UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Risk prediction of progression to multiple myeloma from MGUS or smoldering myeloma by multi-color flow cytometric analysis
Title of the study (Brief title)	MM-MFC2017
Region	Japan

Condition
Condition	MGUS, smoldering myeloma, and multiple myeloma
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We analyze the phenotypes of BM plasma cells in patients with MGUS, smoldering multiple myeloma and multiple myeloma using multi-color flow cytometer, and identify the markers to predict the progression to multiple myeloma.
Basic objectives2	Others
Basic objectives -Others	biological characteristics
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	We investigate the phenotype of BM plasma cells collected from patients with MGUS, smoldering multiple myeloma and multiple myeloma using multi-color flow cytometer, and analyze the difference by the type of the diseases.
Key secondary outcomes	We identify the markers to predict the risk of progression to multiple myeloma from MGUS and smoldering myeloma.

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with MGUS, smoldering multiple myeloma and untreated multiple myeloma whose clinical diagnosis is determined accurately using medical examination containing bone marrow puncture.
Key exclusion criteria	Exclusion criteria are not set up. However, patients who received anti-myeloma treatment are excluded.
Target sample size	60

Research contact person
Name of lead principal investigator	Yasushi Takamatsu
Organization	Fukuoka University Faculty of Medicine
Division name	Division of Medical Oncology, Hematology and Infectious Diseases, Department of Medicine
Address	7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan
TEL	092-801-1011
Email	yasushi@fukuoka-u.ac.jp

Public contact
Name of contact person	Yasushi Takamatsu
Organization	Fukuoka University Faculty of Medicine
Division name	Division of Medical Oncology, Hematology and Infectious Diseases, Department of Medicine
Address	7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan
TEL	092-801-1011
Homepage URL
Email	yasushi@fukuoka-u.ac.jp

Sponsor
Institute	Fukuoka University
Institute
Department

Funding Source
Organization	Fukuoka University
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor	National Hospital Organization Kyushu Cancer Center JCHO Kyushu Hospital
Name of secondary funｄer(s)

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	2018 Year 02 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 06 Month 08 Day
Anticipated trial start date	2017 Year 06 Month 29 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	We analyze the phenotypes of BM plasma cells in patients with MGUS, SMM and MM by multi-color flow cytometer at the diangnosis. The analysis is repeated when the disease progression is observed. Laboratory data including the time to progression, the time to next treatment, and overall survival, is collected.

Management information
Registered date	2018 Year 01 Month 30 Day
Last modified on	2018 Year 01 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035412