UMIN-CTR Clinical Trial

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
Email	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
Email	h-kosugi@umin.ac.jp

Sponsor
Institute	Ogaki Municipal Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052418