Evaluation of the Spectra Optia® Apheresis System Mononuclear Cell (MNC) Collection Procedure in Multiple Myeloma Patients
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Days Until Neutrophil Recovery Following Peripheral Blood Stem Cell Transplant Minus the Historical Median Day Until Recovery.
Neutrophil recovery is defined as the day on which the peripheral blood absolute neutrophil count exceeds 500/μL (ANC500)for the first of three consecutive measurements obtained on different days following transplant of peripheral blood stem cells in patients treated with myeloablative therapy for their underlying disease. As this was a test of non-inferiority, the null hypothesis to be tested (H0) was that the difference between the observed day to neutrophil recovery and the historical median day of neutrophil recovery was greater than two days. At two of the enrolling sites, Duke and Emory Universities, the median day to ANC500 was 12, while at the other two sites, Indiana University and the University of Utah, it was 11 days. Consequently, in the equation below, site specific-historic medians were compared to the observed days to achieve ANC500. H0: D > /2/, where D = Observed median day of neutrophil recovery - Site specific historic median day of neutrophil recovery.
up to 28 days following transplant
Yes
Jerry R Bill, MD
Study Director
Terumo BCT
United States: Food and Drug Administration
BCT10-02
NCT01292486
February 2011
December 2011
Name | Location |
---|---|
University of Utah | Salt Lake City, Utah |
Duke University Medical Center | Durham, North Carolina 27710 |
Emory University | Atlanta, Georgia 30322 |
Indiana University | Indianapolis, Indiana 46202 |