UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034399 |
|---|---|
| Receipt number | 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 | 2022/04/08 09:40:45 |
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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 | Toshio |
| Middle name | |
| Last name | Kitawaki |
Organization
Kyoto University Hospital
Division name
Department of Hematology and Oncology
Zip code
606-8507
Address
54 Shogoin-Kawara-cho, Sakyo-ku, Kyoto city, Kyoto, Japan
TEL
(075)751-4694
hemato@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshio |
| Middle name | |
| Last name | Kitawaki |
Organization
Kyoto University Hospital
Division name
Department of Hematology and Oncology
Zip code
606-8507
Address
54 Shogoin-Kawara-cho, Sakyo-ku, Kyoto city, Kyoto, Japan
TEL
(075)751-4694
Homepage URL
hemato@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
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
Terminated
Date of protocol fixation
| 2018 | Year | 09 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 31 | Day |
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
| 2022 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039221
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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