A Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL Amyloidosis

INCLUSION CRITERIA * Newly diagnosed or relapsed AL amyloidosis * Biopsy-proven amyloidosis with evidence of an underlying plasma cell dyscrasia * abnormal clonal dominance of plasma cells in the bone marrow * detection of a monoclonal gammopathy by immunofixation electrophoresis of serum and/or urine * an abnormal serum free light chain or ratio, or AL fibrils seen on biopsy) * Measurable disease defined by an abnormal serum-free light chain or monoclonal protein by immunofixation * proteinuria ≥ 0.5 g/day, cardiac involvement with interventricular septal thickness ≥ 15 mm * hepatomegaly in the absence of congestive heart failure with elevated alkaline phosphatase * Age ≥ 18 years at the time of signing the informed consent form. * All previous cancer therapy must have been discontinued at least 4 weeks prior to treatment in this study * ECOG performance status of ≤ 3 at study entry * Laboratory test results: * Absolute neutrophil count ≥ 1.0 x 10e9 / L * Platelet count ≥ 75 x 10e9 / L * Creatinine clearance ≥ 15 mL/ minute * Total bilirubin ≤ 2-fold upper limits of normal * Disease-free of prior malignancies (excluding multiple myeloma) for ≥ 3 years with exception of: * currently treated basal cell * squamous cell carcinoma of the skin * carcinoma "in situ" of the cervix or breast. * Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test * Females of childbearing potential must either: * commit to continued abstinence from heterosexual intercourse * acceptable methods of birth control and agree to ongoing pregnancy testing * Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy * All study participants must be registered into the mandatory RevAssist program, and able to comply with its requirements * Able to take aspirin (81 mg) daily • Understand and voluntarily sign an informed consent form * Able to adhere to the study visit schedule and other protocol requirements EXCLUSION CRITERIA * Any serious medical condition that would prevent the subject from signing the informed consent form * Pregnant * breast-feeding females * Use of any other experimental drug or therapy within 28 days of baseline * Known hypersensitivity to thalidomide * Erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs * Any prior use of lenalidomide * Concurrent use of other anti-cancer agents or treatments * Known positivity for human immunodeficiency virus HIV)