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
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
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
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
