Phase 1b Study Evaluating OPomD in Relapsed or Refractory Multiple Myeloma

Status: Active

Description

A study evaluating two new formulations of oprozomib plus pomalidomide and dexamethasone in patients with relapsed refractory multiple myeloma.

Eligibility Criteria

Inclusion Criteria

  • Subject 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.
  • Subject must be 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 or 5 half-lives whichever is shorter since ending treatment on another investigational device or drug study(s).
  • 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 < 90 days prior to study day 1.
  • Multiple myeloma with IgM subtype.
  • POEMs syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
  • Plasma cell leukemia (> 2.0 X109/L circulating plasma cells by standard differential).
  • Waldenstrom's macroglobulinemia.
  • Other Exclusion Criteria May Apply

Locations & Contacts

Florida

Tampa
Moffitt Cancer Center
Status: Active
Name Not Available

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: Active
Name Not Available

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: Active
Name Not Available

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available

Trial Objectives and Outline

A multicenter, non-randomized, open-label, dose-exploration study evaluating two new formulations of oprozomib plus pomalidomide and dexamethasone in patients with relapsed refractory multiple myeloma. The study will be conducted in two parts. Part 1 will evaluate the formulations of oprozomib in combination with dexamethasone only. Part 2 will evaluate the formulations of oprozomib administered at increasing dose levels (dose escalation) in combination with pomalidomide and dexamethasone.

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Amgen, Inc.

Trial IDs

Primary ID 20160104
Secondary IDs NCI-2017-00142
Clinicaltrials.gov ID NCT02939183