UMIN-CTR Clinical Trial

Public title

A Multicenter Retrospective Study on the Clinical Course of Smoldering Multiple Myeloma(SMM) Patients in Asia

Acronym

Retrospective Study of SMM in Asia

Scientific Title

A Multicenter Retrospective Study on the Clinical Course of Smoldering Multiple Myeloma(SMM) Patients in Asia

Scientific Title:Acronym

Retrospective Study of SMM in Asia

Region

Japan

Asia(except Japan)

Condition

Smoldering multiple myeloma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

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.

Basic objectives2

Others

Basic objectives -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.

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

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)

Key secondary outcomes

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

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

Key exclusion criteria

symptomatic multiple myeloma

Target sample size

400

Name of lead principal investigator

1st name
Middle name
Last name	Tadao Ishida

Organization

Sapporo Medical University School of Medicine

Division name

Department Gastroenterology, Rheumatology and Clinical Immunol

Zip code

Address

S-1, W-16, CHUO-KU, SAPPORO, JAPAN

TEL

011-611-2111

Email

ishidat@sapmed.ac.jp

Name of contact person

1st name
Middle name
Last name	TADAO ISHIDA

Organization

Sapporo Medical University School of Medicine

Division name

Department Gastroenterology, Rheumatology and Clinical Immun

Zip code

Address

S-1, W-16, CHUO-KU, SAPPORO, JAPAN

TEL

011-611-2111

Homepage URL

Email

ishidat@sapmed.ac.jp

Institute

Sapporo Medical University School of MedicineDepartment Gastroenterology, Rheumatology and Clinical Immunol

Institute

Department

Personal name

Organization

Sapporo Medical University School of Medicine, Department Gastroenterology, Rheumatology and Clinical Immunol

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

09

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2015

Year

07

Month

21

Day

Date of IRB

Anticipated trial start date

2015

Year

09

Month

14

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

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.

Registered date

2015

Year

09

Month

17

Day

Last modified on

2015

Year

09

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021825