Lenalidomide and Temsirolimus in Treating Patients With Previously Treated Multiple Myeloma

Inclusion Criteria

• •Diagnosis of multiple myeloma (MM)
• •* Salmon-Durie stage IIA or IIIA
• •* No stage B disease
• •Meets ≥ 1 major AND 1 minor criterion OR ≥ 3 minor criteria
• •* The following are considered major criteria:
• •* Plasmacytoma on tissue biopsy
• •* Bone marrow plasmacytosis with ≥ 30% plasma cells
• •* Monoclonal paraprotein ≥ 3,500 mg/dL (IgG) or ≥ 2,000 mg/dL (IgA) OR monoclonal protein (Bence-Jones protein) ≥ 1,000 mg by 24-hour urine collection
• •* The following are considered minor criteria:
• •* Bone marrow plasmacytosis 10-29% of marrow cellularity
• •* Monoclonal globulin spike \< 3,500 mg/dL (IgG) or \< 2,000 mg/dL (IgA)
• •* Lytic bone lesions
• •* Decrease in normal IgM (\< 50 mg/dL), IgA (\< 100 mg/dL), or IgG (\< 600 mg/dL)
• •Disease progression after ≥ 1 prior systemic treatment regimen\* for MM (e.g., chemotherapy, high-dose corticosteroids, thalidomide, or bortezomib), defined as \> 25% increase in serum or urine M-protein
• •No solitary plasmacytoma
• •No non-secretory MM (absent serum or urinary M-protein)
• •ECOG performance status 0-2
• •Life expectancy \> 6 months
• •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• •AST and ALT ≤ 3 times ULN
• •Creatinine ≤ 2.0 mg/dL
• •Absolute neutrophil count ≥ 1,500/mm³
• •Platelet count ≥ 100,000/mm³
• •Fasting cholesterol ≤ 350 mg/dL
• •Fasting triglycerides ≤ 400 mg/dL
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective double-method contraception
• •Must agree not to donate blood, sperm, or ova during and for 4 weeks after completion of study treatment
• •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 history of recurrent deep vein thrombosis (DVT)/pulmonary embolism (PE) or DVT/PE occurring while on therapeutic levels of anticoagulation
• •* Patients with DVT/PE within the past 6 months are eligible provided they receive full anticoagulation during study treatment
• •No active infection requiring oral or intravenous antibiotics
• •No uncontrolled illness including, but not limited to, any of the following:
• •* Ongoing or active infection
• •* Symptomatic congestive heart failure
• •* Unstable angina pectoris
• •* Cardiac arrhythmia
• •* Psychiatric illness or social situations that would preclude study compliance
• •No known hepatitis B or C
• •No history of allergic reactions attributed to compounds of similar chemical or biologic composition to lenalidomide or CCI-779
• •See Disease Characteristics
• •Prior lenalidomide allowed
• •Prior high-dose chemotherapy with stem cell transplantation allowed
• •More than 4 weeks since prior chemotherapy or other antimyeloma systemic therapy (e.g., thalidomide, bortezomib, or high-dose corticosteroids) and recovered
• •No prior exposure to both lenalidomide and mTOR inhibitors (given together)
• •* Treatment with single-agent lenalidomide or single-agent mTOR inhibitor allowed
• •No other concurrent investigational agents
• •No concurrent corticosteroids unless for physiologic maintenance
• •No concurrent antiretroviral therapy for HIV-positive patients
• •No concurrent myeloid growth factors (e.g., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\])
• •No concurrent grapefruit or grapefruit juice