NCT02851056

Survivin Vaccine : Multiple Myeloma Autologous Hematopoietic Cell Transplant (HCT)

Evaluating the Safety and Biological Activity of a Dendritic Cell Survivin Vaccine in Patients With Multiple Myeloma Undergoing Autologous Hematopoietic Cell Transplantation

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 (DC:AdmS). The vaccine is made using the participant's 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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	Survivin Vaccine	Pre-transplant vaccination : The target dose of Survivin+ Dendritic cells (survivin+, CD11c+, Human Leukocyte Antigen - antigen D Related (HLA-DR)+ by flow-cytometry) is 15 x 10\^6 cells. A minimum of 1 x 10\^6 cells and a maximum of 20 x 10\^6 cells will be administered. Post-transplant vaccination: The target dose of Survivin+ Dendritic cells (survivin+, CD11c+, HLA-DR+ by flow-cytometry) is 15 x 10\^6 cells. A minimum of 1 x 10\^6 cells and a maximum of 20 x 10\^6 cells will be administered.
PROCEDURE	Autologous Hematopoietic Cell Transplantation	The participant's own cells are collected from their blood, frozen, and then given back to them after they receive chemotherapy.
BIOLOGICAL	Prevnar 13	13-Valent Pneumococcal Conjugate Vaccine (PCV13, Prevnar13). Co-Immunization: All participants will be co-immunized with Prevnar at each time they receive the survivin vaccine. This vaccine will be administered intramuscular (IM) 0.5cc.
DRUG	Granulocyte-colony Stimulating Factor	After the first survivin vaccination, participants will be mobilized with G-CSF.

Timeline

• Start date: 2016-09-27
• Primary completion: 2018-07-16
• Completion: 2018-08-09
• First posted: 2016-08-01
• Last updated: 2022-11-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study