Study of Ibrutinib in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma

Study Identifier
PCYC-1138-CA
CT.gov Identifier
NCT02548962
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

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Protocol
Available Language(s): English
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Statistical Analysis Plan
Available Language(s): English
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Study Details

Medical Condition
  • Blood Cancer - Multiple Myeloma
    • Study Drug
  • Ibrutinib
  • Pomalidomide
  • Dexamethasone
  • Placebo
    • Phase
    Phase 1/Phase 2
    Sex
    Female & Male
    Age
    18 - 100 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Subjects with relapsed/refractory MM who have received at least two prior lines of therapy including lenalidomide and either bortezomib or carfilzomib and have demonstrated disease progression on or within 60 days of the completion of the most recent treatment regimen. * Measurable disease defined by at least ONE of the following: 1. Serum monoclonal protein (SPEP) ≥1 g/dL. 2. Urine monoclonal protein (UPEP) ≥200 mg by 24 hour urine. * Adequate hematologic, hepatic, and renal function * ECOG performance status of ≤ 2
    Exclusion Criteria:
    * Subject must not have primary refractory disease * Plasma cell leukemia, primary amyloidosis or POEMS syndrome * Unable to swallow capsules or disease significantly affecting gastrointestinal function * Requires treatment with strong CYP3A inhibitors * Women who are pregnant or breast feeding.

    Protocol Summary

    Phase 1 is an open-label, dose finding, multicenter study of ibrutinib in combination with pomalidomide and dexamethasone in subjects with relapsed/refractory multiple myeloma.

    Phase 2b is a randomized, double-blind, multicenter study of ibrutinib or placebo, in combination with pomalidomide and dexamethasone in subjects with relapsed/refractory multiple myeloma.

    Study Locations

    Location
    Status
    Location
    City of Hope
    Duarte, California, United States, 91010
    Status
    Not applicable
    Location
    Dana-Farber Cancer Institute
    Boston, Massachusetts, United States, 02215
    Status
    Not applicable
    Location
    Cleveland Clinic
    Cleveland, Ohio, United States, 44195
    Status
    Not applicable
    Location
    Medical University of South Carolina
    Charleston, South Carolina, United States, 29425
    Status
    Not applicable
    Location
    Virginia Commonwealth University
    Richmond, Virginia, United States, 23298
    Status
    Not applicable
    Location
    Concord Repatriation General Hospital
    Concord, New South Wales, Australia, 2139
    Status
    Not applicable
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