Japanese POEMS Syndrome with Thalidomide Trial

JMACCT ID: JMA-IIA00084

Registered date:19/03/2012

Basic Information

• Recruitment status: Completed
• 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.

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
• 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
• 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