Spots Global Cancer Trial Database for Study of BTK Inhibitor, Ibrutinib in Combination With Carfilzomib in Subjects With Relapsed and Refractory Multiple Myeloma
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Trial Identification
Brief Title: Study of BTK Inhibitor, Ibrutinib in Combination With Carfilzomib in Subjects With Relapsed and Refractory Multiple Myeloma
Official Title: 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 ID: NCT01962792
Conditions
Study Description
Brief 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
Detailed Description: Bruton's tyrosine kinase (Btk) is an enzyme that is present in hematopoietic cells other than T cells and is necessary for downstream signal transduction from various hematopoietic receptors including the B cell receptor as well as some Fc, chemokine, and adhesion receptors, and is crucial for both B cell development and osteoclastogenesis. Although down-regulated in normal plasma cells, Btk is highly expressed in the malignant cells from many myeloma patients and some cell lines. PCI-32765 is a potent and specific inhibitor of Btk currently in Phase 2 and 3 clinical trials. The current study is designed and intended to determine the safety and efficacy of PCI-32765 in combination with carfilzomib (Kyprolis™) with and without dexamethasone in subjects with relapsed or relapsed and refractory multiple myeloma (MM).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope, Duarte, California, United States
University of California Los Angeles, Los Angeles, California, United States
Colorado Blood Cancer Institute, Denver, Colorado, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
New York Presbyterian Hospital - Weill-Cornell, New York, New York, United States
Mount Sinai Hospital, New York, New York, United States
Carolinas Healthcare System, Charlotte, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
University of Cincinnati, Cincinnati, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
MUSC Hollings Cancer Center, Charleston, South Carolina, United States
Vanderbilt Ingram Cancer Center, Nashville, Tennessee, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Methodist Healthcare System, San Antonio, Texas, United States
Virginia Commonwealth University, Richmond, Virginia, United States
McGill University, Montreal, Quebec, Canada
Contact Details
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