UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000034815 |
|---|---|
| Receipt number | R000039704 |
| Scientific Title | 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 12:19:52 |
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Basic information
Public title
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
Acronym
Response-oriented MPB/Rd sequential therapy for NDMM
Scientific Title
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
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | JUNYA KURODA |
Organization
Kyoto Prefectural University of Medicine
Division name
Division of Hematology and Oncology
Zip code
Address
Kyoto
TEL
0752515740
junkuro@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | JUNYA KURODA |
Organization
Kyoto Prefectural University of Medicine
Division name
Division of Hematology and Oncology
Zip code
Address
Kyoto
TEL
0752515740
Homepage URL
junkuro@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Completed
Date of protocol fixation
| 2012 | Year | 03 | Month | 13 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039704
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