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

OBJECTIVES:

• Determine the efficacy of induction chemotherapy followed by autologous tumor cell vaccine and autologous peripheral blood stem cell transplantation in patients with multiple myeloma.
• Determine the safety of this regimen in these patients.

OUTLINE: Autologous tumor cells are harvested. The vaccine is prepared in vitro by mixing autologous tumor cells with a bystander cell expressing sargramostim (GM-CSF). Patients receive induction chemotherapy followed by autologous tumor cell vaccination (ATCV) once. Patients then undergo autologous peripheral blood stem cell transplantation. At 6 weeks after transplantation, patients receive additional ATCVs every 3 weeks for a total of 8 vaccinations.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

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