This phase II trial is studying how well temsirolimus works in treating patients with relapsed or refractory multiple myeloma. Drugs used in chemotherapy such as temsirolimus work in different ways to stop cancer cells from dividing so they stop growing or die.
PRIMARY OBJECTIVES: I. Determine the overall response rate in patients with relapsed or refractory multiple myeloma treated with CCI-779. SECONDARY OBJECTIVES: I. Determine the progression-free survival of patients treated with this drug. II. Determine the toxicity of this drug in these patients. III. Determine the presence of PTEN mutation in patients treated with this drug. IV. Correlate the pharmacokinetics of this drug with response in these patients. V. Correlate the pharmacodynamic effects of this drug with response in these patients. OUTLINE: This is an open-label study. Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Proportion of patients with objective overall response rate (PR+CR)
Time frame: Up to 5 years
Progression-free survival
Time frame: Time from the initial administration of temsirolimus to first documentation of disease progression or death, assessed up to 5 years
Incidence of toxicities
Time frame: Up to 5 years
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