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