UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of the responsible genome by the next generation sequencing (NGS) for drug sensitivity and prediction of prognosis in patients with newly diagnosed untreated multiple myeloma
Title of the study (Brief title)	Gene analysis using NGS of patients with newly diagnosed untreated multiple myeloma
Region	Japan

Condition
Condition	Multiple Myeloma
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To Identify genes that are associate with the dismal prognosis of multiple myeloma patients by analyzing targeted sequencing before treatment.
Basic objectives2	Others
Basic objectives -Others	To evaluate the correlation between tumor burden and prognosis by quantifying tumor volume in peripheral blood three months after the start of treatment with the use of NGS. To evaluate the correlation between tumor burden and prognosis by quantifying tumor volume in peripheral blood six months after the start of treatment with the use of NGS.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Progression free survival (PFS) in each of the baseline genomic subgroup of at diagnosis.
Key secondary outcomes	Correlation of PFS and quantity of tumor element evaluated three months after the start of therapy Correlation of PFS and quantity of tumor element evaluated six months after the start of therapy Correlation of TNT and quantity of tumor element evaluated three months after the start of therapy Correlation of TNT and quantity of tumor element evaluated six months after the start of therapy Genetic mutations of myeloma cells associated with treatment

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	Previously untreated multiple myeloma patients diagnosed according to criteria of IMW conference report for 2014 and who are eligible for systemic treatment. 2.Provide who has written informed consent
Key exclusion criteria	1. 19 years or younger 2. Patients identified as ineligible by the directors and co-working of each institute.
Target sample size	150

Research contact person
Name of lead principal investigator	Yoshikazu Kamiya
Organization	National Hospital Organization, Higashi Nagoya National Hospital
Division name	Division of Hematology and Medical Oncology
Address	5-101 Umemorizaka, Meitou-Ku, Nagoya, Aichi
TEL	+81-52-801-1151
Email	yskzkmy@e-nagoya.hosp.go.jp

Public contact
Name of contact person	Yoshikazu Kamiya
Organization	National Hospital Organization, Higashi Nagoya National Hospital
Division name	Division of Hematology and Medical Oncology
Address	5-101 Umemorizaka, Meitou-Ku, Nagoya, Aichi
TEL	+81-52-801-1151
Homepage URL
Email	yskzkmy@e-nagoya.hosp.go.jp

Sponsor
Institute	National Hospital Organization,
Institute
Department

Funding Source
Organization	National Hospital Organization,
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	国立病院機構：渋川医療センター（群馬県）、千葉医療センター（千葉県）、東京医療センター（東京都）、まつもと医療センター（長野県）名古屋医療センター（愛知県）、東名古屋病院（愛知県）、あわら病院（福井県）、岡山医療センター（岡山県）、四国がんセンター（愛媛県）、九州医療センター（福岡県）、長崎医療センター（長崎県）鹿児島医療センター（鹿児島県）、 日本赤十字医療センター（東京都）京都鞍馬口医療センター（京都府）、新潟県立がんセンター新潟病院（新潟県）、豊橋市民病院（愛知県）、徳島大学（徳島県）、徳島県立中央病院（徳島県）

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 01 Month 13 Day
Anticipated trial start date	2017 Year 05 Month 21 Day
Last follow-up date
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	Data not published

Management information
Registered date	2017 Year 01 Month 25 Day
Last modified on	2018 Year 07 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029569