Mobilization of Stem Cells With Plerixafor, Chemotherapy and G-CSF in Multiple Myeloma or Non-Hodgkin's Lymphoma Patients
Treatment With Plerixafor in Multiple Myeloma or Non-Hodgkin's Lymphoma Patients to Increase the Number of Peripheral Blood Stem Cells When Given With A Mobilizing Regimen of Chemotherapy and G-CSF
研究概览
详细说明
An open label, multi-center, phase 2 study was conducted in patients with MM or NHL who were to be treated with peripheral blood stem cells (PBSC) autologous transplantation. The only change to the standard of care was the addition of plerixafor to a mobilization regimen of chemotherapy and G-CSF. Patients were first given a mobilizing regimen of chemotherapy as per local practice guidelines and G-CSF (at customary doses) and apheresis was performed. After the first apheresis, plerixafor was given at 10PM, 10-11 hours before the second apheresis the next day or in the morning of the second day, 6 hours before the second apheresis. The change in the patient's peripheral CD34+ cell count between the plerixafor dose and the start of apheresis was measured. The apheresis yields on Day 1 and Day 2 were compared.
This study was previously posted by AnorMED, Inc. In November 2006, AnorMED, Inc. was acquired by Genzyme Corporation. Genzyme Corporation is the sponsor of the trial.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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California
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Duarte、California、美国
- City of Hope National Medical Center
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Indiana
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Beech Grove、Indiana、美国
- Indiana Blood and Marrow Transplantation
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New York
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Rochester、New York、美国
- University of Rochester Medical Center
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Oregon
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Portland、Oregon、美国
- Oregon Health and Science University
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Washington
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Seattle、Washington、美国
- Fred Hutchinson Cancer Research Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria (Abbreviated List):
- MM in first partial response/complete response, first relapse, or second partial/complete response
- NHL in first or second partial or complete remission
- NHL patients who do not have bone marrow involvement and < 10% for follicular involvement
- MM patients who have stable disease with < 40% bone marrow involvement
- No more than three prior regimens of chemotherapy (thalidomide and Decadron are not considered chemotherapy)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- White blood cell count (WBC) >3.0 x 10^9/L
- Absolute neutrophil count >1.5 x 10^9/L
- Platelet count >100 x 10^9/L
Exclusion Criteria (Abbreviated List):
- Brain metastases or carcinomatous meningitis
- Hypercalcaemia [>1 mg/dl above the upper limit of normal (ULN)]
- Cardiovascular disease that includes proven or predisposition to ventricular arrhythmias
- Acute Infection
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Plerixafor PM
Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days. Called 'Cohort A' in protocol, study report and publications. |
G-CSF and plerixafor were administered as described in the treatment arms.
其他名称:
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实验性的:Plerixafor AM
Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days. Called 'Cohort B' in protocol, study report and publications. |
G-CSF and plerixafor were administered as described in the treatment arms.
其他名称:
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实验性的:Low CD34+ Count/ Plerixafor PM
Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of >=10 cells/µL but <20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was administered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days. Called 'Cohort C' in protocol, study report and publications. |
G-CSF and plerixafor were administered as described in the treatment arms.
其他名称:
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实验性的:Plerixafor After Chemo
This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery. Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms. Called 'Investigational Cohort' in protocol, study report and publications. |
G-CSF and plerixafor were administered as described in the treatment arms.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Overall Participant Counts of Adverse Events (AEs) Up to Twelve Months Post Transplant
大体时间:13 months
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Safety assessment was based on the incidence of adverse event reports.
Participant count of AEs (Adverse Events) by severity and by relationship to study drug.
AEs were reported regardless of relationship to study treatment.
The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale and provided assessments of seriousness and relatedness to study treatment.
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13 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
参与者在外周血干细胞 (PBSC) 移植后第 12 天但不晚于第 21 天实现多形核白细胞 (PMN) 植入的移植次数
大体时间:2个月
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根据当地护理标准,监测参与者的多形核白细胞 (PMN) 移植情况。
植入的目标是在 PBSC 移植后 12 天,没有移植物植入需要超过 21 天。
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2个月
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Fold (i.e., Relative) Increase in Peripheral Blood (PB) CD34+ Cells/µL
大体时间:Days 4-5 (first dose of plerixafor to apheresis)
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The fold increase was measured by fluorescence activated cell sorting (FACS) analysis and was expressed as a ratio.
Fold increase = (pre-apheresis PB CD34+ cells/µL)/(pre-plerixafor dosing PB CD34+ cells/µL).
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Days 4-5 (first dose of plerixafor to apheresis)
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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淋巴瘤,非霍奇金的临床试验
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Rutgers, The State University of New Jersey完全的
G-CSF and plerixafor的临床试验
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Genzyme, a Sanofi Company终止
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Genzyme, a Sanofi Company完全的
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GPCR Therapeutics, Inc.完全的
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Centre for Endocrinology and Reproductive Medicine...未知