Phase II Study of Salvage Radiation Treatment After B-cell Maturation Antigen Chimeric Antigen Receptor T-cell Therapy for Relapsed Refractory Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Duration of response (DoR) among responders
研究概览
简要总结
This study is a Phase II study to determine the preliminary safety and efficacy of salvage radiation treatment after BCMA CAR-T therapy in subjects with RRMM.
The study population will consist of subjects with RRMM previously treated with SOC BCMA CAR-T cell therapy with active disease on the D30+ PET or other imaging scan after CAR-T infusion. Patients who are planned for salvage chemotherapy less than 14 days after completion of radiation treatment will be excluded.
Radiation treatment will be to bony or soft tissue plasmacytomas in up to five radiation treatment fields to 10-20Gy (or equivalent dose in 2Gy fractions of 10-21Gy). Final dose, target, and technique are per treating radiation physician discretion within these guidelines.
Thirty patients will be enrolled. The co-primary endpoints are objective response rate (ORR) at 6 months and duration of response (DOR) among responders.
详细描述
Objectives
Primary Objective:
• The primary objective of the study is to evaluate the preliminary efficacy of salvage radiation therapy after BCMA CAR-T cell therapy in subjects with RRMM.
Secondary Objectives:
• Evaluate the safety of and other efficacy parameters of radiation treatment after BCMA CAR-T cell therapy in subjects with RRMM
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Subjects must satisfy the following criteria to be enrolled in the study:
- •Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF)
- •Subject is diagnosed with multiple myeloma
- •Subject previously received treatment with standard of care BCMA CAR-T cell therapy
- •Day 30 or later PET scan or other imaging scan after CAR-T infusion shows active disease
- •Subject has at least one myeloma lesion (plasmacytoma either in bone or soft tissue) that can be treated with radiation
- •Able to provide informed consent
排除标准
- •The presence of any of the following will exclude a subject from enrollment:
- •Subjects in whom salvage chemotherapy is planned less than 14 days after the completion of radiation treatment
- •Subject is undergoing active treatment for another malignancy other than multiple myeloma
- •Pregnant women will be excluded from this study.
研究组 & 干预措施
Radiation Therapy
Radiation treatment will be to bony or soft tissue plasmacytomas in up to five radiation treatment fields to 10-20Gy (or equivalent dose in 2Gy fractions of 10-21Gy
干预措施: Radiation Therapy (Drug)
结局指标
主要结局
Duration of response (DoR) among responders
时间窗: through study completion, an average of 1 year
Time from first documentation of response (PR or greater) to first documentation of progressive disease (PD) or death from any cause, whichever occurs first
Overall response rate (ORR)
时间窗: through study completion, an average of 1 year
Percentage of subjects who achieved partial response (PR) or better according to IMWG Uniform Response Criteria for Multiple Myeloma (Kumar, 2016)
次要结局
未报告次要终点