Daratumumab, Pomalidomide, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma
Part of paid clinical trials in Wichita, Kansas.
- Sponsor
- Academic and Community Cancer Research United
- Study ID
- NCT03841565
- Phase
- PHASE2
- Status
- Withdrawn
Conditions
- Recurrent Plasma Cell Myeloma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Daratumumab — BIOLOGICALGiven IV
- Dexamethasone — DRUGGiven PO
- Pomalidomide — DRUGGiven PO
Study Details
This phase II trial studies how well daratumumab, pomalidomide, and dexamethasone work in treating patients with multiple myeloma that has come back (relapsed). Immunotherapy with daratumumab may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as pomalidomide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving daratumumab with dexamethasone and pomalidomide may work bettering in treating patient compared to dexamethasone and pomalidomide alone.
Key Dates
- Start date
- Aug 7, 2020
- Status verified
- Aug 2021
- Primary completion
- Feb 9, 2022
- Completion
- Feb 9, 2022
Study Design
- Enrollment
- 0 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (pomalidomide, daratumumab, dexamethasone)Patients receive pomalidomide PO QD on days 1-21 and daratumumab IV on days 1, 8, 15, and 22 of cycles 1-2, days 1-15 of cycles 3-6, and day 1 of subsequent cycles. Patients also receive dexamethasone PO on days 1, 8, 15, and 22 of cycles 1-12. Cycles every 28 days in the absence of disease progression or unacceptable toxicity.
Primary Outcome Measure
Best overall response rate to the therapy [ Time Frame: Up to 3 years ]
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cancer Center of Kansas - Wichita | Wichita | Kansas | 67214 | - |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | - |
| Metro Minnesota Community Oncology Research Consortium | Saint Louis Park | Minnesota | 55416 | - |
| State University of New York Upstate Medical University | Syracuse | New York | 13210 | - |
| McLeod Regional Medical Center | Florence | South Carolina | 29506 | - |
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