POEMS Syndrome Clinical Trials

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A Single-center, Prospective, Open-label Investigation of the KCD (Carfilzomib/Cyclophosphamide/Dexamethasone) Regimen for the Treatment of Newly Diagnosed POEMS Syndrome

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Shanghai Changzheng Hospital
RECRUITING
Shanghai
Contact Information
Primary
Haiyan He, Dr.
doctorhehaiyan@126.com
+86 13661513012
Backup
Xuerou Yu
Time Frame
Start Date: 2026-06-15
Estimated Completion Date: 2028-01
Participants
Target number of participants: 20
Treatments
Experimental: carfilzomib, cyclophosphamide and dexamethasone
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 in 28 days cycles
Related Therapeutic Areas
Sponsors
Leads: Shanghai Changzheng Hospital

This content was sourced from clinicaltrials.gov