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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036377
Receipt No. 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

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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
Email 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
Email jkita-gif@umin.ac.jp

Sponsor
Institute Gifu university hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041445

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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