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NCT02076009 · OUTCOME

Time to Disease Progression (TTP)

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 disease progression (up to 21 months)

What was measured

TTP was defined as time from date of randomization to date of first documented evidence of progressive disease (PD). 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 \>=0.5 g/dL; Increase of \>=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be \>=200 mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of \>=25% in difference between involved and uninvolved free light chain (FLC) levels from lowest response value and absolute increase must be \>10 milligram per deciliter (mg/dL); Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to plasma cell (PC) proliferative disorder.

Analysis population: ITT analysis set included all participants who were randomly assigned to the DRd or Rd group.

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)283
Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)286

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Lenalidomide, Low-dose Dexamethasone (Rd)18.43Not reported14.78NAUpper limit of 95% CI was not estimable due to short follow-up.
Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)NANot reportedNANAMedian and 95% CI was not estimable due to short follow-up.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Upper limit of 95% CI was not estimable due to short follow-up.
        group Id
        OG000
        lower Limit
        14.78
        upper Limit
        NA
        value
        18.43
      2. comment
        Median and 95% CI was not estimable due to short follow-up.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      283
    2. group Id
      OG001
      value
      286
    units
    Participants
description
TTP was defined as time from date of randomization to date of first documented evidence of progressive disease (PD). 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 \>=0.5 g/dL; Increase of \>=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be \>=200 mg/24hours; Only in participants without measurable serum and urine M-protein levels: increase of \>=25% in difference between involved and uninvolved free light chain (FLC) levels from lowest response value and absolute increase must be \>10 milligram per deciliter (mg/dL); Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to plasma cell (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
ITT analysis set included all participants who were randomly assigned to the DRd or Rd group.
reporting Status
POSTED
time Frame
From randomization to disease progression (up to 21 months)
title
Time to Disease Progression (TTP)
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice