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.
Patients with newly diagnosed multiple myeloma status post 1st auto-HCT (day 60 - 180 post-transplant).
Disease status (MRD positive or negative), partial response, or better.
Age > 18-year and 75-year. Non-English speaking patients are eligible.
Karnofsky performance status 70 (Appendix A.).
History of progressive disease at any time before starting maintenance.
Patients with smoldering MM (IMWG criteria, Appendix F.).
Patients with plasma cell leukemia.
Patients with non-secretory MM (no measurable disease on electrophoresis and immunofixation). Patients with a measurable disease on PET scan or bone marrow will be eligible.
Parallel
Belantamab mafodotin
DrugBelantamab Mafodotin Belantamab mafodotin dose levels: Dose level -2 = 1.4 mg/kg IV every 12 weeks Dose level -1 = 1.9 mg/kg IV every 12 weeks Dose level 0 = 1.9 mg/kg IV every 8 weeks Cycles 1 - 6: All patients will start at dose level 0. Cycles 7 and onwards\*: Patients previously on dose level 0 (1.9 mg/kg IV every 8 weeks) will change to dose level -1 (1.9 mg/kg IV every 12 weeks) Patients previously on dose level -1 (1.9 mg/kg IV every 12 weeks) will continue at the same dose level. Patients previously on dose level -2 (1.4 mg/kg IV every 12 weeks) will continue at the same dose level. \*Reduction to a lower dose level is allowed in case of development of adverse effects or poor tolerance as determined by the treating physician.
Lenalidomide
DrugLenalidomide dose levels: Dose level 0 (starting dose): Lenalidomide 10 mg/day PO continuously. Dose level -1: Lenalidomide 10 mg/day PO. One week off after every three weeks of treatment. Dose level -2: Lenalidomide 5 mg/day PO. One week off after every three weeks of treatment.
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.
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