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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017005
Receipt No. R000019725
Scientific Title Studies on the genetic abnormality and therapeutic effects and prognosis of multiple myeloma
Date of disclosure of the study information 2015/04/20
Last modified on 2019/04/04

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Basic information
Public title Studies on the genetic abnormality and therapeutic effects and prognosis of multiple myeloma
Acronym NHOH-MMM study/H26-NHO(Hematology)-01
Scientific Title Studies on the genetic abnormality and therapeutic effects and prognosis of multiple myeloma
Scientific Title:Acronym NHOH-MMM study/H26-NHO(Hematology)-01
Region
Japan

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

Objectives
Narrative objectives1 o investigate the proportion of different genetic abnormalities detected by the multiplex ligation-dependent probe amplification (MLPA) method and clinical implication of its abnormality in symptomatic myeloma
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Proportion of different genetic abnormalities detected by the MLPA method
Key secondary outcomes 1. Complete response rate with the initial treatment of different genetic abnormalities detected by MLPA method
2. Progression free survival with the initial treatment of different genetic abnormalities detected by MLPA method
3. Overall survival with the initial treatment of different genetic abnormalities detected by MLPA method

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 1.Untreated symptomatic myeloma more than 20 years at diagnosis
2.Patiets that the initial treatment is possible and survival is expected more than 6 months
Key exclusion criteria 1.Solitary plasmacytoma
2.Patients to use the insurance unapproved drugs to initial treatment
3.Patients that NHOMM study and MARBLE study are not registered
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Kazutaka
Middle name
Last name Sunami
Organization National Hospital Organization Okayama Medical Center
Division name Department of Hematology
Zip code 701-1192
Address 1711-1, Tamasu, Kita-ku, Okayama, 701-1192, Japan
TEL 086-294-9911
Email kazusuna@pop12.odn.ne.jp

Public contact
Name of contact person
1st name Kazutaka
Middle name
Last name Sunami
Organization National Hospital Organization Okayama Medical Center
Division name Department of Hematology
Zip code 701-1192
Address 1711-1, Tamasu, Kita-ku, Okayama, 701-1192, Japan
TEL 086-294-9911
Homepage URL
Email kazusuna@pop12.odn.en.jp

Sponsor
Institute Clinical Hematlogy Study Group of National Hospital Organization (CHSGONHO)
Institute
Department

Funding Source
Organization National Hospital Organization
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization National Hospital Organization
Address 2-5-1, Higashigaoka, Meguroku, Tokyo, 152-8621, Japan
Tel 03-5712-5075
Email kenkyu2004@hosp.go.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
2015 Year 04 Month 20 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 85
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
2015 Year 02 Month 20 Day
Date of IRB
2015 Year 04 Month 14 Day
Anticipated trial start date
2015 Year 04 Month 20 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Detection of the mutation of 1p32-p12, 1q21-q23, 5q31, chr.9, 12p13, 13q14, 14q32, 16q12-q23, 17p13 by MLPA method

Management information
Registered date
2015 Year 04 Month 01 Day
Last modified on
2019 Year 04 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019725

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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