Vaccine Therapy in Treating Patients With Multiple Myeloma Who Have Undergone Stem Cell Transplantation
|Refractory Multiple Myeloma Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Multiple Myeloma||Biological: autologous immunoglobulin idiotype-KLH conjugate vaccine Biological: sargramostim Biological: aldesleukin Other: laboratory biomarker analysis||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||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|
- Toxicities graded using the National Cancer Institute (NCI) Common Toxicity Criteria [ Time Frame: Up to 2 years ]Descriptive statistics will be used to summarize changes from baseline in clinical laboratory parameters for each cohort.
- Immune response [ Time Frame: Up to 2 years ]Descriptive statistics will be used to summarize changes from baseline in clinical laboratory parameters for each cohort.
|Study Start Date:||March 1996|
|Primary Completion Date:||December 2002 (Final data collection date for primary outcome measure)|
Experimental: Treatment (vaccine therapy)
Patients receive autologous immunoglobulin idiotype-KLH conjugate vaccine combined with sargramostim SC in weeks 0, 2, 6, and 10 and sargramostim SC QD for three days following each vaccine injection. Some patients also receive aldesleukin SC daily from weeks 2-14.
Biological: autologous immunoglobulin idiotype-KLH conjugate vaccine
Other Names:Biological: sargramostim
Other Names:Biological: aldesleukin
Other Names:Other: laboratory biomarker analysis
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002787
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||David Maloney||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|