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

Initial 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 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 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 Inclusion Criteria:

• Patient received transplant < 12 months of enrollment onto BMT CTN 1401.
• No disease progression since initiation of systemic anti-myeloma therapy as determined within seven days of randomization/enrollment.
• Received an autologous cell transplant with melphalan 200mg/m^2 with a minimum cell dose of 2x10^6 CD34+ cells/kg (actual body weight).
• Mucositis and gastrointestinal symptoms resolved, off hyperalimentation and intravenous hydration.
• No evidence of uncontrolled infection requiring systemic therapy. Patients who completed treatment for an infection but are continuing antibiotics, anti-viral, or anti-fungal therapy for prophylaxis are eligible to continue on protocol.
• Platelet count ≥75, 000/mm^3 (without transfusion in previous 7 days).
• Absolute neutrophil count (ANC) ≥ 1, 500/mm^3 without filgrastim administration within 7 days, or pegfilgrastim within 14 days of measurement.
• Hepatic: bilirubin < 2x the upper limit of normal and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5x the upper limit of normal. (Patients who have been diagnosed with Gilbert's Disease are allowed to exceed the defined bilirubin value of 2x the upper limit of normal)
• Renal: Creatinine clearance of ≥ 40 mL/min, estimated or calculated. Patients with creatinine clearance ≥30 bu