Unique ID issued by UMIN | UMIN000022099 |
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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 |
Prospective observational study to assess the prognosis of patients with plasma cell neoplasms in Japan
Prospective observational study for MM in Japan (JSH-MM-15)
Prospective observational study to assess the prognosis of patients with plasma cell neoplasms in Japan
Prospective observational study for MM in Japan (JSH-MM-15)
Japan |
Newly diagnosed plasma cell neoplasms
Hematology and clinical oncology |
Malignancy
NO
The objective of this study is to figure out the prognosis and the prognostic factor in patients with plasma cell neoplasms.
Efficacy
Exploratory
Pragmatic
Not applicable
3-year overall survival in patients with symptomatic myeloma who have received drug therapies in novel drug era
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
Observational
Not applicable |
Not applicable |
Male and Female
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
none
1100
1st name | Shinsuke |
Middle name | |
Last name | Iida |
Nagoya City University Graduate School of Medical Sciences
Hematology and Oncology
467-8601
1 Kawasumi,Mizuho-cho,Mizuho-ku,Nagoya City,Aichi 467-8601,Japan
052-853-8738
iida@med.nagoya-cu.ac.jp
1st name | Hirohiko |
Middle name | |
Last name | Shibayama |
National Hospital Organization Osaka National Hospital
Hematology
540-0006
2-1-14, Hoenzaka, Chuo-ku, Osaka City, Japan
06-6942-1331
http://www.jshem.or.jp/shikkan/mm.html
shibayama.hirohiko.ec@mail.hosp.go.jp
THE JAPANESE SOCIETY OF HEMATOLOGY
THE JAPANESE SOCIETY OF HEMATOLOGY
Non profit foundation
Japan
Nagoya City University Graduate School of Medical Sciences and Nagoya City Hospital Institutional Review Board
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya City, Aichi, Japan
052-858-7215
clinical_research@med.nagoya-cu.ac.jp
NO
2016 | Year | 05 | Month | 01 | Day |
http://www.jshem.or.jp/shikkan/mm.html
Unpublished
No longer recruiting
2016 | Year | 03 | Month | 28 | Day |
2016 | Year | 03 | Month | 28 | Day |
2016 | Year | 05 | Month | 01 | Day |
2022 | Year | 04 | Month | 30 | Day |
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.
2016 | Year | 04 | Month | 27 | Day |
2021 | Year | 05 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025347
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