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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034815
Receipt No. R000039704
Official scientific title of the study Response-oriented sequential therapy with four cycles of bortezomib, melphalan, and prednisolone followed by continuous lenalidomide and dexamethasone for transplant-ineligible newly diagnosed multiple myeloma
Date of disclosure of the study information 2018/11/08
Last modified on 2018/11/08

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Basic information
Official scientific title of the study Response-oriented sequential therapy with four cycles of bortezomib, melphalan, and prednisolone followed by continuous lenalidomide and dexamethasone for transplant-ineligible newly diagnosed multiple myeloma
Title of the study (Brief title) Response-oriented MPB/Rd sequential therapy for NDMM
Region
Japan

Condition
Condition multiple myeloma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To develop a treatment strategy which makes the most of bortezomib/melphalan/prednisolone therapy (MPB) and lenalidomide/dexamethasone therapy (Ld), we conducted the multi-institutional phase 2 study of response-oriented first-line 4 cycles of MPB followed by continuous Ld therapy to investigate its efficacy and feasibility in Japanese transplant-ineligible NDMM.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes response rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 We treat transplant ineligible newly diagnosed myeloma patients aged between 66-80 with up to 4 cycles of MPB. Treatment will be switched to Ld in case patients who did not achieve complete response by up to 4 cycles of MPB or who are intolerable to MPB.
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
66 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Transplant-ineligible symptomatic untreated myeloma
Key exclusion criteria plasma cell leukemia, cardiac amyloidosis, POEMS syndrome, grade 2-4 neuropathy, other malignancy within past 3 years, and other serious complications
Target sample size 35

Research contact person
Name of lead principal investigator JUNYA KURODA
Organization Kyoto Prefectural University of Medicine
Division name Division of Hematology and Oncology
Address Kyoto
TEL 0752515740
Email junkuro@koto.kpu-m.ac.jp

Public contact
Name of contact person JUNYA KURODA
Organization Kyoto Prefectural University of Medicine
Division name Division of Hematology and Oncology
Address Kyoto
TEL 0752515740
Homepage URL
Email junkuro@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2018 Year 11 Month 08 Day

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 03 Month 13 Day
Anticipated trial start date
2012 Year 03 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 08 Day
Last modified on
2018 Year 11 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039704

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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