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.
Help us drive excellence in approaches to multiple myeloma with the support, tools, and educational resources for anyone considering belantamab mafodotin.
DREAMM 9 is currently recruiting with an estimated study completion date of November 3, 2025
A Phase 1/2, Randomized, Open-label Platform Study Utilizing a Master Protocol to Study Belantamab Mafodotin as Monotherapy and in Combination With Anticancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma3
A Phase 1/2, Open-label, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-Drug Conjugate Belantamab Mafodotin Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed/Refractory Multiple Myeloma4,5
A Multicenter, Open-Label, Randomized Phase 3 Study to Evaluate the Efficacy and Safety of the Combination of Belantamab Mafodotin, Bortezomib, and Dexamethasone (B-Vd) Compared With the Combination of Daratumumab, Bortezomib and Dexamethasone (D-Vd) in Participants With Relapsed/Refractory Multiple Myeloma6
A Phase 3, Multicenter, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Pomalidomide and Dexamethasone (B-Pd) Versus Pomalidomide Plus Bortezomib and Dexamethasone (PVd) in Participants With Relapsed/Refractory Multiple Myeloma7
A Phase 1 Study to Evaluate the Pharmacokinetics and Safety of Belantamab Mafodotin Monotherapy in Participants With Relapsed or Refractory Multiple Myeloma Who Have Normal and Varying Degrees of Impaired Renal Function9
A Phase 1 Study to Evaluate the Pharmacokinetics and Safety of Belantamab Mafodotin Monotherapy in Participants With Relapsed or Refractory Multiple Myeloma Who Have Normal and Varying Degrees of Impaired Hepatic Function10
A Phase 2, Randomized, Parallel, Open-label Study to Investigate the Safety, Efficacy, and Pharmacokinetics of Various Dosing Regimens of Single-agent Belantamab Mafodotin in Participants With Relapsed or Refractory Multiple Myeloma11
This information is intended for healthcare providers only. This website includes ongoing clinical trials for both approved and investigational compounds. Some agents are approved in select indications. Inclusion in this website does not imply regulatory approval for these compounds or all indications. Information about all trials can be found at www.clinicaltrials.gov. All clinical study information updated as of May 2023.