Belantamab mafodotin is an antibody-drug conjugate (ADC) containing humanized anti- B-cell maturation antigen (BCMA) monoclonal antibody (mAb). Renal impairment is a major complication of multiple myeloma (MM) and majority of MM participants either are at risk or already have renal dysfunction at initial diagnosis. The purpose of this study is assess the pharmacokinetics (PK), safety, and tolerability of belantamab mafodotin monotherapy in participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment and have either normal or impaired renal functions. The study will consist of two parts: part 1 will include participants with normal renal function and severe renal impairment and part 2 will include participants with end-stage renal disease (ESRD) where participants are either not undergoing or require hemodialysis. Participants will be administered belantamab mafodotin at a dose of 2.5 milligram per kilogram (mg/kg) intravenously in Part 1 and in Part 2, dose will depend on the evaluation of pharmacokinetic and safety data of Part 1. However, dose in Part 2 will not exceed 2.5 mg/kg. Participants will be treated with belantamab mafodotin monotherapy until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first. This study will include a screening phase, treatment phase, and follow-up phase. The total duration of the study is approximately up to 48 months.
Help us drive excellence in approaches to multiple myeloma with the support, tools, and educational resources for anyone considering belantamab mafodotin.
DREAMM 12 is currently recruiting with an estimated study completion date of March 7, 2025
A Phase 3, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Single Agent Belantamab Mafodotin Compared to Pomalidomide Plus Low dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma1
A Phase 1/2 Single Arm Open-Label Study to Explore Safety and Clinical Activity of Belantamab Mafodotin Administered in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Multiple Myeloma2
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, 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 Myeloma8
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 2021.