Expired Study
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Baltimore, Maryland 21231


Purpose:

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Vaccines made from a person's cancer cells may make the body build an immune response to kill cancer cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. Combining chemotherapy with vaccine therapy and peripheral stem cell transplantation may be effective in treating multiple myeloma. PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy followed by vaccine therapy and peripheral stem cell transplantation in treating patients who have newly diagnosed multiple myeloma.


Study summary:

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.


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


NCT ID:

NCT00024466


Primary Contact:

Study Chair
Ivan Borrello, MD
Sidney Kimmel Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21231
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 20, 2017

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