UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017005 |
|---|---|
| Receipt number | R000019725 |
| Scientific Title | Studies on the genetic abnormality and therapeutic effects and prognosis of multiple myeloma |
| Date of disclosure of the study information | 2015/04/20 |
| Last modified on | 2024/04/08 10:03:08 |
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Basic information
Public title
Studies on the genetic abnormality and therapeutic effects and prognosis of multiple myeloma
Acronym
NHOH-MMM study/H26-NHO(Hematology)-01
Scientific Title
Studies on the genetic abnormality and therapeutic effects and prognosis of multiple myeloma
Scientific Title:Acronym
NHOH-MMM study/H26-NHO(Hematology)-01
Region
| Japan |
Condition
Condition
Multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
o investigate the proportion of different genetic abnormalities detected by the multiplex ligation-dependent probe amplification (MLPA) method and clinical implication of its abnormality in symptomatic myeloma
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of different genetic abnormalities detected by the MLPA method
Key secondary outcomes
1. Complete response rate with the initial treatment of different genetic abnormalities detected by MLPA method
2. Progression free survival with the initial treatment of different genetic abnormalities detected by MLPA method
3. Overall survival with the initial treatment of different genetic abnormalities detected by MLPA method
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1.Untreated symptomatic myeloma more than 20 years at diagnosis
2.Patiets that the initial treatment is possible and survival is expected more than 6 months
Key exclusion criteria
1.Solitary plasmacytoma
2.Patients to use the insurance unapproved drugs to initial treatment
3.Patients that NHOMM study and MARBLE study are not registered
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kazutaka |
| Middle name | |
| Last name | Sunami |
Organization
National Hospital Organization Okayama Medical Center
Division name
Department of Hematology
Zip code
701-1192
Address
1711-1, Tamasu, Kita-ku, Okayama, 701-1192, Japan
TEL
086-294-9911
kazusuna@pop12.odn.ne.jp
Public contact
Name of contact person
| 1st name | Kazutaka |
| Middle name | |
| Last name | Sunami |
Organization
National Hospital Organization Okayama Medical Center
Division name
Department of Hematology
Zip code
701-1192
Address
1711-1, Tamasu, Kita-ku, Okayama, 701-1192, Japan
TEL
086-294-9911
Homepage URL
kazusuna@pop12.odn.en.jp
Sponsor or person
Institute
Clinical Hematlogy Study Group of National Hospital Organization (CHSGONHO)
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization
Address
2-5-1, Higashigaoka, Meguroku, Tokyo, 152-8621, Japan
Tel
03-5712-5075
kenkyu2004@hosp.go.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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 20 | 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
85
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Analysing
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
| 2015 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Detection of the mutation of 1p32-p12, 1q21-q23, 5q31, chr.9, 12p13, 13q14, 14q32, 16q12-q23, 17p13 by MLPA method
Management information
Registered date
| 2015 | Year | 04 | Month | 01 | Day |
Last modified on
| 2024 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019725
