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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000014197
Receipt No. R000015992
Scientific Title Evaluation of minimal residual disease,immune cells dynamics and quality of life in bortezomib based induction therapy followed by lenalidomide maintenance for newly diagnosed patients with multiple myeloma ineligible for stem cell transplantation.
Date of disclosure of the study information 2014/07/01
Last modified on 2018/04/28

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Basic information
Public title Evaluation of minimal residual disease,immune cells dynamics and quality of life in bortezomib based induction therapy followed by lenalidomide maintenance for newly diagnosed patients with multiple myeloma ineligible for stem cell transplantation.
Acronym KHSG MM14
Scientific Title Evaluation of minimal residual disease,immune cells dynamics and quality of life in bortezomib based induction therapy followed by lenalidomide maintenance for newly diagnosed patients with multiple myeloma ineligible for stem cell transplantation.
Scientific Title:Acronym KHSG MM14
Region
Japan

Condition
Condition Multiple Myeloma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Analyzing and measuring minimal residual disease (MRD), serum concentration of cytokines and QoL score during lenalidomide monotherapy as maintenace following bortezomib containing induction therapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The colleration between the clinical efficacy of lenalidomide for multiple myeloma and the MRD, the serum concentration of cytokines, and QoL socre
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Symptomatic multiple myeloma newly diagnosed by WHO criteria, are ineligible for autologous stem cell transplantation
Key exclusion criteria patient who is not suitable for taking part in this study from the sight of the physician in charge
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akifumi Takaori-Kondo
Organization Kyoto university hospital
Division name Department of Hematology and Oncology
Zip code
Address 54 Shogoin-Kawaharacho, Sakyo, Kyoto, 606-8507, JAPAN
TEL 075-751-3150
Email atakaori@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiyuki Kitano
Organization Kyoto university hospital
Division name Department of Hematology and Oncology
Zip code
Address 54 Shogoin-Kawaharacho, Sakyo, Kyoto, 606-8507, JAPAN
TEL 075-751-3152
Homepage URL
Email tkitano@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Hematology Study Group
Institute
Department

Funding Source
Organization Graduate school of medicine, Kyoto university, Department of Hematology and Oncology
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2014 Year 07 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 Preinitiation
Date of protocol fixation
2014 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective study
The evaluation of MRD, the concentration of serum cytokines and QoL score during Lenalidomide maintenance in newly diagnosed mutiple myeloma patients who are ineligible for autologous transplantation

Management information
Registered date
2014 Year 06 Month 06 Day
Last modified on
2018 Year 04 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015992

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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