NCT00019097

Vaccine Therapy in Treating Patients With Multiple Myeloma

Phase II Study of Autologous Myeloma-Derived Immunoglobulin Idiotype Conjugated to Keyhole Limpet Hemocyanin Plus Sargramostim (GM-CSF) in Patients With Multiple Myeloma Undergoing Second Autologous Peripheral Blood Stem Cell Transplantation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

RATIONALE: Vaccines made from a person's tumor cells may make the body build an immune response and kill their tumor cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation plus vaccine therapy and chemotherapy in treating patients who have multiple myeloma.

Detailed description

OBJECTIVES: I. Determine whether autologous myeloma-derived immunoglobulin idiotype conjugated to keyhole limpet hemocyanin plus sargramostim (GM-CSF) can induce cellular and humoral immunity against the unique idiotype expressed on the surface of myeloma cells in patients with multiple myeloma undergoing second autologous peripheral blood stem cell transplantation. II. Determine the clinical efficacy and safety of this regimen in these patients. PROTOCOL OUTLINE: Within 6 months after the first autologous peripheral blood stem cell transplantation (APBSCT), patients receive melphalan IV over 30 minutes on day -2 and the second APBSCT on day 0. Sargramostim (GM-CSF) is administered subcutaneously (SC) beginning on day 1 and continuing until blood counts recover. Patients are also assigned to 1 of 3 vaccination groups. Group 1: Patients receive autologous myeloma-derived immunoglobulin idiotype conjugated to keyhole limpet hemocyanin (Id-KLH) SC on day 1 and GM-CSF SC on days 1-4 of months 2, 3, and 5 after the second APBSCT for a total of 3 vaccinations. Group 2: Patients receive Id-KLH SC on day 1 and GM-CSF SC on days 1-4 of months 2, 3, 4, 5, 6, and 8 after the second APBSCT for a total of 6 vaccinations. Group 3: Patients receive Id-KLH SC on day 1 and GM-CSF SC on days 1-4 of weeks -8, -6, and -2 before and months 2, 3, and 5 after the second APBSCT for a total of 6 vaccinations. Patients are followed within 3 months and then every 6 months. PROJECTED ACCRUAL: A maximum of 60 patients (20 per treatment group) will be accrued for this study within 3 years.

Conditions

• Stage II Multiple Myeloma
• Stage III Multiple Myeloma
• Refractory Plasma Cell Neoplasm

Interventions

Type	Name	Description
DRUG	autologous tumor cell vaccine
DRUG	keyhole limpet hemocyanin
DRUG	melphalan
DRUG	sargramostim

Timeline

• Start date: 1995-07-01
• Completion: 2007-03-01
• First posted: 2007-03-05
• Last updated: 2024-03-04

Locations

3 sites across 1 country: United States