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

Completed · Phase 1

Conditions studied: Relapsed or Refractory Multiple Myeloma

In brief

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

Key facts

Study ID

NCT02939183

Run by

Amgen

People needed

61

Starts

2017-01-17

Expected to finish

2022-10-06

Last updated by the study team

2024-09-26

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — West Hollywood, California, United States
• Research Site — Tampa, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Bethesda, Maryland, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Hackensack, New Jersey, United States
• Research Site — New York, New York, United States
• Research Site — Charlotte, North Carolina, United States
• Research Site — Canton, Ohio, United States
• Research Site — Cleveland, Ohio, United States
• Research Site — San Antonio, Texas, United States
• Research Site — Milwaukee, Wisconsin, United States
• Research Site — Clayton, Victoria, Australia
• Research Site — Murdoch, Western Australia, Australia
• Research Site — Perth, Western Australia, Australia
• Research Site — Calgary, Alberta, Canada
• Research Site — Toronto, Ontario, Canada
• Research Site — Salamanca, Castille and León, Spain
• Research Site — Pamplona, Navarre, Spain

Full record on ClinicalTrials.gov

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