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