Japanese POEMS syndrome with thalidmaide trial for compassionate use
Not Applicable
- Conditions
- Crow-Fukase(POEMS) syndrome
- Registration Number
- JPRN-UMIN000018660
- Lead Sponsor
- Chiba University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Not provided
Exclusion Criteria
(1) Patients with the complication which leading to a high risk of severe adversed event by thalidomide (Absolute neutrophil count < 1000, Platelet count< 50000, repeated ileus,severe cardiac arrhythmias) (2) Female patients who are pregnant, desire childbearing or breastfeeding (3) Males patients who desire fertility. (4) Patients with severe complicaitons ( cardiac failure, renal failure liver failure, bleeding enterogastric ulcer, ileus, poorly controlled diabetes) (5) Patients who allergic to thalidomide (6) Patients with severe phychiatric disorders (7) Patients who has been participated any other clinical trial (8)Patients who are not appropriate to participate to the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety:Adverse event during FPF300 treatment Efficacy:Overall survival
- Secondary Outcome Measures
Name Time Method 1.Serum VEGF level 2.Motor function(Manual Muscle Test, grip strength,ONLS) 3.Median nerve conducton study (conduction velocity, CMAP amplitude, F-wave latency, SNAP amplitudes), Sural nerve conduction study (SNAP amlitudes and conduction velocity) 4.M protein (immunofixation) 5. Pleural effusion 6. Body weight