UMIN-CTR Clinical Trial

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
Email	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
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	Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address	Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501
Tel	075-753-4680
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039221