NCT04876248

Belantamab Mafodotin and Lenalidomide for the Treatment of Multiple Myeloma in Patients With Minimal Residual Disease Positive After Stem Cell Transplant

Phase 2 Trial of Belantamab Mafodotin Consolidation Treatment in Patients With Multiple Myeloma and MRD Positivity After Autologous Stem Cell Transplantation

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Plasma Cell Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	Belantamab Mafodotin	Given IV
DRUG	Lenalidomide	Given PO

Timeline

• Start date: 2024-08-19
• Primary completion: 2026-09-01
• Completion: 2027-09-01
• First posted: 2021-05-06
• Last updated: 2026-03-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study