MAGE-A3 Protein + AS15 as Consolidation for Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation

Inclusion Criteria:

• Symptomatic multiple myeloma, ISS stage 1, 2 or 3 within 12 months of starting therapy.
• Completion of induction therapy with Very Good Partial Response (VGPR), or better, by International Myeloma Working Group (IMWG) criteria. All induction myeloma therapy (oral or intravenous, including steroids) must be discontinued for 3 weeks prior to first immunization. Patients do not need to have measurable disease at the time of this screening visit.
• Has signed separate informed consent for stem cell mobilization and high dose chemotherapy/autologous stem cell transplant, and is found to be eligible for stem cell transplant by standard institutional criteria.
• MAGE-A3 expression determined by IHC must be present in a bone marrow specimen or plasmacytoma specimen.
• ECOG performance status 0-1 .
• The following laboratory parameters must be within the ranges specified: Neutrophil count ≥ 1.5 x 109/L, Lymphocyte count ≥ 0.5 x 109/L, Platelet count ≥ 50 x 109/L, Serum creatinine ≤ 2 mg/dL, Serum bilirubin up to 1.5 x ULN for lab, AST and ALT up to 2 x ULN for lab, Hemoglobin ≥ 8.0 g/dL, INR ≤ 1.5, Partial thromboplastin time ≤ 1.5 x ULN for lab unless known history of anti-phospholipid antibody or lupus anticoagulant)
• Age ≥ 18 years.
• Able and willing to give valid written informed consent.

Exclusion Criteria:

• Prior treatment with melphalan (Alkeran®), other than 1 cycle (4 days) of oral melphalan.
• Prior autologous or allogeneic stem cell transplant.
• Previous immunization against MAGE-A3 or other cancer-testis antigens.
• Concurrent malignancies, except for treated non-melanoma skin cancer and cervical carcinoma in situ.
• Known immunodeficiency, HIV positivity, Hepatitis B or Hepatitis C.
• Known allergy or history of life threatening reaction to G-CSF or GM-CSF.
• History of autoimmune disease (eg., rheumatoid arthritis, lupus), other than vitiligo, diabetes, or treated thyroiditis, which are allowed.
• History of severe allergic reactions to vaccines or unknown allergens.
• History of myocardial infarction, angina, congestive heart failure, ventricular tachyarrhythmia, stroke or transient ischemic attack within the past 6 months.
• Other serious illnesses or co-morbid conditions (e.g., serious infections requiring antibiotics, bleeding disorders, other heart or lung conditions) that in the opinion of the investigator make the patient inappropriate for high-dose melphalan and autologous stem cell transplant.
• Pregnancy and breastfeeding.
• Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first immunization.
• Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
• Lack of availability for immunological and clinical follow-up assessment.