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A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of Oprozomib in Combination with Pomalidomide and Dexamethasone in Subjects with Relapsed or Refractory Multiple Myeloma
The purpose of this study is to evaluate two new formulations of oprozomib plus pomalidomide and dexamethasone in patients with relapsed refractory multiple myeloma.
Primary Objective: Identify the maximum tolerated dose (MTD) of oprozomib formulations in combination with pomalidomide and dexamethasone (OPomd) in subjects with relapsed or refractory multiple myeloma. Evaluate the safety and tolerability of the OPomd combination in subjects with relapsed or refractory multiple myeloma. Secondary Objective(s): Characterize the pharmacokinetics (PK) of oprozomib. Evaluate the efficacy of OPomd combination according to International Myeloma Working Group (IMWG) uniform response criteria. Identify the recommended formulation and Phase 3 dose (RP3D) of oprozomib in combination with pomalidomide and dexamethasone in subjects with relapsed or refractory multiple myeloma. Exploratory Objective(s): Evaluate the pharmacodynamic (PDn) biomarkers that may correlate with anti-tumor activity. Evaluate genomic and transcriptional biomarkers that may correlate with anti-tumor activity and resistance to treatment.