UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter phase I/II study of switching therapy from lenalidomide and dexamethasone to elotuzumab plus lenalidomide and dexamethasone for multiple myeloma patients not achieving deep response
Title of the study (Brief title)	Switching study from Rd to ERd for multiple myeloma (EAO-18 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 switching therapy to elotuzumab plus lenalidomide and dexamethasone for multiple myeloma patients not achieving deep response with lenalidomide and dexamethason
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The improvement rate of best response until 12 months after switching to elotuzumab plus lenalidomide and dexamethasone
Key secondary outcomes	1. Progression-free survival and overall survival rate at 1 and 2-year 2. Overall survival rate at 1 and 2-year 3. The improvement rate of best response until 24 months after switching to elotuzumab plus lenalidomide and dexamethasone 4. The time to best response 5. Duration of response 6. The time to treatment failure 7. The time to next treatment for MM 8. The change of level of immunoglobulin and free light chain (for 24 months) 9. The change of lymphocyte subset in peripheral blood (for 12 months) 10. Safety of elotuzumab plus lenalidomide and dexamethasone (Incidence rate of grade 3 and 4 adverse event)

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	Switched ERd from Rd is started with weekly elotuzumab at first 2 cycles following monthly administration. ERd is continued until the decision to stop due to ineffectiveness, adverse event or patients request. For 25 months from registration, assessments of response status, adverse events and taking medication are performed during study treatment. Patients are followed for progression, next treatment and survival after discontinuation of study treatment.
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. Patients are >= 20 years of age at consent 2. Patients under Rd therapy 3. Patients who achieved >= partial response but not achieved stringent CR 4. Patients ineligible for autologous transplant or who already have undertaken autologous transplant 5. Patients with ECOG performance status 0,1 or 2 6. Patients with normal function of major organ function except for kidney a. Ejection fraction >= 50% at ultrasonic cardiography b. Total bilirubin <= 2.0 mg/dL and AST/ALT <= 4xULN c. SpO2 >= 95% at room air 7. Patients who fully understood this study with sufficient description and agreed by written consent.
Key exclusion criteria	1. Patients with HIV-antibody positive 2. Patients with synchronous or metachronous malignancy except carcinoma in situ or cancer confined to the mucosa and curatively treated by local resection 3. Patients with active infectious disease 4. Pregnant women, women who could be pregnant or women who is breast feeding 5. Patients with history of hypersensitivity for the component of elotuzumab 6. Patients with other inadequate conditions determined by investigators
Target sample size	27

Research contact person
Name of lead principal investigator	Katsuya Fujimoto
Organization	Hokkaido Cancer Center
Division name	Department of Hematology
Address	3-54, Kikusui 4-2, Shiroishi-ku, Sapporo
TEL	011-811-9111
Email	kats_fujim@sap-cc.go.jp

Public contact
Name of contact person	Katsuya Fujimoto
Organization	Hokkaido Cancer Center
Division name	Department of Hematology
Address	3-54, Kikusui 4-2, Shiroishi-ku, Sapporo
TEL	011-811-9111
Homepage URL
Email	kats_fujim@sap-cc.go.jp

Sponsor
Institute	North Japan Hematology Study Group
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 06 Month 08 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 11 Month 30 Day
Anticipated trial start date	2017 Year 12 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 06 Month 02 Day
Last modified on	2018 Year 06 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037459