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NCT04113018 · OUTCOME

Number of Participants With Complete Response or Stringent Complete Response to Induction

Study of Daratumumab Combined With Carfilzomib, Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma · Source last updated 2026-08-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From enrollment to best response determined at the end of induction (8 28-day cycles); the median length of induction was 32 weeks

What was measured

The primary endpoint is a binary variable determined for each subject indicating whether the subject achieved a complete response (CR) or stringent complete response (sCR) to induction treatment with KRd-Dara, as defined by the IMWG 2016 response criteria. Per IMWG 2016 criteria, CR is defined as negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow aspirates. sCR is defined as CR plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry.

Analysis population: The response evaluable population is defined as all subjects who initiate treatment with daratumumab and who have measurable disease at baseline.

Groups in this outcome

KRd-Daratumumab

Induction: Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab: Experimental

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

Analysis denominator · Participants

GroupSource count
KRd-Daratumumab39

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
KRd-Daratumumab21Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    0.3718
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.6991
    estimate Comment
    Confidence interval estimated using the Clopper Pearson method.
    group Description
    A minimax 2-stage design was used to test the hypothesis that the CR+ rate less than or equal to 50%. Twenty-three evaluable subjects were enrolled in the first stage, followed by an additional 16 subjects for a total of 39 subjects. This design provided 90% power to detect a difference of 20% under the alternative hypothesis, assuming a one-sided alpha=0.10 significance level. If at least 24 of 39 participants had achieved CR or better to induction, the null hypothesis would have been rejected.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.375
    param Type
    Response rate
    param Value
    0.5385
    statistical Method
    Fisher Exact
Complete source fields
analyses
  1. ci Lower Limit
    0.3718
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.6991
    estimate Comment
    Confidence interval estimated using the Clopper Pearson method.
    group Description
    A minimax 2-stage design was used to test the hypothesis that the CR+ rate less than or equal to 50%. Twenty-three evaluable subjects were enrolled in the first stage, followed by an additional 16 subjects for a total of 39 subjects. This design provided 90% power to detect a difference of 20% under the alternative hypothesis, assuming a one-sided alpha=0.10 significance level. If at least 24 of 39 participants had achieved CR or better to induction, the null hypothesis would have been rejected.
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.375
    param Type
    Response rate
    param Value
    0.5385
    statistical Method
    Fisher Exact
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        21
denoms
  1. counts
    1. group Id
      OG000
      value
      39
    units
    Participants
description
The primary endpoint is a binary variable determined for each subject indicating whether the subject achieved a complete response (CR) or stringent complete response (sCR) to induction treatment with KRd-Dara, as defined by the IMWG 2016 response criteria. Per IMWG 2016 criteria, CR is defined as negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow aspirates. sCR is defined as CR plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry.
groups
  1. description
    Induction: Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab: Experimental
    id
    OG000
    title
    KRd-Daratumumab
param Type
COUNT_OF_PARTICIPANTS
population Description
The response evaluable population is defined as all subjects who initiate treatment with daratumumab and who have measurable disease at baseline.
reporting Status
POSTED
time Frame
From enrollment to best response determined at the end of induction (8 28-day cycles); the median length of induction was 32 weeks
title
Number of Participants With Complete Response or Stringent Complete Response to Induction
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice