Cyclophosphamide, Lenalidomide and Dexamethasone (CLD) for Previously Treated Patients With AL Amyloidosis

Inclusion criteria: * Diagnosis of AL amyloidosis. * Evidence of a monoclonal light chain at serum and/or urine immunofixation electrophoresis. * Elevated circulating free light chain (of the type identified by immunofixation) above the upper limit of the normal range and abnormal kappa/lambda ratio. * Previously treated and requiring further treatment. * Symptomatic organ involvement. * Bone marrow plasma cell \<30%. * Echocardiographic ejection fraction \>40%. * Troponin I \<0.1 ng/mL. * Hemoglobin \>10 g/dL. * Absolute neutrophil count \>1500/uL. * Platelet count \>140000/uL. * Total bilirubin \<2.5 mg/dL. * Alkaline phosphatase \<4 x upper reference limit (u.r.l.). * ALT \<3 x u.r.l.. * Glomerular filtration rate \>30 mL/min. * Performance status ECOG 1-3. * Female subjects of childbearing potential must have two negative pregnancy tests prior to starting study drug. Exclusion Criteria: * Prior treatment with the association of cyclophosphamide, lenalidomide and dexamethasone or with lenalidomide. * Requirement for other concomitant chemotherapy, immunotherapy or radiotherapy, or any investigational ancillary therapy. * Presence of other active malignancies, with the exception of nonmelanoma skin cancer, cervical cancer, treated early-stage prostate cancer provided that prostate specific antigen is within normal limits. * Clinically overt multiple myeloma. * Uncontrolled infection. * New York Heart Association (NYHA) class 4 heart failure. * Enzyme documented myocardial infarction within 6 months before enrollment. * Grade 2 or 3 atrioventricular block (Mobitz type I is permitted). * Repetitive ventricular arrhythmias at 24 h Holter electrocardiogram in spite of treatment with amiodarone. * Supine systolic blood pressure \<90 mmHg, or symptomatic orthostatic hypotension, or a decrease in systolic blood pressure on standing of \>20 mmHg in spite of being treated for orthostatic hypotension. * Prior history of thrombosis or venous thromboembolism or pulmonary embolism. Prior diagnosis of antiphospholipid antibodies or lupus anticoagulant, factor V Leiden mutation, prothrombin G21210A mutation, antithrombin, protein C or S deficiency. * Indication to receive clopidogrel, ticlopidine or warfarin. * Factor X level \<20%. * Poorly controlled diabetes mellitus (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months). * Previous or ongoing psychiatric illness (with the exclusion of reactive depression). * Pregnant or nursing women.