Selinexor Combined With Ixazomib and Lenalidomide as Maintenance Therapy in Patients With Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- PFS
研究概览
简要总结
The goal of this phase 2 trial is to test the safety and efficacy of selinexor combined with ixazomib and lenalidomide as maintenance therapy in patients with multiple myeloma.
详细描述
The investigators will evaluate safety and efficacy of selinexor combined with ixazomib and lenalidomide as maintenance therapy in patients with multiple myeloma post complete remission. Event-free survival (EFS), progression-free survival (PFS), overall survival (OS), adverse events (AEs) will be assessed.
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed Multiple Myeloma according World Health Organization (WHO) classification;
- •Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).
- •Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted;
- •Patient is willing and able to adhere to the study visit schedule and other protocol requirements;
- •Documented response to ASCT (PR, VGPR, CR/stringent complete response [sCR]) according to IMWG criteria.
排除标准
- •Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.
- •Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.
- •Pregnant or lactating women
研究组 & 干预措施
Maintenance Therapy
Patients were treated by Selinexor combined with Ixazomib and Lenalidomide as Maintenance Therapy
干预措施: Selinexor combined with Ixazomib and Lenalidomide as Maintenance Therapy (Drug)
结局指标
主要结局
PFS
时间窗: 2 years
PFS was defined as the time from study entry until disease progression
次要结局
- EFS(2 years)
- OS(2 years)
研究者
Liren Qian
Associate Chief Physician, Associate Professor
Navy General Hospital, Beijing