A Study of Daratumumab in Patients With Relapsed or Refractory Waldenström Macroglobulinemia
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Dana-Farber Cancer Institute
- Study ID
- NCT03187262
- Phase
- PHASE2
- Status
- Completed
Conditions
- Waldenström Macroglobulinemia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Daratumumab — DRUGDaratumumab is a monoclonal human antibody. Daratumumab has shown the ability to slow or stop the growth of cells that have CD38 on the cell surface when tested in laboratories
Study Details
This research study is studying Daratumumab as a possible treatment for Waldenström Macroglobulinemia.
Key Dates
- Start date
- Nov 27, 2017
- Status verified
- Nov 2022
- Primary completion
- Jan 31, 2021
- Completion
- Dec 31, 2021
Study Design
- Enrollment
- 13 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Daratumumab* Daratumumab will be administered in three phases: Induction, consolidation and maintenance * During induction, participants will receive daratumumab on days 1, 8, 15 and 22 of each 28-day * During consolidation, daratumumab will be administered on days 1 and 15 of each 28-day cycle * During maintenance, daratumumab will be administered on day 1 of each 28-day cycle
Primary Outcome Measure
Overall Response Rate [ Time Frame: 2 years ]
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | - |
| Massachusetts General Hospital | Boston | Massachusetts | 02214 | - |
| Mayo Clinic | Rochester | Minnesota | 55905 | - |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | - |
| University of Washington | Seattle | Washington | 98109 | - |
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