UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007878 |
|---|---|
| Receipt number | R000009215 |
| Scientific Title | Phase II study of auto-gamma/delta T cell therapy for multiple myeloma. |
| Date of disclosure of the study information | 2012/05/16 |
| Last modified on | 2018/04/19 14:50:37 |
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Basic information
Public title
Phase II study of auto-gamma/delta T cell therapy for multiple myeloma.
Acronym
Phase II study of auto-gamma/delta T cell therapy for multiple myeloma.
Scientific Title
Phase II study of auto-gamma/delta T cell therapy for multiple myeloma.
Scientific Title:Acronym
Phase II study of auto-gamma/delta T cell therapy for multiple myeloma.
Region
| Japan |
Condition
Condition
Multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate standard value achievement rate of auto-gamma/delta T cell therapy using leukapheresis for multiple myeloma. Moreover, efficacy and safety are searched for and examined secondarily.
Basic objectives2
Others
Basic objectives -Others
Standard value achievement rate
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Standard value achievement rate
Key secondary outcomes
Time to progression
Overall survival
Change of serum M protein, serum beta 2-microglobulin, free light chain and Bence Jones protein.
Safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Auto-gamma/delta T cells are injected on days 0, 14, 28 and 42.
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
Multiple myeloma patients
(The patient judged after an induction chemotherapy to be Very good PR or the patient of smoldering multiple myeloma whom free light chain shows an abnormal value)
who meet the following:
- Age >= 20 years at informed consent.
- Performance status is 0-1;
- No serious abnormality in bone marrow, liver, and renal functions.
Key exclusion criteria
Patients who have:
- Uncontrolled infections;
- Continuous systemic administration of steroids;
- Active autoimmune diseases;
- Pregnant, to be pregnant, or nursing mothers;
- Active enteritis and/or gastrointestinal bleeding;
- Other cancers;
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenshi Suzuki |
Organization
Japanese Red Cross Medical Center
Division name
Hematological Department
Zip code
Address
4-1-22, Hiroo, Shibuya-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Japanese Red Cross Medical Center
Division name
Hematological Department
Zip code
Address
4-1-22, Hiroo, Shibuya-ku, Tokyo, Japan
TEL
Homepage URL
Sponsor or person
Institute
Japanese Red Cross Medical Center
Institute
Department
Personal name
Funding Source
Organization
Medinet Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Seta Clinic Group
Juntendo university hospital
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
日本赤十字社医療センター（東京都）、順天堂大学医学部附属順天堂医院（東京都）、瀬田クリニック東京（東京都）、瀬田クリニック新横浜（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | 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
Completed
Date of protocol fixation
| 2012 | Year | 03 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | 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
| 2012 | Year | 05 | Month | 02 | Day |
Last modified on
| 2018 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009215
