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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014270
Receipt No. R000016627
Scientific Title Prospective cohort study to investigate the clinical factors associated with the prognosis of newly diagnosed multiple myeloma in National Hospital Organization
Date of disclosure of the study information 2014/08/01
Last modified on 2017/06/17

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Basic information
Public title Prospective cohort study to investigate the clinical factors associated with the prognosis of newly diagnosed multiple myeloma in National Hospital Organization
Acronym NHO MM Cohort Study
Scientific Title Prospective cohort study to investigate the clinical factors associated with the prognosis of newly diagnosed multiple myeloma in National Hospital Organization
Scientific Title:Acronym NHO MM Cohort Study
Region
Japan

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

Objectives
Narrative objectives1 The aims of the study are to determine an epidemiological findings of MGUS, plasmacytoma and multiple myeloma in Japan.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Progression free survival (PFS) according to the initial chemotherapy of patients with symptomatic multiple myeloma.
Key secondary outcomes Overall survival (OS)and treatment toxicity of patients with symptomatic multiple myeloma. Extension rate from MGUS or SMM to symptomatic myeloma. The process evaluation of the diagnosis and treatment of multiple myeloma.

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria MUGUS, plasmacytoma and multiple myeloma.
Key exclusion criteria A history of the chemotherapy for multiple myeloma.
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuya Komeno
Organization National Hospital Organization Mito Medical Center
Division name Department of Hematology
Zip code
Address 280 Sakuranosato, Ibaraki-machi, Ibaraki 311-3193 Japan
TEL 029-240-7711
Email t.komeno.d@mn.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takuya Komeno
Organization National Hospital Organization Mito Medical Center
Division name Department of Hematology
Zip code
Address 280 Sakuranosato, Ibaraki-machi, Ibaraki 311-3193 Japan
TEL 029-240-7711
Homepage URL
Email t.komeno.d@mn.hosp.go.jp

Sponsor
Institute Clinical Hematology Study Group of National Hospital Organization (CHSG-NHO)
Institute
Department

Funding Source
Organization National Hospital Organization (NHO)
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
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 H25- NHO (hematology) -01
Org. issuing International ID_1 National Hospital Organization
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 国立病院機構血液・造血器疾患政策医療ネットワーク(CHSG-NHO)参加施設

Other administrative information
Date of disclosure of the study information
2014 Year 08 Month 01 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 No longer recruiting
Date of protocol fixation
2014 Year 04 Month 03 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 22 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design: Prospective cohort study.
Major outcome: Progression free survival (PFS) according to the initial chemotherapy of patients with symptomatic multiple myeloma.
Secondary outcomes: Overall survival (OS) and treatment toxicity of patients with symptomatic multiple myeloma. Extension rate from MGUS or SMM to symptomatic myeloma. The process evaluation of the diagnosis and treatment of multiple myeloma.

Management information
Registered date
2014 Year 06 Month 15 Day
Last modified on
2017 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016627

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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