Japanese POEMS Syndrome with Thalidomide Trial
Phase 3
Completed
- Conditions
- Crow-Fukase (POEMS) syndrome
- Registration Number
- JPRN-jRCT2091220084
- Lead Sponsor
- J-POST Clinical Trial Office
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
(1) Patients who complete the precede J-post 10 trial
(2) Patients who have an clinicaly probrematic ECG
(3) Patients with written informed consent.
(4) Patients with informed consent to thalidomide education and risk management system
Exclusion Criteria
(1) Patients who have severe complications (cardiac failure, renal failure, liver failure)
(2) Patients who have recieved oral or intravenous administration of steroid (not including inhalant)
(3) 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 Adverse event associated with FPF 300
- Secondary Outcome Measures
Name Time Method 1. Serum VEGF level<br>2. Achievement of targeted value (< 1000 pg/ml) of serum VEGF level <br>3. Motor function(grip strength,ONLS)<br>4. Median nerve conducton study (conduction velocity, CMAP amplitude, F-wave latency) <br>5. M protein (immunofixation)<br>6. Pleural effusion<br>7. Body weight<br>8. Response rate<br>9. Overall survival<br>10. Progression free survival<br>11. Time to treatment failure<br>12. Total adverse event