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

Overview

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

SparkCures ID 885
Trial Phase Phase 1
Enrollment 64 Patients
Treatments
Trial Sponsors
  • Amgen
NCT Identifier

NCT02939183

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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 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 < 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

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Verified Medical College of Wisconsin<br />Froedtert Hospital
Verified Winship Cancer Institute of Emory University<br />

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James R Berenson, MD, Inc.

West Hollywood, CA

Center for Cancer and Blood Disorders

Bethesda, MD

Weill Cornell Medicine

New York, NY

California
James R Berenson, MD, Inc.

West Hollywood, CA

Florida
Georgia
Verified Winship Cancer Institute of Emory University<br />

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Illinois
Maryland
Center for Cancer and Blood Disorders

Bethesda, MD

Missouri
New York
Weill Cornell Medicine

New York, NY

North Carolina
Wisconsin
Verified Medical College of Wisconsin<br />Froedtert Hospital

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Resources

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