Unique ID issued by UMIN | UMIN000014493 |
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Receipt number | R000016819 |
Scientific Title | Single arm open-label trial to investigate the efficacy and safety of Lenlidomide as a treatment for recurrent or refractory Crow-Fukase (POEMS) syndrome. |
Date of disclosure of the study information | 2014/07/08 |
Last modified on | 2014/07/07 12:04:27 |
Single arm open-label trial to investigate the efficacy and safety of Lenlidomide as a treatment for recurrent or refractory Crow-Fukase (POEMS) syndrome.
Single arm open-label trial to investigate the efficacy and safety of Lenlidomide as a treatment for recurrent or refractory Crow-Fukase (POEMS) syndrome.
Single arm open-label trial to investigate the efficacy and safety of Lenlidomide as a treatment for recurrent or refractory Crow-Fukase (POEMS) syndrome.
Single arm open-label trial to investigate the efficacy and safety of Lenlidomide as a treatment for recurrent or refractory Crow-Fukase (POEMS) syndrome.
Japan |
Crow-Fukase (POEMS) syndrome
Hematology and clinical oncology | Neurology |
Others
NO
This study investigates the efficacy and safety of Lenalidomide as a treatment for recurrent or refractory POEMS (Crow-Fukase) syndrome.
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
Reduction rate of serum VEGF after 24 weeks
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Cycle1 : Lenalidomide 15mg/day (day 1-21)
Cycle2-6 : Lenalidomide 25mg/day (day 1-21)
Dexamethasone 20mg/day (day 2. 9, 16, 23)
20 | years-old | <= |
Not applicable |
Male and Female
(1) Patients with Crow-Fukase syndrome (confirmed by diagnostic criteria.)
(2) Patients with recurrent or refractory Crow-Fukase syndrome.
(3) Patients without severe liver or renal dysfunction.
(4) Patients without severe neutropenia or thrombocytopenia.
(5) Patients without clinically problematic ECG findings
(6) Negative on the pregnacy test on the day 1 of cycle 1.
(7) Patients who can undertake prevention of pregnancy, if necessary.
(8) Patients with written informed consent.
(9) Patients who are capable of ambulatory hospital visits every 4 weeks.
(10) Patients with informed consent to the registration and rules of RevMate.
(1) Patients who have been administered, bortezomib, lenalidomide, melpharan within 4 weeks prior to the registration.
(2) Patients who have been on steroid treatment (more than 10mg/day in predonine) within 2 weeks prior to the registration.
(3) Patients who have been administered bevacizumab within 12 weeks prior to the registration.
(4) Patients who could worsen acutely during the clinical trial period.
(5) Patients with severe complicaitons ( cardiac failure, renal failure liver failure, bleeding enterogastric ulcer, ileus, poorly controlled diabetes.
(6) Patients with malignancies.
(7) Female patients who are pregnant or desire childbearing. Males who desire fertility.
(8) Patients who allergic to lenalidomide or dexamethasone.
5
1st name | |
Middle name | |
Last name | Sonoko Misawa |
Chiba University Graduate School of Medicine
Department of Neurology
1-8-1 Inohana Chuo-ku, Chiba 260-8670
043-226-2129
sonoko.m@mb.infoweb.ne.jp
1st name | |
Middle name | |
Last name | Sonoko Misawa |
Chiba University Graduate School of Medicine
Department of Neurology
1-8-1 Inohana Chuo-ku, Chiba 260-8670
043-226-2129
sonoko.m@mb.infoweb.ne.jp
Chiba University Graduate School of Medicine
Chiba university hospital
Self funding
NO
千葉大学医学部付属病院
2014 | Year | 07 | Month | 08 | Day |
Unpublished
Open public recruiting
2014 | Year | 04 | Month | 23 | Day |
2014 | Year | 07 | Month | 01 | Day |
2014 | Year | 07 | Month | 07 | Day |
2014 | Year | 07 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016819
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