Evaluation of the Spectra Optia® Apheresis System Mononuclear Cell (MNC) Collection Procedure in Multiple Myeloma Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 8
- 主要终点
- Days Until Neutrophil Recovery Following Peripheral Blood Stem Cell Transplant Minus the Historical Median Day Until Recovery.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%
排除标准
- •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
结局指标
主要结局
Days Until Neutrophil Recovery Following Peripheral Blood Stem Cell Transplant Minus the Historical Median Day Until Recovery.
时间窗: up to 28 days following transplant
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.
次要结局
- Days Until Platelet Recovery(up to 28 days following transplant)
- CD34+ Cell Collection Efficiency.(up to 7 days)
- Mononuclear Cel (MNC) Collection Efficiency(up to 7 days)
- Platelet Collection Efficiency(up to 7 days)
- Hematocrit of MNC Product(7 days)
- Granulocyte % of MNC Product(7 days)