UMIN-CTR Clinical Trial

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
Email	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
Email	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
Email	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
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	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	in progress

Management information
Registered date	2019 Year 07 Month 20 Day
Last modified on	2019 Year 07 Month 20 Day

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

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