Temsirolimus in Treating Patients With Relapsed or Refractory Multiple Myeloma
Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma
About this trial
This is an interventional treatment trial for Refractory Multiple Myeloma
Eligibility Criteria
Inclusion Criteria: Diagnosis of multiple myeloma (MM) Salmon-Durie stage IIA or IIIA OR progressive stage IA disease Meets at least 1 major AND 1 minor criterion OR at least 3 minor criteria The following are considered major criteria: Plasmacytoma on tissue biopsy Bone marrow plasmacytosis with >= 30% plasma cells Monoclonal globulin spike on serum protein electrophoresis exceeding 3.5 g/dL for immunoglobulin (Ig) G peaks or 2.0 g/dL for IgA peaks OR the presence of Bence-Jones protein of >= 1 g/24 hour-urine collection The following are considered minor criteria: Bone marrow plasmacytosis 10-29% Monoclonal globulin spike present, but less than the levels defined for a major criterion Lytic bone lesion Decrease in normal IgM < 50 mg/dL, IgA < 100 mg/dL, or IgG < 600 mg/dL No non-secretory MM (absent serum or urinary M-protein) Failed at least 1 prior systemic therapy* (e.g., chemotherapy, high-dose corticosteroids, thalidomide, or bortezomib) for the treatment of MM No solitary plasmacytoma Performance status - ECOG 0-2 More than 6 months Absolute neutrophil count > 1,200/mm^3 Platelet count > 75,000/mm^3 AST and ALT =< 2.5 times upper limit of normal (ULN) Bilirubin =< 1.5 times ULN Creatinine =< 1.5 times ULN No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Fasting cholesterol =< 350 mg/dL Triglycerides =< 400 mg/dL No other concurrent uncontrolled illness No active or ongoing infection requiring oral or IV antibiotics No prior allergic reaction to compounds of similar chemical or biological composition to CCI-779 No other prior or concurrent malignancy or myelodysplasia except for the following: Basal cell or squamous cell skin cancer Carcinoma in situ of the cervix Localized cancer treated with surgery only with no evidence of disease for > 5 years No psychiatric illness or social situation that would preclude study compliance More than 4 weeks since prior thalidomide and recovered Prior high-dose chemotherapy and stem cell transplantation allowed More than 4 weeks since prior chemotherapy and recovered More than 4 weeks since prior high-dose corticosteroids and recovered More than 4 weeks since prior bortezomib and recovered More than 4 weeks since other prior anti-myeloma systemic therapy and recovered No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent investigational agents No other concurrent anticancer therapy
Sites / Locations
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
- Ohio State University Medical Center
Arms of the Study
Arm 1
Experimental
Treatment (temsirolimus)
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.