Mobilization and Collection of Autologous Stem Cell for Transplantation (ASCT) for Plasma Cell Myeloma (PCM)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Average Number of Cluster of Differentiation 34 (CD34) Cells Collected (Per kg Recipient Body Weight (BW))
研究概览
简要总结
Background:
- One beneficial treatment for plasma cell myeloma is high-dose chemotherapy followed by stem cell transplant. Researchers want to collect stem cells from the blood for later transplant.
Objectives:
- To collect stem cells for transplant as part of treatment for plasma cell myeloma.
Eligibility:
- Individuals at least 18 years of age who will have chemotherapy and stem cell transplant for plasma cell myeloma.
Design:
- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected.
- Participants will have filgrastim injections for 5 days before collection. This will move stem cells from the bone marrow to the blood.
- Participants will have apheresis to collect the stem cells.
- Participants who need additional apheresis procedures to collect stem cells will have filgrastim and a dose of plerixafor to improve the collection yield.
详细描述
Background:
High-dose chemotherapy followed by autologous hematopoietic cell transplant (AHCT) remains a critical part of the Plasma Cell Myeloma (PCM) treatment in subjects eligible for the procedure. The timing of the procedure however, has become more controversial recently. This protocol will allow collection of Hematopoietic Progenitor Cells by Apheresis (HPC, Apheresis) in potential candidates for various PCM protocols at the Clinical Center.
The mobilizing agent plerixafor (Mozobil, Genzyme) has been recently approved by the Food and Drug Administration (FDA) for mobilization in PCM. However, the best and most cost effective strategy for its use remains to be defined.
Objectives:
Evaluate the overall validity of an HPC mobilization strategy (with granulocyte-colony stimulating factor (G-CSF) alone or in combination with plerixafor) using a formula calculating the likelihood of collecting greater than or equal to 5 time 10^6 cluster of differentiation 34 (CD34) plus cells/kg in a single mobilization cycle.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Hematopoietic Progenitor Cells (HPC)
Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.
干预措施: Filgrastim (Drug)
Hematopoietic Progenitor Cells (HPC)
Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.
干预措施: Plerixafor (Drug)
Hematopoietic Progenitor Cells (HPC)
Subjects will undergo mobilization and collection of HPC, Apheresis for subsequent use in various clinical protocols.
干预措施: Apheresis (Procedure)
结局指标
主要结局
Average Number of Cluster of Differentiation 34 (CD34) Cells Collected (Per kg Recipient Body Weight (BW))
时间窗: Through Day 2 of collection
Progenitor cells by apheresis was determined by flow cytometry.
Percentage of Patients Achieving at Least 2 x 10^6 Cluster of Differentiation 34 (CD34) Cells Per Kg Recipient Body Weight on Day 1 of Apheresis
时间窗: Day 1 of apheresis
Progenitor cells by apheresis was determined by flow cytometry. The stated goal was a minimum dose of 2x10EE\^6/kg following apheresis.
Percentage of Patients Requiring 2 Days to Achieve at Least 2 x 10^6 Cluster of Differentiation 34 (CD34) Cells Per Kg Recipient Body Weight
时间窗: Through Day 2 of collection
Progenitor cells by apheresis was determined by flow cytometry.
Median and Standard Deviation of Cluster of Differentiation 34 (CD34) Cells Collected (Per Kg Recipient Body Weight) (BW)
时间窗: Through Day 2 of collection
Progenitor cells by apheresis was determined by flow cytometry.
Range of Cluster of Differentiation 34 (CD34) Cells Collected
时间窗: Through Day 2 of collection
Progenitor cells by apheresis was determined by flow cytometry.
25th and 75th Percentile Values of Cluster of Differentiation 34 (CD34) Cells Collected
时间窗: Through Day 2 of collection
Progenitor cells by apheresis was determined by flow cytometry.
Number of Hematopoietic Progenitor Cell (HPC) Apheresis Products Collected and Cryopreserved for Subsequent Use in Autologous Hematopoietic Cell Transplantation (AHCT) in Subjects With Plasma Cell Myeloma (PCM)
时间窗: Indefinitely until a referring physician requests the product for standard clinical care or until product(s) is no longer needed and disposed of
The cryopreserved stem cells are stored under Good Manufacturing Practice (GMP) conditions in the National Institutes of Health (NIH) Department of Transfusion Medicine until a referring physician requests the products for standard clinical care.
次要结局
- Percentage of Patients That Achieved or Did Not Achieve 5 x 10^6 Cluster of Differentiation 34 (CD34) Cells/kg(Through Day 2 of collection)
- Percentage of Patients That Required Plerixafor + Granulocyte-colony Stimulating Factor (G-CSF) And Only G-CSF (no Plerixafor)(One week of mobilization therapy)
- Number of Participants With Serious and Non-Serious Adverse Events(27 months and 27 days)
- Percentage of Patients That Achieved ≥ 2 x 10^6 But Less Than 5 x 10^6 Cluster of Differentiation 34 (CD34) Cells/kg (Day One Collection)(Day one of collection)
- Degree of Tumor Cell Contamination in the Final Product(Day 1 of apheresis)
- Impact of Plerixafor in the Degree of Tumor Cell Contamination in the Final Product(Day 1 of apheresis)
研究者
Jennifer Kanakry, M.D.
Principal Investigator
National Cancer Institute (NCI)