UMIN-CTR Clinical Trial

Basic information
Public title	Feasibility study of clinical sequence in multiple myeloma and related Diseases; Additional study of JSH-MM-15 (JSH-MM-15-Cseq)
Acronym	Study of clinical sequence in multiple myeloma; JSH-MM-15-Cseq
Scientific Title	Feasibility study of clinical sequence in multiple myeloma and related Diseases; Additional study of JSH-MM-15 (JSH-MM-15-Cseq)
Scientific Title:Acronym	Study of clinical sequence in multiple myeloma; JSH-MM-15-Cseq
Region	Japan

Condition
Condition	Multiple myeloma and related disease
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To investigate the feasibility of clinical sequence in the diagnosis and treatment of multiple myeloma and related disease
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Ratio of potentially actionable findings(PAF), used as a feedback to the attending physician
Key secondary outcomes

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) A case enrolled in the JSH-MM-15 study(Prospective observational study to assess the prognosis of patients with plasma cell neoplasms in Japan) 2) diagnosed as having plasma cell neoplasms including symptomatic myeloma, non-secretary myeloma, multiple plasmacytoma of bone, and plasame cell leukemia 3) A case with sufficient tumor and non-tumor samples for the genomic analysis 4) A subject with written informed consent
Key exclusion criteria	A subject considered as an inappropriate participant for the current study
Target sample size	25

Research contact person
Last name of lead principal investigator	1st name Shinsuke Middle name Last name Iida
Organization	Nagoya City University Graduate School of Medical 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
1st name of contact person	1st name Masaki Middle name Last name Ri
Organization	Nagoya City University Graduate School of Medical 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	rrmasaki@med.nagoya-cu.ac.jp

Sponsor
Institute	1) THE JAPANESE SOCIETY OF HEMATOLOGY 2) Agency for Medical Research and Development; Program for an Integrated Database of Clinical and Genomic Information; Horibe research team
Institute
Department

Funding Source
Organization	Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	NCU IRB
Address	1 Kawasumi,Mizuho-cho,Mizuho-ku,Nagoya City,Aichi 467-8601,Japan
Tel	052-851-5511
Email	clinical_research@med.nagoya-cu.ac.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	日本赤十字社医療センター　血液内科 群馬大学医学部附属病院　 血液内科　 埼玉医科大学総合医療センター　血液内科　 名古屋市立大学病院　 血液・腫瘍内科　 大阪大学医学部附属病院　血液・腫瘍内科 徳島大学病院 血液内科 国立病院機構　岡山医療センター　血液内科 国立病院機構　九州医療センター　血液内科

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 08 Day

Related information
URL releasing protocol
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	Open public recruiting
Date of protocol fixation	2017 Year 09 Month 12 Day
Date of IRB
Anticipated trial start date	2017 Year 11 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Prospective observational study Using the next generation sequencing, we evaluate the ratio of the MM cases with PAF(Potentially actionable findings), and evaluate the feasibility of clinical sequence in the diagnosis and treatment of multiple myeloma.

Management information
Registered date	2017 Year 11 Month 08 Day
Last modified on	2019 Year 05 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034120