NCT07743957尚未招募2 期
Selinexor Combined With Daratumumab and Dexamethasone (XDd) for the Treatment of Patients With Advanced Light-Chain Cardiac Amyloidosis: A Prospective, Multicenter, Phase II Clinical Study
Beijing Anzhen Hospital0 个研究点目标入组 63 人开始时间: 2026年7月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 63
- 主要终点
- Hematologic complete response rate
研究概览
简要总结
The goal of this clinical trial is to evaluate whether selinexor combined with daratumumab and dexamethasone (XDd) can treat patients with advanced light-chain cardiac amyloidosis. The main questions it aims to answer are:
Does XDd regimen achieve hematologic complete response in patients with advanced light-chain cardiac amyloidosis? Does XDd regimen improve cardiac response, organ response, progression-free survival, overall survival, quality of life, and safety?
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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.
- •Confirmed systemic light-chain amyloidosis, meeting both of the following:
- •Tissue biopsy confirms amyloid deposition, and the amyloid precursor protein is immunoglobulin light chain or heavy-light chain. Pathologic evidence includes at least one of the following: Congo red staining positive with apple-green birefringence under polarized light microscopy; Light-chain restricted expression demonstrated by immunohistochemistry, immunofluorescence, or immunoelectron microscopy, or mass spectrometry confirming the precursor protein as immunoglobulin light chain; Electron microscopy showing nonbranching, rigid, randomly arranged fibrils with a diameter of 8 to 14 nm.
- •Evidence of monoclonal immunoglobulin or free light chain in serum or urine, or detection of monoclonal plasma cells/B cells in bone marrow examination.
- •Clinical manifestations, physical examination, laboratory tests, or imaging studies confirm involvement of one or more organs, with mandatory cardiac involvement. Cardiac involvement is defined as either:
- •Mean ventricular wall thickness > 12 mm on echocardiography, with other cardiac diseases excluded; or
- •NT-proBNP > 332 ng/L in the absence of renal insufficiency and atrial fibrillation.
- •Mayo 2004 stage IIIa or IIIb disease, including newly diagnosed and relapsed/refractory patients.
- •Measurable disease in light-chain amyloidosis, defined by at least one of the following:
- •Serum monoclonal protein ≥ 0.5 g/dL by serum protein electrophoresis and immunofixation performed by the central laboratory;
- •Serum free light chain ≥ 50 mg/L with an abnormal kappa/lambda ratio; or
- •Difference between involved and uninvolved free light chains (dFLC) ≥ 50 mg/L. Note: Urine Bence Jones proteinuria alone is not sufficient to define measurable disease for eligibility.
- •Not pregnant or breastfeeding. Men and women of childbearing potential must agree to use appropriate contraception before treatment, during treatment, during any treatment interruption, and for 4 weeks after treatment completion.
- •Written informed consent has been signed by the participant. If the participant is unable to sign because of their medical condition, informed consent may be signed by a legal guardian or immediate family member.
排除标准
- •Active hepatitis B virus (HBV) infection, hepatitis C virus (HCV) infection, or other acquired or congenital immunodeficiency disorders.
- •Baseline peripheral neuropathy or neuropathic pain of grade ≥ 2 according to NCI CTCAE v4.
- •Major surgery within 30 days before enrollment.
- •Epilepsy requiring medication, dementia, or other psychiatric conditions that prevent understanding of or compliance with the study protocol.
- •Any severe physical or psychiatric illness that may interfere with participation in this clinical study.
- •Any other condition that the investigator considers unsuitable for enrollment.
研究组 & 干预措施
XDd
Experimental
干预措施: XDd (Drug)
结局指标
主要结局
Hematologic complete response rate
时间窗: From enrollment to the end of treatment at 1 year
次要结局
- Overall survival(From first dose until date of death from any cause, assessed up to 12 months.)
- Cardiac organ response rate(From enrollment to the end of treatment at 1 year)
- Organ response rate (heart, kidney, and liver)(From enrollment to the end of treatment at 1 year)
- Duration of response(From first documented response until documented progression or death, assessed up to 1 years.)
- Time to response(From first dose until first documented response, assessed up to 1 years)
- Progression-free survival(From first dose until date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.)
- Quality of life assessed by EORTC QLQ-C30(Through study completion, up to 1 year.)
- Incidence and Severity of Adverse Events(From the first dose through 28 days after the last dose)
- Biomarker Outcome: dFLC(Baseline and every 4 weeks during treatment, up to 12 months.)
- Biomarker outcome: NT-proBNP(Baseline and every 4 weeks during treatment, up to 12 months.)
- Biomarker outcome: MRD(Baseline and at end of treatment, up to 12 months.)
研究者
Yini Wang
Principal Investigator
Beijing Anzhen Hospital
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