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NCT03901963 · OUTCOME

Percentage of Participants Who Had Minimal Residual Disease (MRD) Conversion From Baseline to 12 Months After Start of Maintenance Treatment as Determined by Next Generation Sequencing (NGS)

A Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Participants With Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant · Source last updated 2026-06-23

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
95% Confidence Interval
Time frame
From randomization up to 12 months

What was measured

Percentage of participants who achieved MRD negative (MRD conversion) status from baseline to 12 months after maintenance treatment was defined as percentage of participants who were MRD positive at baseline (randomization) and achieved MRD negative status (at 10\^-5) during the time period from randomization to 12 months plus 2 months window, but prior to progressive disease (PD) and subsequent anti-myeloma therapy.

Analysis population: The full analysis set (FAS) which included all participants randomly assigned to daratumumab in combination with lenalidomide or the lenalidomide alone.

Groups in this outcome

Daratumumab + Lenalidomide

Participants received daratumumab 1800 milligrams (mg) subcutaneous (SC) injection weekly during Cycle 1 and Cycle 2 (that is, on Day 1, Day 8, Day 15 and Day 22 of each Cycle), followed by every-2-week dosing from Cycle 3 to Cycle 6 (that is, on Weeks 9, 11, 13, 15, 17, 19, and 21) and then every-4-week dosing from Cycle 7 onwards (that is, from Week 25). In addition, participants received maintenance therapy with lenalidomide 10 mg capsule orally (PO) from Day 1 to 28 in each treatment cycle. Participants received study treatment until confirmed disease progression (PD), unacceptable toxicity, or until end of study treatment, whichever occurred first. After Cycle 3, if lenalidomide was well tolerated, dose might be increased to 15 mg at the discretion of the investigator. Each treatment cycle was of 28 days.

Lenalidomide

Participants received lenalidomide 10 mg capsule PO as maintenance therapy from Day 1 to Day 28 of each 28-day treatment cycle until confirmed PD, unacceptable toxicity, or the end of the study treatment, whichever occurred first. After Cycle 3, if lenalidomide was well tolerated, dose might be increased to 15 mg at the discretion of the investigator.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Daratumumab + Lenalidomide99
Lenalidomide101

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Daratumumab + Lenalidomide50.5Not reported40.360.7Not reported
Lenalidomide18.8Not reported11.727.8Not reported

Source statistical analyses

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

  1. ci Lower Limit
    2.37
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    8.57
    estimate Comment
    Odds ratio and 95% CI were estimated by Mantel-Haenszel method. Stratification factor included baseline cytogenetic risk per investigator's assessment (high risk versus standard/unknown risk) as used for randomization of the study.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    Tested at 2-sided 0.05 significance level through stratified CMH method. Stratification factor included baseline cytogenetic risk per investigator'
    param Type
    Odds Ratio (OR)
    param Value
    4.51
    statistical Method
    stratified Cochran-Mantel-Haenszel (CMH)
Complete source fields
analyses
  1. ci Lower Limit
    2.37
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    8.57
    estimate Comment
    Odds ratio and 95% CI were estimated by Mantel-Haenszel method. Stratification factor included baseline cytogenetic risk per investigator's assessment (high risk versus standard/unknown risk) as used for randomization of the study.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    Tested at 2-sided 0.05 significance level through stratified CMH method. Stratification factor included baseline cytogenetic risk per investigator'
    param Type
    Odds Ratio (OR)
    param Value
    4.51
    statistical Method
    stratified Cochran-Mantel-Haenszel (CMH)
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        40.3
        upper Limit
        60.7
        value
        50.5
      2. group Id
        OG001
        lower Limit
        11.7
        upper Limit
        27.8
        value
        18.8
denoms
  1. counts
    1. group Id
      OG000
      value
      99
    2. group Id
      OG001
      value
      101
    units
    Participants
description
Percentage of participants who achieved MRD negative (MRD conversion) status from baseline to 12 months after maintenance treatment was defined as percentage of participants who were MRD positive at baseline (randomization) and achieved MRD negative status (at 10\^-5) during the time period from randomization to 12 months plus 2 months window, but prior to progressive disease (PD) and subsequent anti-myeloma therapy.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received daratumumab 1800 milligrams (mg) subcutaneous (SC) injection weekly during Cycle 1 and Cycle 2 (that is, on Day 1, Day 8, Day 15 and Day 22 of each Cycle), followed by every-2-week dosing from Cycle 3 to Cycle 6 (that is, on Weeks 9, 11, 13, 15, 17, 19, and 21) and then every-4-week dosing from Cycle 7 onwards (that is, from Week 25). In addition, participants received maintenance therapy with lenalidomide 10 mg capsule orally (PO) from Day 1 to 28 in each treatment cycle. Participants received study treatment until confirmed disease progression (PD), unacceptable toxicity, or until end of study treatment, whichever occurred first. After Cycle 3, if lenalidomide was well tolerated, dose might be increased to 15 mg at the discretion of the investigator. Each treatment cycle was of 28 days.
    id
    OG000
    title
    Daratumumab + Lenalidomide
  2. description
    Participants received lenalidomide 10 mg capsule PO as maintenance therapy from Day 1 to Day 28 of each 28-day treatment cycle until confirmed PD, unacceptable toxicity, or the end of the study treatment, whichever occurred first. After Cycle 3, if lenalidomide was well tolerated, dose might be increased to 15 mg at the discretion of the investigator.
    id
    OG001
    title
    Lenalidomide
param Type
NUMBER
population Description
The full analysis set (FAS) which included all participants randomly assigned to daratumumab in combination with lenalidomide or the lenalidomide alone.
reporting Status
POSTED
time Frame
From randomization up to 12 months
title
Percentage of Participants Who Had Minimal Residual Disease (MRD) Conversion From Baseline to 12 Months After Start of Maintenance Treatment as Determined by Next Generation Sequencing (NGS)
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice