Combination Immunotherapy and Autologous Stem Cell Transplantation for Myeloma

Inclusion Criteria

• Written informed consent
• Patients must be registered with the Sponsor's Monitor
• Patients must have a diagnosis of myeloma
• Patients must meet one of the following criteria:
• Myeloma has relapsed, progressed, or failed to respond after at least one prior course of therapy (consisting of at least 2 treatment cycles or months of therapy).
• Myeloma has responded partially to initial therapy but a complete response (immunofixation negative and normal serum free light chain studies)has NOT developed after a minimum of 3 cycles or months of initial therapy.
• Myeloma has high-risk features as defined by the presence of one or more cytogenetic abnormalities known to confer a poor outcome even after standard autotransplants:complex karyotype (> or = to 3 abnormalities),t(4;14),t(14;16),del (17)(p13.1),and/or chromosome 13 abnormalities.
• Patients must have measurable disease on study entry
• Patients must be between ages 18-80 (inclusive).
• Patients should have adequate vital organ function as defined by the protocol.
• ECOG performance status 0-2 (unless due solely to bone pain)
• Prior to Lenalidomide maintenance phase, all study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
• Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test as per the protocol
• Lenalidomide treatment phase: able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).

Exclusion Criteria

• Pregnant or nursing females
• HIV or HTLV-1/2 seropositivity
• Known history of myelodysplasia
• Known history of chronic active hepatitis or liver cirrhosis (if suspected by laboratory studies, should be confirmed by liver biopsy).
• Active Hepatitis B (as defined by + Hepatitis B surface antigen); + Hepatitis C virus (HCV) antibody is NOT an exclusion
• Prior autotransplant or allogeneic transplant
• More than 4 distinct, prior courses of therapy for myeloma
• History of severe autoimmune disease requiring steroids or other immunosuppressive treatments.
• Active immune-mediated diseases including: connective tissue diseases, uveitis,sarcoidosis,inflammatory bowel disease, multiple sclerosis.
• Evidence or history of other significant cardiac,hepatic,renal, ophthalmologic,psychiatric,or gastrointestinal disease which would likely increase the risks of participating in the study
• Active bacterial, viral or fungal infections.