Oprozomib

Hematologic Malignancies

Phase 1b/2, Multicenter, Open-label Study of the Safety and Activity of Oprozomib in Patients With Hematologic Malignancies
Currently enrolling
Study Design: Interventional, non-randomized, open-label
Patients: Patients with multiple myeloma or Waldenstrom Macroglobulinemia with symptomatic relapse
Purpose: To determine the maximum tolerated dose (MTD), activity, and safety of oprozomib in multiple myeloma and Waldenstrom Macroglobulinemia
Locations: Multiple centers throughout the U.S.

Phase 1b/2, Multicenter, Open-label Study of Oprozomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma
Currently enrolling
Study Design: Interventional, non-randomized, open-label
Patients: Patients with relapsed and/or refractory multiple myeloma
Purpose: To determine the maximum tolerated dose, activity, and safety and tolerability of oprozomib in combination with dexamethasone
Locations: U.S., France

Phase Ib/2, Multicenter, Open-label Study of Oprozomib and Dexamethasone in Combination With Lenalidomide or Oral Cyclophosphamide in Patients with Newly Diagnosed Multiple Myeloma
Actively recruiting patients
Study Design: Interventional, non-randomized, open-label
Patients: Patients with newly diagnosed multiple myeloma
Purpose: To determine the maximum tolerated dose (MTD), activity, and safety of oprozomib and dexamethasone in combination with lenalidomide or cyclophosphamide.
Locations: Multiple centers throughout the U.S.

Ph Ib/2, Multicenter, Open-label Study of Oprozomib, Melphalan and Prednisone in Transplant Ineligible Patients with Newly Diagnosed Multiple Myeloma
Actively recruiting patients
Study Design: Interventional, non-randomized, open-label
Patients: Patients with newly diagnosed multiple myeloma
Purpose: To determine the maximum tolerated dose (MTD), activity, and safety of oprozomib in combination with melphalan and prednisone.
Locations: Multiple centers in the Netherlands, Italy and Greece

Phase 1b/3 Multicenter Study of Oprozomib, Pomalidomide, and Dexamethasone in Primary Refractory or Relapsed and Refractory Multiple Myeloma Subjects
Actively recruiting for Part 1 (Phase 1b dose escalation)
Study Design: Interventional, randomized
Patients: Primary Refractory or Relapsed and Refractory Multiple Myeloma Subjects
Purpose: To determine the maximum tolerated dose (MTD), safety, and identify the recommended Phase 3 dose (RP3D) and schedule of oprozomib in combination with pomalidomide and dexamethasone (OPomd)
Locations: Part 1 (Phase 1b dose escalation and dose expansion): Multiple centers in the US & Part 2 (Randomized Phase 3): Multiple centers throughout the U.S. and EU, CAN.