UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014493
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public 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.
Acronym Single arm open-label trial to investigate the efficacy and safety of Lenlidomide as a treatment for recurrent or refractory Crow-Fukase (POEMS) syndrome.
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.
Scientific Title:Acronym Single arm open-label trial to investigate the efficacy and safety of Lenlidomide as a treatment for recurrent or refractory Crow-Fukase (POEMS) syndrome.
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 This study investigates the efficacy and safety of Lenalidomide as a treatment for recurrent or refractory POEMS (Crow-Fukase) syndrome.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Reduction rate of serum VEGF after 24 weeks
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
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 Cycle1 : Lenalidomide 15mg/day (day 1-21)

Cycle2-6 : Lenalidomide 25mg/day (day 1-21)

Dexamethasone 20mg/day (day 2. 9, 16, 23)
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 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.
Key exclusion criteria (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.

Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sonoko Misawa
Organization Chiba University Graduate School of Medicine
Division name Department of Neurology
Zip code
Address 1-8-1 Inohana Chuo-ku, Chiba 260-8670
TEL 043-226-2129
Email sonoko.m@mb.infoweb.ne.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 1-8-1 Inohana Chuo-ku, Chiba 260-8670
TEL 043-226-2129
Homepage URL
Email sonoko.m@mb.infoweb.ne.jp

Sponsor
Institute Chiba University Graduate School of Medicine
Institute
Department

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
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 千葉大学医学部付属病院

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 08 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 Open public recruiting
Date of protocol fixation
2014 Year 04 Month 23 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 01 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
2014 Year 07 Month 07 Day
Last modified on
2014 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016819

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.