NCT07564128尚未招募不适用
An Italian Registry for Infection Surveillance of Patients Undergoing Salvage Treatment With Elranatamab Monotherapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Infection rate in the first 12 months of therapy with elranatamab
研究概览
简要总结
The primary objective of this study is to measure the infection rate and presentation pattern in first 12 months of therapy with elranatamab as standard clinical practice in adult patients with Relapsed/Refractory Multiple Myeloma.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •adult patients (age >18 years) with no upper age limit
- •confirmed Relapsed and Refractory Multiple Myeloma (RRMM) according to IMWG criteria (demonstrated disease progression on the last therapy (progressed on or within 60 days of last therapy).
- •Patients must have received at least three (3) prior lines of therapy, including at least: one Immunomodulatory agent (e.g., Lenalidomide, Pomalidomide), one Proteasome Inhibitor (e.g., Bortezomib, Carfilzomib), one Anti-CD38 Monoclonal Antibody (e.g., Daratumumab, Isatuximab).
- •Treatment with elranatamab within standard clinical practice
- •Written informed consent signature
排除标准
- 未提供
研究组 & 干预措施
Adult patients with R/R Multiple Myeloma treated with elranatamab as standard clinical practice
结局指标
主要结局
Infection rate in the first 12 months of therapy with elranatamab
时间窗: 12 months
次要结局
未报告次要终点
研究者
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