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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027259
Receipt No. R000031225
Scientific Title MRD assessment of multiple myeloma patients who received carfilzomib by EuroFlow and a simple multicolor flow cytometry
Date of disclosure of the study information 2017/05/15
Last modified on 2018/02/08

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Basic information
Public title MRD assessment of multiple myeloma patients who received carfilzomib by EuroFlow and a simple multicolor flow cytometry
Acronym MRD assessment of MM patients who received carfilzomib by EuroFlow and a simple MFC
Scientific Title MRD assessment of multiple myeloma patients who received carfilzomib by EuroFlow and a simple multicolor flow cytometry
Scientific Title:Acronym MRD assessment of MM patients who received carfilzomib by EuroFlow and a simple MFC
Region
Japan

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

Objectives
Narrative objectives1 To establish a simple multiparameter flow cytometry (MFC) method to assess minimal residual disease (MRD) in multiple myeloma (MM) patients.
Basic objectives2 Others
Basic objectives -Others To compare MRD levels among EuroFlow, next-generation sequencing (NGS) and a simple MFC in Kameda medical center.
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes MRD correlation between a simple MFC (Kameda-Flow) and EuroFlow
Key secondary outcomes (1) 1-year PFS and 3-year PFS post KRD treatment
(2) 1-year OS and 3-year OS post KRD treatment
(3) MRD negativity post KRD treatment

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 Active multiple myeloma patients who were diagnosed by IMWG criteria and relapse/refractory after the treatments of bortezomib/lenalidomide/thalidomide and have achieved complete response (CR) post carfilzomib+lenalidomide+dexamethasone (KRD) therapy.
Key exclusion criteria Dementia patients who can not understand this clinical research.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Takamatsu
Organization Kanazawa University Hospital
Division name Hematology
Zip code
Address 13-1 Takaramachi, Kanazawa, Ishikawa 920-8641, JAPAN
TEL 0762652276
Email takamaz@staff.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Takamatsu
Organization Kanazawa University Hospital
Division name Hematology
Zip code
Address 13-1 Takaramachi, Kanazawa, Ishikawa 920-8641, JAPAN
TEL 0762652276
Homepage URL
Email takamaz@staff.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University Hospital
Institute
Department

Funding Source
Organization ONO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 05 Month 15 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
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 Enrolling by invitation
Date of protocol fixation
2017 Year 01 Month 18 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Bone marrow (BM) of 6mL is aspirated and anaylzed as follows: MRD in BM of 2mL by EuroFlow; MRD in BM of 2mL by MFC in Kameda Medical Center: 2mL by NGS.

Management information
Registered date
2017 Year 05 Month 06 Day
Last modified on
2018 Year 02 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031225

Research Plan
Registered date File name
2017/05/07 KRD_EuroFlow_ホームページ掲載文書.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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