A Phase II Trial of CCI-779 in Patients With Relapsed or Refractory Multiple Myeloma
I. Determine the overall response rate in patients with relapsed or refractory multiple
myeloma treated with CCI-779.
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients with objective overall response rate (PR+CR)
Up to 5 years
Ohio State University
United States: Food and Drug Administration
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center||Columbus, Ohio 43210-1240|
|Ohio State University Medical Center||Columbus, Ohio 43210|