Crow-Fukase (POEMS) syndrome
Conditions
Sponsors
J-POST Clinical Trial Office
Hokkaido University, Hokkaido Medical Center, Tohoku University, Chiba University, Saitama Medical University, Niigata University, Shinshu University, Nagoya University, Kinki University, Kobe City Medical Center General Hospital, Yamaguchi University, Kyushu University, Kagoshima University
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event associated with FPF 300 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Serum VEGF level 2. Achievement of targeted value (< 1000 pg/ml) of serum VEGF level 3. Motor function(grip strength,ONLS) 4. Median nerve conducton study (conduction velocity, CMAP amplitude, F-wave latency) 5. M protein (immunofixation) 6. Pleural effusion 7. Body weight 8. Response rate 9. Overall survival 10. Progression free survival 11. Time to treatment failure 12. Total adverse event | — |
Countries
Japan
Contacts
Public ContactSonoko Misawa
Chiba University, Graduate School of Medicine
Outcome results
None listed