NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JMACCT ID: JMA-IIA00084

Registered date:19/03/2012

Japanese POEMS Syndrome with Thalidomide Trial

Basic Information

Recruitment status Completed
Health condition(s) or Problem(s) studiedCrow-Fukase (POEMS) syndrome
Date of first enrollment22/03/2012
Target sample size24
Countries of recruitmentJapan
Study typeINTERVENTIONAL
Intervention(s)Intervention type:DRUG. Intervention1:FPF 300 (thalidomide), Dose form:CAPSULE, Route of administration:ORAL.

Outcome(s)

Primary OutcomeAdverse event associated with FPF 300.
Secondary Outcome1. 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
Age maximumNo Limit
GenderBOTH
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

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
E-mail 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
E-mail
Affiliation Chiba University, Graduate School of Medicine