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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 302
- 试验地点
- 39
- 主要终点
- Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 2 or Fewer Days of Apheresis.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
G-CSF plus plerixafor
干预措施: Granulocyte colony-stimulating factor plus plerixafor (Drug)
G-CSF plus placebo
干预措施: Granulocyte colony-stimulating factor plus placebo (Drug)
结局指标
主要结局
Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 2 or Fewer Days of Apheresis.
时间窗: 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.
次要结局
- Number of Participants With Adverse Events(up to Day 38)
- Median Number of Days to ≥6*10^6 CD34+ Cells/kg(up to Day 8)
- Proportion of Participants Achieving a Target of ≥ 6*10^6 CD34+ Cells/kg in 4 or Fewer Days of Apheresis.(up to Day 8)
- Proportion of Participants Achieving a Target of ≥ 2*10^6 CD34+ Cells/kg in 4 or Fewer Days of Apheresis.(up to Day 8)
- Graft Durability at 6 Months Post Transplantation(approximately Month 7)
- Median Number of Days to Platelet (PLT) Engraftment(Up to Month 13)
- Graft Durability at 12 Months Post Transplantation(approximately Month 13)
- Graft Durability at 100 Days Post Transplantation(approximately Day 138)
- Median Number of Days to Polymorphonuclear (PMN) Cell Engraftment(Up to Month 13)