Ensayo Fase II de Trasplante autólogo de Sangre periférica en Pacientes Con Mieloma múltiple Tras Acondicionamiento Con Busulfan Intravenoso y Melfalan
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- The primary objective of this study is to analyze the safety profile and determine the overall response rate after ASCT with this conditioning regimen.
研究概览
简要总结
Analyze the results of ASCT using intravenous Busulfan and Melphalan as conditioning regimen for patients with Multiple Myeloma.
详细描述
Primary Efficacy and safety of the procedure in terms of number of remissions, survival, event-free survival, relapse risk, and early transplant-related mortality (up to day +100).
Secondary Graft kinetics (time to neutrophil and platelet recovery after ASCT) 2.Analyze the presence of transplant-related complications (infections, sinusoidal occlusive syndrome and others) 3.Analyze prognostic factors for engraftment, remission rate, relapse risk, disease-free and overall survival after ASCT
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Symptomatic multiple myeloma
- •Male or female subject age >= 70 years
- •The subject has received at least one previous line of therapy including:
- •Front-line treatment with VBMCP/VBAD or VAD or second-line therapy with regimens including bortezomib, thalidomide or lenalidomide
- •The subject has given voluntary written informed consent
排除标准
- •Use of bortezomib, thalidomide or lenalidomide as front-line therapy
- •ECOG satus >=2
- •Left ventricular ejection fraction <40%
- •DLCO and FVC <39% theoretical value
- •Abnormal liver function(total bilirubin > 2 mg/dL and/or ALT or AST > 3 x ULN)
- •Serum creatinine at transplant >1.6 mg/dL and/or creatinine clearance < 65 mL/minute
- •Subject has an active systemic infection requiring treatment
- •Subject had a myocardial infarction within 6 months of enrollment or has NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrythmias
- •Subject has any other serious medical condition (severe hepatic impairment, pericardial disease, acute diffuse infiltrative pulmonary disease) or psychiatric illness that could potentially interfere with the completion of treatment of this protocol
- •Subject is known to be immunodeficiency virus (HIV)-positive
- •Subject has received an experimental drug or used and experimental medical device within 4 weeks before enrollment
- •If female, the subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative pregnancy test at screening. Pregnancy testing is not required for postmenopausal or surgically sterilized women
研究组 & 干预措施
Intravenous busulfan and melphalan
干预措施: Intravenous busulfan and melphalan (Drug)
结局指标
主要结局
The primary objective of this study is to analyze the safety profile and determine the overall response rate after ASCT with this conditioning regimen.
时间窗: Within the first three months after transplant
次要结局
- Evaluate the complete response (CR) rate, the duration of the response, time to progression, event-free and overall survival(Up to 5 years after transplant)