A Randomized Phase II Trial of Fludarabine/Melphalan 140 VS. Fludarabine/Melphalan 100 Followed By Allogeneic Peripheral Blood Stem Cell or Bone Marrow Transplantation for Patients With Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Number of Participants With Successful Engraftment at Day 100
研究概览
简要总结
The goal of this clinical research study is to learn if there is a difference in transplant outcomes between two different doses of melphalan given in combination with fludarabine followed by transfusion of a related or unrelated volunteer donor's peripheral blood or bone marrow progenitor cells (allogeneic stem cell transplant) in patients with multiple myeloma. This study will also look at whether treatment with a antibody called rituximab against a specific type of lymphocyte (B cell) will reduce the risks of developing graft versus host disease after transplant. The safety of these treatments will also be compared.
详细描述
Fludarabine is a chemotherapy drug that is used in various diseases. Melphalan is a chemotherapy drug that has been widely used in the treatment of multiple myeloma for many years.
Before beginning therapy, patients will have a complete work-up. This includes a bone marrow aspiration and biopsy, bone survey, blood tests, and tests to check the heart and lung function. All patients will receive tacrolimus and methotrexate to prevent graft-versus-host disease.
Patients in this study will be randomly picked (as in the toss of a coin) to be in one of two treatment groups. There is an equal chance that a patient will be in either group.
Patients in the first group will receive fludarabine through the vein every day for four days. On the fourth day, patients will receive a dose of melphalan through the vein over 20 minutes. On the following day, patients will receive the donor cells as an infusion through their catheter.
Patients in the second group will receive fludarabine through the vein every day for four days. Patients in this group will receive a lower dose of melphalan through the vein over 20 minutes. After the last dose of fludarabine, patients will receive the donor cells as an infusion through their catheter the next day.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Multiple Myeloma in any of the following disease categories: a) Primary Refractory considered poor candidate for autologous transplant, b) Remission Consolidation in patients with Chromosome 13 abnormalities or plasma cell leukemia, c) All relapsing patients.
- •Age up to 70 years.
- •Related or unrelated donor who is HLA-compatible in at least 9/10 alleles (A,B, C, DRB1 and DQ) by molecular techniques.
- •Zubrod Performance Score (PS)<
- •Life expectancy is not severely limited by concomitant illness. Left ventricular ejection fraction >40%. No uncontrolled arrhythmias or symptomatic cardiac disease. Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and diffusing capacity of the lungs for carbon monoxide (DLCO) >40%.
- •Patient and donor or guardian willing and able to sign informed consent.
排除标准
- •Patients with active central nervous system (CNS) disease are ineligible for this study as documented by clinical symptoms and/or testing.
研究组 & 干预措施
Fludarabine + Melphalan + Stem Cell Infusion
Fludarabine 30 mg/m^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4).
Melphalan 140 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5.
干预措施: Melphalan (Drug)
Fludarabine + Melphalan + Stem Cell Infusion
Fludarabine 30 mg/m^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4).
Melphalan 140 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5.
干预措施: Fludarabine (Drug)
Fludarabine + Melphalan + Stem Cell Infusion
Fludarabine 30 mg/m^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4).
Melphalan 140 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5.
干预措施: Stem Cell Infusion (Procedure)
Fludarabine + Melphalan + Stem Cell Infusion
Fludarabine 30 mg/m^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4).
Melphalan 140 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5.
干预措施: Rituximab (Drug)
Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion
Fludarabine 30 mg/m^2 intravenous daily over 30 minutes for 4 Days (Beginning Day -4).
Lower-Dose Melphalan 100 mg/m^2 intravenous over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 intravenous infused starting on day -5.
干预措施: Melphalan (Drug)
Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion
Fludarabine 30 mg/m^2 intravenous daily over 30 minutes for 4 Days (Beginning Day -4).
Lower-Dose Melphalan 100 mg/m^2 intravenous over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 intravenous infused starting on day -5.
干预措施: Fludarabine (Drug)
Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion
Fludarabine 30 mg/m^2 intravenous daily over 30 minutes for 4 Days (Beginning Day -4).
Lower-Dose Melphalan 100 mg/m^2 intravenous over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 intravenous infused starting on day -5.
干预措施: Stem Cell Infusion (Procedure)
Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion
Fludarabine 30 mg/m^2 intravenous daily over 30 minutes for 4 Days (Beginning Day -4).
Lower-Dose Melphalan 100 mg/m^2 intravenous over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 intravenous infused starting on day -5.
干预措施: Rituximab (Drug)
结局指标
主要结局
Number of Participants With Successful Engraftment at Day 100
时间窗: Day 100
次要结局
- Acute Grade II-IV Graft Versus Host Disease (GVHD)(GVHD grading weekly during first 100 days; Annual examinations for nine year study period)