Refractory Multiple Myeloma Clinical Trial
Official title:
A Phase I Trial of CC-5013 (Lenalidomide) and CCI-779 in Patients With Relapsed or Refractory Multiple Myeloma
This phase I trial is studying the side effects and best dose of temsirolimus when given together with lenalidomide in treating patients with previously treated multiple myeloma. Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. Drugs used in chemotherapy, such as temsirolimus, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Temsirolimus may also stop the growth of cancer cells by blocking some of the enzymes needed for their growth. Giving lenalidomide together with temsirolimus may kill more cancer cells.
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose of CCI-779 (temsirolimus) when given together with
lenalidomide in patients with previously treated multiple myeloma.
SECONDARY OBJECTIVES:
I. Determine the toxicity of this regimen in these patients. II. Determine the clinical
response of patients treated with this regimen. III. Determine the pharmacokinetics of this
regimen. IV. Determine the pharmacodynamic effects of this regimen in these patients. V.
Determine the effect of this regimen on immunological cellular and serological parameters
and hematopoietic precursor cells.
OUTLINE: This is a dose-escalation study of CCI-779.
Patients receive temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22
and oral lenalidomide once daily on days 1-21. Treatment repeats every 28 days for 12
courses in the absence of disease progression or unacceptable toxicity.
Patients achieving at least a partial response after 12 courses may continue to receive
CCI-779 and lenalidomide as above in the absence of disease progression. Cohorts of 3
patients receive escalating doses of CCI-779 until the maximum tolerated dose (MTD) is
determined. The MTD is defined as the dose preceding that at which 2 of 6 patients
experience dose-limiting toxicity. Ten patients are treated at the MTD. Patients undergo
blood sample and bone marrow collection periodically during study treatment for
pharmacokinetic and pharmacodynamic studies, and to determine the immunomodulatory effects
of CCI-779 and lenalidomide.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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