UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034975 |
|---|---|
| Receipt number | 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 | 2023/05/29 10:06:06 |
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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
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Suyama |
Organization
Hitachi general hospital
Division name
hematology,oncology
Zip code
3170005
Address
2-1-1 Jonan-cho,Hitachi City,Ibaraki prefecture
TEL
0294231111
sutaku2468@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Suyama |
Organization
Hitachi general hospital
Division name
hematology,oncology
Zip code
3170005
Address
2-1-1 Jonan-cho,Hitachi City,Ibaraki prefecture
TEL
0294231111
Homepage URL
sutaku2468@yahoo.co.jp
Sponsor or person
Institute
Hitachi general hospital
Institute
Department
Personal name
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
Hitachi General Hospital
Address
2-1-1 Jonan-cho,Hitachi City,Ibaraki prefecture
Tel
0294231111
sutaku2468@yahoo.co.jp
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
10
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
Terminated
Date of protocol fixation
| 2018 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 14 | Day |
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
| 2023 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039824
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
