CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
Ex-vivo expanded effector cellsbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00439465
NCT00439465Phase 2Completed
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Adoptive Cellular Immunotherapy Following Autologous Peripheral Blood Stem Cell Transplantation for Multiple Myeloma

Dartmouth-Hitchcock Medical Center·interventional·Posted Feb 23, 2007·Updated Mar 26, 2019

In Brief

A Phase 2 clinical trial evaluating Ex-vivo expanded effector cells for Myeloma and Transplant-eligible Patients. Completed, enrolled 23 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyeloma, Transplant-eligible Patients
CountriesUnited States
CollaboratorsThe Leukemia and Lymphoma Society

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 23, 2007
Enrollment StartJan 1, 2007
Primary CompletionOct 15, 2012
Study CompletionNov 30, 2012
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 19.4 years ago

Interventions

Ex-vivo expanded effector cellsbiological

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.