Phase II Study of Belantamab Mafodotin in Combination With Carfilzomib, Pomalidomide, and Dexamethasone (KPd) in Patients With Relapsed Multiple Myeloma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Rate of Overall Response (Prior CAR T-Cell Therapy Cohort)
研究概览
简要总结
Doctors leading this study hope to learn if the combination of belantamab mafodotin, carfilzomib, pomalidomide, and dexamethasone is effective and safe when given to people who have multiple myeloma that has gotten worse and is not responding to standard drugs that are used for treating multiple myeloma, including chimeric antigen receptor T-cell therapy.
Participation in this research will last about 6 -24 months, but it may be less or more depending on your response to treatment.
详细描述
Doctors leading this study hope to learn if the combination of belantamab mafodotin, carfilzomib, pomalidomide, and dexamethasone is effective and safe when given to people who have multiple myeloma that has gotten worse and is not responding to standard drugs that are used for treating multiple myeloma, including chimeric antigen receptor T-cell therapy.
Participation in this research will last about 6 -24 months, but it may be less or more depending on your response to treatment.
The purpose of this research is to gather information on the safety and effectiveness of belantamab mafodotin, carfilzomib, pomalidomide, and dexamethasone for patients with a history of two or more prior lines of myeloma therapy. This combination is not FDA-approved, although carfilzomib and pomalidomide, are separately FDA-approved agents in combination with dexamethasone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort 1: No Prior CAR T-Cell Therapy
This cohort will consist of 19 participants who have not had CAR T-Cell Therapy. Participants will receive belantamab mafodotin, carfilzomib, pomalidomide and dexamethasone.
干预措施: Belantamab mafodotin (Drug)
Cohort 1: No Prior CAR T-Cell Therapy
This cohort will consist of 19 participants who have not had CAR T-Cell Therapy. Participants will receive belantamab mafodotin, carfilzomib, pomalidomide and dexamethasone.
干预措施: Carfilzomib (Drug)
Cohort 1: No Prior CAR T-Cell Therapy
This cohort will consist of 19 participants who have not had CAR T-Cell Therapy. Participants will receive belantamab mafodotin, carfilzomib, pomalidomide and dexamethasone.
干预措施: Pomalidomide (Drug)
Cohort 1: No Prior CAR T-Cell Therapy
This cohort will consist of 19 participants who have not had CAR T-Cell Therapy. Participants will receive belantamab mafodotin, carfilzomib, pomalidomide and dexamethasone.
干预措施: Dexamethasone (Drug)
Cohort 2: Prior CAR T-Cell Therapy
This cohort will consist of 64 participants who have had prior CAR T-Cell Therapy. Participants will receive belantamab mafodotin, carfilzomib, pomalidomide and dexamethasone.
干预措施: Belantamab mafodotin (Drug)
Cohort 2: Prior CAR T-Cell Therapy
This cohort will consist of 64 participants who have had prior CAR T-Cell Therapy. Participants will receive belantamab mafodotin, carfilzomib, pomalidomide and dexamethasone.
干预措施: Carfilzomib (Drug)
Cohort 2: Prior CAR T-Cell Therapy
This cohort will consist of 64 participants who have had prior CAR T-Cell Therapy. Participants will receive belantamab mafodotin, carfilzomib, pomalidomide and dexamethasone.
干预措施: Pomalidomide (Drug)
Cohort 2: Prior CAR T-Cell Therapy
This cohort will consist of 64 participants who have had prior CAR T-Cell Therapy. Participants will receive belantamab mafodotin, carfilzomib, pomalidomide and dexamethasone.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Rate of Overall Response (Prior CAR T-Cell Therapy Cohort)
时间窗: 6-24 months
Prior CAR T-cell therapy cohort: Rate of overall response (ORR) as determined by investigator assessment.
Rate of Very Good Partial Response (No Prior CAR T-Cell Therapy Cohort)
时间窗: 6-24 months
No prior CAR T-cell therapy cohort: Rate of very good partial response (VGPR) or better after 6 cycles according to the 2016 International Myeloma Working Group (IMWG) Response Criteria by Independent Review Committee (IRC).
次要结局
- Overall Survival Among Participants(6-24 months)
- Frequency and Severity of Adverse Events (AEs)/ Serious Adverse Events(6-24 months)
- Overall Response Rate(6-24 months)
- Minimal Residual Disease Negativity Rate(6-24 months)
- Progression-Free Survival(6-24 months)