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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041478
Receipt No. R000047347
Scientific Title Sarclisa Special Drug Use Investigation (Relapsed or refractory multiple myeloma)
Date of disclosure of the study information 2020/08/31
Last modified on 2020/08/20

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Basic information
Public title Sarclisa Special Drug Use Investigation (Relapsed or refractory multiple myeloma)
Acronym Sarclisa Special Drug Use Investigation (Relapsed or refractory multiple myeloma)
Scientific Title Sarclisa Special Drug Use Investigation (Relapsed or refractory multiple myeloma)
Scientific Title:Acronym Sarclisa Special Drug Use Investigation (Relapsed or refractory multiple myeloma)
Region
Japan

Condition
Condition Relapsed or refractory multiple myeloma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To collect the safety and effectiveness information of use of Sarclisa in Japanese patients with relapsed or refractory multiple myeloma.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety (Adverse Drug Reaction)
Key secondary outcomes Effectiveness

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 who will receive the treatment with Sarclisa.
Key exclusion criteria NA
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Masahiro
Middle name
Last name TAMURA
Organization Sanofi K.K.
Division name Post-authorization regulatory studies, Medical Affairs
Zip code 163-1488
Address 3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo
TEL 03-6301-3867
Email Sanofi_Medical@sanofi.com

Public contact
Name of contact person
1st name Public contact for Drug use surveillance
Middle name
Last name -
Organization Sanofi K.K.
Division name Post-authorization regulatory studies, Medical Affairs
Zip code 163-1488
Address 3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo
TEL 03-6301-3867
Homepage URL
Email Sanofi_Medical@sanofi.com

Sponsor
Institute Sanofi K.K.
Institute
Department

Funding Source
Organization Sanofi 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 -
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
2020 Year 08 Month 31 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
2020 Year 07 Month 31 Day
Date of IRB
2020 Year 07 Month 31 Day
Anticipated trial start date
2020 Year 08 Month 31 Day
Last follow-up date
2022 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Special Drug Use Investigation

Management information
Registered date
2020 Year 08 Month 20 Day
Last modified on
2020 Year 08 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047347

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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