Grants and Contracts Details
Description
This is a multi-center phase II clinical trial in which patients (n=100) with multiple myeloma undergoing high-dose chemotherapy melphalan and autologous stem cell transplantation will be randomized to either hyperbaric oxygen (HBO) or no HBO prior to their stem cell infusion. The study’s primary objective is to evaluate the role of HBO in neutrophil count recovery post-transplant. Other objectives include evaluating the role of HBO in platelet count recovery and NK cell recovery post-transplant. Finally, this study evaluates HBO effects on plasma erythropoietin and IL-15 as potential mediators of HBO effects on blood count recovery post-transplant.
The subrecipient is expected to accrue patients (n=10) to this study. The subrecipient is expected to adhere the most updated version of the protocol. Study activities include subject enrollment, subject treatment, study monitoring, and obtaining correlative laboratory samples. Some of these samples will be analyzed by the recipients labs (erythropoietin and NK cell flow cytometry). Other samples will be processed and shipped to the University of Rochester Cancer Center Center Clinical Trial Office (CTO). The study is expected to be monitored locally by the recipient DSMB. The overall study activities will be monitored by the University of Rochester Cancer CTO in collaboration with the recipient center.
Status | Finished |
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Effective start/end date | 4/1/20 → 3/31/22 |
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