Trial Outcomes & Findings for Daratumumab Plus Ibrutinib in Patients With Waldenstrӧm's Macroglobulinemia (NCT NCT03679624)
NCT ID: NCT03679624
Last Updated: 2023-10-23
Results Overview
Number of patients that experience 1 or more adverse event
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
3 months
Results posted on
2023-10-23
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Daratumumab Plus Ibrutinib in Patients With Waldenstrӧm's Macroglobulinemia
Baseline characteristics by cohort
| Measure |
Cohort A - Ibrutinib Naive
n=1 Participants
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.
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 0 subjects were enrolled in Cohort B.
Number of patients that experience 1 or more adverse event
Outcome measures
| Measure |
Cohort A - Ibrutinib Naive
n=1 Participants
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.
|
|---|---|---|
|
Safety of Combination Treatment With Ibrutinib and Daratumumab as Measured by the Number of Patients That Experience 1 or More Adverse Event
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: The patient in Cohort A did not complete enough cycles to evaluate for a response. 0 subjects were enrolled in Cohort B.
Number of patients in Cohort A who achieve VGPR, PR, or CR
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsPopulation: The patient in Cohort A did not complete enough cycles to evaluate for a response. 0 subjects were enrolled in Cohort B.
Number of patients in Cohort B who achieve a VGPR, PR, or CR from baseline IgM prior to ibrutinib
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsPopulation: The patient in Cohort A did not complete enough cycles to evaluate for a response. 0 subjects were enrolled in Cohort B.
Measured from time of first response to progression or death, measured in months.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsPopulation: Cohort A participant did not complete enough cycles to get a response. 0 subjects were enrolled in Cohort B.
Measured from time of study drug administration to progression, measured in months.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 monthsPopulation: Cohort A participant did not complete enough cycles to evaluate for response. 0 subjects were enrolled in Cohort B.
Measured from time of study drug administration to progression or death, measured in months.
Outcome measures
| Measure |
Cohort A - Ibrutinib Naive
n=1 Participants
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.
|
|---|---|---|
|
Progression Free Survival
|
NA months
lack of participants with events
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: The patient in Cohort A did not complete enough cycles to evaluate for a response. 0 subjects were enrolled in Cohort B.
Measured from time of study drug administration to death, measured in months.
Outcome measures
| Measure |
Cohort A - Ibrutinib Naive
n=1 Participants
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.
|
|---|---|---|
|
Overall Survival
|
NA months
lack of participants with events
|
—
|
Adverse Events
Cohort A - Ibrutinib Naive
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort B - Ibrutinib Response Plateau
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A - Ibrutinib Naive
n=1 participants at risk
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.
|
|---|---|---|
|
General disorders
Elevated ALT/AST
|
100.0%
1/1 • Number of events 1 • 3 months
0 subjects were enrolled in Cohort B
|
—
0/0 • 3 months
0 subjects were enrolled in Cohort B
|
Other adverse events
| Measure |
Cohort A - Ibrutinib Naive
n=1 participants at risk
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.
|
|---|---|---|
|
Metabolism and nutrition disorders
Vomiting
|
100.0%
1/1 • Number of events 1 • 3 months
0 subjects were enrolled in Cohort B
|
—
0/0 • 3 months
0 subjects were enrolled in Cohort B
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
1/1 • Number of events 1 • 3 months
0 subjects were enrolled in Cohort B
|
—
0/0 • 3 months
0 subjects were enrolled in Cohort B
|
|
Injury, poisoning and procedural complications
Infusion related
|
100.0%
1/1 • Number of events 1 • 3 months
0 subjects were enrolled in Cohort B
|
—
0/0 • 3 months
0 subjects were enrolled in Cohort B
|
|
Respiratory, thoracic and mediastinal disorders
Scratchy Throat
|
100.0%
1/1 • Number of events 1 • 3 months
0 subjects were enrolled in Cohort B
|
—
0/0 • 3 months
0 subjects were enrolled in Cohort B
|
|
Investigations
ALT increased
|
100.0%
1/1 • Number of events 1 • 3 months
0 subjects were enrolled in Cohort B
|
—
0/0 • 3 months
0 subjects were enrolled in Cohort B
|
|
Investigations
AST increased
|
100.0%
1/1 • Number of events 1 • 3 months
0 subjects were enrolled in Cohort B
|
—
0/0 • 3 months
0 subjects were enrolled in Cohort B
|
|
Gastrointestinal disorders
Abdominal Pain
|
100.0%
1/1 • Number of events 1 • 3 months
0 subjects were enrolled in Cohort B
|
—
0/0 • 3 months
0 subjects were enrolled in Cohort B
|
|
General disorders
Malaise- flu like symptoms
|
100.0%
1/1 • Number of events 1 • 3 months
0 subjects were enrolled in Cohort B
|
—
0/0 • 3 months
0 subjects were enrolled in Cohort B
|
Additional Information
Dr. John Allan, Associate Professor of Medicine
Weill Cornell Medicine
Phone: 2127463481
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place