Refractory Multiple Myeloma Clinical Trial
Official title:
A Phase II Trial of CCI-779 in Patients With Relapsed or Refractory Multiple Myeloma
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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