The purpose of this study is to determine safety and the maximum tolerated dose (MTD) of GRN163L and Velcade with and without Decadron when administered to patients with refractory or relapsed multiple myeloma.
GRN163L is a telomerase template antagonist with in vitro and in vivo activity in a variety of tumor model systems. Telomerase is an enzyme that is active primarily in tumor cells and is crucial for the indefinite growth of tumor cells. Inhibition of telomerase may result in antineoplastic effects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
40
25% dose escalation infused over 2 hours weekly
Karmanos Cancer Center
Detroit, Michigan, United States
St. Vincent's Comprehensive Cancer Center
New York, New York, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Maximum tolerated dose
Time frame: First 3 weeks
Safety, PK and efficacy
Time frame: Baseline to 28 days after last dose of treatment
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