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

Recruiting now · Phase 2

Conditions studied: POEMS Syndrome

In brief

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.

Key facts

Study ID

NCT07652879

Run by

Shanghai Changzheng Hospital

People needed

20

Starts

2026-06-15

Expected to finish

2028-01-01

Last updated by the study team

2026-06-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Shanghai Changzheng Hospital — Shanghai, China (enrolling)

Full record on ClinicalTrials.gov

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