A Phase 3 Randomized, Placebo-controlled, Double-blind, Multicenter Study Comparing SG301 in Combination With Pomalidomide and Dexamethasone Versus Placebo in Combination With Pomalidomide and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 12
- 主要终点
- Progression Free Survival (Stage 2)
研究概览
简要总结
The purpose of this study is to evaluate the effects of the addition of SG301 injection to pomalidomide and dexamethasone in subjects with relapsed or refractory multiple myeloma.
详细描述
This is a randomized, placebo-controlled, double-blind, multicenter phase III clinical study to compare SG301 injection in combination with pomalidomide and dexamethasone versus placebo in combination with pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma who have received at least 1 prior treatment regimen with both lenalidomide and a proteasome inhibitor and have demonstrated disease progression.
This study consists of two stages. Stage 1 is the dose exploration stage to confirm the recommended stage 2 dose of SG301 injection in combination with pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma. Stage 2 is the randomized controlled stage of SG301 injection in combination with pomalidomide and dexamethasone versus placebo in combination with pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Stage 1#Open-label Stage 2#Double-blind
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understand and voluntarily sign the informed consent form (ICF).
- •Males and females aged 18-75 years (inclusive)
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2
- •Expected survival time of ≥3 months.
- •Subjects had a documented diagnosis of multiple myeloma with evidence of measurable disease.
- •Subjects had received at least 1 prior lines of anti-myeloma therapy, which must include lenalidomide and a proteasome inhibitor (bortezomib, carfilzomib or ixazomib) given alone or in combination.
- •Subjects must have documented evidence of PD on or after the last regimen.
- •Adequate function of vital organs
- •Women of childbearing potential (WOCBP) must agree to follow instructions for methods of contraception for 4 weeks before the start of study treatment, for the duration of study treatment, and for 6 months after cessation of SG301 or 4 weeks after cessation of pomalidomide, whichever is longer. WOCBP must have 2 negative serum or urine pregnancy tests, one 10-14 days prior to start of study treatment and one 24 hours prior to the start of study treatment.
排除标准
- •Primary refractory multiple myeloma defined as participants who had never achieved at least a minimal response (MR) with any treatment during the disease course.
- •Bone independent extramedullary disease at screening.
- •Subjects who are primary refractory to a prior CD38 monoclonal antibody therapy.
- •Previous exposure to pomalidomide.
- •Subject has received chemotherapy or small molecule antitumor therapy within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is shorter, before the first dose of study treatment;
- •Subject has received tumor biotherapy within 4 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is shorter, before the first dose of study treatment;
- •Subject has received investigational agents within 4 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is shorter (but not less than 14 days), before the first dose of study treatment;
- •Active hepatitis B, or C.
- •Known HIV infection.
- •Known active tuberculosis or positive treponema pallidum antibodies.
- •Subjects with clinical significant organ dysfunction that does not meet the study needs.
- •Previous allogenic stem cell transplant or autologous stem cell transplantation (ASCT) before the first dose of study treatment.
- •Known allergy to any component of the investigational medicinal product.
- •Any concurrent medical or psychiatric condition or disease (eg, active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) that is likely to interfere with the study procedures or results or that, in the opinion of the investigator, would constitute a hazard for participating in this study.
研究组 & 干预措施
Placebo in combination with pomalidomide and dexamethasone
Participants in Stage 2 who randomized to this arm will receive placebo in combination with pomalidomide and dexamethasone. Treatment cycles have a duration of 28 days. Participants will continue to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria are met.
干预措施: SG301 placebo (Drug)
SG301 Injection in combination with pomalidomide and dexamethasone
Participants will receive SG301 Injection in combination with pomalidomide and dexamethasone. Treatment cycles have a duration of 28 days. Participants will continue to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria are met.
干预措施: SG301 Injection (Drug)
SG301 Injection in combination with pomalidomide and dexamethasone
Participants will receive SG301 Injection in combination with pomalidomide and dexamethasone. Treatment cycles have a duration of 28 days. Participants will continue to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria are met.
干预措施: dexamethasone (Drug)
SG301 Injection in combination with pomalidomide and dexamethasone
Participants will receive SG301 Injection in combination with pomalidomide and dexamethasone. Treatment cycles have a duration of 28 days. Participants will continue to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria are met.
干预措施: pomalidomide (Drug)
Placebo in combination with pomalidomide and dexamethasone
Participants in Stage 2 who randomized to this arm will receive placebo in combination with pomalidomide and dexamethasone. Treatment cycles have a duration of 28 days. Participants will continue to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria are met.
干预措施: pomalidomide (Drug)
Placebo in combination with pomalidomide and dexamethasone
Participants in Stage 2 who randomized to this arm will receive placebo in combination with pomalidomide and dexamethasone. Treatment cycles have a duration of 28 days. Participants will continue to receive study treatment until confirmed disease progression, unacceptable toxicity, or any other treatment discontinuation criteria are met.
干预措施: dexamethasone (Drug)
结局指标
主要结局
Progression Free Survival (Stage 2)
时间窗: From baseline through the end of study. Assessed every 4 weeks after randomization until C19D1, and every 8 weeks thereafter until disease progression (IMWG criteria) or death whichever occurs first, assessed up to approximately 4 years.
Comparison of Progression Free Survival between treatment arms (SG301/Pomalidomide/Dexamethasone vs Placebo/Pomalidomide/Dexamethasone).
Recommended stage 2 dose of SG301 (Stage 1)
时间窗: Up to approximately 6 months.
Recommended stage 2 dose of SG301 will be determined based on the DLTs and safety data
Adverse events （stage 1）
时间窗: From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.
AEs, DLTs, laboratory abnormality, Vital signs or ECG abnormalities, ECOG scores, abnormal physical examination
次要结局
- Overall Survival(From baseline through the end of study, assessed up to approximately 4 years.)
- Pharmacokinetics (PK): AUC(From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.)
- Pharmacokinetics (PK): Cmax(From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.)
- Pharmacokinetics (PK):limination half-life (T1/2)(From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.)
- Percentage of Participants With Very Good Partial Response (VGPR) or Better (≥VGPR Rate)(From baseline through the end of study. It is measured from the start of treatment until disease progression, death, initiation of further anti-myeloma treatment, or cut-off date, whichever occurs first, assessed up to approximately 4 years.)
- Immunogenicity endpoints(From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.)
- Overall Response Rate(From baseline through the end of study. It is measured from the start of treatment until disease progression, death, initiation of further anti-myeloma treatment, or cut-off date, whichever occurs first, assessed up to approximately 4 years.)
- Duration of Response(From baseline through the end of study. It is measured from the time that the criteria for objective response are first met until the date of a progression event, assessed up to approximately 4 years.)
- Percentage of Participants With Minimal Residual Disease (MRD)(From baseline through the end of study. It is measured from the time that the criteria for CR are first met until the date of a progression event, assessed up to approximately 4 years.)