UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046387 |
|---|---|
| Receipt number | R000052418 |
| Scientific Title | Retrospective study of immune response post COVID-19 vaccination in patients with multiple myeloma and related disease |
| Date of disclosure of the study information | 2021/12/20 |
| Last modified on | 2021/12/15 20:22:21 |
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Basic information
Public title
Retrospective study of immune response post COVID-19 vaccination in patients with multiple myeloma and related disease
Acronym
Retrospective study of immune response post COVID-19 vaccination in patients with multiple myeloma and related disease
Scientific Title
Retrospective study of immune response post COVID-19 vaccination in patients with multiple myeloma and related disease
Scientific Title:Acronym
Retrospective study of immune response post COVID-19 vaccination in patients with multiple myeloma and related disease
Region
| Japan |
Condition
Condition
multiple myeloma and related disease
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the immune response in patients with multiple myeloma and related disease after vaccination with mRNA vaccine against SARS-COV-2.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
correlation between serum antibody titer to SARS-COV2-S after vaccination and the length of time after vaccination
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 plasma cell disorders whose serum anti-S antibody titer was measured after SARS-CoV-2 vaccination.
Key exclusion criteria
Patient who is considered ineligible for enrolling the study by a principal investigator or sub-investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kosugi |
Organization
Ogaki Municipal Hospital
Division name
Department of Hematology
Zip code
503-8502
Address
4-86 Minaminokawa-cho, Ogaki City, Gifu
TEL
0584-81-3341
h-kosugi@umin.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kosugi |
Organization
Ogaki Municipal Hospital
Division name
Department of Hematology
Zip code
503-8502
Address
4-86 Minaminokawa-cho, Ogaki City, Gifu
TEL
0584-81-3341
Homepage URL
h-kosugi@umin.ac.jp
Sponsor or person
Institute
Ogaki Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Ogaki municipal hospital Institutional Review Board
Address
4-86 Minaminokawa-cho, Ogaki City, Gifu
Tel
0584-81-3341
clinical-trial@omh.ogaki.gifu.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
大垣市民病院（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | 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
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
| 2021 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients with plasma cell disorders whose serum anti-S antibody titer was measured after SARS-CoV-2 vaccination between October and November 2021.
Management information
Registered date
| 2021 | Year | 12 | Month | 15 | Day |
Last modified on
| 2021 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052418
