UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010169 |
|---|---|
| Receipt number | R000011879 |
| Scientific Title | Prospective observational study of newly diagnosed multiple myeloma in elderly patients |
| Date of disclosure of the study information | 2013/03/06 |
| Last modified on | 2013/06/06 09:58:08 |
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Basic information
Public title
Prospective observational study of newly diagnosed multiple myeloma in elderly patients
Acronym
Prospective observational study of newly diagnosed multiple myeloma in elderly patients
Scientific Title
Prospective observational study of newly diagnosed multiple myeloma in elderly patients
Scientific Title:Acronym
Prospective observational study of newly diagnosed multiple myeloma in elderly patients
Region
| Japan |
Condition
Condition
Multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this observational study is to assess the relationship between patient outcomes, treatment regimens in newly diagnosed multiple myeloma aged 66 years and over.
Basic objectives2
Others
Basic objectives -Others
The objective of this observational study is to assess the relationship between patient outcomes, treatment regimens in newly diagnosed multiple myeloma aged 66 years and over.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
3 year survival rate
Key secondary outcomes
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
| 66 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Symptomatic multiple myeloma diagnosed by the criteria of International Myeloma Working Group(IMWG).
2) Age >=66 years
3) A life expectancy of at least 3 months
4) Voluntary written informed consent
Key exclusion criteria
Plasma cell leukemia.
Target sample size
216
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiro Miyamoto |
Organization
Kyushu University Hospital
Division name
Hematology and Oncology
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5230
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Fukuoka Blood and Marrow Transplantation Group (FBMTG)
Division name
EMM13 DC
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan
TEL
Homepage URL
fbmtg@intmed1.med.kyushu-u.ac.jp
Sponsor or person
Institute
Fukuoka Blood and Marrow Transplantation Group (FBMTG)
Institute
Department
Personal name
Funding Source
Organization
Janssen Pharmaceutical K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 03 | Month | 06 | 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
| 2013 | Year | 01 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient characteristics
Treatment and progress summary
Management information
Registered date
| 2013 | Year | 03 | Month | 05 | Day |
Last modified on
| 2013 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011879
