NCT03952091已完成3 期
A Phase 3, Randomized, Open-label, Parallel-controlled, Multi-center Study Comparing TJ202, Lenalidomide and Dexamethasone vs. Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma Who Received at Least 1 Prior Line of Treatment
TJ Biopharma Co., Ltd.39 个研究点 分布在 2 个国家目标入组 289 人开始时间: 2019年3月27日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 289
- 试验地点
- 39
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
A phase 3, randomized, open-label, parallel-controlled, multi-center study comparing TJ202, Lenalidomide and Dexamethasone vs. Lenalidomide and Dexamethasone in subjects with relapsed or refractory multiple myeloma who received at least 1 prior line of treatment
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
- •Age ≥ 18, male or female;
- •Subjects must have had documented MM;
- •At the screening phase, subject must have one or more measurable disease;
- •Subjects must have received at least 1 prior line treatment* for relapsed or refractor MM;
- •Subjects who are in a state of progressive disease (PD);
- •Subjects must have life expectancy of no less than 6 months;
- •Subjects must have an ECOG (Eastern Cooperative Oncology Group) performance status score of 0~2;
- •A woman of child-bearing potential must have a negative serum pregnancy test within 14 days prior to the first study agent administration, and a negative urine pregnancy test on the day of the first study agent administration; as well as those should avoid sexual intercourse with the opposite sex or should adopt two reliable methods of contraception at the same time during the study period. A woman of child-bearing potential is required to take effective contraceptive measures throughout this study and within 6 months after the last dosing; female subjects must agree not to donate any eggs for the purpose of assisted reproduction throughout this study and within 6 months after completion of this study;
- •Male subjects who are sexually active with women of child-bearing potential and have not undergone vasoligation must agree to use barrier methods of birth control, or that their partners use block caps (cervical cap or dome cap), spermicidal foam, contraceptive gel, contraceptive diaphragm, contraceptive cream, or suppository, and all male subjects are not allowed to donate sperms throughout this study and within 6 months after the last dosing;
- •Subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study;
- •Subject must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
排除标准
- •Subject has received anti-CD38 monoclonal antibody treatment previously;
- •Subject has received CAR-T cell therapy previously;
- •Subject has previously received allogenic stem cell transplant, or subject has received autologous stem cell transplant within 3 months before administration of the study agent;
- •Primary refractory multiple myeloma;
- •Subject's disease shows evidence of resistance to lenalidomide;
- •Subject's disease shows evidence of intolerance to lenalidomide;
- •Subject is exhibiting clinical signs of central nervous system (CNS) involvement of MM;
- •Subjects with known moderate or severe persistent asthma within the past 5 years;
- •Subject has active hepatitis B or C virus infection
- •Subject is seropositive for human immunodeficiency virus (HIV);
- •Subject has clinically significant cardiac disease;
- •Subject has known allergies, hypersensitivity, or intolerance to lenalidomide, corticosteroids, monoclonal antibodies or human proteins, or their excipients or known sensitivity to mammalian-derived products;
- •Subject with known or suspicious conditions that would lead to failure to abide by the study protocol.
研究组 & 干预措施
TJ202, Lenalidomide and Dexamethasone
Experimental
干预措施: TJ202, Lenalidomide and Dexamethasone (Drug)
Lenalidomide and Dexamethasone
Active Comparator
干预措施: Lenalidomide and Dexamethasone (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: 18.4 months(Active) 30.7 months(experimental)
defined as the duration from the date of randomization to either PD, according to the IMWG criteria, or death, whichever occurs first
次要结局
未报告次要终点
研究者
研究点 (39)
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