NCT04379817已完成2 期
Somatostatin Receptors Imaging in Relapsing and Refractory Multiple Myeloma Patients
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Somatostatin receptor expression
研究概览
简要总结
This study wil assess somatostatin receptor (SSTR) expression via the uptake of Gallium-68 labelled DOTA-conjugated SSTR targeting peptide using PET/CT imaging in multiple myeloma lesions pre-identified on 18F-FDG PET/CT in order to evaluate the feasibility of molecular radionuclide therapy in refractory and relapsing mutiple myeloma using the Lutetium-177 radiolabelled targeting peptide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •Age above or equal to 18 years
- •Written informed consent in accordance with institutional guidelines and obtained prior to any study procedures
- •Confirmed diagnosis of multiple myeloma according to the Salmon and Durie criteria
- •Has received at least 3 lines of treatment, exposed and refractory (or non-eligible) to the 5 major drugs (lenalidomid, pomalidomid, bortezomib, carfilzomib, daratumumab)
- •Life expectancy above 3 months
- •Active (relapsing or refractory) and measurable disease (on 18F-FDG PET/CT (performed within 4 weeks prior SSTR PET/CT) and biologically)
- •Adequate renal function with GFR above or equal to 30mL/min/1.73m²
- •Bone marrow aspiration and biopsy sample available within 30 days prior study enrolment with positive SSTR2 IHC
排除标准
- •Pregnant or lactating patients
- •Other active neoplastic disease
- •Treatment by another molecule that is object of investigation within 30 days prior SSTR PET/CT
- •Eastern Cooperative Oncology Group Performance Status above or equal to 3
- •Corticoids administration at a therapeutic level (total dose of 160 mg of dexamethasone or equivalent) two weeks prior enrolment
结局指标
主要结局
Somatostatin receptor expression
时间窗: through study completion, an average of 1,5 year
Biodistribution of 68Ga-DOTA cojugated SSTR targeting peptide on PET/CT images
次要结局
未报告次要终点
研究者
研究点 (2)
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