Evaluation of the Spectra OptiaÂ® 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 OptiaÂ® 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 COBEÂ® 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

sites

Indiana University

425 University Blvd.
Indianapolis, Indiana 46202

(317) 274-4591