UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004179
Receipt number R000005019
Scientific Title Thalidomide Treatment for Crow Fukase (POEMS) Syndrome: A Multicenter, Randomized, Double blind, Placebo controlled, Parallel group Trial with an Extension Phase to Evaluate the Long term Safety
Date of disclosure of the study information 2010/09/10
Last modified on 2016/07/28 10:38:52

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Basic information

Public title

Thalidomide Treatment for Crow Fukase (POEMS) Syndrome: A Multicenter, Randomized, Double blind, Placebo controlled, Parallel group Trial with an Extension Phase to Evaluate the Long term Safety

Acronym

J - POST Trial

Scientific Title

Thalidomide Treatment for Crow Fukase (POEMS) Syndrome: A Multicenter, Randomized, Double blind, Placebo controlled, Parallel group Trial with an Extension Phase to Evaluate the Long term Safety

Scientific Title:Acronym

J - POST Trial

Region

Japan


Condition

Condition

Crow-Fukase (POEMS)syndrome

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of FPF 300 (thalidomide) compared to placebo in patients with Crow-Fukase (POEMS) syndrome and also to evaluate the long-term safety and efficacy of FPF 300.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Reduction rate of serum VEGF level at 24 weeks

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

FPF300 100-300mg/day

Interventions/Control_2

FPF300-palacebo 100-300mg/day

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) Over 20 years old
(3) Patients whose ECOG Performance Status not exceeding 3
(4) Patients whose overall neuropathy limitaion scale not exceeding 9
(5) Patients whose liver function test and renal function test are within below limits. AST (GOT) smaller than 4.0 X upper limit of normal ALT (GPT) smaller than 4.0 X upper limit of normal Creatinine smaller than 1.5 X upper limit of normal
(6) Patients who are capable of undergoing in hospital examinations at the time of starting and quitting the trial.
(7) Patients who are capable of ambulatory hospital visits.
(8) Patients who have an clinicaly probrematic ECG
(9) Patients with written informed consent.
(10) Patients who are not candidates for high dose chemotherapy with autologous stem cel rescue
(11) Patients with informed consent to thalidomide education and risk management system

Key exclusion criteria

(1) Patients who have recieved thalidomide, melpharan, or bortezomib within 24 weeks prior to the informed consent.
(2) Pateints who could worsen acutely during the clinical trial period
(3) Patients who have recieved oral or intravenous administration of steroid (not including inhalant) within 4 weeks of providing informed consent.
(4) Females who are pregnant or desire childbearing. Males who desire fertility
(5) Patients who have severe complications (cardiac failure, renal failure, liver failure, bleedin ulcer, ileus, diabetes with poorly controlled hyperglycemia)
(6) Patients who have other malignancy
(7) Patients with past medical history of allergy to thalidomide or dexamethasone
(8) Patients with serious mental disorder
(9) Patients who have participated in other clinical trials within 12 weeks prior to the informed consent.
(10) Patients who have received drugs or therapy prohibited in the clinical trial within 4 weeks
(11) Patients who are not appropriate to participate to the trial

Target sample size

24


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Satoshi Kuwabara

Organization

Chiba University, Graduate School of Medicine

Division name

Department of Neurology

Zip code


Address

Inohana 1-8-1, Chuo-ku, Chiba-shi, Chiba 260-8670, Japan

TEL

043-222-7171

Email

kuwabara-s@faculty.chiba-u.jp


Public contact

Name of contact person

1st name
Middle name
Last name Sonoko Misawa

Organization

Chiba University, Graduate School of Medicine

Division name

Department of Neurology

Zip code


Address

Inohana 1-8-1, Chuo-ku, Chiba-shi, Chiba 260-8670, Japan

TEL

043-222-7171

Homepage URL

http://www.m.chiba-u.ac.jp/class/neurol/kenkyu/ishisyudou/index.html

Email

sonoko.m@mb.infoweb.ne.jp


Sponsor or person

Institute

Chiba University, Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Japan Medical Association

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

北海道大学(北海道)、北海道医療センター(北海道)、東北大学(宮城県)、千葉大学(千葉県)、埼玉医科大学(埼玉県)、新潟大学(新潟県)、信州大学(長野県)、名古屋大学(愛知県)、近畿大学(大阪府)、神戸市立医療センター中央市民病院(兵庫県)、山口大学(山口県)、九州大学(福岡県)、鹿児島大学(鹿児島県)


Other administrative information

Date of disclosure of the study information

2010 Year 09 Month 10 Day


Related information

URL releasing protocol

http://opac.ll.chiba-u.jp/da/curator/100005/?lang=1

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

2010 Year 05 Month 31 Day

Date of IRB


Anticipated trial start date

2010 Year 11 Month 11 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 09 Month 09 Day

Last modified on

2016 Year 07 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005019


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name