Evaluation of the Spectra Optia® Mononuclear Cell Collection Procedure

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.

Inclusion Criteria:

• Histologic confirmation of Multiple Myeloma
• Patients intended to be treated with myeloablative therapy and autologous hematopoetic stem-cell transplant within one month of stem-cell collection
• Patients whose stem-cell mobilization regimen includes G-CSF (granulocyte-colony stimulating factor)
• Males or non-pregnant females, who are 18 years of age or older
• Karnofsky score of ≥70%

Exclusion Criteria:

• Patients with pre-mobilization platelet count < 75,000/µL
• Patients who have received pelvic bone marrow irradiation as part of their conditioning therapy
• Patients who have had a previous hematopoetic stem-cell transplant
• Patients who have had a previous hematopoetic stem-cell collection failure
• Impaired cardiac function, as evidenced by left ventricular ejection fraction <40%.
• Impaired hepatic function, as evidenced by alanine transaminase >2.5 x normal
• Impaired pulmonary function as evidenced by diffusion capacity of the lung for carbon monoxide (adjusted for patient hematocrit, if indicated) or forced expiratory volume in 1 second <50% of predicted
• Impaired renal function, as evidenced by a creatinine clearance < 40 mL/min
• Impaired coagulation, as evidenced by a prothrombin time (PT) > twice normal
• Pregnancy or lactation
• Seropositivity for Human Immunodeficiency Virus-1/2, Hepatitis B Virus, or Hepatitis C Virus
• Documented bacterial or fungal infection that requires intravenous antibiotics to be started or continued while undergoing apheresis collection on the Spectra Optia device
• Subjects enrolled in study protocols that could affect number of CD34+ cells (pluripoten hematopoetic stem stells) collected or kinetics of neutrophil recovery
• Altered mental status, as evidenced by the inability to provide effective informed consent