UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of auto-gamma/delta T cell therapy for multiple myeloma.
Title of the study (Brief title)	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	Kenshi Suzuki
Organization	Japanese Red Cross Medical Center
Division name	Hematological Department
Address	4-1-22, Hiroo, Shibuya-ku, Tokyo, Japan
TEL
Email

Public contact
Name of contact person
Organization	Japanese Red Cross Medical Center
Division name	Hematological Department
Address	4-1-22, Hiroo, Shibuya-ku, Tokyo, Japan
TEL
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	Seta Clinic Group Juntendo university hospital
Name of secondary funｄer(s)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 03 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009215