A Phase II, Single Arm, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Cevostamab in Combination With Pomalidomide and Dexamethasone in Patients With Multiple Myeloma Who Have Received a Prior BCMA-Targeting CAR T-Cell Therapy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR) as assessed by an Independent Review Committee
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of cevostamab in combination with pomalidomide and dexamethasone (CevosPd) in patients with multiple myeloma (MM) who have received one to four prior lines of therapy and have been exposed to an anti-cluster of differentiation 38 (CD38) antibody, lenalidomide, a proteasome inhibitor (PI) and a B cell maturation antigen (BCMA)-targeting chimeric antigen receptor (CAR) T-cell therapy.
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
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at screening and immediately prior to the start of administration of study treatment.
- •Received one to four lines of prior therapy, including prior B-cell maturation antigen (BCMA)-targeting Chimeric Antigen Receptors (CAR) T-cell therapy
- •Multiple Myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria
- •Is triple-class exposed, i.e. received anti- cluster of differentiation 38 (CD38) therapy, a proteasome inhibitor (PI) and lenalidomide in any prior line
- •Participants must have measurable disease during screening
排除标准
- •Known history of amyloidosis (e.g., positive Congo Red stain or equivalent in tissue biopsy or documented within serum amyloid P component scan)
- •Plasma cell leukemia or circulating plasma cell count exceeding 500 cells/µL or 5% of the peripheral blood white cells
- •History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant antibody-related fusion proteins) or known hypersensitivity to any of the excipients of cevostamab
- •Gastrointestinal (GI) disease that might significantly alter absorption of oral drugs
- •Known active Central Nervous System (CNS) involvement, or exhibits clinical signs of meningeal involvement of MM. If either is suspected, negative whole-brain MRI and lumbar cytology are required.
研究组 & 干预措施
Cevostamab plus Pomalidomide and Dexamethasone (Pd)
Cevostamab will be combined with pomalidomide and dexamethasone as the experimental treatment in this study. Participants will receive Cevostamab as per the schedule in the protocol.
干预措施: Dexamethasone (Drug)
Cevostamab plus Pomalidomide and Dexamethasone (Pd)
Cevostamab will be combined with pomalidomide and dexamethasone as the experimental treatment in this study. Participants will receive Cevostamab as per the schedule in the protocol.
干预措施: Pomalidomide (Drug)
Cevostamab plus Pomalidomide and Dexamethasone (Pd)
Cevostamab will be combined with pomalidomide and dexamethasone as the experimental treatment in this study. Participants will receive Cevostamab as per the schedule in the protocol.
干预措施: Cevostamab (Drug)
Cevostamab plus Pomalidomide and Dexamethasone (Pd)
Cevostamab will be combined with pomalidomide and dexamethasone as the experimental treatment in this study. Participants will receive Cevostamab as per the schedule in the protocol.
干预措施: Tocilizumab (Drug)
结局指标
主要结局
Overall Response Rate (ORR) as assessed by an Independent Review Committee
时间窗: Up to approximately 3 years
次要结局
- Duration of Response (DOR)(Up to approximately 3 years)
- Progression-free Survival (PFS)(Start of study treatment to first date of disease progression or death from any cause, whichever occurs first (up to approximately 3 years))
- Overall Survival (OS)(Baseline up until death from any cause (up to approximately 3 years))
- MRD-negative CR rate at 9 months measured in bone marrow aspirate by next-generation sequencing (NGS)(At 9 months)
- Overall MRD-Negative Complete Response Rate(Up to approximately 3 years)
- Time to Response (TTR)(Baseline up to approximately 3 years)
- Time to Better Response (TTBR)(Baseline up to approximately 3 years)
- Progression-Free Survival 2 (PFS2)(Up to approximately 3 years)
- Time to Confirmed Deterioration in the Disease Symptoms Scale of the EORTC QLQ-MY20(Up to approximately 3 years)
- Time to Confirmed Deterioration in the Global Health Status/Quality of Life (GHS/QoL) of the EORTC QLQ-Core 30 (C30)(Up to approximately 3 years)
- Incidence and Severity of Adverse Events (AEs)(Up to approximately 3 years)
- Change From Baseline in the Disease Symptoms Scale of the EORTC QLQ-MY20(Baseline and up to 3 years)
- ORR, as assessed by the Investigator(Up to approximately 3 years)
- Rate of Very Good Partial Response (VGPR) or Better(Up to approximately 3 years)
- Complete Response/Stringent Complete Response (CR/sCR) Rate(Up to approximately 3 years)
- Change From Baseline in the GHS/QoL of the EORTC QLQ-Core 30 (C30)(Baseline and up to 3 years)
- Change From Baseline in Fatigue as Assessed by the EORTC QLQ-C30(Baseline and up to 3 years)
- Time to Confirmed Deterioration in Fatigue as Assessed by the EORTC QLQ-C30(Up to approximately 3 years)
- Percentage of Participants Experiencing Clinically Meaningful Improvement in Disease Symptoms as Assessed by the EORTC QLQ-MY20(Up to approximately 3 years)
- Percentage of Participants Experiencing Clinically Meaningful Improvement in GHS/QoL as Assessed by the EORTC QLQ-C30(Up to approximately 3 years)
- Percentage of Participants Experiencing Clinically Meaningful Improvement in Fatigue as Assessed by the EORTC QLQ-C30(Up to approximately 3 years)
- Percentage of Participants with Anti-Drug Antibodies (ADAs) to Cevostamab at Baseline(Baseline)
- Percentage of Participants with ADAs to Cevostamab during the Study(Up to approximately 3 years)