.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      211
    2. group Id
      OG001
      value
      261
    units
    Participants
description
DOR was defined for participants with confirmed response (PR or better) as time between first documentation of response and disease progression/death due to PD, whichever occurs first. PD was defined as meeting any one of following criteria: Increase of \>=25% in level of serum M-protein from lowest response value and absolute increase must be \>=0.5g/dL; Increase of \>=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be \>=200mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of \>=25% in difference between involved and uninvolved FLC levels from lowest response value and absolute increase must be \>10mg/dL; Definite increase in size of existing bone lesions/soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium \>11.5mg/dL) that can be attributed solely to PC proliferative disorder.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received lenalidomide at a dose of 25 milligrams (mg) orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone at a total dose of 40 mg weekly (or 20 mg weekly for participants greater than \[\>\] 75 years old or with a body mass index less than \[\<\] 18.5 kilograms per meter square \[kg/m\^2\]).
    id
    OG000
    title
    Lenalidomide, Low-dose Dexamethasone (Rd)
  2. description
    Participants received daratumumab 16 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks, each 28-day cycle); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks, each 28-day cycle); once only on Day 1 during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Day 1 through Day 21 of each 28-day treatment cycle and low-dose dexamethasone was administered at a total dose of 40 mg weekly (or 20 mg weekly for participants \>75 years old or with a body mass index \< 18.5 kg/m\^2).
    id
    OG001
    title
    Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)
param Type
MEDIAN
population Description
Response-evaluable set included participants who have a confirmed diagnosis of multiple myeloma and measurable disease and must have received at least 1 administration of study treatment and have at least 1 post baseline disease assessment. Here 'N' signifies number of participants who had PR or better response.
reporting Status
POSTED
time Frame
From randomization to the date of first documented evidence of PD (up to 21 months)
title
Duration of Response (DOR)
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice