Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002787
Status:
COMPLETED
Last Update Posted:
2019-05-06
First Post:
1999-11-01
Brief Title:
Vaccine Therapy in Treating Patients With Multiple Myeloma Who Have Undergone Stem Cell Transplantation
Sponsor:
Fred Hutchinson Cancer Research CenterUniversity of Washington Cancer Consortium
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Phase I Trial of Post Transplant Immunization With Autologous Myeloma Idiotype-KLHGM-CSF In Myeloma Patients Following Autologous or Allogeneic Marrow or Stem Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-00669 | REGISTRY | CTRP Clinical Trial Reporting Program | None |