Belantamab Mafodotin and Lenalidomide for the Treatment of Multiple Myeloma in Patients With Minimal Residual Disease Positive After Stem Cell Transplant
Part of paid clinical trials in Buffalo, New York.
- Sponsor
- Roswell Park Cancer Institute
- Study ID
- NCT04876248
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
- Plasma Cell Myeloma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Belantamab Mafodotin — BIOLOGICALGiven IV
- Lenalidomide — DRUGGiven PO
Study Details
This phase II trial investigates the effect of belantamab mafodotin and lenalidomide on minimal residual disease negative rates in patients with multiple myeloma with minimal residual disease positive after stem cell transplant. Belantamab mafodotin is a monoclonal antibody, called belantamab, linked to a chemotherapy drug, called mafodotin. Belantamab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as B-cell maturation antigen (BCMA) receptors, and delivers mafodotin to kill them. Lenalidomide may help block the formation of growths that may become cancer, and is used as a standard of care treatment for multiple myeloma. Giving belantamab mafodotin and lenalidomide may help to maintain minimal residual disease negativity in patients with multiple myeloma.
Key Dates
- Start date
- Aug 19, 2024
- Status verified
- Mar 2026
- Primary completion
- Sep 1, 2026
- Completion
- Sep 1, 2027
Study Design
- Enrollment
- 4 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (belantamab mafodotin, lenalidomide)Patients receive belantamab mafodotin IV over 30 minutes on day 1 and lenalidomide PO QD on days 1-28. Treatment repeats every 8 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.
Primary Outcome Measure
Minimal residual disease (MRD) negative rate [ Time Frame: After 6 cycles of post-transplant consolidation with belantamab mafodotin and lenalidomide (1 cycle = 8 weeks) ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | - |
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