Lenalidomide, Cyclophosphamide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis

DISEASE CHARACTERISTICS:

• Histochemical diagnosis of AL amyloidosis based on detection of green birefringent material in Congo red-stained tissue specimens by polarizing microscopy

• Measurable disease, as defined by one of the following:

  • Serum monoclonal protein ≥ 1.0 g by serum electrophoresis
  • Urine monoclonal protein > 200 mg by 24-hour urine electrophoresis
  • Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio

• Symptomatic organ involvement with amyloid to justify therapy

  • May include liver involvement, cardiac involvement, renal involvement, grade 1 peripheral neuropathy, or soft tissue involvement
  • Must have more than skin purpura or carpal tunnel syndrome

• No amyloid-specific syndrome, such as carpal tunnel syndrome or skin purpura, as only evidence of disease

  - Vascular amyloid only in a bone marrow biopsy specimen or in a plasmacytoma is not indicative of systemic amyloidosis

• No clinically overt multiple myeloma (i.e., monoclonal BMPC > 30%, bone lesions, or hypercalcemia)

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• ANC ≥ 1,000/μL
• Platelet count ≥ 75,000/μL
• Creatinine < 3.0 mg/dL
• Not pregnant
• Negative pregnancy test
• Fertile patients must use two acceptable methods of contraception for ≥ 28 days prior to, during, and for ≥ 28 days after completion of study treatment
• No nursing during and for ≥ 28 days after completion of study treatment
• No blood, semen, or sperm donation during and for ≥ 28 days after completion of study treatment
• No malignancies within the past 5 years except treated basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast
• No neuropathy ≥ grade 2, defined as motor neuropathy (symptomatic weakness interfering with function, but not interfering with activities of daily living [ADL]) or sensory neuropathy (sensory alteration or paresthesia [including tingling], interfering with function, but not interfering with ADL)
• No uncontrolled infection
• No syncope within the past 30 days
• No known hypersensitivity to thalidomide, including desquamating rash with thalidomide in the past
• No known seropositivity for HIV
• No active hepatitis A, B, or C
• No New York Heart Association class III or IV heart disease
• No venous thromboembolic event within the past 42 days
• Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation - Patients intolerant to aspirin may use low molecular weight heparin

PRIOR CONCURRENT THERAPY:

• No prior lenalidomide
• More than 2 weeks since prior and no other concurrent anticancer agents or treatments
• More than 4 weeks since prior experimental agents
• No other concurrent corticosteroids except chronic steroids (maximum dose 20 mg/day of prednisone equivalent) for disorders other than amyloidosis (e.g., adrenal insufficiency or rheumatoid arthritis)