UMIN-CTR Clinical Trial

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

Multiple myeloma

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Adverse events

Key secondary outcomes

Minimal residual disease, overall survivaland progression free survival
response rate

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name	Junji
Middle name
Last name	Tanaka

Organization

Tokyo Women's University

Division name

Department of hematology

Zip code

162-8666

Address

8-1 Kawadacho Shinjuku

TEL

0333538111

Email

shagiwar@twmu.ac.jp

Name of contact person

1st name	Shotaro
Middle name
Last name	Hagiwara

Organization

Tokyo Women's Medical University

Division name

Department of hematology

Zip code

162-8666

Address

8-1Kawadacho, Shinjuku, Tokyo

TEL

+81-3-3353-8111

Homepage URL

Email

shagiwar@twmu.ac.jp

Institute

Department of Hematology, Tokyo Women's University

Institute

Department

Personal name

Organization

Bristol Myers Squibb Company

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Tokyo Women's Medical University

Address

81- Kawadacho, Shinjuku

Tel

0333538111

Email

ogata.yasutaka@twmu.ac.jp

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

東京女子医科大学

Date of disclosure of the study information

2018

Year

06

Month

24

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2018

Year

05

Month

15

Day

Date of IRB

2018

Year

05

Month

11

Day

Anticipated trial start date

2018

Year

06

Month

01

Day

Last follow-up date

2024

Year

05

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

06

Month

24

Day

Last modified on

2020

Year

06

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037776