UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029367
Receipt number R000033563
Scientific Title Comparison of MRD detection by multiparameter flow cytometry among EuroFlow, Kameda-flow and SRL-flow methods
Date of disclosure of the study information 2017/10/10
Last modified on 2022/10/05 14:05:53

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033563


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name