Phase 1b Study Evaluating OPomD in Relapsed or Refractory Multiple Myeloma
NCT ID: NCT02939183
Last Updated: 2024-09-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
61 participants
INTERVENTIONAL
2017-01-17
2022-10-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part 1 Oprozomib Immediate-release (IR) + Dexamethasone
Oprozomib IR plus dexamethasone
Immediate Release (IR) Formulation
Immediate Release (IR) Formulation
Dexamethasone
Dexamethasone
Part 1 Oprozomib Gastro-retentive (GR) + Dexamethasone
Oprozomib GR plus dexamethasone
Gastro-Retentive (GR) Formulation
Gastro-Retentive (GR) Formulation
Dexamethasone
Dexamethasone
Part 2 Oprozomib IR + Pomalidomide + Dexamethasone
Oprozomib IR plus pomalidomide and dexamethasone
Immediate Release (IR) Formulation
Immediate Release (IR) Formulation
Dexamethasone
Dexamethasone
Pomalidomide
Pomalidomide
Part 2 Oprozomib GR + Pomalidomide + Dexamethasone
Oprozomib GR plus pomalidomide and dexamethasone
Gastro-Retentive (GR) Formulation
Gastro-Retentive (GR) Formulation
Dexamethasone
Dexamethasone
Pomalidomide
Pomalidomide
Open-label Roll-over
Oprozomib GR monotherapy, or oprozomib GR plus dexamethasone
Gastro-Retentive (GR) Formulation
Gastro-Retentive (GR) Formulation
Dexamethasone
Dexamethasone
Interventions
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Immediate Release (IR) Formulation
Immediate Release (IR) Formulation
Gastro-Retentive (GR) Formulation
Gastro-Retentive (GR) Formulation
Dexamethasone
Dexamethasone
Pomalidomide
Pomalidomide
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
100 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20160104
Identifier Type: -
Identifier Source: org_study_id
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