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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000042502
Receipt No. R000047571
Scientific Title Multicenter retrospective analysis of Elotuzumab, lenalidomide plus dexamethasone in relapsed or refractory multiple myeloma
Date of disclosure of the study information 2020/11/20
Last modified on 2020/11/19

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Basic information
Public title Multicenter retrospective analysis of Elotuzumab, lenalidomide plus dexamethasone in relapsed or refractory multiple myeloma
Acronym Multicenter retrospective analysis of Elotuzumab, lenalidomide plus dexamethasone in relapsed or refractory multiple myeloma
Scientific Title Multicenter retrospective analysis of Elotuzumab, lenalidomide plus dexamethasone in relapsed or refractory multiple myeloma
Scientific Title:Acronym Multicenter retrospective analysis of Elotuzumab, lenalidomide plus dexamethasone in relapsed or refractory multiple myeloma
Region
Japan

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

Objectives
Narrative objectives1 Purpose is to analyze efficacy and tolerability of Elotuzumab, lenalidomide plus dexamethasone in the patients with relapsed of refractory multiple myeloma.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes overall response rate, very good partial response rate, complete response rate
Key secondary outcomes progression free survival
overall survival
time to nexuses treatment

Base
Study type Others,meta-analysis etc

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Cases are diagnosed as multiple myeloma.
Cases received 4 cycles or more of Elotuzumab, lenalidomide plus dexamethasone (ERd) from November 2016 to June 2018.
Key exclusion criteria Cases received ERd as clinical trial.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Kenshi
Middle name
Last name Suzuki
Organization Japan Red Cross Medical Center
Division name Hematology
Zip code 150-0012
Address 4-1-22 Hiroo, Shibuya-ku, Tokyo, Japan
TEL 03-3400-1311
Email ken-suzuki@mtb.biglobe.ne.jp

Public contact
Name of contact person
1st name Kenshi
Middle name
Last name Suzuki
Organization Japan Red Cross Medical Center
Division name Hematology
Zip code 150-0012
Address 4-1-22 Hiroo, Shibuya-ku, Tokyo, Japan
TEL 03-3400-1311
Homepage URL
Email ken-suzuki@mtb.biglobe.ne.jp

Sponsor
Institute Japan Red Cross Medical Center
Institute
Department

Funding Source
Organization Bristol-Myers Squibb
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Shonan Kamakura Hospital
the Jikei University Kashiwa Hospital
Disaster Medical Center
Shibukawa Medical Center
Japan Red Cross Himeji Medical Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization Japan Red Cross Medical Center
Address 4-1-22, Hiroo, Shibuya-ku, Tokyo, Japan
Tel 03-3400-1311
Email ken-suzuki@mtb.biglobe.ne.jp

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 11 Month 20 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 50
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
2018 Year 10 Month 17 Day
Date of IRB
2018 Year 10 Month 04 Day
Anticipated trial start date
2019 Year 01 Month 01 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2020 Year 11 Month 19 Day
Last modified on
2020 Year 11 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047571

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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