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Phase 1b Study Evaluating OPomD in Relapsed or Refractory Multiple Myeloma
Trial Status: complete
A study evaluating two new formulations of oprozomib plus pomalidomide and dexamethasone
in participants with relapsed refractory multiple myeloma.
Inclusion Criteria
Participant must have a pathologically documented, definitively diagnosed, multiple myeloma relapse, 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.
Participant 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.
POEM 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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02939183.
Locations matching your search criteria
United States
Florida
Tampa
Moffitt Cancer Center
Status: Active
Name Not Available
Georgia
Atlanta
Emory University Hospital/Winship Cancer Institute
Status: Active
Name Not Available
A multicenter, non-randomized, open-label, dose-exploration study evaluating two new
formulations of oprozomib plus pomalidomide and dexamethasone in participants 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.