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NCT03679624 · OUTCOME

Safety of Combination Treatment With Ibrutinib and Daratumumab as Measured by the Number of Patients That Experience 1 or More Adverse Event

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
3 months

What was measured

Number of patients that experience 1 or more adverse event

Analysis population: 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 Naive1
Cohort B - Ibrutinib Response Plateau0

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A - Ibrutinib Naive1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Number of patients that experience 1 or more adverse event
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
param Type
COUNT_OF_PARTICIPANTS
population Description
0 subjects were enrolled in Cohort B.
reporting Status
POSTED
time Frame
3 months
title
Safety of Combination Treatment With Ibrutinib and Daratumumab as Measured by the Number of Patients That Experience 1 or More Adverse Event
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice