A Phase I Trial of CC-5013 (Lenalidomide) and CCI-779 in Patients With Relapsed or Refractory Multiple Myeloma
I. Determine the maximum tolerated dose of CCI-779 (temsirolimus) when given together with
lenalidomide in patients with previously treated multiple myeloma.
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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose (MTD) of temsirolimus when given together with lenalidomide
The MTD is the dose level at which less than 2 out of 6 patients experience dose limiting toxicities (DLT). The National Cancer Institute Common Terminology Criteria for Adverse events (CTCAE) version 3.0 will used to characterize toxicities.
Course 1 (first 28 days)
Ohio State University
United States: Food and Drug Administration
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