Chemotherapy, Vaccine Therapy, and Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma

INCLUSION CRITERIA

Initial Presentation

Age between 18 and 70 years
ECOG 0 - 2
Patients with histologically confirmed multiple myeloma with ≥ 30% bone
marrow involvement and a de novo presentation. One cycle of prior
chemotherapy for myeloma is allowed. Local radiation therapy is permitted
Ability to give informed consent
No existing secondary malignancies and no history of secondary malignancies in the past 5 years (other than a history of carcinoma in situ of the cervix, superficial skin cancer, or superficial bladder cancer)
No active autoimmune disease, nor a history of any autoimmune disease requiring medical treatment with systemic immunosuppressants
No corticosteroids within 28 days of tumor harvest
No major active medical or psychosocial problems that could be exacerbated or complicated by this treatment
Not pregnant
HIV negative
AST/ALT, total bilirubin < threefold normal
Absolute neutrophil count >500/mm3
Platelet count >30,000/mm3

Prior to Transplantation

ECOG performance status of 0 - 2.
No active/uncontrolled infection.
Absolute neutrophil count (ANC) >1000/mm3.
Platelet count >50,000/mm3.
Hemoglobin >8g/dL
AST/ALT, total bilirubin <3-fold normal.
50% or greater reduction in tumor burden with prior chemotherapy
Patient has received a minimum of 2 cycles of an accepted induction
chemotherapy regimen
Patient fulfills the requirements for standard peripheral stem cell transplantation Prior to Posttransplant Vaccination
No active/uncontrolled infection
Absolute neutrophil count (ANC) >1000/mm3
Platelet count >50,000/mm3
Hemoglobin >8g/dL
AST/ALT, total bilirubin <3-fold normal
No unresolved Grade 3 or 4 adverse events related to the transplant

EXCLUSION CRITERIA

• Failure of autologous tumor-cell processing for vaccine production