Mobilization of Stem Cells With AMD3100 (Plerixafor) in Multiple Myeloma Patients
2014年2月10日 更新者：Genzyme, a Sanofi Company
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Comparative Trial of AMD3100 Plus G-CSF Versus G-CSF Plus Placebo to Mobilize and Collect ≥ 6*10^6 CD34+ Cells/kg in Multiple Myeloma Patients for Autologous Transplantation
The purpose of this study is to determine whether the combination of AMD3100 (plerixafor) and granulocyte colony-stimulating factor (G-CSF, generic name of filgrastim) is better than G-CSF alone to mobilize and collect the optimal number of stem cells in multiple myeloma patients for autologous transplantation.
研究概览
地位
完全的
条件
详细说明
A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Currently filgrastim (G-CSF), a colony stimulating factor, is used to cause the growth and mobilization of stem cells from bone marrow to peripheral blood, which can then be collected from the peripheral blood by a process called apheresis. Plerixafor aids in the release of the stem cells from the bone marrow into the peripheral blood, possibly allowing for a more rapid collection of a larger number of stem cells from the peripheral blood. Larger stem cell doses for transplantation correlate to faster recovery times after high dose chemotherapy followed with stem cell transplantation. This study is intended to determine whether the combination of plerixafor with filgrastim (G-CSF)is better than filgrastim (G-CSF) alone in helping multiple myeloma patients collect at least 6 million stem cells in two or less apheresis sessions.
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
介入性
注册 (实际的)
302
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
British Columbia
-
Vancouver、British Columbia、加拿大、V5Z 1M9
- Vancouver General Hospital
-
-
-
-
-
Heidelberg、德国、69120
- Universitätsklinikum Heidelberg,
-
-
-
-
Arizona
-
Phoenix、Arizona、美国、85006
- City of Hope Samaritan Bone Marrow Transplant Program
-
-
Arkansas
-
Little Rock、Arkansas、美国、72205
- Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences
-
-
California
-
Duarte、California、美国、91010
- City of Hope National Medical Center
-
Los Angeles、California、美国、90048
- Cedars-Sinai
-
Los Angeles、California、美国、90095
- University of California
-
-
Colorado
-
Denver、Colorado、美国、80218
- Rocky Mountain Cancer Center
-
-
Connecticut
-
New Haven、Connecticut、美国、06520
- Yale University School of Medicine
-
-
Florida
-
Gainesville、Florida、美国、32611
- University of Florida
-
Tampa、Florida、美国、33612
- H. Lee Moffitt Cancer Center and Research Institute
-
-
Georgia
-
Atlanta、Georgia、美国、30322
- Emory University
-
-
Illinois
-
Maywood、Illinois、美国、60153
- Loyola University Medical Center
-
-
Indiana
-
Beech Grove、Indiana、美国、46107
- Indiana Blood and Marrow Transplantation Center
-
-
Iowa
-
Iowa City、Iowa、美国、52242
- University of Iowa Hosptials and Clinics
-
-
Minnesota
-
Minneapolis、Minnesota、美国、55455
- Fairview-University Medical Center, University of Minnesota
-
Rochester、Minnesota、美国、55905
- Mayo Clinic
-
-
Missouri
-
Kansas City、Missouri、美国、64111
- Kansas City Cancer Center
-
Saint Louis、Missouri、美国、63110
- Washington University School of Medicine, Division of Bone Marrow Transplantation and Leukemia
-
-
New Jersey
-
Hackensack、New Jersey、美国、07601
- The Cancer Center at Hackensack University Medical Center
-
-
New York
-
Buffalo、New York、美国、14263
- Roswell Park Cancer Institute
-
New York、New York、美国、10011
- St. Vincent's Comprehensive Cancer Center
-
New York、New York、美国、10065
- Memorial Sloan Kettering
-
New York、New York、美国、10032
- New York Hospital
-
Rochester、New York、美国、14642
- University of Rochester Medical Center
-
-
North Carolina
-
Durham、North Carolina、美国、27705
- Duke University Medical Center
-
-
Ohio
-
Cleveland、Ohio、美国、44106
- Case Western Reserve University
-
Cleveland、Ohio、美国、44195
- Cleveland Clinic Foundation
-
Columbus、Ohio、美国、43210
- Ohio State University
-
-
Oregon
-
Portland、Oregon、美国、97239
- Oregon Health & Science University
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、美国、19104
- Hospital of the University of Pennsylvania
-
Philadelphia、Pennsylvania、美国、19107
- Thomas Jefferson University
-
-
Texas
-
Houston、Texas、美国、77030
- The University of Texas MD Anderson Cancer Center
-
Lackland AFB、Texas、美国、78236
- Wilford Hall Medical Center
-
San Antonio、Texas、美国、78229
- Texas Transplant Institute
-
San Antonio、Texas、美国、78229
- University of Texas Health Science Center
-
-
Utah
-
Salt Lake City、Utah、美国、84132
- Utah Blood and Marrow Transplant Program, University of Utah
-
-
Virginia
-
Richmond、Virginia、美国、23298
- Virginia Commonwealth University
-
-
Washington
-
Seattle、Washington、美国、98109
- Fred Hutchinson Cancer Research Center
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 78年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Diagnosis of multiple myeloma in first or second complete or partial remission
- >= 4 weeks since last cycle of chemotherapy (thalidomide, dexamethasone, and Velcade were not considered prior chemotherapy for the purpose of this study)
- Recovered from all acute toxic effects of prior chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- White Blood Cell count (WBC) > 2.5*10^9/L
- Absolute polymorphonuclear leukocytes (PMN) count > 1.5*10^9/L
- Platelet (PLT) > 100*10^9/L
- Serum creatinine <=2.2 mg/dL
- Cardiac and pulmonary status sufficient to undergo apheresis and transplantation
- Negative for HIV
Exclusion Criteria):
- Failed previous stem cell collection
- Previous stem cell transplantation
- Brain metastases or myelomatous meningitis
- Radiation to ≥ 50% of the pelvis
- Abnormal electrocardiogram (ECG) with rhythm disturbance (ventricular arrhythmias) or other conduction abnormality
- Received bone-seeking radionuclides (e.g. holmium)
- A residual acute medical condition resulting from prior chemotherapy
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：G-CSF加plerixafor
|
Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection.
On the evening of Day 4, participants received plerixafor (240 µg/kg), administered by SC injection.
On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx.
10 to 11 hours after the dose of plerixafor (within 60 minutes of G-CSF administration).
Participants continued to receive an evening dose of plerixafor followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.
其他名称：
|
|
安慰剂比较：G-CSF加安慰剂
|
Participants underwent mobilization with granulocyte colony-stimulating factor (G-CSF) (10 µg/kg/day) for 4 days, administered by subcutaneous (SC) injection.
On the evening of Day 4, participants received placebo, administered by SC injection.
On Day 5, participants received a morning dose of G-CSF (10 µg/kg) and underwent apheresis approx.
10 to 11 hours after the dose of placebo (within 60 minutes of G-CSF administration).
Participants continued to receive an evening dose of placebo followed by a morning dose of G-CSF and apheresis for up to 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
Participants who participated in the rescue procedure underwent an additional daily treatment with plerixafor (240 µg/kg) and apheresis for up to 4 days.
|
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 |
|---|---|---|
|
Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 2 or Fewer Days of Apheresis.
大体时间：up to Day 6
|
Proportion of participants achieving a target of ≥ 6*10^6 CD34+ cells/kg in 2 or fewer days of apheresis.
Central lab data were taken from Days 5 to 6 of the Treatment/Apheresis period.
Each participant's value was calculated as the sum of all daily values collected over the 2 apheresis days.
|
up to Day 6
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
出现不良事件的参与者人数
大体时间：至第 38 天
|
发生治疗紧急不良事件 (AE) 的参与者人数。
治疗紧急 AE 的时间范围定义为第 1 天（G-CSF 动员开始）至开始化疗前一天（约 38 天后）。
无论与研究治疗的关系如何，均报告了 AE。
研究人员使用世界卫生组织 (WHO) 不良事件分级量表对每个 AE 进行分级。
3 级 AE 被认为是严重的，4 级被认为是危及生命的。
|
至第 38 天
|
|
Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 4 or Fewer Days of Apheresis.
大体时间：up to Day 8
|
Proportion of participants achieving a target of ≥ 6*10^6 CD34+ cells/kg in 4 or fewer days of apheresis.
Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period.
Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.
|
up to Day 8
|
|
Proportion of Participants Achieving a Target of ≥ 2*10^6 CD34+ Cells/kg in 4 or Fewer Days of Apheresis.
大体时间：up to Day 8
|
Proportion of participants achieving a target of ≥ 2*10^6 CD34+ cells/kg in 4 or fewer days of apheresis.
Central lab data were taken from Days 5 to 8 of the Treatment/Apheresis period.
Each participant's value was calculated as the sum of all daily values collected over the 4 apheresis days.
|
up to Day 8
|
|
Median Number of Days to ≥6*10^6 CD34+ Cells/kg
大体时间：up to Day 8
|
The Kaplan Meier estimate of median number of days (number of days at which 50% of participants have experienced the event, accounting for censored values) in each treatment arm to collect an optimum number of cells (≥6*10^6 CD34+ cells/kg) for transplantation.
|
up to Day 8
|
|
Median Number of Days to Polymorphonuclear (PMN) Cell Engraftment
大体时间：Up to Month 13
|
The Kaplan Meier estimate of median number of days to PMN engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint.
Engraftment was defined as PMN counts ≥ 0.5*10^9/L for 3 consecutive days or ≥ 1.0*10^9/L for 1 day.
Time to engraftment corresponded to the first day that the criteria were met and was evaluated up to 12 months post transplant.
|
Up to Month 13
|
|
Median Number of Days to Platelet (PLT) Engraftment
大体时间：Up to Month 13
|
The Kaplan Meier estimate of median number of days to PLT engraftment (number of days at which 50% of participants have experienced the event, accounting for censored values) was a secondary efficacy endpoint.
Engraftment was defined as ≥ 20*10^9/L without transfusion for the preceding 7 days.
Time to engraftment corresponded to the first day that the criteria were met and was evaluated up to 12 months post transplant.
|
Up to Month 13
|
|
Graft Durability at 100 Days Post Transplantation
大体时间：approximately Day 138
|
The proportion of participants maintaining a durable graft at 100 days post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.
|
approximately Day 138
|
|
Graft Durability at 6 Months Post Transplantation
大体时间：approximately Month 7
|
The proportion of participants maintaining a durable graft at 6 months post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.
|
approximately Month 7
|
|
Graft Durability at 12 Months Post Transplantation
大体时间：approximately Month 13
|
The proportion of participants maintaining a durable graft at 12 months post-transplantation by at least 2 of the following criteria (without erythropoietin (EPO), G-CSF, or transfusions): (1) a platelet count >50000/µL without transfusion for at least 2 weeks, (2) hemoglobin >=10g/dL for at least 1 month, (3) and absolute neutrophil count >1000/µL for at least 1 week.
|
approximately Month 13
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2005年1月1日
初级完成 (实际的)
2006年10月1日
研究完成 (实际的)
2008年1月1日
研究注册日期
首次提交
2005年2月11日
首先提交符合 QC 标准的
2005年2月11日
首次发布 (估计)
2005年2月14日
研究记录更新
最后更新发布 (估计)
2014年3月13日
上次提交的符合 QC 标准的更新
2014年2月10日
最后验证
2014年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.