title: Evaluation of the spectra Optia® mononuclear cell collection procedure in multiple myeloma patients.
abstract: BACKGROUND
  Peripheral blood stem cell (PBSC) rescue following myeloablative therapy is a mainstay of cancer therapy. To evaluate the ability of the Spectra Optia Apheresis System (SO), a newly developed apheresis device, the device was studied in multiple myeloma patients undergoing a first autologous PBSC transplant.
  
  
  OBJECTIVE
  To demonstrate that neutrophil recovery was not inferior to historical controls when SO harvested PBSCs were reinfused following myeloablative therapy.
  
  
  METHODS
  Multiple myeloma patients were mobilized according to the standard practice at four clinical sites. Following mobilization, MNC collections were performed on the SO. The collected cells were cryopreserved and reinfused following myeloablative chemotherapy. Neutrophil recovery defined by an absolute neutrophil count exceeding 500/μL (ANC500) was compared to historical data for patients transplanted following apheresis using the COBE Spectra (CS) device.
  
  
  RESULTS
  The median day to neutrophil recovery was 12 days (range 10-14 days), with no significant difference in engraftment comparing patients transplanted with stem cells collected using the SO versus historical cohort of patients collected with the CS. CD34+ cell and MNC collection efficiency (CE) were 69.3% and 65.0% for the SO and CS, respectively. Platelet CE, product hematocrit and product granulocytes (as % of WBCs) using the SO were 21%, 2.3% and 28%, respectively. There were no device-related severe adverse events.
  
  
  CONCLUSIONS
  The study's results confirm that the Spectra Optia Apheresis System's MNC Collection Protocol is safe and effective for its intended use and that engraftment kinetics of cells collected by SO is not inferior to the CS System.
authors.affiliation: Department of Medicine, Division of Cellular Therapy, Duke University School of Medicine, Durham, North Carolina.
authors.forename: Gwynn
authors.initials: G
authors.lastname: Long
authors.forename: Edmund K
authors.initials: EK
authors.lastname: Waller
authors.forename: Steven
authors.initials: S
authors.lastname: Gregurek
authors.forename: Guido
authors.initials: G
authors.lastname: Tricot
authors.forename: Susanne
authors.initials: S
authors.lastname: Marschner
authors.forename: Jerry
authors.initials: J
authors.lastname: Bill
mesh_terms: D000368:Aged; D005260:Female; D019650:Hematopoietic Stem Cell Mobilization; D006801:Humans; D007937:Leukapheresis / Q000295:instrumentation*; D007958:Leukocyte Count; D007963:Leukocytes, Mononuclear / Q000637:transplantation; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000097:blood* / Q000628:therapy*; D019653:Myeloablative Agonists / Q000627:therapeutic use; D009504:Neutrophils; D061214:Patient Safety; D036102:Peripheral Blood Stem Cell Transplantation; D014182:Transplantation, Autologous; D016896:Treatment Outcome
chemical_list: D019653:Myeloablative Agonists
keywords: apheresis; autologous transplantation; mononuclear cell collection; neutrophil recovery; peripheral blood stem-cell transplant