Non-Invasive Minimal Residual Disease (MRD) Assessment in Multiple Myeloma Via Functional Imaging and Liquid Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Sensitivity of non-invasive MRD assessment
研究概览
简要总结
The purpose of this study is to investigate the sensitivity and accuracy of non-invasive MRD assessment using liquid biopsy (blood draw) and functional imaging (whole body MRI) in participants with new diagnosed and previously treated multiple myeloma. The long-term goal of this study is to investigate whether non-invasive methods for MRD assessment can replace bone marrow aspiration and biopsy in a substantial percentage of participants with multiple myeloma.
详细描述
There is an unmet clinical need for an easier, non-invasive, and reliable method to perform MRD assessments that can be used in clinical trials and routine practice. The two non-invasive modalities that are most promising for MRD assessment are liquid biopsy to detect circulating tumor cells (CTCs) and functional imaging to detect focal myeloma lesions. However, there are no prospective data on the sensitivity and specificity of non-invasive MRD assessment with respect to the gold standard of bone marrow sampling.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Adults age ≥18 years
- •Patients with newly diagnosed multiple myeloma
- •Patients with previously treated multiple myeloma with a maximum of two prior lines of therapy
- •Expected life expectancy of greater than one year and intention to start a new line of treatment
排除标准
- •Patients without cognitive capacity to give informed consent for participation
- •Patients with contraindications to MRI, which include the following:
- •Claustrophobia, which, at investigator's discretion, would prohibit patient from undergoing whole body diffusion-weighted magnetic resonance imaging (WB-DWI)
- •Pacemaker
- •Metallic implants, which would prohibit patient from undergoing MRI All subjects will be screened for any contraindication to MRI as per their guidelines at the time of patient enrollment.
- •Patients must not receive granulocyte colony stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) injection within 1 week prior to WB-DWI.
- •Patients must not have been initiated on treatment prior to baseline disease assessment by bone marrow aspiration/biopsy and/or WB-DWI Up to 160 mg of dexamethasone (or equivalent) and/or 1 dose of bortezomib (+/- Cyclophosphamide-Dexamethasone) is allowed prior to disease assessment by bone marrow aspiration and WB-DWI.
研究组 & 干预措施
Myeloma Group
Patients with newly diagnosed and previously treated multiple myeloma will receive bone marrow sampling and functional imaging.
干预措施: MRD Assessment (Other)
结局指标
主要结局
Sensitivity of non-invasive MRD assessment
时间窗: 6 months
MRD assessment includes liquid biopsy and functional imaging.
Specificity of non-invasive MRD assessment
时间窗: 6 months
MRD assessment includes liquid biopsy and functional imaging.
次要结局
- Specificity of two MRD-testing algorithms(6 months)
- Progression Free Survival(2 years)
- Overall Survival(2 years)
- Sensitivity of two MRD-testing algorithms(6 months)
研究者
Rajshekhar Chakraborty, MD
Assistant Professor of Medicine
Columbia University