UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031866 |
|---|---|
| Receipt number | R000036386 |
| Scientific Title | An exploratory study to identify biomarkers of resistance to chemotherapy in multiple myeloma |
| Date of disclosure of the study information | 2018/03/23 |
| Last modified on | 2023/08/08 09:09:28 |
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Basic information
Public title
An exploratory study to identify biomarkers of resistance to chemotherapy in multiple myeloma
Acronym
biomarker study in MM
Scientific Title
An exploratory study to identify biomarkers of resistance to chemotherapy in multiple myeloma
Scientific Title:Acronym
biomarker study in MM
Region
| Japan |
Condition
Condition
Multiple Myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate whether genes involved in the oncogenic properties of multiple myeloma can be a biomarker of resistance to lenalidomide
Basic objectives2
Others
Basic objectives -Others
feasibility study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
genetic mutations in tumor DNA
Key secondary outcomes
genetic mutations in circulating cell-free DNA
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
Filling out the written informed consent form before study participation of the patients' own volition
Age 20 years or older
Key exclusion criteria
Patients who are found to be inappropriate for this trial as judged by the principal investigator or the sub-investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoichi |
| Middle name | |
| Last name | Imai |
Organization
IMSUT hospital, The Institute of Medical Science, The University of Tokyo
Division name
Department of Hematology/Oncology
Zip code
108-8639
Address
4-6-1 Shirokanedai, Minato-ku, Tokyo
TEL
03-5449-8111
imaitky@ims.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Yasui |
Organization
IMSUT hospital, The Institute of Medical Science, The University of Tokyo
Division name
Department of Hematology/Oncology
Zip code
108-8639
Address
4-6-1 Shirokanedai, Minato-ku, Tokyo
TEL
03-5449-8111
Homepage URL
hiroyasu@ims.u-tokyo.ac.jp
Sponsor or person
Institute
The Institute of Medical Science, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Celgene 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
the 3rd Research Ethics Committee
Address
4-6-1, Shirokanedai, Minato-ku, Tokyo, 108-8639, JAPAN
Tel
03-5449-8111
dctsm@ims.u-tokyo.ac.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
東京大学医科学研究所附属病院（東京都）、日本医科大学付属病院（東京都）、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）、群馬大学医学部附属病院（群馬県）、埼玉医科大学総合医療センター（埼玉県）、東京女子医科大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 23 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s10147-021-01991-z
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s10147-021-01991-z
Number of participants that the trial has enrolled
14
Results
Results: We identified several driver mutations by combined analysis of next-generation sequencing and existing databases of candidate oncogenes. Furthermore, relapse was detected more sensitively by monitoring the circulating cfDNA with these driver mutations than by conventional serum free-light chain examination.
Conclusion: These results suggest the potential utility of cfDNA in the PB plasma of patients as a relevant early biomarker for MM relapse.
Results date posted
| 2023 | Year | 08 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Background: Multiple myeloma (MM) is an incurable hematological malignancy. Despite the introduction of several novel drugs, most patients relapse. Biomarkers to identify the early signs of relapse will make it possible to adjust the therapeutic strategy before the disease worsens. Although understanding genetic changes is important for the treatment of MM, currently known biomarkers of relapse, including serum free-light chains and monoclonal paraproteins, are not associated with genetic changes.
Participant flow
Methods: We therefore performed a multicenter study to examine the usefulness of circulating cell-free DNA (cfDNA) present in the peripheral blood (PB) plasma of patients as a biomarker for MM relapse.
Adverse events
N/A
Outcome measures
Relapse was detected more sensitively by monitoring the circulating cfDNA with these driver mutations than by conventional serum free-light chain examination.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2018 | Year | 03 | Month | 23 | Day |
Last modified on
| 2023 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036386
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/03/26 | 2021IJCO_Circulating cell-free DNA in PB plasma for MM relapse.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2022/03/26 | 2021IJCO_Circulating cell-free DNA in PB plasma for MM relapse.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2022/03/26 | 2021IJCO_Circulating cell-free DNA in PB plasma for MM relapse.pdf |
