UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029806
Receipt number R000034052
Scientific Title The outcomes of chemotherapy for light chain amyloidosis(AL amyloidosis): Retrospective analysis
Date of disclosure of the study information 2017/11/02
Last modified on 2017/11/02 15:31:00

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Basic information

Public title

The outcomes of chemotherapy for light chain amyloidosis(AL amyloidosis): Retrospective analysis

Acronym

The outcomes of chemotherapy for light chain amyloidosis(AL amyloidosis): Retrospective analysis

Scientific Title

The outcomes of chemotherapy for light chain amyloidosis(AL amyloidosis): Retrospective analysis

Scientific Title:Acronym

The outcomes of chemotherapy for light chain amyloidosis(AL amyloidosis): Retrospective analysis

Region

Japan


Condition

Condition

AL amyloidosis

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to assess hematological response, organ response, safety and overall survival rate of the chemotherapy, including bortezomib and lenalidomide for AL amyloidosis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Overall survival rate

Key secondary outcomes

Response rate
Relapse rate
Adverse event
Event-free survival
Time to next treatment


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

16 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Inclusion criteria for this study:
(1) diagnosis of AL amyloidosis between January 2008 and December 2016
(2) ages >= 16

Key exclusion criteria

none

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Emiko Sakaida

Organization

Chiba University Hospital

Division name

Department of Hematology

Zip code


Address

1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba

TEL

043-222-7171

Email

esakaida@faculty.chiba-u.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yusuke Takeda

Organization

Chiba University Hospital

Division name

Department of Hematology

Zip code


Address

1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba

TEL

043-222-7171

Homepage URL


Email

take-you@hospital.chiba-u.jp


Sponsor or person

Institute

Department of Hematology, Chiba University Hospital

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Other

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



Other administrative information

Date of disclosure of the study information

2017 Year 11 Month 02 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

Enrolling by invitation

Date of protocol fixation

2017 Year 10 Month 03 Day

Date of IRB


Anticipated trial start date

2017 Year 11 Month 02 Day

Last follow-up date

2017 Year 12 Month 31 Day

Date of closure to data entry

2017 Year 12 Month 31 Day

Date trial data considered complete

2018 Year 01 Month 31 Day

Date analysis concluded

2018 Year 03 Month 31 Day


Other

Other related information

Retrospective multicenter analysis


Management information

Registered date

2017 Year 11 Month 02 Day

Last modified on

2017 Year 11 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034052


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name