UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014270
Receipt number 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 2021/06/25 10:41:33

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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 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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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