UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032849 |
|---|---|
| Receipt number | R000037459 |
| Scientific Title | 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 21:28:00 |
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Basic information
Public title
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
Acronym
Switching study from Rd to ERd for multiple myeloma (EAO-18 study)
Scientific Title
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
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Katsuya Fujimoto |
Organization
Hokkaido Cancer Center
Division name
Department of Hematology
Zip code
Address
3-54, Kikusui 4-2, Shiroishi-ku, Sapporo
TEL
011-811-9111
kats_fujim@sap-cc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuya Fujimoto |
Organization
Hokkaido Cancer Center
Division name
Department of Hematology
Zip code
Address
3-54, Kikusui 4-2, Shiroishi-ku, Sapporo
TEL
011-811-9111
Homepage URL
kats_fujim@sap-cc.go.jp
Sponsor or person
Institute
North Japan Hematology Study Group
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2017 | Year | 11 | Month | 30 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037459
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| Registered date | File name |
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