Cevostamab in Combination With Pomalidomide and Dexamethasone After BCMA- Targeting CAR T-Cell Therapy in Participants With Previously Treated Multiple Myeloma
2026年9月14日 更新者:Hoffmann-La Roche
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
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.
研究概览
研究类型
介入性
注册 (估计的)
45
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Reference Study ID Number: CO46577 https://forpatients.roche.com/No attachments to email below.
- 电话号码:888-662-6728 (U.S. and Canada)
- 邮箱:global-roche-genentech-trials@gene.com
研究联系人备份
- 姓名:Fastest Response:use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
学习地点
-
-
-
Jena、德国、07747
- 招聘中
- Universitätsklinikum Jena, Klinik für Innere Medizin II
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的: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.
|
Tocilizumab may be used as rescue medication for participants who experience a cytokine release syndrome (CRS) event.
其他名称:
Participants will receive cevostamab as per the schedule given in the protocol.
其他名称:
Pomalidomide will be administered as per the schedule given in the protocol.
Dexamethasone will be administered as a premedication as per the schedule given in the protocol.
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Overall Response Rate (ORR) as assessed by an Independent Review Committee
大体时间:Up to approximately 3 years
|
Up to approximately 3 years
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
缓解持续时间 (DOR)
大体时间:最长约 3 年
|
最长约 3 年
|
|
ORR, as assessed by the Investigator
大体时间:Up to approximately 3 years
|
Up to approximately 3 years
|
|
Rate of Very Good Partial Response (VGPR) or Better
大体时间:Up to approximately 3 years
|
Up to approximately 3 years
|
|
Complete Response/Stringent Complete Response (CR/sCR) Rate
大体时间:Up to approximately 3 years
|
Up to approximately 3 years
|
|
Progression-free Survival (PFS)
大体时间:Start of study treatment to first date of disease progression or death from any cause, whichever occurs first (up to approximately 3 years)
|
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)
大体时间:Baseline up until death from any cause (up to approximately 3 years)
|
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)
大体时间:At 9 months
|
At 9 months
|
|
Overall MRD-Negative Complete Response Rate
大体时间:Up to approximately 3 years
|
Up to approximately 3 years
|
|
Time to Response (TTR)
大体时间:Baseline up to approximately 3 years
|
Baseline up to approximately 3 years
|
|
Time to Better Response (TTBR)
大体时间:Baseline up to approximately 3 years
|
Baseline up to approximately 3 years
|
|
Progression-Free Survival 2 (PFS2)
大体时间:Up to approximately 3 years
|
Up to approximately 3 years
|
|
Time to Confirmed Deterioration in the Disease Symptoms Scale of the EORTC QLQ-MY20
大体时间:Up to approximately 3 years
|
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)
大体时间:Up to approximately 3 years
|
Up to approximately 3 years
|
|
Incidence and Severity of Adverse Events (AEs)
大体时间:Up to approximately 3 years
|
Up to approximately 3 years
|
|
Change From Baseline in the Disease Symptoms Scale of the EORTC QLQ-MY20
大体时间:Baseline and up to 3 years
|
Baseline and up to 3 years
|
|
Change From Baseline in the GHS/QoL of the EORTC QLQ-Core 30 (C30)
大体时间:Baseline and up to 3 years
|
Baseline and up to 3 years
|
|
Change From Baseline in Fatigue as Assessed by the EORTC QLQ-C30
大体时间:Baseline and up to 3 years
|
Baseline and up to 3 years
|
|
Time to Confirmed Deterioration in Fatigue as Assessed by the EORTC QLQ-C30
大体时间:Up to approximately 3 years
|
Up to approximately 3 years
|
|
Percentage of Participants Experiencing Clinically Meaningful Improvement in Disease Symptoms as Assessed by the EORTC QLQ-MY20
大体时间:Up to approximately 3 years
|
Up to approximately 3 years
|
|
Percentage of Participants Experiencing Clinically Meaningful Improvement in GHS/QoL as Assessed by the EORTC QLQ-C30
大体时间:Up to approximately 3 years
|
Up to approximately 3 years
|
|
Percentage of Participants Experiencing Clinically Meaningful Improvement in Fatigue as Assessed by the EORTC QLQ-C30
大体时间:Up to approximately 3 years
|
Up to approximately 3 years
|
|
Percentage of Participants with Anti-Drug Antibodies (ADAs) to Cevostamab at Baseline
大体时间:Baseline
|
Baseline
|
|
Percentage of Participants with ADAs to Cevostamab during the Study
大体时间:Up to approximately 3 years
|
Up to approximately 3 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年10月1日
初级完成 (估计的)
2029年4月13日
研究完成 (估计的)
2031年1月30日
研究注册日期
首次提交
2026年9月14日
首先提交符合 QC 标准的
2026年9月14日
首次发布 (实际的)
2026年9月17日
研究记录更新
最后更新发布 (实际的)
2026年9月17日
上次提交的符合 QC 标准的更新
2026年9月14日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- CO46577
- 2026-525736-42-00 (克蒂斯)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
是的
IPD 计划说明
For eligible studies, qualified researchers may request access to individual patient level clinical data.
See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
是的
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.