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

RecruitingPhase 2Ages 18 Years - 75 YearsAllShanghai Changzheng Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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 \<2 × ULN; left ventricular ejection fraction within normal range on echocardiography, and no clinically significant electrocardiogram abnormalities; 7. Absolute neutrophil count ≥1.5 × 10\^9/L without prior growth factor support; platelet count ≥50 × 10\^9/L without platelet transfusion within 7 days prior to screening; hemoglobin ≥60 g/L; 8. Ability to swallow and take medication orally; 9. Completion of all screening and assessments as outlined in the study protocol; 10. Signed informed consent for chemotherapy. Exclusion Criteria: 1. POEMS syndrome complicated by multiple myeloma, light chain amyloidosis, or Waldenström macroglobulinemia; 2. HIV positivity, or active hepatitis A, hepatitis B, or hepatitis C infection; or hepatitis B virus DNA \>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.
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What it tests

  • CARFILZOMIB, CYCLOPHOSPHAMIDE, DEXAMETHASONE
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Where

1 site
Shanghai Changzheng Hospital
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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