A Phase 3 Randomized, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of SCTC21C in Combination With Bortezomib, Lenalidomide and Dexamethasone Versus Bortezomib, Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 292
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
The purpose of this study is to evaluate if the addition of SCTC21C to bortezomib, lenalidomide and dexamethasone (VRd) in patients with newly diagnosed multiple myeloma not eligible for transplant will prolong progression-free survival (PFS) and/or improve overall minimal residual disease (MRD) negativity rate compared with VRd alone.
详细描述
This study comprises two phases: Part 1 is the safety run in, while Part 2 is a randomized, controlled, open-label, multicenter study. Both parts are divided into three stages: the screening period (up to 28 days before first dose/randomization), the treatment period (from Cycle 1 [28 days] Day 1 and continues until disease progression or unacceptable toxicity), and the follow-up period (Postintervention). Safety endpoints include treatment-emergent adverse events , treatment-related adverse events, serious adverse events, clinical laboratory tests, vital signs, physical examinations, electrocardiograms , etc. Efficacy endpoints include objective response rate (ORR), progression-free survival (PFS), and minimal residual disease (MRD) negativity rate.
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
- •Newly diagnosed multiple myeloma (IMWG criteria) not eligible for transplant.
- •Evidence of measurable disease.
- •With adequate organ function and hematological parameters.
- •Contraception，and during the study period and for 5 months after the last dose, all subjects must not donate reproductive cells.
排除标准
- •Other hematologic malignancies.
- •Subjects with confirmed or suspected central nervous system infiltration or meningeal involvement.
- •Uncontrolled infection.
- •Subjects with conditions that may affect safety or efficacy assessments include, but are not limited to, cardiovascular, respiratory, endocrine/metabolic, immune system, hepatic, gastrointestinal (such as gastrointestinal bleeding, perforation, ulcers, etc.), and malignant neoplasms, and are deemed clinically significant by the investigator.
- •Subjects who have undergone major surgery or experienced significant trauma within 4 weeks prior to the first use of the investigational drug, or who require elective surgery during the trial period.
- •Received a live or attenuated vaccine within 30 days prior to the first dose; Female subjects who are currently breastfeeding.
- •Subjects with mental disorders or poor compliance, or other circumstances deemed unsuitable for participation in this study by other investigators.
研究组 & 干预措施
SCTC21C + VRd (S-VRd)
干预措施: SCTC21C (Drug)
SCTC21C + VRd (S-VRd)
干预措施: Bortezomib (Drug)
SCTC21C + VRd (S-VRd)
干预措施: Lenalidomide (Drug)
SCTC21C + VRd (S-VRd)
干预措施: Dexamethasone (Drug)
VRd
干预措施: Bortezomib (Drug)
VRd
干预措施: Lenalidomide (Drug)
VRd
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Progression free survival (PFS)
时间窗: Up to approximately 84 months after the First Participant In (FPI)
Defined as the time from the date of randomization to the date of first documentation of progression disease (PD) or the date of death from any cause, whichever occurs first.
Minimal residual disease (MRD) negativity rate for participants with CR
时间窗: Up to approximately 84 months after the FPI
Proportion of participants with CR for whom MRD measurement is negative
次要结局
- Overall response rate (ORR)(Up to approximately 84 months after the FPI)
- Duration of response (DOR)(Up to approximately 84 months after the FPI)
- Adverse Events(Up to approximately 84 months after the FPI)