AL Amyloidosis and Anti-CD38-Daratunumab
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- organ responses were defined according to the updated International Society of Amyloidosis criteria
研究概览
简要总结
AL Amyloidosis and anti-CD38
详细描述
AL amyloidosis is a systemic disorder characterized by progressive multiorgan failure and premature death. While autologous stem cell transplantation (ASCT) is considered the standard therapy, eligibility is limited, and excludes a substantial proportion of patients. Recent guidelines recommend daratumumab-based regimens for these patients, but, particularly for cases with severe renal involvement, optimal treatment remains a challenge.
This study explore the efficacy of daratumumab monotherapy in patients with histologically proven severe renal involvement who are ineligible for ASCT
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients affected by AL amyloidosis
- •Patients who were ineligible for high dose therapy and bone marrow transplantation due to age and/or frailty score.
- •Exclusion criteria:
- •Diagnosis of AL amyloidosis not biospy proven
排除标准
- 未提供
研究组 & 干预措施
anti-CD38
Daratumumab is intravenously given at the dose of 16 mg/kg weekly for 8 weeks, then every two weeks for 8 more times, and lastly monthly until the 52nd week (8 more administrations)
干预措施: Anti-CD38 Monoclonal Antibody (Drug)
结局指标
主要结局
organ responses were defined according to the updated International Society of Amyloidosis criteria
时间窗: "through study completion, an average of 1 year".
次要结局
未报告次要终点