Phase 1(a \& b): To evaluate the side effects and determine the best dose of oral ACY-1215 as monotherapy, and also in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma. Phase 2a: To determine the objective response rate of oral ACY-1215 in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Liquid oral dose on Days 1-5 and 8-12 of 21-day treatment cycle
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Mt. Sinai Medical Center
New York, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Phase 1 (a & b): To determine the maximum tolerated dose of ACY-1215 as monotherapy or in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma.
Time frame: Upon completion of 21-day treatment cycle
Phase 2a: To determine the objective response rate to ACY-1215 in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma.
Time frame: Assessed every other treatment cycle (cycles 2, 4 and 6)
Characterize the safety of ACY-1215 alone or in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma
Time frame: Up to 24 weeks
Determine the single- and multiple-dose PK of ACY-1215 alone and in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma
Time frame: Upon completion of 21 day treatment cycle
Evaluate the pharmacodynamics of ACY-1215 alone or in combination with bortezomib and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma.
Time frame: Up to 24 weeks.
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MD Anderson Cancer Center
Houston, Texas, United States
Medical College of Wisconsin - Clinical Cancer Center
Milwaukee, Wisconsin, United States