UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of NK cell function in patients with multiple myeloma
Title of the study (Brief title)	MM-NK function
Region	Japan

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

Objectives
Narrative objectives1	To analyze the quantitive and qualitative status of NK cells in patients with multiple myeloma
Basic objectives2	Others
Basic objectives -Others	1)The number of NK cells 2)Surface proteins 3)Cytotoxic activities 4)Response to cytokines in NK cells
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	To analyze the quantitive and qualitative status in patients with multiple myeloma. 1)The number of NK cells 2)Surface proteins 3)Cytotoxic activities 4)Response to cytokines in NK cells
Key secondary outcomes	To evaluate the effect of monoclonal antibodies on NK cells. 1)Proliferation effects 2)Survival effects 3)Cytotoxic activities To evaluate the effect of NK cells on myeloma cells. 4)Cytotoxic activities of NK cells against myeloma cells 5)Effects of chemotherapy and stem cell transplantation on NK cells

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Newly diagnosed myeloma Patients (>=20 years old) with symptomatic myeloma defined by IMWG criteria 2. Relapse/Refractory myeloma Relapse or refractory (defined by IMWG) to induction, stem cell transplantation, consolidation and/or maintenance therapy. 3. Plateau phase of myeloma Patients who achieved plateau phase after treaments. 4. Healthy donor (>=20 years old) with written informed concent.
Key exclusion criteria	1)Who does not agree with the participation into the study. 2)Who can not understant the explanation about this study. 3)Who should be excluded judged by principal investigator.
Target sample size	40

Research contact person
Name of lead principal investigator	Shotaro Hagiwara
Organization	National Center for Global Health and Medicine
Division name	Division of Hematology
Address	1-21-1Toyama, Shinjuku, Tokyo
TEL	+81-3-3202-7181
Email	shagiwar@hosp.ncgm.go.jp

Public contact
Name of contact person	Shotaro Hagiwara
Organization	National Center for Global Health and Medicine
Division name	Division of Hematology
Address	1-21-1Toyama, Shinjuku, Tokyo
TEL	+81-3-3202-7181
Homepage URL
Email	shagiwar@hosp.ncgm.go.jp

Sponsor
Institute	Division of Hematology National Center for Global Health and Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	国立国際医療研究センター

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 16 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 04 Month 19 Day
Anticipated trial start date	2016 Year 05 Month 16 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 03 Month 31 Day
Date trial data considered complete	2021 Year 03 Month 31 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Data not published

Management information
Registered date	2016 Year 06 Month 16 Day
Last modified on	2016 Year 06 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026225