UMIN-CTR Clinical Trial

Public title

Survey on Minimal Residual Disease (MRD) Measurement in Multiple Myeloma

Acronym

Survey on Minimal Residual Disease (MRD) Measurement in Multiple Myeloma

Scientific Title

Survey on Minimal Residual Disease (MRD) Measurement in Multiple Myeloma

Scientific Title:Acronym

Survey on Minimal Residual Disease (MRD) Measurement in Multiple Myeloma

Region

Japan

Condition

Multiple Myeloma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To analyze the current status of MRD measurement and its issues in Japan and clarify unmet medical needs

Basic objectives2

Others

Basic objectives -Others

Not applicable

Trial characteristics_1

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

To analyze the actual status of MRD measurement and its issues in the treatment of multiple myeloma and clarify unmet medical needs

1_Whether or not minimal residual disease (MRD) is measured
2_Whether or not imaging tests (PET/CT, MRI) are performed
3_Reasons for not measuring MRD
4_MRD measurement method
5_Criteria (detection sensitivity)
6_Purpose of measuring
7_Frequency of measurement

Key secondary outcomes

I.To clarify the prospects for the MRD measurement method as a prognostic factor in the future
II.To provide a basis for future evidence generation activities

1_Purpose of MRD measurement
2_What is needed to promote MRD measurement
3_Challenges of imaging tests

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Those who meet all of the following inclusion criteria will be included:

1_Belong to the department of hematology
2_Work at a hospital (with 80 beds or more)
3_Treated "at least 2 patients with multiple myeloma in the last year" or "at least 1 patient per month"
4_Agreed to participate in the survey

Key exclusion criteria

Not applicable

Target sample size

150

Name of lead principal investigator

1st name	Heigoroh
Middle name
Last name	Shirai

Organization

Sanofi K.K.

Division name

Oncology Medical in Specialty Care

Zip code

160-0023

Address

Tokyo Opera City Tower, 3-20- 2, Nishi Shinjuku, Shinjuku-ku, Tokyo, Japan

TEL

03-6301-3000

Email

Heigoroh.Shirai@sanofi.com

Name of contact person

1st name	Tomoyuki
Middle name
Last name	Kusaka

Organization

Social Survey Research Information Co., Ltd.

Division name

Healthcare BI & MA Service Division Health Outcomes Research

Zip code

162-0067

Address

NMF Shinjuku EAST Bldg., 10-5 Tomihisacho, Shinjuku-ku, Tokyo, Japan

TEL

03-6709-9710

Homepage URL

Email

HOR@ssri.com

Institute

Sanofi K.K.

Institute

Department

Personal name

Organization

Sanofi K.K.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Review Committee, Kitamachi Clinic, Toukeikai Medical Corporation

Address

1-1-3 Kichijoji-Kita-machi, Musashino-shi, Tokyo

Tel

03-6779-8166

Email

chi-pr-ec-kitamachi@cmicgroup.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

10

Month

12

Day

URL releasing protocol

N/A (not available)

Publication of results

Published

URL related to results and publications

https://www.jstage.jst.go.jp/article/ijm/14/6/14_53/_article/-char/ja

Number of participants that the trial has enrolled

158

Results

An online survey was conducted among 158 Japanese hematologists to clarify MRD measurement in multiple myeloma. Of them, 85% (n=135) utilized MRD in routine practice, mainly to evaluate treatment response (79%) and assist with treatment planning (73%). The most common sensitivity threshold was 10^-5 (39%), and flow cytometry was predominant (96%). While >70% desired future MRD use, the results highlighted the need for further evidence regarding the correlation of MRD status with response and prognosis.

Results date posted

2026

Year

06

Month

05

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participants were recruited from registered hematologists on the Japanese medical information website "m3.com". Eligible physicians were restricted to those affiliated with a hematology department of a medium-to-large hospital (>80 beds) who had treated two or more patients with MM in the previous year (or at least one patient with MM per month).
The demographics and facility characteristics of the 158 included physicians were as follows:

Age (years):
20-29 (4.4%)
30-39 (31.6%)
40-49 (23.4%)
50-59 (21.5%)
>=60 (19.0%)

Institute type:
University hospital (26.6%)
National/public hospital (29.7%)
General hospital (43.7%)

Number of beds:
80-99 (1.3%)
100-199 (10.1%)
200-299 (5.7%)
300-399 (15.8%)
400-499 (8.9%)
>=500 (58.2%)

Facility clinical capabilities:
Cancer treatment coordination base hospital (72.8%)
Hematopoietic SCT available (67.1%)
Outpatient chemotherapy facility (93.7%)

Participant flow

A total of 231 member physicians accessed the online questionnaire survey. Among them, 71 respondents were excluded due to lack of consent (n=4), screening failure (n=45), or incomplete questionnaires (n=22). Although 160 physicians completed all survey questions, 2 respondents were excluded due to inappropriate or invalid responses (e.g., excessively rapid completion or repetitive choices). Consequently, a final analysis set of 158 physicians was established and evaluated.

Adverse events

Because this study was a cross-sectional, observational questionnaire survey directed at physicians with the specific objective of clarifying the clinical reality and challenges of MRD measurement, queries regarding adverse events or product complaints were not included. Furthermore, as the questionnaire utilized a closed-ended format, the collected data did not contain any reports or evaluations of such events or complaints.

Outcome measures

Primary Objective: To analyze the actual status of MRD measurement and its issues in the treatment of multiple myeloma and clarify unmet medical needs

1_Whether or not minimal residual disease (MRD) is measured
2_Whether or not imaging tests (PET/CT, MRI) are performed
3_Reasons for not measuring MRD
4_MRD measurement method
5_Criteria (detection sensitivity)
6_Purpose of measuring
7_Frequency of measurement


Secondary Objective:
I.To clarify the prospects for the MRD measurement method as a prognostic factor in the future
II.To provide a basis for future evidence generation activities

1_Purpose of MRD measurement
2_What is needed to promote MRD measurement
3_Challenges of imaging tests

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2023

Year

04

Month

14

Day

Date of IRB

2023

Year

05

Month

24

Day

Anticipated trial start date

2023

Year

06

Month

05

Day

Last follow-up date

2023

Year

06

Month

26

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

To examine the relationship between the actual status of MRD measurement and measurement decision by subgroup*
1_Whether or not minimal residual disease (MRD) is measured
2_Criteria (detection sensitivity)

*The subgroups are assumed to be as follows:
1_Type of facility
2_Number of patients with multiple myeloma seen

Registered date

2023

Year

10

Month

12

Day

Last modified on

2026

Year

06

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059876