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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022099
Receipt No. R000025347
Scientific Title Prospective observational study to assess the prognosis of patients with plasma cell neoplasms in Japan
Date of disclosure of the study information 2016/05/01
Last modified on 2019/04/30

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Basic information
Public title Prospective observational study to assess the prognosis of patients with plasma cell neoplasms in Japan
Acronym Prospective observational study for MM in Japan (JSH-MM-15)
Scientific Title Prospective observational study to assess the prognosis of patients with plasma cell neoplasms in Japan
Scientific Title:Acronym Prospective observational study for MM in Japan (JSH-MM-15)
Region
Japan

Condition
Condition Newly diagnosed plasma cell neoplasms
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to figure out the prognosis and the prognostic factor in patients with plasma cell neoplasms.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 3-year overall survival in patients with symptomatic myeloma who have received drug therapies in novel drug era
Key secondary outcomes In patients with symptomatic myeloma who have received drug therapies:
overall response rate(ORR), progression-free survival(PFS), time to next treatment(TNT), treatment-free interval(TFI), overall survival(OS)
according to the difference of induction therapies, clinical stages, and cytogenetic risk groups
in addition to exploring the incidence of second primary malignancies(SPM) after initial treatment

In patients with plasma cell neoplasms except for symptomatic myeloma, systemic amyloidosis and POEMS syndrome, i.e., MGUS, smoldering myeloma, solitary plasmacytoma, multiple plasmacytoma and plasma cell leukemia:
overall survival(OS),
disease progression

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 1)diagnosed as having plasma cell neoplasms including MGUS, smoldering myeloma, symptomatic myeloma, non-secretary myeloma, solitary plasmacytoma of bone, extramedullary plasmacytoma based on International Myeloma Working Group(IMWG) criteria in 2014
2)newly diagnosed on January 1 in 2016 or later
Key exclusion criteria none
Target sample size 1100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinsuke Iida
Organization Nagoya City University Graduate School of Medical Sciences
Division name Hematology and Oncology
Zip code
Address 1 Kawasumi,Mizuho-cho,Mizuho-ku,Nagoya City,Aichi 467-8601,Japan
TEL 052-853-8738
Email iida@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirohiko Shibayama
Organization Osaka University Hospital
Division name Hematology and Oncology
Zip code
Address 2-15 Yamadaoka,Suita,Osaka 565-0871,Japan
TEL 06-6879-5111
Homepage URL http://www.jshem.or.jp/shikkan/mm.html
Email hiro@bldon.med.osaka-u.ac.jp

Sponsor
Institute THE JAPANESE SOCIETY OF HEMATOLOGY
Institute
Department

Funding Source
Organization THE JAPANESE SOCIETY OF HEMATOLOGY
Organization
Division
Category of Funding Organization Non profit foundation
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 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
2016 Year 05 Month 01 Day

Related information
URL releasing protocol http://www.jshem.or.jp/shikkan/mm.html
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
2016 Year 03 Month 28 Day
Date of IRB
2016 Year 03 Month 28 Day
Anticipated trial start date
2016 Year 05 Month 01 Day
Last follow-up date
2022 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study
In patients with symptomatic myeloma, several factors such as age, clinical stage, cytogenetic risk group and difference of initial therapies are considered to influence on the efficacy endpoints such as overall survival and progression-free survival.
In patients with MGUS and asymptomatic myeloma, several factors such as paraprotein level, marrow plasma cell percentage, serum free light chain ratio are considered to influence on the disease progression.

Management information
Registered date
2016 Year 04 Month 27 Day
Last modified on
2019 Year 04 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025347

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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