A Prospective Randomized Controlled Study of Helical Tomotherapy for Pre-transplantation Pretreatment of Autologous Hematopoietic Stem Cells in Multiple Myeloma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Complete response rate and above 100 days after transplantation (≥ CR rate)
研究概览
简要总结
To explore the safety and efficacy of systemic radiotherapy (TBI) combined with melphalan (Mel) for pretreatment of autologous hematopoietic stem cells in multiple myeloma.
详细描述
This study is a single-center, prospective clinical study targeting myeloma patients requiring transplantation, and investigating the efficacy and safety of TBI combined with Mel regimen for transplant pretreatment. Subjects who meet the enrollment criteria were screened to enter the study and receive the corresponding regimen treatment.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Multiple myeloma patients receiving induction therapy and stem cell mobilization preparation for autologous transplantation;
- •Should agree to comply with all contraceptive requirements; 3, ECOG≤2;
- •Total bilirubin, ALT and AST <2×UNL (upper limit of normal), BUN < 30 mg/dL;
- •At least 2 x 10^6 CD34+ cells /kg were collected; 6.absolute neutrophil count >1000/uL and a platelet count of >100,000/uL;
- •The expected survival time is more than 3 months;
- •Written informed consent was obtained from the patients or their immediate family members.
排除标准
- •Any of the following was an exclusion criterion:
- •According to the investigator's judgment, patients who cannot tolerate melphalan and radiotherapy;
- •Patients with known active hepatitis B virus (HBV) or hepatitis C virus (HCV), or seropositive for human immunodeficiency virus (HIV);
- •patients with uncontrolled or severe cardiovascular disease
- •According to the protocol or the investigator's judgment, the patient has a serious physical or mental illness
结局指标
主要结局
Complete response rate and above 100 days after transplantation (≥ CR rate)
时间窗: through study completion, an average of 1 year
Complete response rate and above 100 days after transplantation (≥ CR rate)
次要结局
- 1-year Progression-free Survival rate(1 year)
研究者
Fuling Zhou
Chief physician
Zhongnan Hospital