sdAb-based Targeted Radionuclide Therapy of Multiple Myeloma: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Fraction of Patients (n=3) for Whom a sdAb Could be Generated That Binds to the Idiotype of the Paraprotein.
研究概览
简要总结
This study aims to show that antiidiotypic sdAb are a new, sensitive, specific and non-invasive tool for imaging and therapeutic purposes and provides a rationale for their clinical evaluation as a personalized treatment option for MM patients expressing surface paraprotein.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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 will only be included in the study if they meet all of the following criteria:
- •Patients who have given informed consent
- •Patients at least 18 years old
- •Patients scheduled to undergo bone marrow sampling in clinical routine because of a clinically suspected or pathologically confirmed multiple myeloma.
排除标准
- •Patients will not be included in the study if one of the following criteria applies:
- •Patients who cannot communicate reliably with the investigator
- •Patients who are unlikely to cooperate with the requirements of the study
- •Patients at increased risk of death from a pre-existing concurrent illness
- •Patients who participated already in part I of this study
研究组 & 干预措施
Clinically Suspected or Pathologically Confirmed Multiple Myeloma.
Patients with a clinically suspected or pathologically confirmed multiple myeloma.
干预措施: Blood sampling and bone marrow analysis (Other)
结局指标
主要结局
Fraction of Patients (n=3) for Whom a sdAb Could be Generated That Binds to the Idiotype of the Paraprotein.
时间窗: Within 2 years after study completion
Reporting of the relative amount of patients for whom such sdAb could be successfully obtained
Amount of Paraprotein-targeting sdAbs Generated Per Patient
时间窗: Within 2 years after study completion
Absolute amount of unique sdAbs obtained per patient
次要结局
未报告次要终点