UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027778
Receipt number R000031839
Scientific Title Drug Use-results survey for Mantle cell lymphoma of Velcade Injection 3mg
Date of disclosure of the study information 2017/06/19
Last modified on 2023/12/21 14:13:05

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Basic information

Public title

Drug Use-results survey for Mantle cell lymphoma of Velcade Injection 3mg

Acronym

Drug Use-results survey for Mantle cell lymphoma of Velcade Injection 3mg

Scientific Title

Drug Use-results survey for Mantle cell lymphoma of Velcade Injection 3mg

Scientific Title:Acronym

Drug Use-results survey for Mantle cell lymphoma of Velcade Injection 3mg

Region

Japan


Condition

Condition

Mantle cell lymphoma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To primarily investigate the safety of VELCADE Injection 3 mg (hereinafter referred to as VELCADE) under actual conditions of use in patients with mantle cell lymphoma (MCL), and also to examine efficacy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Safety(Adverse Drug Reaction)
Effectiveness(Best assessment result)

Key secondary outcomes



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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with untreated MCL who receive VELCADE (in combination with R-CAP) for the first time.

Key exclusion criteria

NA

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Toshiya
Middle name
Last name Kato

Organization

Janssen Pharmaceutical K.K

Division name

Safety Risk Management Dept.

Zip code

101-0065

Address

5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo

TEL

04-4411-5478

Email

tkato1@its.jnj.com


Public contact

Name of contact person

1st name Keiko
Middle name
Last name Imai

Organization

Janssen Pharmaceutical K.K

Division name

Safety Risk Management Dept.

Zip code

101-0065

Address

5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo

TEL

080-2361-8773

Homepage URL


Email

kimai4@its.jnj.com


Sponsor or person

Institute

Janssen Pharmaceutical K.K

Institute

Department

Personal name



Funding Source

Organization

Janssen Pharmaceutical K.K

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Janssen Pharmaceutical K.K

Address

5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo

Tel

080-2361-8773

Email

kimai4@its.jnj.com


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 06 Month 19 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

No longer recruiting

Date of protocol fixation

2015 Year 06 Month 19 Day

Date of IRB

2015 Year 06 Month 19 Day

Anticipated trial start date

2015 Year 09 Month 08 Day

Last follow-up date

2022 Year 12 Month 17 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Drug use result survey


Management information

Registered date

2017 Year 06 Month 16 Day

Last modified on

2023 Year 12 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031839


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name