Evaluation of the Spectra Optia® Mononuclear Cell Collection Procedure
| Status: | Archived |
|---|---|
| Conditions: | Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | February 2011 |
| End Date: | August 2011 |
Evaluation of the Spectra Optia® Apheresis System Mononuclear Cell (MNC) Collection Procedure in Multiple Myeloma Patients
The purpose of this investigation is to establish that hematopoetic stem cells collected on
a new centrifugal blood separator, CaridianBCT's Spectra Optia Apheresis System, are able to
reconstitute the hematopoetic systems of patients treated with myeloablative therapy,
equivalent to hematopoetic cells harvested on the predicate COBE® Spectra platform.
This is a multi-center (3-5) single-arm study that will compare the performance of the
Spectra Optia Apheresis System's MNC protocol to that of the historical performance of the
COBE Spectra MNC protocol. In order to demonstrate the substantial equivalence of the two
devices, a non-inferiority design will be used. The study will enroll patients with multiple
myeloma who are to be treated with myeloablative chemotherapy, followed by bone-marrow
rescue with an autologous peripheral blood stem-cell transplant. Peripheral blood stem cells
will be collected using the Spectra Optia MNC protocol and re-infused following
myeloablative chemotherapy.
We found this trial at
5
sites
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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University of Utah Research is a major component in the life of the U benefiting...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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