NCT06895512尚未招募3 期
A Randomized, Double-blind, Parallel-controlled, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of HLX15-IV Versus DARZALEX® in Combination with Lenalidomide-Dexamethasone (Rd) in Transplant-ineligible Patients with Newly Diagnosed Multiple Myeloma
Shanghai Henlius Biotech1 个研究点 分布在 1 个国家目标入组 386 人开始时间: 2025年4月最近更新:
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 386
- 试验地点
- 1
- 主要终点
- IRC-assessed Week 24 rate of very good partial response (VGPR) or better
研究概览
简要总结
This is a randomized, double-blind, parallel-controlled, multicenter, phase III study to compare the efficacy and safety of HLX15-IV in combination with Rd (HLX15-IV-Rd) versus DARZALEX® in combination with Rd (D-Rd) in patients with NDMM who are ineligible for autologous stem cell transplantation (ASCT).
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)
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
- •Capable to understand and sign the ICF.
- •Patients aged ≥ 18 years .
- •Patient must have documented multiple myeloma (MM) satisfying the International Myeloma Working Group (IMWG) diagnostic criteria for MM.
- •Newly diagnosed, untreated and not considered candidate for autologous stem cell transplantation (ASCT).
- •Patient must have an ECOG performance status score of
- •Patient must have pretreatment clinical laboratory values.
- •Contraceptive use by men or women should be consistent with local regulations.
- •A WOCBP must have a negative serum pregnancy test at screening within 72 hours prior to randomization.
排除标准
- •Patient has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), Waldenström's disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions.
- •Patient has plasma cell leukemia or POEMS syndrome .
- •Patient has prior or current systemic therapy or ASCT for MM before randomization.
- •Patient has peripheral neuropathy or neuropathic pain Grade 2 or higher.
- •Patient has a history of malignancy (other than MM) within 3 years before randomization .
- •Patient has clinical signs of meningeal involvement of MM.
- •Patient has known COPD, persistent asthma, or a history of asthma within the last 2 years.
- •Patient is known to be seropositive for history of human immunodeficiency virus (HIV) or known to have treponema pallidum antibodies (Anti-TP).
- •Patient is known to have active hepatitis B or C.
- •Patient has any concurrent medical or psychiatric condition or disease that is likely to interfere with the study procedures or results.
- •Patient has clinically significant cardiac disease.
- •Patient has known allergies, hypersensitivity, or intolerance to treatment drugs.
- •Patient has history of drug abuse or substance abuse.
- •Patient is a woman who is pregnant, or breast-feeding, or planning to become pregnant or donate eggs (ova, oocytes).
- •Patient had radiation therapy within 14 days of randomization.
- •Patient had plasmapheresis within 28 days of randomization.
- •Patient had major surgery within 28 days before randomization.
- •Patient in clinical trials of any other drug or device within 3 months before randomization.
- •Patient has any condition could prevent, limit, or confound the protocol-specified assessments.
研究组 & 干预措施
HLX15-IV-Rd
Experimental
HLX15-IV in combination with Lenalidomide-Dexamethasone (Rd)
干预措施: HLX15-IV (Drug)
DARZALEX-Rd
Active Comparator
DARZALEX in combination with Lenalidomide-Dexamethasone (Rd)
干预措施: Darzalex (Drug)
结局指标
主要结局
IRC-assessed Week 24 rate of very good partial response (VGPR) or better
时间窗: 24 weeks
the percentage of patients achieving VGPR or CR (including sCR) until Week 24 after the date of randomization.
次要结局
- Time to reach maximum serum drug concentration at steady state (Tmax, ss)(48 weeks)
- Investigator-assessed Week 24 rate of VGPR or better(24 weeks)
- IRC- and investigator-assessed partial response (PR) rate(48 weeks)
- IRC- and investigator-assessed complete response (CR) or better rate(48 weeks)
- IRC- and investigator-assessed time to response (TTR)(48 weeks)
- IRC- and investigator-assessed progression free survival (PFS)(48 weeks)
- IRC- and investigator-assessed Week 12, 36 and 48 rate of VGPR or better(12,36,48 weeks)
- IRC- and investigator-assessed overall response rate(48 weeks)
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Health Status (EORTC-QLQ-C30).(48 weeks)
- Time to reach maximum serum drug concentration(Tmax)(48 weeks)
- IRC- and investigator-assessed complete response (CR) rate(48 weeks)
- IRC- and investigator-assessed stringent complete response (sCR) rate(48 weeks)
- IRC- and investigator-assessed duration of response (DOR)(48 weeks)
- Minimal residual disease (MRD) negative rate(48 weeks)
- EuroQoL 5-Dimension 5-Level Health Status (EQ-5D-5L) Questionnaire.(48 weeks)
- Immunogenicity(48 weeks)
- Incidence and severity of adverse events (AEs)(52 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Comparison of Efficacy, Pharmacodynamics, Safety, and Immunogenicity Between Bmab 1000 and Prolia® in Postmenopausal Women With OsteoporosisPostmenopausal Women With OsteoporosisNCT05345691Biocon Biologics UK Ltd479
进行中（未招募）
3 期
A Randomized, Double-blind, Placebo Controlled Phase III Study to Investigate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy (Carboplatin-Nanoparticle Albumin Bound (Nab) Paclitaxel) in Patients With Stage IIIB/IIIC or IV NSCLCSquamous Non Small Cell Lung CancerNCT04033354Shanghai Henlius Biotech537
进行中（未招募）
3 期
Clinical Study to Evaluate the Efficacy and Safety of TQB2440 Injection/Perjeta® Combined With Trastuzumab and Docetaxel in the Treatment of Patients With Early or Locally Advanced Breast Cancer.HER2-positive Breast CancerNCT05985187Chia Tai Tianqing Pharmaceutical Group Co., Ltd.412
进行中（未招募）
3 期
A Clinical Trial Comparing HLX10 With Placebo Combined With Chemotherapy (Cisplatin + 5-fu) in the First-line Treatment of Locally Advanced/Metastatic Esophageal Squamous Cell Carcinoma (ESCC)Esophageal Squamous Cell CarcinomaNCT03958890Shanghai Henlius Biotech489
已完成
3 期
A Multicenter, Double-blind, Randomized, Parallel-group, Phase III Study of the Efficacy and Safety of QL1701 Plus Docetaxel Versus Herceptin® Plus Docetaxel as First Line Therapy in Patients With HER2-positive Metastatic Breast CancerBreast CancerNCT05629949Qilu Pharmaceutical Co., Ltd.474