• Overall response rate [ Designated as safety issue: No ]
  

• Progression-free survival [ Designated as safety issue: No ]
  
• Toxicity [ Designated as safety issue: Yes ]
  
• Incidence of PTEN mutation [ Designated as safety issue: No ]
  
• Pharmacodynamics [ Designated as safety issue: No ]
  

OBJECTIVES:

Primary

• Determine the overall response rate in patients with relapsed or refractory multiple myeloma treated with CCI-779.

Secondary

• Determine the progression-free survival of patients treated with this drug.
• Determine the toxicity of this drug in these patients.
• Determine the presence of PTEN mutation in patients treated with this drug.
• Correlate the pharmacokinetics of this drug with response in these patients.
• Correlate the pharmacodynamic effects of this drug with response in these patients.

OUTLINE: This is an open-label study.

Patients receive CCI-779 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.

PROJECTED ACCRUAL: A total of 16-25 patients will be accrued for this study within 8-12.5 months.

DISEASE CHARACTERISTICS:

• 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 NOTE: *Patients who receive only radiotherapy or bisphosphonates are not eligible
• No solitary plasmacytoma

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• More than 6 months

Hematopoietic

• Absolute neutrophil count > 1,200/mm^3
• Platelet count > 75,000/mm^3

Hepatic

• AST and ALT ≤ 2.5 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN

Renal

• Creatinine ≤ 1.5 times ULN

Cardiovascular

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmia

Other

• 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics
• See Chemotherapy
• More than 4 weeks since prior thalidomide and recovered

Chemotherapy

• See Disease Characteristics
• Prior high-dose chemotherapy and stem cell transplantation allowed
• More than 4 weeks since prior chemotherapy and recovered

Endocrine therapy

• See Disease Characteristics
• More than 4 weeks since prior high-dose corticosteroids and recovered

Radiotherapy

• See Disease Characteristics

Other

• 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