Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019097
Status:
COMPLETED
Last Update Posted:
2024-03-04
First Post:
2007-03-01
Brief Title:
Vaccine Therapy in Treating Patients With Multiple Myeloma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
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
Status Verified Date:
2024-02
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:
RATIONALE Vaccines made from a persons 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
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
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
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 |
|---|---|---|---|
| CRB-9409 | None | None | None |
| NCI-97-C-0033B | None | None | None |
| NCI-T94-0094N | None | None | None |