Ignite Creation Date:
2024-05-06 @ 8:54 AM
Last Modification Date:
2024-10-26 @ 12:07 PM
Study NCT ID:
NCT02851056
Status:
COMPLETED
Last Update Posted:
2022-11-14
First Post:
2016-07-28
Brief Title:
Survivin Vaccine Multiple Myeloma Autologous Hematopoietic Cell Transplant HCT
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Evaluating the Safety and Biological Activity of a Dendritic Cell Survivin Vaccine in Patients With Multiple Myeloma Undergoing Autologous Hematopoietic Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2022-11
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 study is to test what effects good and bad a new cancer vaccine will have on participants and their cancer when administered before and after their autologous hematopoietic cell transplant HCT
The name of the vaccine is called Dendritic Cell Survivin Vaccine DCAdmS The vaccine is made using the participants own blood cells The vaccine will contain a virus called an adenovirus similar the virus that causes the common cold The virus has been changed so it cannot infect humans and cause infections The vaccine will be prepared at Moffitt Cancer Center in the Cell Therapy Laboratory Facility
The name of the vaccine is called Dendritic Cell Survivin Vaccine DCAdmS The vaccine is made using the participants own blood cells The vaccine will contain a virus called an adenovirus similar the virus that causes the common cold The virus has been changed so it cannot infect humans and cause infections The vaccine will be prepared at Moffitt Cancer Center in the Cell Therapy Laboratory Facility
Detailed Description:
This study is designed to test the safety and efficacy of the survivin vaccine as well as the biological activity A total sample size of 30 patients will be used for the study In the 1st stage 10 patients will be used to evaluate the safety and futility of the vaccine If it passes the 1st stage investigators will enroll another 20 patients as 2nd stage to evaluate the efficacy The two- stage experiment is based on Simon minmax two-stage design for efficacy Vaccine will be administered in two stages After the first survivin vaccination participants will be mobilized with G-CSF and both in vivo-primed T cells and stem cells will be collected in the same apheresis the graft T cells and the CD34 progenitor cells will be transferred back to the participant at the time of autologous graft infusion Participants will receive re-vaccination on or near day 21 after transplant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None