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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
