Ex-Vivo Depletion of Myeloma Cells From Peripheral Blood Progenitor Cell Grafts
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Neutrophil Engraftment Rate
研究概览
简要总结
The goal of this clinical research study is to learn if cleaning the stem cells of a patient who has multiple myeloma (MM) with the bone marrow of a relative will make a cell product capable of replacing the bone marrow after standard treatment with chemotherapy.
详细描述
A transplant of one's own bone marrow stem cells is part of a standard treatment for MM. Because MM comes from the bone marrow, stem-cell products from the bone marrow can have tumor cells mixed in them when they are transplanted. This may cause the disease to return after transplant. This study will learn about a method of cleaning, or "purging," the MM tumor cells from the stem cells by using the bone marrow of a relative.
Study Drugs:
Melphalan is designed to damage the DNA (the genetic material) of cells, which may cause cancer cells to die.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will be given G-CSF twice a day through a needle under the skin on Days 1-5 to move stem cells from out of the bone marrow and into the blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with multiple myeloma who have relapsed after an autologous transplant or with a chemosensitive relapse more than one year post initial therapy
- •Age 18 to 75 years
- •Left ventricular ejection fraction >/= 40%. No uncontrolled arrhythmias
- •FEV1, FVC and DLCO >/= 40%. No symptomatic pulmonary disease
- •Serum bilirubin </= 2 x upper limit of normal, SGPT </= 4 x upper limit of normal
- •HIV-negative
- •Negative Beta HCG test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization
- •Patient or guardian able to sign informed consent
- •Marrow-MSC Donor Requirements: patients must have a family member who is matched at 2, 3, or 4 HLA antigens and willing to donate 80-100 ml or bone marrow for MSC generation
排除标准
- •International Staging System (ISS) stage I at diagnosis (beta-2 microglobulin < 3.5 mg/L and albumin >/= 3.5 g/dL)
- •Patients with an apheresis collection </= 7 x 10e6 CD34+/Kg
- •A fully matched related donor
研究组 & 干预措施
Stem Cell Collection + Transplantation
Apheresis: On Day 5, 3 hour process to separate blood (stem cells from other cells) done 1 time a day for 1-6 days, or until enough stem cells are collected. Stem cells are cultured with donated stem cells from a relative for two weeks before being returned via transplantation. Co-culture Stem Cell Infusion on Day 0. Melphalan 100 mg/m^2 IV over 30 minutes daily on Days -2 and -1.
干预措施: Apheresis (Procedure)
Stem Cell Collection + Transplantation
Apheresis: On Day 5, 3 hour process to separate blood (stem cells from other cells) done 1 time a day for 1-6 days, or until enough stem cells are collected. Stem cells are cultured with donated stem cells from a relative for two weeks before being returned via transplantation. Co-culture Stem Cell Infusion on Day 0. Melphalan 100 mg/m^2 IV over 30 minutes daily on Days -2 and -1.
干预措施: Stem Cell Transplantation (Procedure)
Stem Cell Collection + Transplantation
Apheresis: On Day 5, 3 hour process to separate blood (stem cells from other cells) done 1 time a day for 1-6 days, or until enough stem cells are collected. Stem cells are cultured with donated stem cells from a relative for two weeks before being returned via transplantation. Co-culture Stem Cell Infusion on Day 0. Melphalan 100 mg/m^2 IV over 30 minutes daily on Days -2 and -1.
干预措施: Melphalan (Drug)
结局指标
主要结局
Neutrophil Engraftment Rate
时间窗: 28 Days
次要结局
未报告次要终点