Viewing Study NCT00024466



Ignite Creation Date: 2024-05-05 @ 11:24 AM
Last Modification Date: 2024-10-26 @ 9:06 AM
Study NCT ID: NCT00024466
Status: COMPLETED
Last Update Posted: 2018-09-19
First Post: 2001-09-13

Brief Title: Chemotherapy Vaccine Therapy and Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Overview

Official Title: Vaccination In Peripheral Stem Cell Transplant Setting For Multiple Myeloma The Use Of Autologous Tumor CellsAn Allo PSCT
Status: COMPLETED
Status Verified Date: 2018-09
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 Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Vaccines made from a persons cancer cells may make the body build an immune response to kill cancer cells Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy Combining chemotherapy with vaccine therapy and peripheral stem cell transplantation may be effective in treating multiple myeloma

PURPOSE Phase III trial to study the effectiveness of chemotherapy followed by vaccine therapy and peripheral stem cell transplantation in treating patients who have newly diagnosed multiple myeloma
Detailed Description: OBJECTIVES

Determine the efficacy of induction chemotherapy followed by autologous tumor cell vaccine and autologous peripheral blood stem cell transplantation in patients with multiple myeloma
Determine the safety of this regimen in these patients

OUTLINE Autologous tumor cells are harvested The vaccine is prepared in vitro by mixing autologous tumor cells with a bystander cell expressing sargramostim GM-CSF Patients receive induction chemotherapy followed by autologous tumor cell vaccination ATCV once Patients then undergo autologous peripheral blood stem cell transplantation At 6 weeks after transplantation patients receive additional ATCVs every 3 weeks for a total of 8 vaccinations

PROJECTED ACCRUAL A total of 25 patients will be accrued for this study

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
01-01-17-06 OTHER JHMIRB httpsreporternihgovquickSearchP30CA006973
P30CA006973 NIH None None