UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000343
Receipt No. R000000442
Scientific Title Clinical dose-escalation study of auto-gammadelta T cell therapy for multiple myeloma to investigate its safety and efficacy
Date of disclosure of the study information 2006/03/01
Last modified on 2006/09/22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Clinical dose-escalation study of auto-gammadelta T cell therapy for multiple myeloma to investigate its safety and efficacy
Acronym Clinical study of gammadelta T cell therapy for multiple myeloma
Scientific Title Clinical dose-escalation study of auto-gammadelta T cell therapy for multiple myeloma to investigate its safety and efficacy
Scientific Title:Acronym Clinical study of gammadelta 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 safety of auto-gammmadelta T cell therapy, as well as its efficacy, for multiple myeloma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Safety : Adverse events
Key secondary outcomes Efficacy : Improvement and maintenance of tumor-related immuno/biochemistrical parameters

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
Medicine
Interventions/Control_1 Gammadelta T cell is to be administrated intravenously four times on a biweekly-basis.
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 who have received a series of induction chemotherapy
20 years or more
Performance status 0-1
No serious abnormality in bone marrow, liver and/or renal functions
Key exclusion criteria Patients who have : uncontrolled infections; active autoimmune diseases; serious cardiac disease; other cancers, and who have received continuous systemic steroids
Target sample size 4

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 150-8935, Japan
TEL
Email

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
TEL 03-3400-1311
Homepage URL
Email

Sponsor
Institute Japanese Red Cross Medical Center
Institute
Department

Funding Source
Organization Medinet Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Shin-Yokohama Medical Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2006 Year 03 Month 01 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
2005 Year 10 Month 14 Day
Date of IRB
Anticipated trial start date
2005 Year 11 Month 01 Day
Last follow-up date
2006 Year 02 Month 01 Day
Date of closure to data entry
2006 Year 08 Month 01 Day
Date trial data considered complete
2006 Year 09 Month 01 Day
Date analysis concluded
2006 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 03 Month 01 Day
Last modified on
2006 Year 09 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000442

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.