UMIN-CTR Clinical Trial

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
Institute	Janssen Pharmaceutical K.K
Institute
Department

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	Open public recruiting
Date of protocol fixation	2015 Year 06 Month 19 Day
Date of IRB
Anticipated trial start date	2015 Year 09 Month 08 Day
Last follow-up date
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	2019 Year 12 Month 19 Day

Link to view the page
URL(English)	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

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