Belantamab Mafodotin Consolidation
Phase 2 Trial of Belantamab Mafodotin Consolidation Treatment in Patients With Multiple Myeloma and MRD Positivity After Autologous Stem Cell Transplantation
What will happen during the trial?
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.
PRIMARY OBJECTIVE:
I. Assess the minimal residual disease (MRD) negative rate after 6 cycles of post autologous stem cell transplant consolidation with belantamab mafodotin and lenalidomide.
SECONDARY OBJECTIVE:
I. Assess sustained MRD negative rate, progression free survival (PFS) and overall survival (OS).
OUTLINE:
Patients receive belantamab mafodotin intravenously (IV) over 30 minutes on day 1 and lenalidomide orally (PO) once daily (QD) on days 1-28. Treatment repeats every 8 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 12 weeks and the periodically for up to 5 years.
More Information
- Trial Status
- Accepting patients
- Trial Phase
- Phase 2
- Enrollment
- 20 patients (estimated)
- Sponsors
- Roswell Park Cancer Institute
- Collaborators
- GlaxoSmithKline
- Tags
- Antibody Drug Conjugate (ADC), B-Cell Maturation Antigen (BCMA)
- Trial Type
- Treatment
- Last Update
- 2 weeks ago
- SparkCures ID
- 1881
- NCT Identifier
- NCT04876248
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