A Multicenter, Randomized, Open-Label, Phase 2 Study Of Carfilzomib With Or Without Arry-520 (Filanesib) In Patients With Advanced Multiple Myeloma.

TPS8612 Background: Immunomodulatory agent (IMiD)/bortezomib (BTZ) combinations are common frontline therapy in patients with multiple myeloma (MM). Despite high initial objective response rates (ORR) and prolonged progression-free survival (PFS), almost all patients eventually relapse. Treatment for relapsed or refractory disease typically includes regimens that maintain IMiDs and/or proteasome inhibitors (PIs) as a foundation. Filanesib is a highly selective, targeted kinesin spindle protein (KSP) inhibitor that has shown promising preliminary activity and manageable toxicity as a single agent and in combination with dexamethasone, BTZ and carfilzomib (CFZ). Due to a distinct mechanism of action, filanesib demonstrates activity in patients with myeloma that has become resistant to IMiDs and PIs, potentially addressing a significant unmet medical need. Methods: This multicenter, randomized (2:1), open-label Phase 2 study is designed to assess the efficacy, safety and pharmacokinetics (PK) of CFZ ± filane...