A Prospective, Multi-center, Randomized Controlled Trial of Microtransplantation Versus Auto-SCT in ≥PR Multiple Myeloma Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
Comparison of the efficacy and safety of microtransplantation and autologous transplantation in the treatment of ≥PR multiple myeloma patients, 2-year PFS and OS were also been observed. To identify the role of microtransplantation in the treatment of multiple myeloma.
详细描述
NDMM patients induction therapy with 4 cycles PCD/PAD regimen, achieve ≥PR, eligible for SCT, were randomly divided into two arms. One arm receive microtransplantation, and the other accept auto-SCT. Comparison of the efficacy and safety of two arms, 2-year PFS and OS were also been observed. Clear the above program related hematopoietic recovery, remission rate, infection and recurrence rate, survival rate and the formation of micro inlay, minimal residual disease and GVHD, etc. To identify the role of microtransplantation in the treatment of multiple myeloma.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis MM compliance with IMWG diagnostic criteria(2014)
- •induction therapy with 4 cycles PCD/PAD regimen, achieve ≥PR
- •KPS ≥60，ECOG≤2 4）Age 18-65，eligible for SCT 5）Heart function < II level (NYHA standard) and ejection fraction > 50% -
排除标准
- •Allergy to bortezomib,epirubicin, or drug ingredients
- •Severe hepatitis and organ dysfunction: a serious infection has not been controlled; cardiac ejection fraction <50%, serum bilirubin >3mg/dl, severe abnormal results of liver function test (AST is greater than 3 times the upper limit), severe renal injury; central nervous system disorders, uncontrolled mental illness
- •With more than 2 bortezomib associated with peripheral neuropathy or neuralgia patients
- •Patients with active stage of the herpes zoster
- •Women in pregnancy or lactation
- •MM with AL or EM plasma cell tumor
- •The patient refused to accept the above treatment and signature
- •Donor does not meet the requirements: including HIV positive, active hepatitis B, bone marrow disease, donor refused to provide hematopoietic stem cells and do not agree to sign.
- •Epirubicin / other anthracyclines previously accumulated more than 240mg/m2 -
结局指标
主要结局
progression-free survival
时间窗: 2 years
overall survival
时间窗: 2 years
次要结局
- rate of complete remission(2 year)
- minimal residual disease(2 year)
- hematopoietic recovery(3 month)
- infection(3 month)
- relapse(2 year)
- GVHD(1 year)
研究者
Chen Wenming
professor
Beijing Chao Yang Hospital