This is a Phase 1 study during which patients with relapsed or refractory multiple myeloma (MM) or plasma cell leukemia (PCL) will receive investigational study drug ARRY-520 and bortezomib, with or without dexamethasone, with granulocyte-colony stimulating factor (G-CSF) support. This study has 2 parts. In the first part, patients will receive increasing doses of study drug (2 dosing schedules will be evaluated) in combination with (1) bortezomib with G-CSF support or (2) bortezomib and dexamethasone with G-CSF support, in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Approximately 45 patients from the US will be enrolled in Part 1 (Active, not recruiting). In the second part of this study, patients will receive the best dose(s) and schedule(s) of study drug, in combination with bortezomib ± dexamethasone + G-CSF, determined from the first part of the study and will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 42 patients from the US will be enrolled in Part 2 (Active, not recruiting).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.
Part 1: standard of care; Part 2: standard of care determined in Part 1.
Part 1: standard of care; Part 2: standard of care determined in Part 1.
Part 1: standard of care; Part 2: standard of care.
Part 1: multiple dose, escalating
Part 1: standard of care
Part 1: standard of care
Clearview Cancer Institute
Huntsville, Alabama, United States
Arizona Clinical Research Center, Inc.
Tucson, Arizona, United States
City of Hope
Duarte, California, United States
Emory University, Winship Cancer Institute
Atlanta, Georgia, United States
Associates in Oncology/Hematology
Rockville, Maryland, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
NYU Cancer Center
New York, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Charleston Hematology Oncology Associates
Charleston, South Carolina, United States
...and 3 more locations
Characterize the safety profile of the study drug in combination with bortezomib ± dexamethasone + G-CSF in terms of adverse events, clinical laboratory tests and electrocardiograms.
Time frame: Part 1
Establish the maximum tolerated dose (MTD) of the study drug in combination with bortezomib ± dexamethasone + G-CSF.
Time frame: Part 1
Assess the efficacy of study drug in combination with bortezomib ± dexamethasone + G-CSF in terms of best overall response
Time frame: Part 2
Assess the efficacy of study drug in combination with bortezomib ± dexamethasone + G-CSF in terms of duration of response, time to progression, treatment-free interval and time to next treatment.
Time frame: Part 1 and Part 2
Characterize the safety profile of the study drug in combination with bortezomib ± dexamethasone + G-CSF in terms of adverse events, clinical laboratory tests and electrocardiograms.
Time frame: Part 2
Assess the pharmacokinetic (PK) drug interactions between ARRY-520 and bortezomib in terms of plasma concentration-time profiles.
Time frame: Part 2
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