Vaccination In Peripheral Stem Cell Transplant Setting For Multiple Myeloma: The Use Of Autologous Tumor Cells/An Allo PSCT
18 Years
70 Years
Both
Multiple Myeloma and Plasma Cell Neoplasm
Trial Information
Vaccination In Peripheral Stem Cell Transplant Setting For Multiple Myeloma: The Use Of Autologous Tumor Cells/An Allo PSCT
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
DISEASE CHARACTERISTICS:
- Newly diagnosed multiple myeloma
- More than 30% bone marrow involvement
- Eligible for autologous peripheral blood stem cell transplantation
PATIENT CHARACTERISTICS:
Age:
- 18 to 70
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count greater than 500/mm^3
- Platelet count greater than 30,000/mm^3
Hepatic:
- Bilirubin less than 3 times normal
- AST/ALT less than 3 times normal
Renal:
- Not specified
Other:
- Not pregnant
- HIV negative
- No prior or active autoimmune disease
- No other prior malignancy within the past 5 years
- No major active medical or psychosocial problems
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- See Disease Characteristics
Chemotherapy:
- No more than 1 prior course of chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- Concurrent local radiotherapy allowed
Surgery:
- Not specified
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Ivan Borrello, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Sidney Kimmel Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000068953
NCT ID:
NCT00024466
Start Date:
March 2001
Completion Date:
Related Keywords:
- Multiple Myeloma and Plasma Cell Neoplasm
- stage I multiple myeloma
- stage II multiple myeloma
- stage III multiple myeloma
- Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
Name | Location |
|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
