A Phase 3 Randomized Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 228
- 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 compare the safety and efficacy of QLS32015 with Pd/Sd for the treatment of relapsed or 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
- 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 years old, regardless of gender.
- •Subjects should be willing and able to comply with the study schedule and protocols.
- •Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria.Must have measurable disease as defined by the following: Serum M-protein greater than or equal to 0.5 g/dL; OR Urine M-protein greater than or equal to 200 mg/24 hours; OR Serum free light chain (FLC) assay; involved FLC level greater than or equal to 10 mg/dL provided the serum FLC ratio is abnormal.
- •Received at least 3 prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory drug, and an anti-CD38 monoclonal antibody (mAb).
排除标准
- •Known hypersensitivity to any of the ingredients of this product.
- •Diagnosis of active plasma cell leukemia or systemic light chain amyloidosis.
- •Has any active severe mental illness, medical illness, or other symptoms/conditions that may affect treatment, compliance, or the ability to provide informed consent, as determined by the investigator.
- •Disease is considered refractory to pomalidomide and selinexor.
研究组 & 干预措施
QLS32015
Participants will receive teclistamab monotherapy.
干预措施: QLS32015 (Drug)
Pomalidomide, Dexamethasone (Pd) or Selinexor and Dexamethasone (Sd)
Participants will receive either Pd or Sd based on principal investigator's choice.
干预措施: Pomalidomide (Drug)
Pomalidomide, Dexamethasone (Pd) or Selinexor and Dexamethasone (Sd)
Participants will receive either Pd or Sd based on principal investigator's choice.
干预措施: Selinexor (Drug)
Pomalidomide, Dexamethasone (Pd) or Selinexor and Dexamethasone (Sd)
Participants will receive either Pd or Sd based on principal investigator's choice.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: Up to 4 years
PFS is defined as the time from the date of randomization to the date of first documented disease progression, as defined in the International myeloma working group (IMWG) 2016 response criteria, or death due to any cause, whichever occurs first.
次要结局
- Overall Response (Partial Response [PR] or Better)(Up to 4 years)
- Very Good Partial Response (VGPR) or Better Response(Up to 4 years)
- Complete Response (CR) or Better Response(Up to 4 years)
- Duration of Response (DOR)(Up to 4 years)
- Minimal Residual Disease (MRD) Negativity(Up to approximately 4 years)
- Number of Participants with Adverse Events (AEs) by Severity(Up to 4 years)
- Change from Baseline in Symptoms, Functioning, and Overall Health-related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30)(Baseline up to 4 years)