Eligible participants with newly diagnosed myeloma who are not considered eligible or refuse bone marrow transplant will be enrolled. Participants will be randomized to either belantamab mafodotin or daratumumab given in combination with bortezomib, lenalidomide and dexamethasone. Treatment will continue until disease progression, unacceptable side effects or withdrawal of consent.
Belantamab mafodotin is a targeted cancer treatment that works against multiple myeloma cells. It combines a homing device (an antibody) with a powerful cell-killing drug (a toxin), delivering the toxin directly to cancer cells while largely sparing healthy cells.
Minimal residual disease (MRD) testing will be done on bone marrow samples obtained standardly during your treatment. MRD shows whether a very small number of cancer cells can still be detected after treatment, even if standard lab tests shows no signs of cancer.
The purpose of this study is to evaluate if belantamab mafodotin, bortezomib, lenalidomide and dexamethasone (BVRd) improves minimal residual disease (MRD) negative status and/or prolongs progression-free survival (PFS) compared with daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) in participants with newly diagnosed multiple myeloma.
Patient must have suspected or confirmed newly diagnosed multiple myeloma (MM) by International Myeloma Working Group (IMWG) criteria and must not have received more than one cycle of any myeloma treatment.
Patient must be considered ineligible for autologous stem cell transplantation by the treating physician because of their age (≥ 70 years) or aged 18 - 70 years with the presence of underlying medical conditions likely to have a negative impact on tolerability of high-dose chemotherapy with stem-cell transplantation, making them transplant ineligible, OR transplant-eligible and refusing stem-cell transplantation until first relapse or later.
Patient must have measurable or evaluable disease as defined by having one or more of the following, obtained within 28 days prior to randomization.
≥ 1g/dL monoclonal protein (M-protein) on serum protein electrophoresis
None
Parallel
Arm A: Belantamab Mafodotin
Drug1.9 milligram/kilogram (mg/kg) intravenous (IV) will be administered every 8 weeks for first 24 weeks (Cycles 1-3), then 1.9 mg/kg every 12 weeks (Cycles 4+) until progression, unacceptable toxicity or participant withdrawal
Arm B: Daratumumab Hyaluronidase
Drug1800 mg subcutaneous (SC) will be administered weekly from Week 1-8 (Cycles 1 and 2), every 2 weeks from Week 9-24 (Cycles 3-6), and every 4 weeks from Week 25 (Cycles 7+) onwards until progression, unacceptable toxicity or participant withdrawal
Bortezomib
Drug1.3 milligrams per square meter (mg /m²) SC on days 1, 8 and 15 of every 28 day bortezomib treatment cycle for 8 cycles
Lenalidomide
Drug25 mg orally (PO) Days 1-21 of every 28 day lenalidomide treatment cycle.
Dexamethasone
Drug40 mg PO on Days 1, 8, 15, and 22 of each 28-day cycle (may decrease to 20 mg if \>75 years old)
MRD Negative Status
MRD negative status, defined as achieving MRD negativity at 10-5 sensitivity threshold assessed by NGS at least once during the time of confirmed CR or better response per IMWG criteria by Independent Review Committee (IRC); MRD negativity is determined by the Adaptive Biotechnologies clonoSEQ® assay result
Progression-Free Survival (PFS)
PFS, defined as the time from the date of randomization to the date of first documented disease progression per IMWG criteria by IRC or death from any cause in the absence of progression, whichever occurs first
Overall Survival (OS)
OS, defined as the time from the date of randomization until the date of death due to any cause
Best Response of Complete Response (CR)
Defined as confirmed CR or better per IMWG criteria by IRC
Best Response of Very Good Partial Response (VGPR)
Defined as confirmed VGPR, CR or better per IMWG criteria by IRC
Overall Response Rate (ORR)
Defined as confirmed PR, VGPR, CR or better per IMWG criteria by IRC
Click on the lead sponsor to view all of their trials.
PrECOG, LLC.
Lead sponsor
GlaxoSmithKline
Collaborator
