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NCT03679624 · OUTCOME

Major Response Rate in Cohort A

Daratumumab Plus Ibrutinib in Patients With Waldenstrӧm's Macroglobulinemia · Source last updated 2023-10-23

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

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
5 years

What was measured

Number of patients in Cohort A who achieve VGPR, PR, or CR

Analysis population: The patient in Cohort A did not complete enough cycles to evaluate for a response. 0 subjects were enrolled in Cohort B.

Groups in this outcome

Cohort A - Ibrutinib Naive

Cohort A will consist of subjects who are ibrutinib naïve and appropriate for ibrutinib based treatment. Treatment naïve subjects will be eligible to enroll in this cohort. All subjects in this cohort will receive ibrutinib plus daratumumab Ibrutinib: Ibrutinib, 420mg orally, once daily Daratumumab: Daratumumab, 16 mg/kg intravenously, weekly for 8 weeks, bi weekly for 16 weeks, then monthly for up to 19 months.

Cohort B - Ibrutinib Response Plateau

Cohort B will consist of subjects who have had at least 6 months of exposure to single agent ibrutinib and who have demonstrated an IgM response plateau defined by two IgM measurements, at least 8 weeks apart that have changed \<15% from the previous mark. All subjects in this cohort will receive ibrutinib plus daratumumab Ibrutinib: Ibrutinib, 420mg orally, once daily Daratumumab: Daratumumab, 16 mg/kg intravenously, weekly for 8 weeks, bi weekly for 16 weeks, then monthly for up to 19 months.

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

Analysis denominator · Participants

GroupSource count
Cohort A - Ibrutinib Naive0
Cohort B - Ibrutinib Response Plateau0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Number of patients in Cohort A who achieve VGPR, PR, or CR
groups
  1. description
    Cohort A will consist of subjects who are ibrutinib naïve and appropriate for ibrutinib based treatment. Treatment naïve subjects will be eligible to enroll in this cohort. All subjects in this cohort will receive ibrutinib plus daratumumab Ibrutinib: Ibrutinib, 420mg orally, once daily Daratumumab: Daratumumab, 16 mg/kg intravenously, weekly for 8 weeks, bi weekly for 16 weeks, then monthly for up to 19 months.
    id
    OG000
    title
    Cohort A - Ibrutinib Naive
  2. description
    Cohort B will consist of subjects who have had at least 6 months of exposure to single agent ibrutinib and who have demonstrated an IgM response plateau defined by two IgM measurements, at least 8 weeks apart that have changed \<15% from the previous mark. All subjects in this cohort will receive ibrutinib plus daratumumab Ibrutinib: Ibrutinib, 420mg orally, once daily Daratumumab: Daratumumab, 16 mg/kg intravenously, weekly for 8 weeks, bi weekly for 16 weeks, then monthly for up to 19 months.
    id
    OG001
    title
    Cohort B - Ibrutinib Response Plateau
population Description
The patient in Cohort A did not complete enough cycles to evaluate for a response. 0 subjects were enrolled in Cohort B.
reporting Status
POSTED
time Frame
5 years
title
Major Response Rate in Cohort A
type
SECONDARY

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

Preserved source evidence · Not medical advice