UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042502 |
|---|---|
| Receipt number | 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 17:31:29 |
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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
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
ken-suzuki@mtb.biglobe.ne.jp
Sponsor or person
Institute
Japan Red Cross Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047571
