[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641381":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":34,"responsibleParty":46,"collaborators":30,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":30,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":30,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":36,"whyStopped":30,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Shanghai Changzheng Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"carfilzomib, cyclophosphamide and dexamethasone","EXPERIMENTAL","carfilzomib at a dose of 27 mg\u002Fm2 (20 mg\u002Fm2 only in the first infusion) intravenously (iv) on days 1, 8, and 15, cyclophosphamide at a dose of 200 mg\u002Fm2 iv on days 1, 8 and 15, and dexamethasone at a dose of 20 mg (10 mg for patients \\>75 years) days 1, 2, 8, 9, 15 and 16 in 28 days cycles",[13],"Drug: CARFILZOMIB, CYCLOPHOSPHAMIDE, DEXAMETHASONE",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","CARFILZOMIB, CYCLOPHOSPHAMIDE, DEXAMETHASONE","carfilzomib at a dose of 27 mg\u002Fm2 (20 mg\u002Fm2 only in the first infusion) intravenously (iv) on days 1, 8, and 15,cyclophosphamide at a dose of 200 mg\u002Fm2 iv on days 1, 8 and 15 and dexamethasone at a dose of 20 mg (10 mg for patients \\>75 years) days 1, 2, 8, 9, 15 and 16",[9],[21],"KCD",[23],{"name":24,"affiliation":5,"role":25},"Haiyan He, Dr.","PRINCIPAL_INVESTIGATOR",[27,32],{"name":24,"role":28,"phone":29,"phoneExt":30,"email":31},"CONTACT","+86 13661513012",null,"doctorhehaiyan@126.com",{"name":33,"role":28,"phone":30,"phoneExt":30,"email":30},"Xuerou Yu",[35],{"facility":5,"status":36,"city":37,"state":30,"zip":30,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":30},"RECRUITING","Shanghai","China","CN",{"type":41,"coordinates":42},"Point",[43,44],121.45806,31.22222,{"lat":44,"lon":43},{"type":25,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Haiyan He","Associate chief physician","100641381","phase-2-kcd-carfilzomibcyclophosphamidedexamethasone-regimen-for-the-treatment-of-newly-diagnosed-poems-syndrome-100641381",false,"NCT07652879","KCD (Carfilzomib\u002FCyclophosphamide\u002FDexamethasone) Regimen for the Treatment of Newly Diagnosed POEMS Syndrome","A Single-center, Prospective, Open-label Investigation of the KCD (Carfilzomib\u002FCyclophosphamide\u002FDexamethasone) Regimen for the Treatment of Newly Diagnosed POEMS Syndrome","Inclusion Criteria:\n\n1. Newly diagnosed POEMS syndrome meeting the Dispenzieri diagnostic criteria (2023 version);\n2. Age 18-75 years;\n3. ECOG performance status 0-3, with an estimated life expectancy \\>3 months;\n4. No active infective diseases;\n5. No prior anti-POEMS therapy except for corticosteroids;\n6. No severe organic impairment of major organs, meeting the following laboratory requirements: creatinine clearance ≥40 mL\u002Fmin, total bilirubin ≤1.5 × upper limit of normal (ULN); AST and ALT ≤2.5 × ULN; cardiac enzymes \\\u003C2 × ULN; left ventricular ejection fraction within normal range on echocardiography, and no clinically significant electrocardiogram abnormalities;\n7. Absolute neutrophil count ≥1.5 × 10\\^9\u002FL without prior growth factor support; platelet count ≥50 × 10\\^9\u002FL without platelet transfusion within 7 days prior to screening; hemoglobin ≥60 g\u002FL;\n8. Ability to swallow and take medication orally;\n9. Completion of all screening and assessments as outlined in the study protocol;\n10. Signed informed consent for chemotherapy.\n\nExclusion Criteria:\n\n1. POEMS syndrome complicated by multiple myeloma, light chain amyloidosis, or Waldenström macroglobulinemia;\n2. HIV positivity, or active hepatitis A, hepatitis B, or hepatitis C infection; or hepatitis B virus DNA \\>10\\^2 copies\u002FmL;\n3. Concurrent severe unstable medical conditions, including heart failure, renal failure, liver failure, bleeding disorders, arterial\u002Fvenous thrombotic events within 6 months, uncontrolled diabetes mellitus, or a history of active hemorrhagic cystitis;\n4. History of autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) within the past 2 years that caused end-organ damage or required systemic immunosuppressive or disease-modifying therapy;\n5. Severe active infections (e.g., untreated tuberculosis, pulmonary aspergillosis);\n6. Presence of other malignancies (except non-melanoma skin cancer, in situ cervical, bladder, or breast cancer with disease-free survival \\>5 years);\n7. Epilepsy requiring medication, dementia, or other mental status abnormalities that interfere with understanding or complying with the study protocol;\n8. Drug use, medical, psychological, or social conditions that may interfere with study participation or outcome assessment;\n9. Pregnancy or breastfeeding;\n10. Any condition deemed by the investigator to make the patient unsuitable for enrollment.","ALL","18 Years","75 Years",{"count":60,"type":61},20,"ESTIMATED","INTERVENTIONAL",[64],"PHASE2","This study is a single-center, prospective, open-label clinical study to evaluate the efficacy and safety of KCD(Carfilzomib\u002FCyclophosphamide\u002FDexamethasone) regimen in subjects with newly diagnosed POEMS Syndrome.",[67],"POEMS Syndrome",[69],"POEMS syndrome, Carfilzomib","2026-06-16",{"date":72,"type":73},"2026-06-17","ACTUAL",{"date":75,"type":61},"2026-06-15",{"date":77,"type":61},"2028-01",{"name":5,"class":6},1]