Adoptive Cellular Immunotherapy Following Autologous Peripheral Blood Stem Cell Transplantation for Multiple Myeloma
The purpose of this study is to determine whether the administration of highly effective "killer" cells (cytotoxic T cells), along with IL-2 and GM-CSF immediately following Autologous Peripheral Blood Stem Cell Transplantation (APBSCT) will enhance anti-tumor immune reconstitution and improve outcome of Multiple Myeloma patients.
The overall hypothesis of this proposal is that immediately following APBSCT the immune reconstitution is optimal to administer "killer" cells, combined with the administration of IL-2 and GM-CSF.
|Myeloma Transplant-eligible Patients||Biological: Autologous ex-vivo expanded effector cells||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Adoptive Cellular Immunotherapy Following Autologous Peripheral Blood Stem Cell Transplantation for Multiple Myeloma|
- To establish the safety (toxicity), time to engraftment and clinical outcomes of myeloma patients treated with high dose melphalan, APBSCT& adoptive transfer of cytotoxic effector cells with IL-2 and GM-CSF. [ Time Frame: From initiation of treatment on protocol until Day 100 ]
- Identify CD8+ effector cell-versus-myeloma effects in vivo by determining recovery,function& mechanism of tumor cell killing of PB CD8+ cells prior to& after completing therapy. [ Time Frame: From initiation of treatment on protocol until Day 100 ]
|Study Start Date:||January 2007|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||February 2018 (Final data collection date for primary outcome measure)|
Autologous ex-vivo expanded effector cells
Infusing IL-2 and GM-CSF post-HCST
Biological: Autologous ex-vivo expanded effector cells
This trial will test if the combination of infusing ex vivo expanded cytotoxic effector cells with IL-2 and GM-CSF post-transplant will accelerate immune reconstitution, resulting in an effector cell-versus-myeloma effect and, possibly, improved clinical outcomes.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00439465
|United States, New Hampshire|
|Dartmouth-Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756|
|Principal Investigator:||Kenneth Meehan, MD||Dartmouth-Hitchcock Medical Center|