Myeloma Multiple Clinical Trial
Official title:
Minimal Residual Disease Guided Maintenance Therapy With Belantamab Mafodotin and Lenalidomide After Autologous Hematopoietic Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma
To increase the conversion rate from MRD-positive to MRD-negative CR in patients with newly diagnosed multiple myeloma (NDMM) receiving post-transplant maintenance therapy with belantamab mafodotin plus lenalidomide.
Primary Objective: -To increase the conversion rate from MRD-positive to MRD-negative CR in patients with newly diagnosed multiple myeloma (NDMM) receiving post-transplant maintenance therapy with belantamab mafodotin plus lenalidomide. Secondary Objectives: - To determine the safety and tolerability of belantamab mafodotin plus lenalidomide maintenance therapy after auto-HCT. - To increase the overall MRD-negative CR rate in patients with NDMM receiving post-auto-HCT maintenance therapy with belantamab mafodotin plus lenalidomide. - To determine the PFS and OS in patients who discontinue maintenance therapy after achieving sustained MRD-negative CR. Sustained MRD-negative CR is defined as MRD-negative status in two assessments, at least 1-year apart, without any MRD-positive status in between. - To determine the PFS with belantamab mafodotin plus lenalidomide maintenance therapy after auto-HCT in patients with NDMM. - To determine the OS with belantamab mafodotin plus lenalidomide maintenance therapy after auto-HCT in patients with NDMMM. ;
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