UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013881 |
|---|---|
| Receipt number | R000016183 |
| Scientific Title | Phase II Study to evaluate efficacy and safety of Lenalidomide maintenance therapy for multiple myeloma patients under bortezomib treatment |
| Date of disclosure of the study information | 2014/05/05 |
| Last modified on | 2014/05/02 21:26:15 |
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Basic information
Public title
Phase II Study to evaluate efficacy and safety of Lenalidomide maintenance therapy for multiple myeloma patients under bortezomib treatment
Acronym
L-Defense study
Scientific Title
Phase II Study to evaluate efficacy and safety of Lenalidomide maintenance therapy for multiple myeloma patients under bortezomib treatment
Scientific Title:Acronym
L-Defense 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 efficacy and safety of lenalidomide maintenance therapy for multiple myeloma patients under bortezomib treatment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
best response rate
Key secondary outcomes
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
Lenalidomide 10-15mg/day (Day 1-21) p.o
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 who give written informed consent following sufficient explanation.
2. Patients who have been diagnosed as symptomatic multiple myeloma by the criteria of IMWG.
3. Patients who have measurable M protein or FLC in serum or urine.
4. Patients over 20 years old and not eligible for ASCT.
5. Female patients who are post menopause (patients older than one year from the last menstrual period), of the proper way of surgical contraception (birth control pill, contraceptives, etc.) and who have the intention of contraception during the lenalidmide therapy. Male patients who agree the appropriate method of contraception during the lenalidmide therapy.
6. Patients who have achieved the response more than PR in the initial treatment with bortezomib. There is no limitation on the period of response.
Key exclusion criteria
1. Patients who are pregnant or lactating.
2. Patients who had been determined ineligible for any reason by physician.
3. Patients who have not achieved PR with bortezomib therapy as initial treatment.
4. Patients who progressed in disease status less than PR after the initial response.
Target sample size
29
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumihiko Kimura |
Organization
National Defense Medical College
Division name
Division of Hematology
Zip code
Address
3-2, Namiki, Tokorozawa, Saitama
TEL
04-2995-1617
fkimura@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichi Kobayashi |
Organization
National Defense Medical College
Division name
Division of Hematology
Zip code
Address
3-2, Namiki, Tokorozawa, Saitama
TEL
04-2995-1617
Homepage URL
kobashin@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
National Defense Medical College
Organization
Division
Category of Funding Organization
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
| 2014 | Year | 05 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 02 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 07 | 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
| 2014 | Year | 05 | Month | 03 | Day |
Last modified on
| 2014 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016183
