Carfilzomib and Lenalidomide With Dexamethasone Combination in Newly Diagnosed, Previously Untreated Multiple Myeloma

Inclusion Criteria

• Newly diagnosed, histologically confirmed, previously untreated Stage I, II, or III multiple myeloma requiring systemic chemotherapy
• Diagnosis of symptomatic multiple myeloma per IMWG uniform criteria within the past 90 days
• Measurable disease, per IMWG (International Myeloma Working Group) criteria (>= one of the following) within the past 4 weeks:
• Monoclonal protein >= 0.5 g/dL by serum protein electrophoresis
• Monoclonal light chain >= 200 mg by 24-hour urine protein electrophoresis
• If serum protein electrophoresis is felt to be unreliable for routine M-protein measurement, then quantitative immunoglobulin levels are acceptable
• Life expectancy > 3 months
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Adequate hepatic function, with bilirubin =1.0 x 109/L, hemoglobin >= 8 g/dL, platelet count >= 75 x 109/L
• Calculated creatinine clearance (by Cockroft-Gault) >= 60 ml/min
• Written informed consent in accordance with federal, local, and institutional guidelines.
• Subjects must agree to adhere to all study requirements, including birth control measures and pregnancy testing, visit schedule, outpatient treatment, required concomitant medications, and laboratory monitoring.
• Must be able to take either 81 mg or 325 mg aspirin daily as prophylactic anticoagulation.

Exclusion Criteria

• Non-secretory or hyposecretory multiple myeloma, defined as 2) at the time of the first dose and/or within 14 days before enrollment
• Contraindication to any of the required concomitant drugs
• Subjects in whom the required program of PO and IV fluid hydration is contraindicated
• Subjects with known or suspected amyloidosis of any organ
• Subjects with pleural effusions requiring thoracentesis or ascites requiring paracentesis