Study on the Efficacy and Safety of Low-dose Cyclophosphamide as Maintenance Therapy for Multiple Myeloma Unsuitable for Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- PFS1
研究概览
简要总结
The investigators will conduct randomized and controlled clinical studies in order to preliminarily explore the efficacy and safety of low-dose cyclophosphamide and lenalidomide in maintenance therapy for MM that is not suitable for transplantation in the standard-risk group.
详细描述
The investigators will conduct randomized and controlled clinical studies to preliminarily explore the efficacy and safety of low-dose cyclophosphamide in maintenance therapy for MM that is not suitable for transplantation in the standard -risk group. Standard risk group MM patients who achieve VGPR or above after initial induction and consolidation therapy will use cyclophosphamide or lenalidomide as maintain therapy for 2 years.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •After induction and consolidation therapy (8 courses of chemotherapy), MM patients in the standard-risk group who were initially unsuitable for transplantation achieved a therapeutic effect of VGPR or above;
- •Secretory MM with measurable indicators;
- •Age ≥ 18 years old, gender unlimited;
- •No obvious dysfunction of heart, lungs, etc. (≤ Grade I);
- •General KPS ≥ 70% (excluding those caused by pathological fractures and bone pain).
排除标准
- •Cytogenetic high-risk patients;
- •Recurrent or refractory MM;
- •Using autologous hematopoietic stem cell transplantation as a consolidation therapy;
- •The therapeutic effect did not reach VGPR or above before enrollment;
- •Asymptomatic MM;
- •No measurable indicators;
- •KPS<50%(excluding those caused by pathological fractures）；
- •Dysfunction of heart, lungs, etc. (> Grade I);
- •Unable to cooperate in observing adverse reactions and therapeutic effects;
- •Pregnancy, breastfeeding, or refusal of contraception by women;
- •There is drug abuse and medical, psychological, or social conditions that may interfere with patients participating in research or evaluating research results;
- •Any unstable or potentially endangering patient safety and compliance with the study.
研究组 & 干预措施
arm CTX
Cyclophosphamide monotherapy: CTX, 0.1g×7days，1/every other week, 28 days per course of treatment,total two years
干预措施: Cyclophosphamide (Drug)
arm Len
Lenalidomide monotherapy:Len,10mg/day×21days， 28 days per course of treatment,total two years
干预措施: Lenalidomide (Drug)
结局指标
主要结局
PFS1
时间窗: 3 years
Progression-free Survival 1
次要结局
- Incidence of Efficacy as assessed by IMWG(3 years)
- Incidence of Safety as assessed by CTCAE 4.0(3 years)
研究者
Feng Li
Clinical Professor
Jinling Hospital, China