JMACCT ID: JMA-IIA00084
Registered date:19/03/2012
Japanese POEMS Syndrome with Thalidomide Trial
Basic Information
Recruitment status | Completed |
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Health condition(s) or Problem(s) studied | Crow-Fukase (POEMS) syndrome |
Date of first enrollment | 22/03/2012 |
Target sample size | 24 |
Countries of recruitment | Japan |
Study type | INTERVENTIONAL |
Intervention(s) | Intervention type:DRUG. Intervention1:FPF 300 (thalidomide), Dose form:CAPSULE, Route of administration:ORAL. |
Outcome(s)
Primary Outcome | Adverse event associated with FPF 300. |
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Secondary Outcome | 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. |
Key inclusion & exclusion criteria
Age minimum | >=20 YEARS |
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Age maximum | No Limit |
Gender | BOTH |
Include 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 |
Exclude 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 |
Related Information
Primary Sponsor | J-POST Clinical Trial Office |
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Secondary Sponsor | 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 |
Source(s) of Monetary Support | Japan Medical Association |
Contact
public contact | |
Name | Sonoko Misawa |
Address | Department of Neurology,Inohana 1-8-1, Chuo-ku, Chiba-shi, Chiba 260-8670, Japan |
Telephone | +81-43-222-7171 |
sonoko.m@mb.infoweb.ne.jp | |
Affiliation | Chiba University, Graduate School of Medicine |
scientific contact | |
Name | Sonoko Misawa |
Address | Department of Neurology,Inohana 1-8-1, Chuo-ku, Chiba-shi, Chiba 260-8670, Japan |
Telephone | +81-43-222-7171 |
Affiliation | Chiba University, Graduate School of Medicine |