CC-5013 With or Without Dexamethasone in Treating Patients With Primary Systemic Amyloidosis

Inclusion Criteria:

DISEASE CHARACTERISTICS:

• Histologically confirmed primary systemic (AL) amyloidosis

  • Tissue amyloid deposits or positive fat aspirate

• Meets 1 of the following criteria for AL type disease:

  • Serum or urine monoclonal protein by immunofixation electrophoresis
  • Plasmacytosis of bone marrow by monoclonal staining for kappa- or lambda-light chain isotype

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• SWOG 0-2

Life expectancy

• Not specified

Hematopoietic

• White blood count> 3,000/mm^3
• Hemoglobin > 8 g/dL
• Platelet count > 100,000/mm^3
• Absolute neutrophil count > 1,000/mm^3

Hepatic

• Bilirubin ≤ 2 times upper limit of normal (ULN)
• aspartate aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2 times ULN

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Prior thalidomide for AL amyloidosis allowed

Chemotherapy

• More than 4 weeks since prior cytotoxic chemotherapy

Endocrine therapy

• Prior steroids for AL amyloidosis allowed

Radiotherapy

• More than 4 weeks since prior radiotherapy

Surgery

• Prior surgery allowed

Other

• Recovered from all prior therapy

Exclusion Criteria:

• No secondary or familial amyloidosis
• No multiple myeloma, defined as ≥ 30% plasma cells in bone marrow biopsy specimen OR lytic bone lesions
• No prior CC-5013

Renal

• No dialysis

Cardiovascular

• No symptomatic cardiac arrhythmia
• No oxygen-dependent restrictive cardiomyopathy

Other

• No untreated or uncontrolled infection
• No other malignancy except basal cell skin cancer or carcinoma in situ of the cervix or breast
• No other serious medical illness that would preclude study participation
• No history of hypersensitivity reaction to thalidomide
• HIV negative
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception