Multiple Myeloma Clinical Trial
Phase 1b Study Evaluating OPomD in Relapsed or Refractory Multiple Myeloma
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.
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
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).
Other Exclusion Criteria May Apply
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There are 22 Locations for this study
West Hollywood California, 90069, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60637, United States
Bethesda Maryland, 20817, United States
Saint Louis Missouri, 63110, United States
Hackensack New Jersey, 07601, United States
New York New York, 10021, United States
Charlotte North Carolina, 28204, United States
Canton Ohio, 44718, United States
Cleveland Ohio, 44195, United States
San Antonio Texas, 78229, United States
Milwaukee Wisconsin, 53226, United States
Clayton Victoria, 3168, Australia
Murdoch Western Australia, 6150, Australia
Perth Western Australia, 6000, Australia
Gent , 9000, Belgium
Calgary Alberta, T2N 2, Canada
Toronto Ontario, M5G 2, Canada
Rotterdam , 3015 , Netherlands
Salamanca Castilla León, 37007, Spain
Pamplona Navarra, 31008, Spain
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