UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014493
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

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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 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


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

Value
https://center6.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