Belantamab Mafodotin + Lenalidomide for Multiple Myeloma
Trial Summary
What is the purpose of this trial?
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.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What data supports the effectiveness of the drug Belantamab Mafodotin for treating multiple myeloma?
Belantamab Mafodotin has shown effectiveness in treating relapsed or refractory multiple myeloma, with studies reporting an overall response rate of about 31-34% in patients who had already undergone several other treatments. This drug was approved by the FDA based on these results, although it is associated with some eye-related side effects.12345
Is the combination of Belantamab Mafodotin and Lenalidomide safe for humans?
Belantamab Mafodotin has been associated with eye-related side effects, such as changes in vision and dry eyes, which are common and sometimes severe. It is only available through a special program due to these risks. Other side effects include low platelet counts and infections, but the safety profile is considered manageable with proper monitoring.14567
What makes the drug Belantamab Mafodotin + Lenalidomide unique for treating multiple myeloma?
Belantamab Mafodotin is a unique drug because it is a first-in-class antibody-drug conjugate that targets a specific protein on myeloma cells, delivering a powerful cancer-killing agent directly to the cells. This approach is different from standard treatments and offers hope for patients who have already tried multiple other therapies.12489
Research Team
Jens Hillengass, MD, PhD
Principal Investigator
Roswell Park Cancer Institute
Eligibility Criteria
Adults diagnosed with multiple myeloma who still have minimal residual disease after a stem cell transplant can join. They should be in good enough health to perform daily activities, not pregnant or breastfeeding, and willing to use contraception. People with recent major surgery, active bleeding, severe liver conditions, certain infections like HIV or hepatitis B/C, or poor vision are excluded.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive belantamab mafodotin IV and lenalidomide PO for 6 cycles, each cycle lasting 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
Long-term follow-up
Participants are monitored for progression-free survival and overall survival
Treatment Details
Interventions
- Belantamab Mafodotin (Monoclonal Antibodies)
- Lenalidomide (Anti-metabolites)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Roswell Park Cancer Institute
Lead Sponsor
GlaxoSmithKline
Industry Sponsor