NCT00002787

Vaccine Therapy in Treating Patients With Multiple Myeloma Who Have Undergone Stem Cell Transplantation

Phase I Trial of Post Transplant Immunization With Autologous Myeloma Idiotype-KLH/GM-CSF In Myeloma Patients Following Autologous or Allogeneic Marrow or Stem Cell Transplantation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to test the safety and immune response to four immunizations with this vaccine made from a protein produced by the patient's tumor. There is no guarantee or promise that this procedure will be successful

Detailed description

PRIMARY OBJECTIVES: I. To determine the safety of multiple subcutaneous vaccinations with myeloma Id-KLH (idiotype-keyhole limpet hemocyanin) with GM-CSF (sargramostim) in post allogeneic transplant myeloma patients, or with GM-CSF +/- interleukin (IL)-2 (aldesleukin) in post autologous transplant myeloma patients. II. To evaluate patients pre and post bone marrow transplantation (BMT) for evidence of endogenous idiotype specific immune response. III. To characterize the time course, specificity and persistence of antibody and T cell immune response to myeloma idiotype and to KLH induced by myeloma Ig (Id) immunization. IV. To clone, expand and characterize T cells specific for the tumor idiotype. V. Monitor myeloma involvement in bone marrow and serum paraprotein level following vaccination. VI. Use stored patient samples to clone, expand, and characterize T cells specific for myeloma antigens other than idiotype and identify the antigens they recognize so that they can be used in future studies. OUTLINE: Patients receive autologous immunoglobulin idiotype-KLH conjugate vaccine combined with sargramostim subcutaneously (SC) in weeks 0, 2, 6, and 10 and sargramostim SC once daily (QD) for three days following each vaccine injection. Some patients also receive aldesleukin SC daily from weeks 2-14. After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months for 1 year.

Conditions

• Refractory Multiple Myeloma
• Stage I Multiple Myeloma
• Stage II Multiple Myeloma
• Stage III Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	autologous immunoglobulin idiotype-KLH conjugate vaccine	Given SC
BIOLOGICAL	sargramostim	Given SC
BIOLOGICAL	aldesleukin	Given SC
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 1996-03-01
• Primary completion: 2002-12-01
• First posted: 2004-05-21
• Last updated: 2019-05-06

Locations

1 site across 1 country: United States