Dendritic Cell/Myeloma Fusion Vaccine for Multiple Myeloma (BMT CTN 1401)

Inclusion Criteria

• Patients must be considered transplant eligible by the treating physician at time of study entry.
• Patients must meet the criteria for symptomatic multiple myeloma prior to initiating systemic anti-myeloma treatment.
• Age >18 years and ≤ 70 years at the time of enrollment
• Karnofsky Performance status of ≥ 70%
• Patients must have > 20% plasma cells in the bone marrow aspirate differential <60 days prior to enrollment. The required bone marrow evaluation will need to be repeated for patients who received more than 1 cycle of anti-myeloma therapy (corticosteroid with or without other anti-myeloma agents)
• Patients must have received ≤ 1 cycles of systemic anti-myeloma therapy.
• Renal: Creatinine clearance of ≥ 40 mL/min, estimated or calculated. Initial

Exclusion Criteria

• Patients with a prior autologous or allogeneic HCT
• Patients with purely non-secretory MM [absence of a monoclonal protein (M protein) in serum as measured by electrophoresis and immunofixation and the absence of Bence Jones protein in the urine defined by use of conventional electrophoresis and immunofixation techniques and the absence of involved serum free light chain >100 mg/L]. Patients with light chain MM detected in the serum by free light chain assay are eligible.
• Patients with Plasma Cell Leukemia
• Patients with disease progression prior to enrollment
• Patients seropositive for the human immunodeficiency virus (HIV).
• Myocardial infarction within 6 months prior to enrollment or New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening will be documented by the investigator as not medically relevant.
• Patients with active clinically significant autoimmune disease, defined as a history of requiring systemic immunosuppressive therapy and at ongoing risk for potential disease exacerbation. Patients with a history of autoimmune thyroid disease, asthma, or limited skin manifestations are potentially eligible.
• Patients receiving other investigational immunotherapy or anti-myeloma drugs within 14 days before enrollment.
• Patients with prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent < 5 years prior to enrollment will not be allowed unless approved by the Protocol Officer or one of the Protocol Chairs. Cancer treated with curative intent > 5 years prior to enrollment is allowed.
• Female patients who are pregnant (positive beta-HCG) or breastfeeding.
• Females of childbearing potential (FCBP) or men who have sexual contact with FCBP unwilling to use contraceptive techniques (Appendix D) during the length of lenalidomide maintenance therapy.
• Patients who have received mid-intensity melphalan (>50 mg IV) as part of prior therapy.
• Prior organ transplant requiring immunosuppressive therapy.
• Patients who previously received lenalidomide and have experienced toxicities resulting in treatment discontinuation.
• Patients who experienced thromboembolic events while on full anticoagulation during prior therapy with lenalidomide or thalidomide.
• Patients unwilling to take deep vein thrombosis (DVT) prophylaxis.
• Patients unable or unwilling to provide informed consent.
• Patients unable or unwilling to return to the transplant center for their assigned treatments. Randomization