NCT07652879 KCD (Carfilzomib/Cyclophosphamide/Dexamethasone) Regimen for the Treatment of Newly Diagnosed POEMS Syndrome
| NCT ID | NCT07652879 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shanghai Changzheng Hospital |
| Condition | POEMS Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-06-15 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2026-06-15 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 \<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.
Contact & Investigator
Haiyan He, Dr.
PRINCIPAL INVESTIGATOR
Shanghai Changzheng Hospital
Frequently Asked Questions
Who can join the NCT07652879 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying POEMS Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07652879 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07652879 currently recruiting?
Yes, NCT07652879 is actively recruiting participants. Contact the research team at doctorhehaiyan@126.com for enrollment information.
Where is the NCT07652879 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07652879 clinical trial?
NCT07652879 is sponsored by Shanghai Changzheng Hospital. The principal investigator is Haiyan He, Dr. at Shanghai Changzheng Hospital. The trial plans to enroll 20 participants.