Unique ID issued by UMIN | UMIN000019059 |
---|---|
Receipt number | R000021825 |
Scientific Title | A Multicenter Retrospective Study on the Clinical Course of Smoldering Multiple Myeloma(SMM) Patients in Asia |
Date of disclosure of the study information | 2015/09/17 |
Last modified on | 2015/09/17 19:36:54 |
A Multicenter Retrospective Study on the Clinical Course of Smoldering Multiple Myeloma(SMM) Patients in Asia
Retrospective Study of SMM in Asia
A Multicenter Retrospective Study on the Clinical Course of Smoldering Multiple Myeloma(SMM) Patients in Asia
Retrospective Study of SMM in Asia
Japan | Asia(except Japan) |
Smoldering multiple myeloma
Hematology and clinical oncology |
Malignancy
NO
This is a multicenter retrospective study on the clinical course of smoldering multiple myeloma (SMM) in Asia and this study is intended to identify the risk factors of high risk SMM patients.
Others
To date, the standard of care for SMM patients has been close follow-up without treatment until MM symptoms develop. However it is well recognized that the SMM encompasses patients with early malignancy (MM) that is still asymptomatic as well as patients with MGUS rather than that reported for SMM. SMM still includes a high risk subgroup, and these patients need to be considered for clinical trials testing early therapy. It is very important to develop therapeutic interventions that can prevent and delay progression or even cure the disease before significant clonal heterogeneity occurs. However, we need to establish new high risk criteria of SMM in Asia before developing therapeutic interventions.
Others
Others
Not applicable
High-risk factors in Asian SMM patients (The high-risk factor or the combination of high-risk factors that 60% of SMM patients progress for symptomatic myeloma within two years)
1.Periods from SMM to symptomatic myeloma
2.Progress rate to symptomatic myeloma at two and five years after the diagnosis of SMM
3.Five-year overall survival rate from the diagnosis of SMM
4.Overall survival of SMM
Observational
Not applicable |
Not applicable |
Male and Female
SMM patients who were diagnosed in seven countries in Asia (Japan, Korea, China, Singapore, Taiwan, Hong Kong, and Thailand) by between January 1, 2004 and December 31, 2013
symptomatic multiple myeloma
400
1st name | |
Middle name | |
Last name | Tadao Ishida |
Sapporo Medical University School of Medicine
Department Gastroenterology, Rheumatology and Clinical Immunol
S-1, W-16, CHUO-KU, SAPPORO, JAPAN
011-611-2111
ishidat@sapmed.ac.jp
1st name | |
Middle name | |
Last name | TADAO ISHIDA |
Sapporo Medical University School of Medicine
Department Gastroenterology, Rheumatology and Clinical Immun
S-1, W-16, CHUO-KU, SAPPORO, JAPAN
011-611-2111
ishidat@sapmed.ac.jp
Sapporo Medical University School of MedicineDepartment Gastroenterology, Rheumatology and Clinical Immunol
Sapporo Medical University School of Medicine, Department Gastroenterology, Rheumatology and Clinical Immunol
Self funding
NO
2015 | Year | 09 | Month | 17 | Day |
Unpublished
Preinitiation
2015 | Year | 07 | Month | 21 | Day |
2015 | Year | 09 | Month | 14 | Day |
1.Primary endpoint
To detect high-risk factors with which more than 60% of SMM patients develops symptomatic MM in two years, two-year incidence of MM will be compared by subgroup analyses and two group comparison between groups with/without prognostic factors we measured. It will be estimated by Kaplan-Meier method, and log-rank test will be used as a statistical testing. In addition, subgroup analyses stratified by more than two factor will be performed, and we will assess combined risk of multiple prognostic factors. Cox proportional hazard model will be used for adjustment of confounding, and constructing a prognostic model.
2.Secondary endpoints
Time-to-incidence of symptomatic MM, x-year incidence rate, overall survival and other important prognostic features will be estimated by Kaplan-Meier methods, and subgroup analyses and group comparison will be performed as necessary.
2015 | Year | 09 | Month | 17 | Day |
2015 | Year | 09 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021825