UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009903
Receipt number R000011604
Scientific Title Thrombosis in anti-cancer therapy by bortezomib for multiple myeloma
Date of disclosure of the study information 2013/01/30
Last modified on 2013/01/30 12:54:38

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Basic information

Public title

Thrombosis in anti-cancer therapy by bortezomib for multiple myeloma

Acronym

Bortezomib and thrombosis

Scientific Title

Thrombosis in anti-cancer therapy by bortezomib for multiple myeloma

Scientific Title:Acronym

Bortezomib and thrombosis

Region

Japan


Condition

Condition

multiple myeloma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Thrombosis in anti-cancer therapy by bortezomib for multiple myeloma

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

measurement of thrombosis-related markers

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

Prevention

Type of intervention

Medicine

Interventions/Control_1

Bortemizob

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

multiple myeloma

Key exclusion criteria

pregnancy and allergy

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shosaku Nomura

Organization

Kansai Medical University

Division name

First Department of Internal Medicine

Zip code


Address

10-15, Fumizono-cho, Moriguchi

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Kansai medical Unversity

Division name

First Department of Internal Medicine

Zip code


Address


TEL

06-6993-9453

Homepage URL


Email



Sponsor or person

Institute

Shosaku Nomura

Institute

Department

Personal name



Funding Source

Organization

Kansai Medical University

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



Other administrative information

Date of disclosure of the study information

2013 Year 01 Month 30 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

2013 Year 01 Month 07 Day

Date of IRB


Anticipated trial start date

2013 Year 01 Month 07 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

2013 Year 01 Month 30 Day

Last modified on

2013 Year 01 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011604


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name