UMIN-CTR Clinical Trial

Basic information
Public title	Prospective observational study for multiple myeloma (MM) in Japan
Acronym	JSH-MM-20
Scientific Title	Prospective observational study II to assess the prognosis of patients with plasma cell neoplasms in Japan
Scientific Title:Acronym	JSH-MM-20
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	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 survival rate of MM patients including non-secretory myeloma patients who received drug therapy in the new drug era
Key secondary outcomes	To clarify the following in patients with MM who received drug therapy: overall response rate (ORR); progression-free survival (PFS); time to next treatment (TNT); treatment-free interval (TFI); overall survival (OS); presence or absence of differences in efficacy endpoints by stage, according to differences in initial induction therapy and; presence or absence of differences in these efficacy endpoints by chromosomal risk category; understanding of the actual condition of secondary cancer development after the start of initial treatment; and understanding of the actual condition of arteriovenous thrombosis (including pulmonary embolism) after diagnosis. To clarify the following in plasma cell neoplasms other than MM, systemic AL amyloidosis and POEMS syndrome, which include MGUS, smoldering myeloma, solitary plasmacytoma, plasma cell leukemia: Overall survival; understanding of the actual situation including disease type transition.

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) Patients diagnosed with MGUS, smoldering myeloma, MM, non-secretory myeloma, solitary plasmacytoma of bone/soft tissue, or plasma cell leukemia according to IMWG classification. (2) To use the IMWG Diagnostic Criteria 2014 edition as diagnostic criteria [6]. (3) Newly diagnosed after January 1, 2022. (4) Patients registered in the epidemiological survey of the Japanese Society of Hematology "Blood Disease Registration" or the National Hospital Organization Network Joint Research "Disease Registration in Blood and Hematopoietic Diseases".
Key exclusion criteria	None
Target sample size	1200

Research contact person
Name of lead principal investigator	1st name Shinsuke Middle name Last name Iida
Organization	Nagoya City University Institute of Medical and Pharmaceutical 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 Tomoko Middle name Last name Narita
Organization	Nagoya City University Institute of Medical and Pharmaceutical 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
Homepage URL
Email	jsh-mm-20@hci-bc.com

Sponsor
Institute	THE JAPANESE SOCIETY OF HEMATOLOGY
Institute
Department

Funding Source
Organization	Janssen Pharmaceutical K.K.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Clinical Research Network Fukuoka Ethics Committee
Address	812-0054,3-1-1 Maidashi, Higashi-ku, Fukuoka, Fukuoka
Tel	092-643-7171
Email	mail@crnfukuoka.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	2022 Year 02 Month 28 Day

Related information
URL releasing protocol	http://www.jshem.or.jp/modules/research/index.php?content_id=17
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	Preinitiation
Date of protocol fixation	2021 Year 12 Month 09 Day
Date of IRB	2022 Year 01 Month 19 Day
Anticipated trial start date	2022 Year 02 Month 28 Day
Last follow-up date	2030 Year 02 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

In prospective observational study in patients with multiple 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 smouldering 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	2022 Year 02 Month 24 Day
Last modified on	2022 Year 06 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053611