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Recruiting NCT07652879

KCD (Carfilzomib/Cyclophosphamide/Dexamethasone) Regimen for the Treatment of Newly Diagnosed POEMS Syndrome

Conditions: POEMS Syndrome

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 20
Sponsor: Shanghai Changzheng Hospital

Location: Shanghai Changzheng Hospital Shanghai

Summary

This study is a single-center, prospective, open-label clinical study to evaluate the efficacy and safety of KCD(Carfilzomib/Cyclophosphamide/Dexamethasone) regimen in subjects with newly diagnosed POEMS Syndrome.

Eligibility Criteria

Inclusion Criteria: 1. Newly diagnosed POEMS syndrome meeting the Dispenzieri diagnostic criteria (2023 version); 2. Age 18-75 years; 3. ECOG performance status 0-3, with an estimated life expectancy \>3 months; 4. No active infective diseases; 5. No prior anti-POEMS therapy except for corticosteroids; 6. No severe organic impairment of major organs, meeting the following laboratory requirements: creatinine clearance ≥40 mL/min, total bilirubin ≤1.5 × upper limit of normal (ULN); AST and ALT ≤2.5 × ULN; cardiac enzymes \10\^2 copies/mL; 3. Concurrent severe unstable medical conditions, including heart failure, renal failure, liver failure, bleeding disorders, arterial/venous thrombotic events within 6 months, uncontrolled diabetes mellitus, or a history of active hemorrhagic cystitis; 4. 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; 5. Severe active infections (e.g., untreated tuberculosis, pulmonary aspergillosis); 6. Presence of other malignancies (except non-melanoma skin cancer, in situ cervical, bladder, or breast cancer with disease-free survival \>5 years); 7. Epilepsy requiring medication, dementia, or other mental status abnormalities that interfere with understanding or complying with the study protocol; 8. Drug use, medical, psychological, or social conditions that may interfere with study participation or outcome assessment; 9. Pregnancy or breastfeeding; 10. Any condition deemed by the investigator to make the patient unsuitable for enrollment.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07652879). StuddyBuddy aggregates publicly available trial information.