Lenalidomide and Temsirolimus in Treating Patients With Previously Treated Multiple Myeloma

This is an interventional treatment trial for Refractory Multiple Myeloma Read More

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