Thalidomide Treatment for Crow Fukase (POEMS) Syndrome: a Multicenter, Randomized, Double blind, Placebo controlled, Parallel group Trial with an Extension Phase to Evaluate the Long term Safety

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2010
INTERVENTION: FPF300 100‐300mg/day FPF300‐palacebo 100‐300mg/day CONDITION: Crow‐Fukase (POEMS)syndrome PRIMARY OUTCOME: Reduction rate of serum VEGF level at 24 weeks INCLUSION CRITERIA: (1) Patients with Crow‐Fukase syndrome (confirmed by diagnostic criteria) (2) Over 20 years old (3) Patients whose ECOG Performance Status not exceeding 3 (4) Patients whose overall neuropathy limitaion scale not exceeding 9 (5) Patients whose liver function test and renal function test are within below limits. AST (GOT) smaller than 4.0 X upper limit of normal ALT (GPT) smaller than 4.0 X upper limit of normal Creatinine smaller than 1.5 X upper limit of normal (6) Patients who are capable of undergoing in hospital examinations at the time of starting and quitting the trial. (7) Patients who are capable of ambulatory hospital visits. (8) Patients who have an clinicaly probrematic ECG (9) Patients with written informed consent. (10) Patients who are not candidates for high dose chemotherapy with autologous stem cel rescue (11) Patients with informed consent to thalidomide education and risk management system
Epistemonikos ID: 428bb161e3b6242445a710febdbc6d51bf8bf187
First added on: Aug 22, 2024