UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019918 |
|---|---|
| Receipt number | R000022474 |
| Scientific Title | Efficacy and safety of lenalidomide and dexamethasone as consolidation therapy and lenalidomide as maintenance therapy after autologous stem cell transplantation for newly diagnosed multiple myeloma |
| Date of disclosure of the study information | 2015/11/24 |
| Last modified on | 2019/11/28 15:20:17 |
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Basic information
Public title
Efficacy and safety of lenalidomide and dexamethasone as consolidation therapy and lenalidomide as maintenance therapy after autologous stem cell transplantation for newly diagnosed multiple myeloma
Acronym
Efficacy and safety of lenalidomide and dexamethasone as consolidation therapy and lenalidomide as maintenance therapy after autologous stem cell transplantation for newly diagnosed multiple myeloma (GHSG MM-02)
Scientific Title
Efficacy and safety of lenalidomide and dexamethasone as consolidation therapy and lenalidomide as maintenance therapy after autologous stem cell transplantation for newly diagnosed multiple myeloma
Scientific Title:Acronym
Efficacy and safety of lenalidomide and dexamethasone as consolidation therapy and lenalidomide as maintenance therapy after autologous stem cell transplantation for newly diagnosed multiple myeloma (GHSG MM-02)
Region
| Japan |
Condition
Condition
Multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of lenalidomide and dexamethasone as consolidation therapy and lenalidomide as maintenance therapy after autologous stem cell transplantation for newly diagnosed transplantation-eligible multiple myeloma patients who received bortezomib-containing induction therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Rate of complete response (CR) plus very good partial response (VGPR) after lenalidomide and dexamethasone as consolidation therapy
Key secondary outcomes
(1) Rate of complete response plus very good partial response after lenalidomide as maintenance therapy
(2) Safety: Hematological toxicity of grade 4, non-hematological toxicity of grade 3 to 4, and the secondary malignancy
(3) Overall survival
(4) Progression-free survival (the rate of patients who are not recognized as having progression or recurrence)
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
blank
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
| 20 | years-old | <= |
Age-upper limit
| 71 | years-old | > |
Gender
Male and Female
Key inclusion criteria
blank
Key exclusion criteria
blank
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Tsurumi |
Organization
Gifu University Hospital
Division name
Department of hematology
Zip code
501-1194
Address
1-1 Yanagido Gifu
TEL
058-230-6000
htsuru@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Junichi |
| Middle name | |
| Last name | Kitagawa |
Organization
Gifu University Hospital
Division name
Department of hematology
Zip code
501-1194
Address
1-1 Yanagido Gifu
TEL
058-230-6000
Homepage URL
http://seesaawiki.jp/ghsg/
jkitagawa1128@gmail.com
Sponsor or person
Institute
Gifu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of hematology, Gifu University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Review Board of Gifu University Graduate School of Medicine
Address
1-1 Yanagido Gifu
Tel
058-230-6059
rinri@gifu-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
岐阜大学医学部附属病院（岐阜県）
岐阜県総合医療センター（岐阜県）
岐阜市民病院（岐阜県）
岐阜赤十字病院（岐阜県）
岐北厚生病院（岐阜県）
一宮市立木曽川市民病院（愛知県）
高山赤十字病院（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 24 | Day |
Related information
URL releasing protocol
http://image02.seesaawiki.jp/g/g/ghsg/90d4f8498b88b847.pdf
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
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
| 2014 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 24 | Day |
Last modified on
| 2019 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022474
