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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033128
Receipt No. R000037776
Scientific Title NK cell therapy with Elotuzumab following autologous stem cell transplantation for newly diagnosed multiple myeloma patients
Date of disclosure of the study information 2018/06/24
Last modified on 2018/06/24

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Basic information
Public title NK cell therapy with Elotuzumab following autologous stem cell transplantation for newly diagnosed multiple myeloma patients
Acronym NK cell therapy for myeloma MRD after ASCT
Scientific Title NK cell therapy with Elotuzumab following autologous stem cell transplantation for newly diagnosed multiple myeloma patients
Scientific Title:Acronym NK cell therapy for myeloma MRD after ASCT
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the safety and the efficacy of autologous NK cell therapy for minimal residual disease of multiple myeloma after autologous stem cell transplantation
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Adverse events
Key secondary outcomes Minimal residual disease, overall survivaland progression free survival
response rate

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 NK cell infusion therapy with Elotuzumab-Lenalidomide-Dexamethasone for minimal residual disease of multiple myeloma after autologous stem cell transplantation
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
65 years-old >=
Gender Male and Female
Key inclusion criteria 1.Multiple myeloma diagnosed by IMWG diagnostic criteria
2.Age: 20=<, 65>=
3.ECOG Performance status0-2
4.PR or better after induction therapy
5. Transplant eligible patients without severe organ damages
6.Autologous mononuclear cell>=0.5x10E10 were obtained when autologous stem cell harvest
7. Patients failed to achieve sCR afterstem cell transplantation or minimal residual disease was detected by 6-8 color Flow cytometry.
8. Patients who are expected to live more than 3 months.
9. Written informed consent was obtained.
Key exclusion criteria 1. Patients who were previously transplanted.
2. Failed to obtain more than 2x10E6/kg of CD34+ cells
3. Patients who are not harvest or transplant eligible due to cardiac or pulmonary disorder. AST,ALT, Total bilirubin>2.5xlower limit, serum Cr>=2.0mg/dl
4. Pregnant or breast feeding
5. With uncontrollable active infection
6. Patients who have severe allergy
7. HIV positive, HBV antigen positive or HBV-DNA positive by PCR patients
8. Without written informed consent
9. By medical reasons, patients who arejudged as inappropriate by doctors or researchers.
10. Patient with other active malignancies
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junji Tanaka
Organization Tokyo Women's University
Division name Department of hematology
Zip code
Address 8-1 Kawadacho, Shinjuku, Tokyo
TEL +81-3-3353-8111
Email shagiwar@twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shotaro Hagiwara
Organization Tokyo Women's Medical University
Division name Department of hematology
Zip code
Address 8-1Kawadacho, Shinjuku, Tokyo
TEL +81-3-3353-8111
Homepage URL
Email shagiwar@twmu.ac.jp

Sponsor
Institute Department of Hematology, Tokyo Women's University
Institute
Department

Funding Source
Organization Bristol Myers Squibb Company
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 PC3180049
Org. issuing International ID_1 Ministry of Health and Welfare, Japan
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東京女子医科大学

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 24 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
2018 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 06 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

Management information
Registered date
2018 Year 06 Month 24 Day
Last modified on
2018 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037776

Research Plan
Registered date File name
2018/12/24 再生医療等提供計画書多発性骨髄腫に対するNK細胞療 20180521 審査後修正最終版.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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