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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025835
Receipt No. R000029569
Scientific Title 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
Date of disclosure of the study information 2017/02/01
Last modified on 2018/07/30

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Basic information
Public title 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
Acronym Gene analysis using NGS of patients with newly diagnosed untreated multiple myeloma
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Yoshikazu Kamiya
Organization National Hospital Organization, Higashi Nagoya National Hospital
Division name Division of Hematology and Medical Oncology
Zip code
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
1st name
Middle name
Last name Yoshikazu Kamiya
Organization National Hospital Organization, Higashi Nagoya National Hospital
Division name Division of Hematology and Medical Oncology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Enrolling by invitation
Date of protocol fixation
2017 Year 01 Month 13 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000029569

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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