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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032849
Receipt No. R000037459
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
Date of disclosure of the study information 2018/06/08
Last modified on 2018/06/02

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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

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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