KCD Regimen for Newly Diagnosed POEMS Syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, open-label phase 2 trial enrolling about 20 adults with newly diagnosed POEMS syndrome. Participants will receive 6-8 cycles of the KCD regimen to assess safety and response. POEMS is a rare plasma cell disorder with neuropathy and other systemic features; this study builds on limited prior evidence of carfilzomib use in POEMS. The study is conducted at Shanghai Changzheng Hospital and does not include a control group. Primary goals focus on efficacy signals and tolerability of the regimen in first-line therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai Changzheng Hospital
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Haiyan He, Dr. — Shanghai Changzheng Hospital
• Study coordinator: Haiyan He, Dr.
• Email: doctorhehaiyan@126.com
• Phone: +86 13661513012

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.