Clinical Trial 19079

Cancer Type: Malignant Hematology
Interventions:CC-4047 (Pomalidomide); Dexamethasone; Oprozomib; Pomalidomide

Study Type: Treatment
Phase of Study: Phase I
Investigators:

  • Kenneth Shain

Overview

Study Title

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

Summary

The purpose of this study is to evaluate two new formulations of oprozomib plus pomalidomide and dexamethasone in patients with relapsed refractory multiple myeloma.

Objective

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.

Inclusion Criteria

  • Must have a pathologically documented, definitively diagnosed, multiple myeloma relapsed, or refractory progressive disease after at least 2 lines of therapy for multiple myeloma. Prior therapeutic treatment or regimens must include a proteasome inhibitor and lenalidomide.
  • Willing and able to undergo bone marrow aspirate per protocol (with or without bone marrow biopsy per institutional guidelines).
  • Measurable disease (assessed within 28 days prior to day 1).
  • Eastern Cooperative Oncology Group (ECOG) performance status of >= 2.
  • Other Inclusion Criteria May Apply.

  • Exclusion Criteria

  • Currently receiving treatment in another investigational device or drug study, or less than 28 days since ending treatment on another investigational device or drug study.
  • Previously received an allogeneic stem cell transplant and the occurrence of one or more of the following: received the transplant within 6 months prior to study day 1; received immunosuppressive therapy within the last 3 months prior to study day 1; having signs or symptoms of acute or chronic graft-versus-host disease.
  • Autologous stem cell transplant > Multiple myeloma with IgM subtype.
  • POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
  • Plasma cell leukemia (> 2.0 X10^9/L circulating plasma cells by standard differential).
  • Waldenstrom's macroglobulinemia.
  • Other Exclusion Criteria May Apply.