[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650255":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":11,"responsibleParty":25,"collaborators":11,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":33,"acronym":11,"eligibilityCriteria":34,"healthyVolunteers":30,"sex":35,"minAge":36,"maxAge":11,"enrollmentInfo":37,"targetDuration":11,"studyType":40,"phases":41,"briefSummary":43,"conditions":44,"keywords":11,"overallStatus":46,"whyStopped":11,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":11},{"fullName":5,"class":6},"Beijing Anzhen Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"XDd","EXPERIMENTAL",null,[13],"Drug: XDd",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","Selinexor (X): 40 mg orally once weekly (QW) Daratumumab (D): 1800 mg per dose, subcutaneous injection; administered once weekly during cycles 1-2, once every 2 weeks during cycles 3-6, and once every 4 weeks from cycle 7 onward. One cycle is 4 weeks.\n\nDexamethasone (d): 20-40 mg once weekly (QW)",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},"Yini Wang","CONTACT","+86-010-84005477","wangyini@ccmu.edu.cn",{"type":26,"investigatorFullName":21,"investigatorTitle":27,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Principal Investigator","100650255","phase-2-selinexor-daratumumab-and-dexamethasone-xdd-for-light-chain-cardiac-amyloidosis-100650255",false,"NCT07743957","Selinexor, Daratumumab, and Dexamethasone (XDd) for Light-Chain Cardiac Amyloidosis","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","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Confirmed systemic light-chain amyloidosis, meeting both of the following:\n\n  1. 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.\n  2. Evidence of monoclonal immunoglobulin or free light chain in serum or urine, or detection of monoclonal plasma cells\u002FB cells in bone marrow examination.\n* 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:\n\n  1. Mean ventricular wall thickness \\> 12 mm on echocardiography, with other cardiac diseases excluded; or\n  2. NT-proBNP \\> 332 ng\u002FL in the absence of renal insufficiency and atrial fibrillation.\n* Mayo 2004 stage IIIa or IIIb disease, including newly diagnosed and relapsed\u002Frefractory patients.\n* Measurable disease in light-chain amyloidosis, defined by at least one of the following:\n\n  1. Serum monoclonal protein ≥ 0.5 g\u002FdL by serum protein electrophoresis and immunofixation performed by the central laboratory;\n  2. Serum free light chain ≥ 50 mg\u002FL with an abnormal kappa\u002Flambda ratio; or\n  3. Difference between involved and uninvolved free light chains (dFLC) ≥ 50 mg\u002FL. Note: Urine Bence Jones proteinuria alone is not sufficient to define measurable disease for eligibility.\n* 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.\n* 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.\n\nExclusion Criteria:\n\n* Active hepatitis B virus (HBV) infection, hepatitis C virus (HCV) infection, or other acquired or congenital immunodeficiency disorders.\n* Baseline peripheral neuropathy or neuropathic pain of grade ≥ 2 according to NCI CTCAE v4.0.\n* Major surgery within 30 days before enrollment.\n* Epilepsy requiring medication, dementia, or other psychiatric conditions that prevent understanding of or compliance with the study protocol.\n* Any severe physical or psychiatric illness that may interfere with participation in this clinical study.\n* Any other condition that the investigator considers unsuitable for enrollment.","ALL","18 Years",{"count":38,"type":39},63,"ESTIMATED","INTERVENTIONAL",[42],"PHASE2","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:\n\nDoes 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?",[45],"Light-chain Cardiac Amyloidosis","NOT_YET_RECRUITING","2026-08-12",{"date":49,"type":50},"2026-08-13","ACTUAL",{"date":52,"type":39},"2026-07-13",{"date":54,"type":39},"2028-06-01",{"name":5,"class":6}]