Bortezomib-lenalidomide-dexamethasone Combined With Radiotherapy for Newly Diagnosed Solitary Plasmacytoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- event-free survival
研究概览
简要总结
Solitary plasmacytoma (SP) is characterized by a localized mass of clonal plasma cells with no or minimal bone marrow plasmacytosis. It can present either as EMP or SBP. Radiotherapy is the first-line treatment with high response rate. However, 65-84% SBP patients and 25-35% EMP patients progress at 10 years. We aimed to investigate whether adjuvant bortezomib based chemotherapy with radiotherapy could prolong event-free survival in treatment-naive SP patients compared to that with radiotherapy alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •treatment-naïve SP.
排除标准
- •Not appropriate for radiotherapy.
- •Co-morbidity of uncontrolled infection.
- •Co-morbidity of other active malignancy.
- •Patients in pregnancy or lactation.
- •Prior or concurrent pulmonary embolism.
- •Patients not able to tolerate thrombosis prophylaxis, bortezomib, lenalidomide or dexamethasone.
- •Seropositive for human immunodeficiency virus, seropositive for hepatitis C, or HBV-DNA > 1000 copies/mL.
- •Myocardial infarction, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled arrhythmias within 6 months prior to enrollment.
- •Grade 2 or higher neuropathy according to National Cancer Institute Common Terminology Criteria for Adverse Events.
- •Neutrophil <1×10E9/L，hemoglobin < 8g/dL，or platelet < 75×10E9/L.
- •Severely compromised hepatic or renal function: ALT or AST > 3 × ULN, total bilirubin > 1.5 × ULN，or eGFR < 40mL/min.
研究组 & 干预措施
Chemotherapy combined with radiotherapy
干预措施: Dexamethasone (Drug)
Radiotherapy
干预措施: radiotherapy (Radiation)
Chemotherapy combined with radiotherapy
干预措施: radiotherapy (Radiation)
Chemotherapy combined with radiotherapy
干预措施: Bortezomib Injection (Drug)
Chemotherapy combined with radiotherapy
干预措施: Lenalidomide (Drug)
结局指标
主要结局
event-free survival
时间窗: 2 years
EFS was calculated from randomization to local progression, local recurrence, distant recurrence, development of smoldering multiple myeloma, multiple myeloma or death.
次要结局
- overall survival(2 years)
- response rate(2 years)
- adverse events(collected until 30 days after treatment completion)