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