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

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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
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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Salt Lake City, UT
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Atlanta, GA
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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