UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018660 |
|---|---|
| Receipt number | R000021237 |
| Scientific Title | Japanese POEMS syndrome with thalidmaide trial for compassionate use |
| Date of disclosure of the study information | 2015/08/17 |
| Last modified on | 2022/01/11 15:30:42 |
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Basic information
Public title
Japanese POEMS syndrome with thalidmaide trial for compassionate use
Acronym
Japanese POEMS syndrome with thalidmaide trial for compassionate use (JPOST15)
Scientific Title
Japanese POEMS syndrome with thalidmaide trial for compassionate use
Scientific Title:Acronym
Japanese POEMS syndrome with thalidmaide trial for compassionate use (JPOST15)
Region
| Japan |
Condition
Condition
Crow-Fukase(POEMS) syndrome
Classification by specialty
| Hematology and clinical oncology | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to provide FPF300 in POEMS syndrome for compationate use and to investigate long term safty and efficacy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety:Adverse event during FPF300 treatment
Efficacy:Overall survival
Key secondary outcomes
1.Serum VEGF level
2.Motor function(Manual Muscle Test, grip strength,ONLS)
3.Median nerve conducton study (conduction velocity, CMAP amplitude, F-wave latency, SNAP amplitudes), Sural nerve conduction study (SNAP amlitudes and conduction velocity)
4.M protein (immunofixation)
5. Pleural effusion
6. Body weight
Base
Study type
Interventional
Study design
Basic design
expanded access
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
FPF300 (thalidomide)100-300mg/day,at bedtime +Dexamethasone 20mg/day (day1-4)
Duration:until the approval of thalidomide for POEMT syndrome
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients with Crow-Fukase syndrome (confirmed by diagnostic criteria)
(2) Patients aged 20 and older
(3) Patients without severe liver or renal dysfunction
(4) Patients without clinicaly probrematic ECG findings or severe bradycardia which require treatment.
(5) Patients with written informed consent
(6) Patients with informed consent to thalidomide education and risk management system
Key exclusion criteria
(1) Patients with the complication which leading to a high risk of severe adversed event by thalidomide (Absolute neutrophil count < 1000, Platelet count< 50000, repeated ileus,severe cardiac arrhythmias)
(2) Female patients who are pregnant, desire childbearing or breastfeeding
(3) Males patients who desire fertility.
(4) Patients with severe complicaitons ( cardiac failure, renal failure liver failure, bleeding enterogastric ulcer, ileus, poorly controlled diabetes)
(5) Patients who allergic to thalidomide
(6) Patients with severe phychiatric disorders
(7) Patients who has been participated any other clinical trial
(8)Patients who are not appropriate to participate to the trial
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Kuwabara |
Organization
Chiba University, Graduate School of Medicine
Division name
Department of Neurology
Zip code
2608677
Address
Inohana 1-8-1, Chuo-ku, Chiba-shi, Chiba 260-8670, Japan
TEL
0432227171
syukari536@chiba-u.jp
Public contact
Name of contact person
| 1st name | Kanako |
| Middle name | |
| Last name | Katayama |
Organization
Chiba University Hospital
Division name
Clinical research center
Zip code
2608677
Address
Inohana 1-8-1, Chuo-ku, Chiba-shi, Chiba 260-8670, Japan
TEL
0432227171
Homepage URL
katayama-k@umin.net
Sponsor or person
Institute
Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Chiba university hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical research center, Chiba university hospital
Address
1-8-1 Inohana Chuo-ku Chiba city
Tel
0432227171
yamazaki@office.chiba-u.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 13 | Day |
Last modified on
| 2022 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021237
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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