UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022238
Receipt number R000025606
Scientific Title Prognostic value of minimal residual disease detection by multiparameter flow cytometry (EuroFlow method) in patients with multiple myeloma who underwent autologous stem cell transplantation: comparison with sequencing-based method
Date of disclosure of the study information 2016/05/23
Last modified on 2020/05/11 12:28:21

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Basic information

Public title

Prognostic value of minimal residual disease detection by multiparameter flow cytometry (EuroFlow method) in patients with multiple myeloma who underwent autologous stem cell transplantation: comparison with sequencing-based method

Acronym

Prognostic value of MRD detection by MFC in MM patients who underwent ASCT: comparison with NGS

Scientific Title

Prognostic value of minimal residual disease detection by multiparameter flow cytometry (EuroFlow method) in patients with multiple myeloma who underwent autologous stem cell transplantation: comparison with sequencing-based method

Scientific Title:Acronym

Prognostic value of MRD detection by MFC in MM patients who underwent ASCT: comparison with NGS

Region

Japan


Condition

Condition

multiple myeloma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Comparison in minimal residual disease (MRD) detection among multiparametric flow cytometry methods and next-generation sequencing (NGS)-based method

Basic objectives2

Others

Basic objectives -Others

To compare EuroFlow and the modified EuroFlow (BML Flow) methods with the NGS-based method that is considered to be the most reliable for MRD detection in post-ASCT bone marrow (BM) and assess the prognostic value of MRD detection by MFC and NGS in patients with MM in the ASCT setting.

Trial characteristics_1

Others

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The correlation of MRD levels between BML-Flow and original EuroFlow methods.

Key secondary outcomes

1) 1-year PFS post-ASCT and 3-year PFS post-ASCT
2) 1-year OS post-ASCT and 3-year OS post-ASCT
3) MRD negative rate in BM post-ASCT


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 newly diagnosed MM who received induction regimens including bortezomib/ lenalidomide/ thalidomide prior to ASCT will be screened and analyzed. The patients receive high-dose melphalan (200 mg/sqm) plus ASCT in the hospitals of our research group and maintenance therapy using lenalidomide. MM is diagnosed according to the IMWG criteria, and the response of patients to therapy is assessed using the International Uniform Response Criteria. The response of patients must be CR or stringent CR (sCR) on days 100-365 post-ASCT. The diagnostic samples which include frozen BM cells/BM aspirate smear slide samples/BM non-decalcified clot samples must be obtained for the MRD analysis using NGS.

Key exclusion criteria

The patients who the physicians in charge judge to be inappropriate to participate in this trial.

Target sample size

49


Research contact person

Name of lead principal investigator

1st name Hiroyuki
Middle name
Last name Takamatsu

Organization

Kanazawa University

Division name

Department of Hematology

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

Department of Hematology

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

Kanazawa University

Institute

Department

Personal name



Funding Source

Organization

International Myeloma Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

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

0762652275

Email

takamaz@staff.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



Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 23 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

66

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

No longer recruiting

Date of protocol fixation

2016 Year 05 Month 09 Day

Date of IRB

2016 Year 04 Month 20 Day

Anticipated trial start date

2016 Year 05 Month 24 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

Clinical data collection
I.
1) The case report form (CRF) will be sent to the participation institutes from the study secretariat.
2) The representative of each institute fills in the CRF and sends to the datacenter.
3) The representative of the study secretariat performs data analysis.
II. Survey contents
1) Anonymous number of the patients
2) Diagnosis date of MM
3) Diagnosis date of symptomatic MM
4) Age, Date of birth
5) Sex
6) Type of M protein (Heavy chain, Light chain, non-secretory)
7) Immunoglobulin (IgG, A, M, D, E)
8) Quantity of Free Light Chain (FLC)
9) Ratio of involved-uninvolved FLC
10) Hemoglobin
11) Platelet
12) Presence of bone lesion
13) Serum LDH level
14) ISS
15) Bone marrow plasma cell ratio
16) Cytogenetic abnormality (FISH)
17) Cytogenetic abnormality (G-Band)
18) Induction chemotherapy regimen
19) Consolidation/maintenance chemotherapy regimen post-ASCT
20) Response (CR or sCR) at BM aspiration
21) PD (Yes or No) and the date of PD
22) Clinical relapse (Yes or No) and the date of clinical relapse
23) Death (Yes or No) and the date of death


Management information

Registered date

2016 Year 05 Month 08 Day

Last modified on

2020 Year 05 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025606


Research Plan
Registered date File name
2016/05/10 2108_IMF-EuroFlow_同意説明文書_final.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name