A Randomized Trial to Compare Busulfan + Melphalan 140 mg/m2 With Melphalan 200 mg/m2 as Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 205
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
The goal of this clinical research study is to compare Busulfex (busulfan) with or without Alkeran (melphalan) to learn which study therapy may be better at helping to control MM in patients who will receive an autologous stem cell transplant. The safety of this combination therapy will also be studied.
Melphalan and busulfan are designed to damage the DNA (genetic material) of cells, which may cause cancer cells to die.
详细描述
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups.
- Group 1 will receive melphalan and busulfan.
- Group 2 will receive melphalan.
Both groups will have a stem cell transplant.
Study Drug Administration:
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 complete remission (CR), partial remission (PR), or very good partial remission (VGPR), or symptomatic stable disease (no evidence of progression) including patients with light chain MM detected in the serum by free light chain assay.
- •Patients with non-secretory multiple myeloma [absence of a monoclonal protein (M protein) in serum as measured by electrophoresis (SPEP) and immunofixation (SIFE) and the absence of Bence Jones protein in the urine (UPEP) defined by use of conventional electrophoresis and immunofixation (UIFE) techniques] but with measurable disease on imaging studies like MRI, CT scan or PET scan.
- •Who have received at least two cycles of initial systemic therapy and are within 2 to 12 months of the first dose. Mobilization therapy is not considered initial therapy.
- •70 years of age or younger.
- •Karnofsky performance score 70% or higher.
- •Cardiac function: left ventricular ejection fraction at rest > 40% within 3 months of registration.
- •Hepatic function: bilirubin < 2x the upper limit of normal and ALT and AST < 2.5x the upper limit of normal.
- •Renal function: creatinine clearance of >/= 40 mL/min, estimated or calculated.
- •Pulmonary function: DLCO, FEV1, FVC >/= 50% of predicted value (corrected for hemoglobin) within 3 months of registration
- •Signed informed consent form.
排除标准
- •Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and progression of clinical symptoms).
- •Patients seropositive for the human immunodeficiency virus (HIV).
- •Patients with history of myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- •Patients participating in an investigational new drug protocol within 14 days before enrollment.
- •Female patients who are pregnant (positive b-HCG) or breastfeeding.
- •Prior stem cell transplantation allogeneic or autologous.
- •Prior organ transplant requiring immunosuppressive therapy.
研究组 & 干预措施
Busulfan + Melphalan
Busulfan test dose (32 mg/m^2) on day -9 then 130 mg/m^2 intravenous (IV) Days -7, -6, -5, and -4 + Melphalan 70 mg/m2 IV on Days -2 and -1. Stem Cell Transplant (SCT) Day 0.
干预措施: Questionnaire (Other)
Busulfan + Melphalan
Busulfan test dose (32 mg/m^2) on day -9 then 130 mg/m^2 intravenous (IV) Days -7, -6, -5, and -4 + Melphalan 70 mg/m2 IV on Days -2 and -1. Stem Cell Transplant (SCT) Day 0.
干预措施: G-CSF (Drug)
Busulfan + Melphalan
Busulfan test dose (32 mg/m^2) on day -9 then 130 mg/m^2 intravenous (IV) Days -7, -6, -5, and -4 + Melphalan 70 mg/m2 IV on Days -2 and -1. Stem Cell Transplant (SCT) Day 0.
干预措施: Busulfan (Drug)
Busulfan + Melphalan
Busulfan test dose (32 mg/m^2) on day -9 then 130 mg/m^2 intravenous (IV) Days -7, -6, -5, and -4 + Melphalan 70 mg/m2 IV on Days -2 and -1. Stem Cell Transplant (SCT) Day 0.
干预措施: Melphalan (Drug)
Busulfan + Melphalan
Busulfan test dose (32 mg/m^2) on day -9 then 130 mg/m^2 intravenous (IV) Days -7, -6, -5, and -4 + Melphalan 70 mg/m2 IV on Days -2 and -1. Stem Cell Transplant (SCT) Day 0.
干预措施: Stem cell transplant (Procedure)
Melphalan
High-dose Melphalan 200 mg/m2/day IV over 30 minutes on day -2. SCT Day 0.
干预措施: Questionnaire (Other)
Melphalan
High-dose Melphalan 200 mg/m2/day IV over 30 minutes on day -2. SCT Day 0.
干预措施: G-CSF (Drug)
Melphalan
High-dose Melphalan 200 mg/m2/day IV over 30 minutes on day -2. SCT Day 0.
干预措施: High Dose Melphalan (Drug)
Melphalan
High-dose Melphalan 200 mg/m2/day IV over 30 minutes on day -2. SCT Day 0.
干预措施: Stem cell transplant (Procedure)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: 3 years after transplant
Participants that are still alive and without Multiple Myeloma 3 years after Stem cell Transplantation.
次要结局
- Number of Participants With Complete Response (CR)(Evaluated 90 days from transplant.)
- Treatment-Related Mortality (TRM) Between 2 Arms.(100 days post treatment)
- Number of Participants That Had Grade 3-4 Toxicities.(At day 90 post SCT (Stem Cell Transplantation))
- Overall Survival (OS)(From time of ASCT to 3 years)