CC-5013 With or Without Dexamethasone in Treating Patients With Primary Systemic Amyloidosis
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring primary systemic amyloidosis
Eligibility Criteria
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
Sites / Locations
- Cancer Research Center at Boston Medical Center
Arms of the Study
Arm 1
Experimental
revlimid
lenalidomide 15 mg/day, for 21 days with 7 days rest (28 day cycle) with or without dexamethasone 20 mg daily (10 mg BID) on Days 1-4, 9-12, and 17-20 of every other 28-day cycle.