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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034975
Receipt No. R000039824
Scientific Title The effect and safety of TJ-14 adverse event associated autologous peripheral blood stem cell transplantation for multiple myeloma
Date of disclosure of the study information 2019/01/01
Last modified on 2019/02/11

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Basic information
Public title The effect and safety of TJ-14 adverse event associated autologous peripheral blood stem cell transplantation for multiple myeloma
Acronym Hangesya-M
Scientific Title The effect and safety of TJ-14 adverse event associated autologous peripheral blood stem cell transplantation for multiple myeloma
Scientific Title:Acronym Hangesya-M
Region
Japan

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

Objectives
Narrative objectives1 We study whether TJ-14 improve gastrointestinal symptom associated autologous peripheral stem cell transplantation
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes The incidence of diarrhea grade 2 or higher between the TJ-14 group and control group in the period from transplantation to engraftment
Key secondary outcomes The incidence of diarrhea in each grade
The incidence of mucositis oral in each grade
The period of appearance of diarrhea of Grade 2 or higher
The period of appearance of mucositis oral of Grade 2 or higher
Differences Alb between before chemotherapy and engraftment

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The patients dissolve TJ-14(2.5 g) in 50-100 ml of water and rinse their oral cavity with the solution three times daily for 10 seconds from chemotherapy to 3 days after engraftment.
Interventions/Control_2 The patients do standard precaution.
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
18 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients who undergo autologous stem cell transplantation
ECOG-Performance Status (PS) is 0-2.
Patients who are not allergic to Kanpo
Patient who provided written consents for this study.
Key exclusion criteria Uncontrolled active infection.
Active gastrointestinal ulcer.
Uncontrolled diabetes mellitus.
Serious psychiatric illness.
Patient who is judged to be medically unfit by physician.
Target sample size 60

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Suyama Takuya
Organization Hitachi general hospital
Division name hematology,oncology
Zip code
Address 2-1-1 Jonan-cho,Hitachi City,Ibaraki prefecture
TEL 0294231111
Email sutaku2468@yahoo.co.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Suyama Takuya
Organization Hitachi general hospital
Division name hematology,oncology
Zip code
Address 2-1-1 Jonan-cho,Hitachi City,Ibaraki prefecture
TEL 0294231111
Homepage URL
Email sutaku2468@yahoo.co.jp

Sponsor
Institute Hitachi general hospital
Institute
Department

Funding Source
Organization Hitachi general hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 日立総合病院(茨城県),

Other administrative information
Date of disclosure of the study information
2019 Year 01 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 Open public recruiting
Date of protocol fixation
2018 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 01 Day
Last follow-up date
2026 Year 02 Month 28 Day
Date of closure to data entry
2027 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded
2026 Year 04 Month 30 Day

Other
Other related information Observation items in this study are listed as follows.
1. Patient backgrounds(Birthday, Age, Diagnosis, Clinical stage(R-ISS), The day of diagnosis, The first day of induction therapy, The day of autologous stem cell transplantation, response at transplantation
2. Clinical examination
1) complete blood cell count
2) TP, Alb, LDH, Cre, immunoglobulin, serum free light chain,
3) Urinary analysis(if only urine M protain positive): protein fraction, protein in 24 hour urine
4) Radiologic examinations: CT

Management information
Registered date
2018 Year 11 Month 22 Day
Last modified on
2019 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039824

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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