Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02076009 · OUTCOME

Percentage of Participants With Negative Minimal Residual Disease (MRD)

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
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
From randomization to the date of first documented evidence of PD (up to 87.5 months)

What was measured

Minimal residual disease was assessed for all participants who achieved a complete response (CR) or stringent complete response (sCR). CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% PCs in bone marrow; sCR: CR and normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4 color flow cytometry. The MRD negativity rate was defined as the percentage of participants who had negative MRD assessment at any time point after the first dose of study drugs by evaluation of bone marrow aspirates or whole blood at 10\^ minus (-) 4, 10\^-5, 10\^-6 threshold.

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

MRD negative rate (10^-4)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide, Low-dose Dexamethasone (Rd)10.2Not reported7.014.4Not reported
Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)40.6Not reported34.846.5Not reported
MRD negative rate (10^-5)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide, Low-dose Dexamethasone (Rd)6.7Not reported4.110.3Not reported
Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)33.2Not reported27.839.0Not reported
MRD negative rate (10^-6)
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Lenalidomide, Low-dose Dexamethasone (Rd)1.8Not reported0.64.1Not reported
Daratumumab, Lenalidomide, Low-dose Dexamethasone (DRd)13.3Not reported9.617.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.0
        upper Limit
        14.4
        value
        10.2
      2. group Id
        OG001
        lower Limit
        34.8
        upper Limit
        46.5
        value
        40.6
    title
    MRD negative rate (10^-4)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.1
        upper Limit
        10.3
        value
        6.7
      2. group Id
        OG001
        lower Limit
        27.8
        upper Limit
        39.0
        value
        33.2
    title
    MRD negative rate (10^-5)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.6
        upper Limit
        4.1
        value
        1.8
      2. group Id
        OG001
        lower Limit
        9.6
        upper Limit
        17.8
        value
        13.3
    title
    MRD negative rate (10^-6)
denoms
  1. counts
    1. group Id
      OG000
      value
      283
    2. group Id
      OG001
      value
      286
    units
    Participants
description
Minimal residual disease was assessed for all participants who achieved a complete response (CR) or stringent complete response (sCR). CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% PCs in bone marrow; sCR: CR and normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4 color flow cytometry. The MRD negativity rate was defined as the percentage of participants who had negative MRD assessment at any time point after the first dose of study drugs by evaluation of bone marrow aspirates or whole blood at 10\^ minus (-) 4, 10\^-5, 10\^-6 threshold.
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
NUMBER
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 the date of first documented evidence of PD (up to 87.5 months)
title
Percentage of Participants With Negative Minimal Residual Disease (MRD)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice