UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036377 |
|---|---|
| Receipt number | R000041445 |
| Scientific Title | Evaluation of efficacy and safety of dose-escalating lenalidomide and dexamethasone (Ld) therapy and adapted therapy adding elotuzumab with insufficient efficacy by Ld therapy in newly diagnosed, transplant ineligible multiple myeloma patients (DELAYED study) |
| Date of disclosure of the study information | 2019/04/02 |
| Last modified on | 2019/04/02 00:22:55 |
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Basic information
Public title
Evaluation of efficacy and safety of dose-escalating lenalidomide and dexamethasone (Ld) therapy and adapted therapy adding elotuzumab with insufficient efficacy by Ld therapy in newly diagnosed, transplant ineligible multiple myeloma patients (DELAYED study)
Acronym
Evaluation of efficacy and safety of dose-escalating lenalidomide and dexamethasone (Ld) therapy and adapted therapy adding elotuzumab with insufficient efficacy by Ld therapy in newly diagnosed, transplant ineligible multiple myeloma patients (DELAYED study)
Scientific Title
Evaluation of efficacy and safety of dose-escalating lenalidomide and dexamethasone (Ld) therapy and adapted therapy adding elotuzumab with insufficient efficacy by Ld therapy in newly diagnosed, transplant ineligible multiple myeloma patients (DELAYED study)
Scientific Title:Acronym
Evaluation of efficacy and safety of dose-escalating lenalidomide and dexamethasone (Ld) therapy and adapted therapy adding elotuzumab with insufficient efficacy by Ld therapy in newly diagnosed, transplant ineligible multiple myeloma patients (DELAYED study)
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 the efficacy and safety of dose-escalating lenalidomide and dexamethasone (Ld) therapy and adapted therapy adding elotuzumab with insufficient efficacy by Ld therapy in newly diagnosed, transplant ineligible multiple myeloma patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
VGPR rate
Key secondary outcomes
Overall response rate
Complete response rate
Efficacy rate of adding Elotuzumab
Overall survival
Progression-free survival
Safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Starting dose of Lenalidomide is 10mg.
Adding elotuzumab with insufficient efficacy by Lenalidomide therapy.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Newly diagnosed, transplant ineligible multiple myeloma
2) Aged 20 or older.
3) Patients that can comply with regulations on the study protocol.
4) Patients in which lenalidomide drug management procedures (RevMate) can be followed.
5) Patients who fall under at least one point in IMWG report and are judged by the attending physician as necessary to reduce the initial dose of lenalidomide.
6) Patients meet all following standard
Absolute neutrophil count >= 1,000/mm3, Platelet count >= 50,000/mm3, Total bilirubin < 3 times facility criteria, AST and ALT < 5 times facility criteria, Creatinine Clearance >= 30ml/min.
7) Written informed consent obtained.
Key exclusion criteria
3) CNS involvement
4) Serologically positive for HIVAb
5) Active malignancy concomitantly existed
6) Pregnant, possible pregnant, or breastfeeding woman
7) Severe infection or clinical complication
8) Severe mental disorder
9) Deep vein thrombosis or pulmonary thrombosis
10) Incompatibility of Lenalidomide, Dexamethasone and Elotuzumab
11) Patients who have been judged by the investigator to be inappropriate for participation in this clinical trial for other reasons.
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Kitagawa |
Organization
Gifu University Hospital
Division name
Department of Hematology
Zip code
501-1194
Address
Yanagido1-1, Gifu
TEL
058-230-6308
jkita-gif@umin.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
Yanagido1-1, Gifu
TEL
058-230-6308
Homepage URL
jkita-gif@umin.ac.jp
Sponsor or person
Institute
Gifu university hospital
Institute
Department
Personal name
Funding Source
Organization
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
Gifu university of medicine
Address
Yanagido1-1, 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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 02 | Day |
Last modified on
| 2019 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041445
