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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000037431 |
Receipt No. | 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 | 2019/07/20 |
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 |
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Condition | ||
Condition | Multiple myeloma | |
Classification by specialty |
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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 |
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Age-upper limit |
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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 |
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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 |
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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 | |
Institute | Graduate School of Medicine, Kyoto University, Department of Hematology and Oncology |
Institute | |
Department |
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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | 162 |
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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | in progress |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042577 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |