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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034399
Receipt No. R000039221
Scientific Title Immunological monitoring in transplant-ineligible myeloma patients treated with lenalidomide
Date of disclosure of the study information 2018/11/01
Last modified on 2018/10/06

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Basic information
Public title Immunological monitoring in transplant-ineligible myeloma patients treated with lenalidomide
Acronym Immunological analysis of lenalidomide therapy
Scientific Title Immunological monitoring in transplant-ineligible myeloma patients treated with lenalidomide
Scientific Title:Acronym Immunological analysis of lenalidomide therapy
Region
Japan

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

Objectives
Narrative objectives1 The aim of the study is to analyze immunological parameters in transplant-ineligible myeloma patients treated with lenalidomide, thereby exploring biological markers that predict therapeutic effects of lenalidomide. These biological markers will help select optimal treatment in myeloma patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Best therapeutic effect
Key secondary outcomes Immunological parameters, progression-free survival, overall survival, time to next treatment, safety

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 1. A 20 to 80 year-old patient who was diagnosed with multiple myeloma according to the diagnostic criteria of the Hematologic Malignancy Practice Guideline published by the Japanese Society of Hematology.
2. A patient who was judged as ineligible for both autologous and allogeneic hematopoietic cell transplantation by the attending physician.
3. A patient who has measurable M-protein in serum or urine.
4. A patient who agreed with the registration for RevMate and can keep its administrative procedures.
5. A newly diagnosed myeloma patient who will be treated with lenalidemide and dexamethasone (Ld) as the first-line treatment, or a relapsed or refractory myeloma patient who will be treated with a combination of Ld and elotuzumab (ELd) or daratumumab (DLd).
6. A patient who provided written informed consent for this study.
Key exclusion criteria A patient who is judged to be inappropriate to participate in this study by the attending physician.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshio Kitawaki
Organization Kyoto University Hospital
Division name Department of Hematology and Oncology
Zip code
Address 54 Shogoin-Kawara-cho, Sakyo-ku, Kyoto city, Kyoto, Japan
TEL (075)751-4694
Email hemato@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshio Kitawaki
Organization Kyoto University Hospital
Division name Department of Hematology and Oncology
Zip code
Address 54 Shogoin-Kawara-cho, Sakyo-ku, Kyoto city, Kyoto, Japan
TEL (075)751-4694
Homepage URL
Email hemato@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Celgene corporation
Organization
Division
Category of Funding Organization Profit organization
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 京都大学医学部附属病院(京都府)

Other administrative information
Date of disclosure of the study information
2018 Year 11 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
2018 Year 09 Month 06 Day
Date of IRB
Anticipated trial start date
2018 Year 11 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 Obtain peripheral blood samples from patients and analyze immune cells in detail by flow cytometry.

Management information
Registered date
2018 Year 10 Month 06 Day
Last modified on
2018 Year 10 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039221

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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