UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046436 |
|---|---|
| Receipt number | R000052984 |
| Scientific Title | KRd consolidation for newly diagnosed multiple myeloma |
| Date of disclosure of the study information | 2022/01/27 |
| Last modified on | 2024/06/25 14:51:44 |
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Basic information
Public title
KRd consolidation for newly diagnosed multiple myeloma
Acronym
OCHA KRd observational research
Scientific Title
KRd consolidation for newly diagnosed multiple myeloma
Scientific Title:Acronym
OCHA KRd observational research
Region
| Japan |
Condition
Condition
Multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm efficacy of KRd after autologous stem cell transplantation for patients with newly diagnosed multiple myeloma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The response rate after 4 cycles of KRd
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patient who is planed KRd consolidation.
2.Patient who provided written consents for this study.
Key exclusion criteria
1.Patient who has passed for more than 180 days after ASCT.
2.Patient who has progressed after ASCT
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Kudo |
Organization
Tokyo-kita Medical Center
Division name
Department of hematology
Zip code
115-0053
Address
4-17-56 Akabanedai Kita-ku, Tokyo, JAPAN
TEL
03-5963-3311
daisukekud@jadecom.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Kudo |
Organization
Tokyo-kita Medical Center
Division name
Department of hematology
Zip code
115-0053
Address
4-17-56 Akabanedai Kita-ku, Tokyo, JAPAN
TEL
03-5963-3311
Homepage URL
daisukekud@jadecom.jp
Sponsor or person
Institute
Ochanomizu Hematology Study Group
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo-kita Medical Center
Address
4-17-56 Akabanedai Kita-ku, Tokyo, JAPAN
Tel
03-5963-3311
tk-umin@tokyokita-jadecom.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
東京北医療センター（東京都）、茨城県立中央病院（茨城県）、水戸医療センター（茨城県）、がん･感染症センター都立駒込病院（東京都）、東京医科歯科大学病院（東京都）、埼玉医科大学附属病院（埼玉県）、武蔵野赤十字病院（東京都）、横須賀共済病院（神奈川県） 、横浜市立みなと赤十字病院（神奈川県）、青梅市立総合病院（東京都）、花と森の東京病院（東京都）、埼玉医科大学国際医療センター（埼玉県）、都立墨東病院（東京都）、永寿総合病院（東京都）、聖マリアンナ医科大学病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 27 | 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
4
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 12 | Month | 22 | Day |
Last modified on
| 2024 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052984
