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A Study in Participants With Relapsed or Refractory Multiple Myeloma for QLS4131

2026年11月6日 更新者:Qilu Pharmaceutical Co., Ltd.

A Phase 3 Randomized Study Comparing QLS4131 Injection Versus Treatment Per Investigator's Choice in Participants With Relapsed or Refractory Multiple Myeloma

The purpose of this clinical trial is to evaluate the efficacy and safety of QLS4131 compared with the investigator's choice regimen (DPd or PVd) in participants with relapsed or refractory multiple myeloma (RRMM).

研究概览

详细说明

This study is an open, multicenter, randomized controlled phase III clinical trial aimed at evaluating the efficacy and safety of QLS4131 compared to the investigator's choice regimen (DPd or PVd) in participants with relapsed or refractory multiple myeloma who have previously received 1-4 lines of therapy and have been exposed to three classes of drugs (proteasome inhibitors, immunomodulators, and anti-CD38 monoclonal antibodies). The plan is to enroll approximately 300 participants, who will be randomly assigned to the experimental group and the control group in a 1:1 ratio. Approximately 150 participants in the experimental group will receive QLS4131 treatment, while about 150 participants in the control group will receive the investigator's choice of treatment (DPd or PVd).

研究类型

介入性

注册 (估计的)

300

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:LUGUI QIU, Doctor of Medicine (MD)
  • 电话号码:022-23608124
  • 邮箱:qiulg@ihcams.ac.cn

研究联系人备份

  • 姓名:GANG AN, Doctor of Medicine (MD)
  • 电话号码:13502181109
  • 邮箱:angang@ihcams.ac.cn

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age ≥18 years.
  • Documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria.
  • At least one of the following measurable disease indicators:
  • Serum M-protein ≥ 5 g/L
  • Urine M-protein ≥200 mg/24h
  • Serum free light chain (FLC) test: affected FLC level ≥100 mg/L and abnormal serum FLC ratio.
  • Received 1-4 prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory drug, and an anti-CD38 monoclonal antibody (mAb).
  • Willing and able to comply with the prohibitions and restrictions specified in this protocol.

Exclusion Criteria:

  • Prior treatment with both the BCMA-targeted therapy and the GPRC5D-targeted therapy. Patients who have received either BCMA-targeted or GPRC5D-targeted therapy alone are eligible.
  • Known hypersensitivity to any of the ingredients of investigational drug.
  • Diagnosis of plasma cell leukemia(peripheral blood plasma cells ≥5%),or primary light chain amyloidosis.
  • Known active central nervous system (CNS) involvement, or clinical signs and symptoms suggestive of meningeal involvement by multiple myeloma.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:QLS4131

Participants will receive QLS4131 injection until death, disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent to participate in the study, or other reasons for discontinuation of study treatment, whichever occurs first.

QLS4131 will be administered subcutaneously.

有源比较器:The investigator's choice regimen (DPd or PVd )

Participants will receive DPd or PVd until death, disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent to participate in the study, or other reasons for discontinuation of study treatment, whichever occurs first.

The DPd treatment regimen, one cycle every 28 days: Pomalidomide 4mg/d orally, on days 1-21;The PVd treatment regimen, one cycle every 21 days: Pomalidomide 4 mg/d orally, on days 1-14 of each treatment cycle.

The PVd treatment regimen, with one cycle every 21 days: Bortezomib on days 1, 4, 8, and 11 of cycles 1-8, and on days 1 and 8 from cycle 9 onwards.

The DPd treatment regimen, one cycle every 28 days: on days 1, 8, 15, and 22 of cycles 1 and 2; on days 1 and 15 from cycles 3-6; and on day 1 from cycle 7 onwards.

The DPd treatment regimen, one cycle every 28 days: Dexamethasone 20 mg orally, on days 1, 2, 8, 9, 15, 16, 22, and 23 (total 40 mg per week).

The PVd treatment regimen, one cycle every 21 days: Dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, and 12 of cycles 1-8, and on days 1, 2, 8, and 9 from cycle 9 onwards.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
PFS assessed by independent review committee
大体时间:up to 2 years after the last enrolled participant receives the first dose of study drug

PFS is defined as the duration from the date of randomization to either PD or death, whichever comes first. Disease progression will be determined according to the IMWG 2016 response criteria.

up to 2 years after the last enrolled participant receives the first dose of study drug

次要结果测量

结果测量
措施说明
大体时间
PFS assessed by investigator
大体时间:up to 2 years after the last enrolled participant receives the first dose of study drug

PFS is defined as the duration from the date of randomization to either PD or death, whichever comes first. Disease progression will be determined according to the IMWG 2016 response criteria.

up to 2 years after the last enrolled participant receives the first dose of study drug
Very good partial response or better rate
大体时间:up to 2 years after the last enrolled participant receives the first dose of study drug

Very good partial response or better rate is defined as the percentage of participants who achieve very good partial response or better prior to subsequent antimyeloma therapy in accordance with the IMWG 2016 response criteria.

up to 2 years after the last enrolled participant receives the first dose of study drug
Negativity rate of minimal residual disease (MRD)
大体时间:up to 2 years after the last enrolled participant receives the first dose of study drug

Defined as the proportion of participants achieving MRD-negative status.

up to 2 years after the last enrolled participant receives the first dose of study drug
Sustained MRD negativity rate
大体时间:up to 2 years after the last enrolled participant receives the first dose of study drug

Defined as the proportion of participants achieving MRD-negative status and maintaining it for at least 1 year.

up to 2 years after the last enrolled participant receives the first dose of study drug
6-month MRD negativity rate
大体时间:up to 2 years after the last enrolled participant receives the first dose of study drug

The proportion of participants achieving a response of CR or better and MRD-negative status at 6 months post-randomization.

up to 2 years after the last enrolled participant receives the first dose of study drug
12-month MRD negativity rate
大体时间:up to 2 years after the last enrolled participant receives the first dose of study drug

The proportion of participants achieving a response of CR or better and MRD-negative status at 12 months post-randomization.

up to 2 years after the last enrolled participant receives the first dose of study drug
Objective response rate
大体时间:up to 2 years after the last enrolled participant receives the first dose of study drug

Objective response rate is defined as the percentage of participants who achieve PR or better prior to subsequent antimyeloma therapy in accordance with the IMWG 2016 response criteria.

up to 2 years after the last enrolled participant receives the first dose of study drug
Complete response or better rate
大体时间:up to 2 years after the last enrolled participant receives the first dose of study drug

Complete response or better rate is defined as the percentage of participants who achieve CR or better prior to subsequent antimyeloma therapy in accordance with the IMWG 2016 response criteria.

up to 2 years after the last enrolled participant receives the first dose of study drug
Duration of response
大体时间:up to 2 years after the last enrolled participant receives the first dose of study drug

DoR is defined as the time interval between the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease according to the IMWG 2016 response criteria or death from any cause.

up to 2 years after the last enrolled participant receives the first dose of study drug
PFS Rate at 6, 12, and 18 Months
大体时间:6, 12, and 18 months after randomization

Percentage of participants who remain alive and progression-free at 6, 12, and 18 months after randomization, as assessed by both the independent review committee (IRC) and the investigator according to IMWG 2016 response criteria.

6, 12, and 18 months after randomization
Overall survival
大体时间:up to 2 years after the last enrolled participant receives the first dose of study drug

OS is defined as the time from the date of randomization to the date of the participant's death due to any cause.

up to 2 years after the last enrolled participant receives the first dose of study drug
OS Rate at 12 and 24 Months
大体时间:12 and 24 months after randomization

Percentage of participants who remain alive at 12 and 24 months after randomization.

12 and 24 months after randomization
Number of Participants with Treatment-Emergent Adverse events (TEAE) by Severity
大体时间:up to 2 years after the last enrolled participant receives the first dose of study drug

Number of participants with AEs by Severity will be reported.

up to 2 years after the last enrolled participant receives the first dose of study drug
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)
大体时间:up to 2 years after the last enrolled participant receives the first dose of study drug

Change from baseline scores

up to 2 years after the last enrolled participant receives the first dose of study drug

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年12月30日

初级完成 (估计的)

2029年12月14日

研究完成 (估计的)

2030年5月21日

研究注册日期

首次提交

2026年11月6日

首先提交符合 QC 标准的

2026年11月6日

首次发布 (实际的)

2026年11月12日

研究记录更新

最后更新发布 (实际的)

2026年11月12日

上次提交的符合 QC 标准的更新

2026年11月6日

最后验证

2026年11月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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