UMIN-CTR Clinical Trial

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
Last 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
1st 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