Amyloidosis Clinical Trial
Official title:
A Dose-Finding and Proof-of-Concept Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refractory AL Amyloidosis
This study evaluates the safety, tolerability, recommended phase II (RP2) dose, and efficacy of Belantamab mafodotin for participants with Relapsed Refractory AL Amyloidosis (RRAL.)
Amyloid light chain amyloidosis (AL amyloidosis, ALA) is a rare plasma cell dyscrasia with an incidence ranging from 9.7-14.0 cases per million person-years. 75% of patients have cardiac involvement at diagnosis as evaluated by plasma cardiac biomarkers. The most common cause of morbidity and mortality is cardiac dysfunction. Belantamab mafodotin has not been evaluated previously in patients with AL amyloidosis. Although Belantamab mafodotin has previously been or is currently being evaluated in patients with relapsed multiple myeloma (MM), these MM studies do not enroll participants with clinically significant cardiac dysfunction. ALA represents a new patient population and therapeutic indication where patients invariably will have clinically significant cardiac, renal or other organ dysfunction at study enrollment. Therefore, the Phase I/IIa RRAL study will be comprised of two parts: Part 1 - Dose Exploration (Escalation) this will be conducted to identify and select an appropriate dose of Belantamab mafodotin in regard to safety, as well as a preliminary evaluation of hematological and organ response. Part 1 will enroll a minimum of 3 to maximum of 18 patients, per dose cohort, and will be guided using the Bayesian optimal interval (BOIN) design. Part 2 - Dose Cohort Expansion this will be an expansion cohort to further define the depth and durability of both hematological and organ response in 19 additional patients for a total of up to 37 patients. ;
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