WCI1680-09: Evaluation of Alterations in Time of Administration of Plerixafor (Mozobil ®, AMD3100) in Combination With G-CSF on Safety and CD34+ Cell Mobilization
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Number of Patients Who Collected ≥ 6 x 10^6 CD34+ Cells by Day 5 (4 Apheresis Sessions) With Plerixafor Administration at 1500.
研究概览
简要总结
Typically, the collection of blood cells for autologous stem cell transplant is done after the drugs granulocyte colony-stimulating factor (G-CSF) and plerixafor have been given to activate the bone marrow stem cells to produce a certain type of blood cell, called CD34+ cells. Currently, plerixafor is given in the evening, about 11 hours before apheresis (removal of blood) begins the following morning. The purpose of this study is to test whether plerixafor can instead be given 17 hours before apheresis. This timing would be more convenient since plerixafor would be given during normal clinic hours, and so patients would be within a clinic environment if any side effects develop.
The study will look for the activation of CD34+ cells in patients who receive plerixafor 17 hours before apheresis. We will follow the number of patients that achieve the target numbers of CD34+ cells, and the total number of CD34+ cells collected. These will be compared to the numbers in previous studies giving plerixafor 11 hours before apheresis.
We will also assess the safety of giving plerixafor 17 hours before apheresis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Age 18-70 years
- •MM patients in first or second complete or partial remission
- •ECOG performance status of 0 or 1
- •Up to 3 prior treatment regimens
- •Meet all eligibility requirements for autologous transplant
- •Adequate marrow function defined as WBC >3,000; ANC >1,500/mm3 ; Platelets >75,000/mm3
- •Adequate renal function defined as creatinine clearance > 30 mL/min by Cockcroft-Gault
- •Adequate liver function defined as AST/ALT/Bilirubin < 2 times upper limit of normal
- •Able to provide informed consent
- •Women not pregnant and agree to use contraception
排除标准
- •High risk co-morbidities for acute treatment complications (e.g., symptomatic coronary artery disease)
- •Brain metastases or carcinomatous meningitis
- •Previous treatment with high dose chemotherapy and autologous transplant.
- •Previous attempt to collect B-HPCs following mobilization with growth factors alone, growth factors and chemotherapy, or plerixafor and growth factors.
- •Acute infection or unexplained fever >38°C
- •Weight > 175% of ideal body weight as defined by the Devine equation.
- •Experimental therapy within 4 weeks
- •Cytokine administration in the previous 14 days
研究组 & 干预措施
Plerixafor 17 hours prior to apheresis
Dosing of plerixafor will occur at 3PM (1500 hours).
干预措施: Plerixafor (Drug)
结局指标
主要结局
Number of Patients Who Collected ≥ 6 x 10^6 CD34+ Cells by Day 5 (4 Apheresis Sessions) With Plerixafor Administration at 1500.
时间窗: Within the first 5 days following plerixafor initiation
次要结局
- Number of Patients Who on Day 1 Collected > 10 x 10^6 CD34+ Cells/kg Following Plerixafor Dosing at 1500 Hrs(Within the first 5 days following plerixafor initiation)
研究者
R. Donald Harvey, PharmD
Principal Investigator
Emory University