A Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI-32765, in Subjects With Relapsed or Relapsed and Refractory Multiple Myeloma
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 clinical trials. The current study is designed and intended to
determine the effects of PCI-32765 in subjects with MM.
Optional Sub-Study:
Subjects entering the main study will be eligible to participate in an exploratory sub-study
to investigate possible mechanisms of treatment sensitivity and resistance. Bone marrow
specimens will be collected at three timepoints.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Efficacy as defined by clinical benefit rate
Participants will be followed until progression of disease or start of another anti-cancer treatment.
Up to 24 Months
No
Thorsten Graef, MD, PHD
Study Director
Pharmacyclics
United States: Food and Drug Administration
PCYC-1111-CA
NCT01478581
March 2012
July 2016
Name | Location |
---|---|
Johns Hopkins University | Baltimore, Maryland 21205 |
University of Michigan | Ann Arbor, Michigan 48109-0624 |
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Mount Sinai Medical Center | New York, New York 10029 |
University of Chicago Medical Center | Chicago, Illinois 60637 |
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
Sarah Cannon Research Institute | Nashville, Tennessee 37203 |