Study of Belantamab Mafodotin Plus Standard of Care (SoC) in Newly Diagnosed Multiple Myeloma
Status:
Recruiting
Trial end date:
2027-02-05
Target enrollment:
Participant gender:
Summary
This study will evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity
of belantamab mafodotin in combination with Velcade (bortezomib), Revlimid (lenalidomide),
dexamethasone (VRd) and will determine recommended phase 3 dose (RP3D) in adult participants
with newly diagnosed multiple myeloma (NDMM). Participants will receive the combination of
bortezomib, lenalidomide and dexamethasone (VRd) on a 3-week cycle until cycle 8, followed by
the combination of lenalidomide and dexamethasone (Rd) on a 4-week cycle thereafter as per
dosing schedule. Participants will receive belantamab mafodotin on a schedule that is
dependent on the cohort to which they are assigned. This will be every cycle of VRd, every
other cycle of VRd, or every third cycle of VRd. Belantamab may also be given as a 'split'
dose, which is 50% of the dose on Day 1 and 50% of the dose on Day 8 of a cycle. Participants
will complete an End of Treatment (EOT) visit at the point of study treatment
discontinuation, followed by a Safety Follow-up visit 70 days after EOT.