A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Cevostamab in Combination With Pomalidomide and Dexamethasone Versus Standard of Care in Patients With Multiple Myeloma Who Have Received One to Three Prior Lines of Therapy
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 380
- 试验地点
- 75
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) versus standard of care (SOC) in participants with multiple myeloma (MM) who have received one to three prior lines of therapy and have been exposed to an anti-CD38 monoclonal antibody (mAb) and lenalidomide.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at screening and immediately prior to start of administration of study treatment.
- •Individuals with ECOG Performance Status of 2 solely due to local symptoms of myeloma (e.g., pain) are eligible
- •MM diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria
- •Received one to three lines of prior therapy that included at least two consecutive cycles of either of the following: A regimen containing an anti-CD38 therapy, a regimen containing lenalidomide
- •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/liter (L) or 5% of the peripheral blood white cells
- •GI disease that might significantly alter absorption of oral drugs
- •Participants must not have any ongoing CNS disease or non-secretory myeloma
研究组 & 干预措施
Cevostamab + Pomalidomide + Dexamethasone
Cevostamab will be administered intravenously on a 21-day cycle in cycle 1 and on a 28-day cycle from cycle 2 onwards.
Pomalidomide will be administered orally (PO) on a 28-day cycle from cycle 2 onwards.
Dexamethasone will be administered as a premedication prior to cevostamab.
干预措施: Pomalidomide (Drug)
Standard of Care (SOC)
Participants will receive investigator's choice of one SOC regimen.
干预措施: Daratumumab (Drug)
Standard of Care (SOC)
Participants will receive investigator's choice of one SOC regimen.
干预措施: Pomalidomide (Drug)
Cevostamab + Pomalidomide + Dexamethasone
Cevostamab will be administered intravenously on a 21-day cycle in cycle 1 and on a 28-day cycle from cycle 2 onwards.
Pomalidomide will be administered orally (PO) on a 28-day cycle from cycle 2 onwards.
Dexamethasone will be administered as a premedication prior to cevostamab.
干预措施: Cevostamab (Drug)
Standard of Care (SOC)
Participants will receive investigator's choice of one SOC regimen.
干预措施: Dexamethasone (Drug)
Cevostamab + Pomalidomide + Dexamethasone
Cevostamab will be administered intravenously on a 21-day cycle in cycle 1 and on a 28-day cycle from cycle 2 onwards.
Pomalidomide will be administered orally (PO) on a 28-day cycle from cycle 2 onwards.
Dexamethasone will be administered as a premedication prior to cevostamab.
干预措施: Dexamethasone (Drug)
Standard of Care (SOC)
Participants will receive investigator's choice of one SOC regimen.
干预措施: Elotuzumab (Drug)
Standard of Care (SOC)
Participants will receive investigator's choice of one SOC regimen.
干预措施: Carfilzomib (Drug)