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

Summary

Participation Requirements

Description

PRIMARY OBJECTIVE: I. Assess the minimal residual disease (MRD) negative rate at the end (after 12 months) of consolidation with belantamab mafodotin in combination with lenalidomide post autologous stem cell transplantation. SECONDARY OBJECTIVE: I. Assess sustained MRD negative rate, progression fr...

PRIMARY OBJECTIVE: I. Assess the minimal residual disease (MRD) negative rate at the end (after 12 months) of consolidation with belantamab mafodotin in combination with lenalidomide post autologous stem cell transplantation. SECONDARY OBJECTIVE: I. Assess sustained MRD negative rate, progression free survival (PFS) and overall survival (OS). EXPLORATORY OBJECTIVES: I. Assess the immune profile in the peripheral blood and bone marrow before stem cell collection (screening), before consolidation with belantamab mafodotin and lenalidomide (enrollment), after 6 months of treatment (optional bone marrow biopsy) and after completion of consolidation (end of study). II. Compare the results of the different techniques (from all enrolled patients) used in the study to assess minimal residual disease: namely, flow cytometry, next generation sequencing and mass spectrometry as well as positron emission tomography (PET)/computed tomography (CT) and diffusion weighted imaging. 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.

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