Phase 2 Study of Belantamab Mafodotin with Cyclophosphamide, Bortezomib, and Dexamethasone for Adults with Newly Diagnosed Amyloid Light Chain AL Amyloidosis

What this Trial Is About

Researchers are evaluating the safety and effectiveness of belantamab mafodotin combined with cyclophosphamide, bortezomib, and dexamethasone for adults newly diagnosed with amyloid light chain AL amyloidosis. This Phase 2, open-label study involves a dose optimization phase followed by a dose expansion phase to determine the best dosing approach for this combination treatment. Participants will receive belantamab mafodotin at one of two dose levels alongside CyBorD cyclophosphamide, bortezomib, and dexamethasone during the dose optimization phase. After selecting the optimal dose, participants will continue treatment with belantamab mafodotin at that dose combined with CyBorD in the dose expansion phase. The study is randomized and sequential in design, with treatment continuing for up to approximately 24 months for primary outcome measurement and longer for secondary outcomes. During the study, participants will be monitored regularly to assess hematologic response, organ response, and safety, including adverse events and eye exams. Blood samples will be collected to measure drug levels and immune responses. The primary outcome is the overall complete hematologic response rate up to about 24 months, with additional safety and efficacy assessments extending up to five years. Participants must be willing to provide informed consent and adhere to study requirements throughout the trial.

A Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin in Combination With Cyclophosphamide, Bortezomib, and Dexamethasone in Adult Participants With Newly Diagnosed Amyloid Light Chain (AL) Amyloidosis