NCT00439465|CompletedPhase 2ResultsDMC
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Sponsor study identifier
interventional
23
1 country
1
Study Start
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 15, 2012
Actual (reported)Study Completion
November 30, 2012
Actual (reported)The purpose of this study is to determine whether the administration of highly effective "killer" cells (cytotoxic T cells), along with Interleukin-2 (IL-2) and Recombinant Human Granulocyte Colony Stimulating Factor (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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 30, 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
February 21, 2007
Actual (reported)February 23, 2007
Actual (reported)October 15, 2012
Actual (reported)November 30, 2012
Actual (reported)March 26, 2019
Actual (reported)Number of Participants With Adverse Events in All Subjects
To establish the safety (toxicity) of myeloma patients treated with high dose melphalan, autologous peripheral blood stem cell transplantation (APBSCT) \& adoptive transfer of cytotoxic effector cells with Interleukin-2 (IL-2) and Recombinant Human Granulocyte Colony Stimulating Factor (GM-CSF).
From initiation of treatment on protocol until Day 100
Count of Participants With Increased CD3+CD8+, CD8+ and CD56+ Concentrations Between Day 15 Post-Transplant and Days 21 to 28 Post-transplant
Day 15 post-transplant and between days 21 to 28 post-transplant
Time to Recovery of Absolute Neutrophil Count
From initiation of treatment on protocol until Day 100
Time to Recovery of Platelet Count
From initiation of treatment on protocol until Day 100
Assessment of Disease Response to Treatment
From initiation of treatment on protocol until Day 100
Number of Participants With Increased Expression of DAP10 and NKG2D on the CD8 Cell Population
Pre-transplant and following the third and fourth cellular infusions
Infusing IL-2 and GM-CSF post-Hematopoietic Stem Cell Transplant (HSCT)
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Kenneth Meehan, MD
Dartmouth-Hitchcock Medical Center
23 participants (actual enrollment reported by the registry).
First Submitted
February 21, 2007
First Posted
February 23, 2007
Study Start
January 2007
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
October 15, 2012
Actual (reported)Study Completion
November 30, 2012
Actual (reported)Last Updated
March 26, 2019
Results First Posted
March 26, 2019
Record last verified: 2019-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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