UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022099
Receipt number 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 2021/05/01 16:39:54

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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 Shinsuke
Middle name
Last name Iida

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Hematology and Oncology

Zip code

467-8601

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 Hirohiko
Middle name
Last name Shibayama

Organization

National Hospital Organization Osaka National Hospital

Division name

Hematology

Zip code

540-0006

Address

2-1-14, Hoenzaka, Chuo-ku, Osaka City, Japan

TEL

06-6942-1331

Homepage URL

http://www.jshem.or.jp/shikkan/mm.html

Email

shibayama.hirohiko.ec@mail.hosp.go.jp


Sponsor or person

Institute

THE JAPANESE SOCIETY OF HEMATOLOGY

Institute

Department

Personal name



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

Nagoya City University Graduate School of Medical Sciences and Nagoya City Hospital Institutional Review Board

Address

1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya City, Aichi, Japan

Tel

052-858-7215

Email

clinical_research@med.nagoya-cu.ac.jp


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

2021 Year 05 Month 01 Day



Link to view the page

Value
https://center6.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