UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of MRD detection by multiparameter flow cytometry among EuroFlow, Kameda-flow and SRL-flow methods
Acronym	Comparison of MRD detection by multiparameter flow cytometry
Scientific Title	Comparison of MRD detection by multiparameter flow cytometry among EuroFlow, Kameda-flow and SRL-flow methods
Scientific Title:Acronym	Comparison of MRD detection by multiparameter flow cytometry
Region	Japan

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

Objectives
Narrative objectives1	Comparison of minimal residual disease (MRD) levels among EuroFlow, Kameda-flow and SRL-flow methods
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation of minimal residual disease (MRD) levels among EuroFlow, Kameda-flow and SRL-flow methods
Key secondary outcomes	1) 1-year and 3-year progression-free survival (PFS) after MRD assessment. 2) 1-year and 3-year overall survival (OS) after MRD assessment. 3) MRD negativity

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with symptomatic multiple myeloma by IMWG criteria who achieved at least partial response (PR).
Key exclusion criteria	patients who are incapacitated are excluded.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Hiroyuki Middle name Last name Takamatsu
Organization	Kanazawa University
Division name	Hematology/Respiratory Medicine
Zip code	920-8641
Address	13-1 Takaramachi, Kanazawa, Ishikawa 920-8641, JAPAN
TEL	076-265-2276
Email	takamaz@staff.kanazawa-u.ac.jp

Public contact
Name of contact person	1st name Hiroyuki Middle name Last name Takamatsu
Organization	Kanazawa University
Division name	Hematology/Respiratory Medicine
Zip code	920-8641
Address	13-1 Takaramachi, Kanazawa, Ishikawa 920-8641, JAPAN
TEL	076-265-2276
Homepage URL
Email	takamaz@staff.kanazawa-u.ac.jp

Sponsor
Institute	Hematology/Respiratory Medicine, Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University
Institute
Department

Funding Source
Organization	SRL Inc.
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	Kanazawa University
Address	13-1 Takaramachi, Kanazawa, Ishikawa 920-8641, JAPAN
Tel	076-265-2110
Email	rinri@adm.kanazawa-u.ac.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	金沢大学附属病院（石川県）

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 10 Day

Related information
URL releasing protocol	https://www.nature.com/articles/s41598-021-89761-9.pdf
Publication of results	Published

Result
URL related to results and publications	https://www.nature.com/articles/s41598-021-89761-9
Number of participants that the trial has enrolled	69
Results	We found Duraclone is a good option to evaluate MRD as the EuroFlow 8-color 2-tube method in multiple myeloma but it should be used with caution and some discrepancies between them may have resulted because of the difference in the number of cells analyzed and antibody panels. Therefore, a sufficient cell acquisition number (more than 5 x 10*6) is essential to achieve high sensitivity in MRD detection in MM.
Results date posted	2022 Year 10 Month 05 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2021 Year 05 Month 27 Day
Baseline Characteristics	Patients with multiple myeloma
Participant flow	After getting the written informed concent, patients took part in this study.
Adverse events	non
Outcome measures	Comparison of MRD levels between DuraClone and EuroFlow 8-color 2-tube methods.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2017 Year 06 Month 28 Day
Date of IRB	2017 Year 06 Month 21 Day
Anticipated trial start date	2017 Year 11 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Minimal residual disease (MRD) levels by EuroFlow, Kameda-flow and SRL-flow. 1 and 3 year-PFS post-MRD assessment. 1 and 3 year-OS post-MRD assessment.

Management information
Registered date	2017 Year 10 Month 01 Day
Last modified on	2022 Year 10 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033563