Mass Accumulation Rate (MAR) as a Predictive Biomarker in Multiple Myeloma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Travera Inc
- 入组人数
- 33
- 试验地点
- 4
- 主要终点
- Best Response 4 months
研究概览
简要总结
This study will collect bone marrow (BM) aspirate samples from patients with relapsed refractory multiple myeloma (RRMM) prior to the start of a new treatment regimen for the purposes of prospectively measuring single-cell mass accumulation rate (MAR) as a biomarker of patient response to that regimen.
The primary study objective is to explore whether the single-cell MAR biomarker can predict patient response in RRMM patients. In order to enable this primary objective, two patient cohorts will be required. First, a small vanguard cohort of patients with treatment naïve disease to define drug concentrations used for testing, and second, the main RRMM patient cohort. Data will be collected to estimate the biomarker's predictive properties (accuracy, sensitivity, specificity), and to support improvement of the MAR biomarker through additional research and discovery within the study dataset.
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
- •Written Informed Consent provided by patient
- •MM, with the following conditions:
- •(CLOSED) *For patients in the Vanguard cohort*
- •Treatment naïve disease with BM clinically indicated
- •*For patients in the RRMM cohort*
- •Relapsed/refractory disease with BM samples clinically indicated
- •Within 4-weeks prior to initiation of 2nd-line or later therapy
- •Patient's oncologist must be planning to change the patient's next line of treatment to a monotherapy or combination therapy composed exclusively of drugs from the following list: Bortezomib (Velcade), Carfilzomib (Kyprolis), Lenalidomide (Revlimid), Pomalidomide (Pomalyst), Cyclophosphamide (Cytoxan), Dexamethasone, Ixazomib (Ninlaro), Venetoclax (Venclexta), Selinexor (Xpovio)
排除标准
- •Unable or unwilling to provide informed consent
- •Daratumumab/Elotuzumab or other antibody-based therapeutic regimens as immediately planned treatment (as prior therapy is acceptable)
- •Patient enrolled/enrolling in a clinical trial where data or specimen sharing provisions preclude use in this study
- •Prior exposure to CAR-T therapy
- •Prior allogeneic stem cell transplant
- •Has received any systemic chemotherapy or RT, including palliative, within 7 days prior to BM biopsy
- •Has received any Ab therapy within 4 weeks prior to BM biopsy
结局指标
主要结局
Best Response 4 months
时间窗: 0-4 months
The best International Myeloma Working Group (IMWG) response of each patient over 4 months of therapy
次要结局
未报告次要终点