This is a Phase 2 study during which patients with advanced multiple myeloma will receive either carfilzomib alone (single-agent) or carfilzomib in combination with investigational study drug filanesib (ARRY-520). Patients will be followed to determine the effectiveness of both single-agent carfilzomib and carfilzomib + filanesib in treating myeloma. Patients will be allowed to crossover from single-agent carfilzomib to carfilzomib + filanesib if disease progression occurs. Approximately 75 patients from the US will be enrolled in this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
77
multiple dose, single schedule
multiple dose, single schedule
as indicated, per the carfilzomib prescribing information
Genesis Cancer Center
Hot Springs, Arkansas, United States
Assess the efficacy of both carfilzomib + study drug and single-agent carfilzomib in terms of progression-free survival.
Time frame: 18 months
Assess the efficacy of both carfilzomib + study drug and single-agent carfilzomib in terms of objective response rate.
Time frame: 18 months
Assess the safety of both carfilzomib + study drug and single-agent carfilzomib in terms of adverse events, clinical laboratory tests and electrocardiograms.
Time frame: 18 months
Characterize the pharmacokinetics (PK) of study drug, carfilzomib and a carfilzomib metabolite in patients treated with carfilzomib + study drug in terms of plasma concentration-time profiles and model-based PK parameters.
Time frame: 6 months
Following crossover from single-agent carfilzomib, assess the efficacy of carfilzomib + study drug in terms of objective response rate.
Time frame: 18 months
Following crossover from single-agent carfilzomib, assess the safety of carfilzomib + study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
Time frame: 18 months
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