Study of Belantamab Mafodotin Plus Standard of Care (SoC) in Newly Diagnosed Multiple Myeloma

Official Title

A Phase 1, Randomized, Dose and Schedule Evaluation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Belantamab Mafodotin Administered in Combination With Standard of Care in Participants With Newly Diagnosed Multiple Myeloma

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.

Trial Description

Primary Outcome:

• Number of participants with dose-limiting toxicities (DLTs)
• Number of participants with adverse events (AEs) and serious adverse events (SAEs)

• Lenalidomide relative dose intensity (RDI ) of treatment with belantamab mafodotin in combination with VRd
• Bortezomib RDI of treatment with belantamab mafodotin in combination with VRd
• Cumulative administered dose of belantamab mafodotin treatment in combination with VRd
• Maximum plasma concentration (Cmax) of belantamab mafodotin
• Cmax of total monoclonal antibody (mAb)
• Cmax of microtubule inhibitor monomethyl auristatin-F with a cysteine linker (cys-mcMMAF)
• Area under the concentration time curve (AUC) of belantamab mafodotin
• AUC of monoclonal antibody (mAb)
• AUC of cys-mcMMAF
• Number of participants with positive anti-drug antibodies (ADAs) against belantamab mafodotin
• Titers of ADAs against belantamab mafodotin
• Overall Response Rate (ORR)
• Complete Response Rate (CRR)
• Rate of Very Good Partial Response (VGPR) or better

View this trial on ClinicalTrials.gov