Minimal Residual Disease Guided Maintenance Therapy With Belantamab Mafodotin and Lenalidomide After Autologous Hematopoietic Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma
M.D. Anderson Cancer Center
Summary
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.
Description
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 m…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * 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.). * Adequate organ function (Please see Table 2. below). Participant agrees to not donate blood while taking lenalidomide and for 28 days after stopping lenalidomide. * Patient agrees to enroll in the lenalidomide REMS program. * Woman of child-bearing potential (WOCPB) must ab…
Interventions
- DrugBelantamab mafodotin
Belantamab 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.
- DrugLenalidomide
Lenalidomide 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.
Location
- MD Anderson Cancer CenterHouston, Texas