KCD (Carfilzomib/Cyclophosphamide/Dexamethasone) Regimen for the Treatment of Newly Diagnosed POEMS Syndrome
Condition(s) studied
Investigational drug(s) / intervention(s)
CARFILZOMIB, CYCLOPHOSPHAMIDE, 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
Study 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
Primary outcome measure(s)
- Overall hematological response rate — 2 years
hematological response rate: * Complete Remission (CR\_H): Normal bone marrow; negative serum and urine immunofixation electrophoresis; disappearance of M-protein. * Very Good Partial Remission (VGPR\_H): Reduction of M-protein by \>90% (baseline M-protein ≥5 g/L). * Partial Remission (PR\_H): Reduction of M-protein by ≥50% (baseline M-protein ≥10 g/L). * No Response (NR\_H): Failure to meet criteria for PR\_H. * Progressive Disease (PD): Reappearance of M-protein in serum and/or urine, or an increase of \>25% from the lowest level (with absolute M-protein increase ≥5 g/L). - Overall VEGF response rate — 2 years
VEGF response rate: * Complete Remission (CR\_V): Normalization of serum VEGF (elevation typically defined as serum VEGF \>2 times the upper limit of normal). * Partial Remission (PR\_V): Reduction of VEGF by ≥50%. * No Response (NR\_V): Failure to meet criteria for PR\_V. * Progressive Disease (PD): Persistent (≥2 consecutive measurements) elevation of VEGF , or persistent elevation of VEGF by 50% from the post-treatment nadir. - Overall neurological response rate — 2 years
Neurological response rate: Neurologic improvement assessed by neurophysiologic examination, modified Rankin Scale, or Overall Neuropathy Limitations Scale (ONLS). 1. Complete response: 0 point; 2. Improvement: Improved by 1 point; 3. Progression: Worsened by 1 point
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Shanghai Changzheng Hospital | Shanghai | China | Recruiting |
More Shanghai Changzheng Hospital trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07652879 on ClinicalTrials.gov ↗ ← All trials in China