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

Inclusion Criteria

• •1. Patients must be considered transplant eligible by the treating physician at time of study entry.
• •2. Patients must meet the criteria for symptomatic multiple myeloma prior to initiating systemic anti-myeloma treatment.
• •3. Age \>18 years and ≤ 70 years at the time of enrollment
• •4. Karnofsky Performance status of ≥ 70%
• •5. 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)
• •6. Patients must have received ≤ 1 cycles of systemic anti-myeloma therapy.
• •7. Renal: Creatinine clearance of ≥ 40 mL/min, estimated or calculated.
• •1. Patient received transplant \< 12 months of enrollment onto BMT CTN 1401.
• •2. No disease progression since initiation of systemic anti-myeloma therapy as determined within seven days of randomization/enrollment.
• •3. Received an autologous cell transplant with melphalan 200mg/m\^2 with a minimum cell dose of 2x10\^6 CD34+ cells/kg (actual body weight).
• •4. Mucositis and gastrointestinal symptoms resolved, off hyperalimentation and intravenous hydration.
• •5. 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.
• •6. Platelet count ≥75,000/mm\^3 (without transfusion in previous 7 days).
• •7. Absolute neutrophil count (ANC) ≥ 1,500/mm\^3 without filgrastim administration within 7 days, or pegfilgrastim within 14 days of measurement.
• •8. 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)
• •9. Renal: Creatinine clearance of ≥ 40 mL/min, estimated or calculated. Patients with creatinine clearance ≥30 but \<40 will be considered with review/approval from the protocol chairs or officer if the cause of renal insufficiency is associated with multiple myeloma.
• •10. All study participants must be registered into the mandatory Revlimid REMs program, and be willing and able to comply with the requirements.
• •11. Females of childbearing potential (FCBP) as defined in section 2.7.1.1 must have a negative serum pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days)
• •12. FCBP must either commit to abstain continuously from sexual intercourse or use TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking lenalidomide, during therapy, during dose interruptions, and continuing for 4 weeks following discontinuation of lenalidomide.
• •13. FCBP must agree to ongoing pregnancy testing as required by the Revlimid REMs program.
• •14. Men must agree to use a latex condom during sexual contact with females of child bearing potential even if they have had a successful vasectomy while taking lenalidomide, during dose interruptions and for 28 days after discontinuing lenalidomide.
• •15. Patients must be willing to receive DVT prophylaxis.