Study of BTK Inhibitor, Ibrutinib in Combination With Carfilzomib in Subjects With Relapsed and Refractory Multiple Myeloma

Study Identifier
PCYC-1119-CA
CT.gov Identifier
NCT01962792
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

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

Medical Condition
  • Blood Cancer - Multiple Myeloma
    • Study Drug
  • Ibrutinib
  • Carfilzomib
  • Dexamethasone
    • Phase
    Phase 1/Phase 2
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Measurable disease of MM as defined by at least ONE of the following: 1. Serum monoclonal protein (SPEP) ≥1 g/dL 2. Urine M-protein ≥200 mg/24 hrs 3. Serum free light chain (SFLC): involved FLC ≥10 mg/dL (≥100 mg/L) AND abnormal kappa to lambda serum free light chain ratio * Relapsed or relapsed and refractory MM after receiving at least 2 previous therapies, including an immunomodulator and bortezomib and had either no response or documented disease progression (according to IMWG criteria) to the most recent treatment regimen * Adequate hematologic, hepatic, and renal function * ECOG performance status of 0-2 Inclusion Criteria for Phase 2 Sub-study Cohort: * Must meet all inclusion criteria defined in main study and in addition the following criteria must be met: * Subject must have received a regimen containing carfilzomib in combination with dexamethasone as their most recent line of therapy and have: 1. Achieved less than a partial response (\
    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 anti-coagulation with warfarin or a vitamin K antagonist * Requires treatment with strong CYP3A inhibitors Exclusion Criteria for Phase 2 Sub-study Cohort: * Must not meet any exclusion criteria defined in main study except for exclusion criteria "Subject must not have primary refractory disease" which is related to prior carfilzomib

    Protocol Summary

    A MULTICENTER PHASE 1/2B STUDY OF THE BRUTON'S TYROSINE KINASE INHIBITOR, IBRUTINIB (PCI-32765), IN COMBINATION WITH CARFILZOMIB (KYPROLIS™) IN SUBJECTS WITH RELAPSED OR RELAPSED AND REFRACTORY MULTIPLE MYELOMA

    Study Locations

    Location
    Status
    Location
    City of Hope
    Duarte, California, United States, 91010
    Status
    Not applicable
    Location
    University of California Los Angeles
    Los Angeles, California, United States, 90095
    Status
    Not applicable
    Location
    Colorado Blood Cancer Institute
    Denver, Colorado, United States, 80218
    Status
    Not applicable
    Location
    University of Nebraska Medical Center
    Omaha, Nebraska, United States, 68198
    Status
    Not applicable
    Location
    New York Presbyterian Hospital - Weill-Cornell
    New York, New York, United States, 10021
    Status
    Not applicable
    Location
    Mount Sinai Hospital
    New York, New York, United States, 10029
    Status
    Not applicable
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