KCD (Carfilzomib/Cyclophosphamide/Dexamethasone) Regimen for the Treatment of Newly Diagnosed POEMS Syndrome
A Single-center, Prospective, Open-label Investigation of the KCD (Carfilzomib/Cyclophosphamide/Dexamethasone) Regimen for the Treatment of Newly Diagnosed POEMS Syndrome
Shanghai Changzheng Hospital
20 participants
Jun 15, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria10
- Newly diagnosed POEMS syndrome meeting the Dispenzieri diagnostic criteria (2023 version);
- Age 18-75 years;
- ECOG performance status 0-3, with an estimated life expectancy >3 months;
- No active infective diseases;
- No prior anti-POEMS therapy except for corticosteroids;
- 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;
- 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;
- Ability to swallow and take medication orally;
- Completion of all screening and assessments as outlined in the study protocol;
- Signed informed consent for chemotherapy.
Exclusion Criteria10
- POEMS syndrome complicated by multiple myeloma, light chain amyloidosis, or Waldenström macroglobulinemia;
- HIV positivity, or active hepatitis A, hepatitis B, or hepatitis C infection; or hepatitis B virus DNA >10\^2 copies/mL;
- 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;
- 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;
- Severe active infections (e.g., untreated tuberculosis, pulmonary aspergillosis);
- Presence of other malignancies (except non-melanoma skin cancer, in situ cervical, bladder, or breast cancer with disease-free survival >5 years);
- Epilepsy requiring medication, dementia, or other mental status abnormalities that interfere with understanding or complying with the study protocol;
- Drug use, medical, psychological, or social conditions that may interfere with study participation or outcome assessment;
- Pregnancy or breastfeeding;
- Any condition deemed by the investigator to make the patient unsuitable for enrollment.
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Interventions
carfilzomib at a dose of 27 mg/m2 (20 mg/m2 only in the first infusion) intravenously (iv) on days 1, 8, and 15,cyclophosphamide at a dose of 200 mg/m2 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
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07652879