UMIN-CTR Clinical Trial

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 Takuya Middle name Last name Komeno
Organization	National Hospital Organization Mito Medical Center
Division name	Department of Hematology
Zip code	3113193
Address	280 Sakuranosato, Ibaraki-machi, Ibaraki 311-3193 Japan
TEL	029-240-7711
Email	komeno.takuya.ze@mail.hosp.go.jp

Public contact
Name of contact person	1st name Takuya Middle name Last name Komeno
Organization	National Hospital Organization Mito Medical Center
Division name	Department of Hematology
Zip code	3113193
Address	280 Sakuranosato, Ibaraki-machi, Ibaraki 311-3193 Japan
TEL	029-240-7711
Homepage URL
Email	komeno.takuya.ze@mail.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	National Hospital Organization
Address	2-5-23 Higashigaoka, Meguro, Tokyo
Tel	03-5712-5075
Email	kenkyu2004@hosp.go.jp

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	Completed
Date of protocol fixation	2014 Year 04 Month 03 Day
Date of IRB	2014 Year 03 Month 20 Day
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	2021 Year 06 Month 25 Day

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