UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037431 |
|---|---|
| Receipt number | R000042577 |
| Scientific Title | The efficacy and safety of KRD and KD regimens for multiple myeloma patients:Retrospective study by Kansai Myeloma Forum |
| Date of disclosure of the study information | 2019/08/01 |
| Last modified on | 2022/08/24 13:35:03 |
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Basic information
Public title
The efficacy and safety of KRD and KD regimens for multiple myeloma patients:Retrospective study by Kansai Myeloma Forum
Acronym
The efficacy and safety of KRD and KD regimens for MM patients:Retrospective study by KMF
Scientific Title
The efficacy and safety of KRD and KD regimens for multiple myeloma patients:Retrospective study by Kansai Myeloma Forum
Scientific Title:Acronym
The efficacy and safety of KRD and KD regimens for MM patients:Retrospective study by KMF
Region
| Japan |
Condition
Condition
Multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Improvement of treatment outcomes is expected by evaluating the safety and efficacy of KRD and KD regimens for Japanese patients with relapsed/refractory multiple myeloma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Progression free survival
Key secondary outcomes
Overall survival, Overall response rate, Adverse event
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
| 35 | years-old | <= |
Age-upper limit
| 84 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Relapsed/refractory multiple myeloma patients who were registered in the KMF database and received KRD or KD therapy
Key exclusion criteria
Patients who disagree to study participation
Target sample size
162
Research contact person
Name of lead principal investigator
| 1st name | Junya |
| Middle name | |
| Last name | Kanda |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Hematology and Oncology
Zip code
606-8507
Address
54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-3152
jkanda16@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Junya |
| Middle name | |
| Last name | Kanda |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Hematology and Oncology
Zip code
606-8507
Address
54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-3152
Homepage URL
jkanda16@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Kyoto University, Department of Hematology and Oncology
Institute
Department
Personal name
Funding Source
Organization
ONO PHARMACEUTICAL CO., LTD.
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
Kyoto University Graduate School and Faculty of Medicine Kyoto University Hospital Ethics Committee
Address
54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto, Japan
Tel
075-753-4680/+81-75-753-4680
ethcom@kuhp.kyoto-u.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
https://myeloma.jp/infomation/551/
Publication of results
Unpublished
Result
URL related to results and publications
https://myeloma.jp/infomation/551/
Number of participants that the trial has enrolled
162
Results
111 patients received KRd. The median progression-free survival (PFS) was 9.7 months. Multivariate analysis showed that reduction of the carfilzomib dose and non-IgG M protein significantly affected PFS.
50 patients received Kd. The median PFS was 7.1 months. Based on the multivariate analysis, reduction of the carfilzomib dose and ISSIII significantly affected PFS.
Our analysis showed that an adequate dose of carfilzomib is important for achieving the best survival benefits in a real-world setting.
Results date posted
| 2022 | Year | 02 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In this study, we included 161 patients from 17 hospitals in the KMF database who received KRd (n = 111) or Kd (n = 50) therapy between March 2016 and June 2019.
Participant flow
This study was conducted in accordance with the Declaration of Helsinki, with the approval of the ethics committees of the KMF and each participating institution.
Adverse events
Grade III or higher adverse events were observed in 48% of KRd cases and 54% of Kd cases. Cardiovascular events, cytopenia, and infectious diseases were frequent, and 4 KRd patients died due to heart failure, arrhythmia, cerebral hemorrhage, and pneumonia.
Outcome measures
PFS
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2016 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Published
Management information
Registered date
| 2019 | Year | 07 | Month | 20 | Day |
Last modified on
| 2022 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042577
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| Registered date | File name |
| Research case data | |
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