UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022764 |
|---|---|
| Receipt number | R000026225 |
| Scientific Title | Analysis of NK cell function in patients with multiple myeloma |
| Date of disclosure of the study information | 2016/06/16 |
| Last modified on | 2016/06/16 07:40:23 |
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Basic information
Public title
Analysis of NK cell function in patients with multiple myeloma
Acronym
MM-NK function
Scientific Title
Analysis of NK cell function in patients with multiple myeloma
Scientific Title:Acronym
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
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
| 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
| 1st name | |
| Middle name | |
| Last name | Shotaro Hagiwara |
Organization
National Center for Global Health and Medicine
Division name
Division of Hematology
Zip code
Address
1-21-1Toyama, Shinjuku, Tokyo
TEL
+81-3-3202-7181
shagiwar@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shotaro Hagiwara |
Organization
National Center for Global Health and Medicine
Division name
Division of Hematology
Zip code
Address
1-21-1Toyama, Shinjuku, Tokyo
TEL
+81-3-3202-7181
Homepage URL
shagiwar@hosp.ncgm.go.jp
Sponsor or person
Institute
Division of Hematology
National Center for Global Health and Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 04 | Month | 19 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026225
