UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007206 |
|---|---|
| Receipt number | R000008481 |
| Scientific Title | Efficacy and cytokines of lenalidomide therapy in Japanese patients with relapsed or refractory multiple myeloma |
| Date of disclosure of the study information | 2012/02/02 |
| Last modified on | 2012/11/20 14:16:46 |
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Basic information
Public title
Efficacy and cytokines of lenalidomide therapy in Japanese patients with relapsed or refractory multiple myeloma
Acronym
Lenalidomide therapy in Japanese patients with relapsed or refractory multiple myeloma
Scientific Title
Efficacy and cytokines of lenalidomide therapy in Japanese patients with relapsed or refractory multiple myeloma
Scientific Title:Acronym
Lenalidomide therapy in Japanese patients with relapsed or refractory multiple myeloma
Region
| Japan |
Condition
Condition
Multiple Myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to find out whether changes of plasma cytokine level are associated with efficacy and safely of lenalidomide therapy in Japanese patients with multiple myeloma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Progression-free survival
Key secondary outcomes
Association of plasma cytokine changes with response rate, PFS, OS and safety of lenalidomide therapy
Association between factors for thromboembolism and adverse events of lenalidomide therapy
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
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
• Without severe complications
• At least one prior therapy of multiple myeloma
• Agree to register and follow RevMate
• In the patients receiving the notice, fully briefed for the consent document and other documents given explanation about the contents of the study physician or study investigator, agreed in writing to voluntarily participate in the study by have been obtained
Key exclusion criteria
• Cardiac infarction within 6 months
• Deep vein thrombosis or pulmonary embolism within 3 years
• Tuberculosis, herpes simplex keratitis, mycosis, or other active infections at baseline
• Uncontrollable diabetes mellitus, hypertension, peptic ulcer, or glaucoma
• Posterior capsule opacification
• Patients with mental illness
• Those who are considered as inappropriate to register by attending physicians
• Pregnant or breast feeding females
• Known hypersensitivity to dexamethasone
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shosaku Nomura |
Organization
Kansai Medical University
Division name
The Department of 1st Internal Medicine
Zip code
Address
2-3-1,Shinmachi,Hirakata-city,Osaka
TEL
072-804-0101
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shosaku Nomura |
Organization
Kansai Medical University
Division name
The First Department of Internal Medicine
Zip code
Address
2-3-1,Shinmachi,Hirakata-city,Osaka
TEL
072-804-0101
Homepage URL
Sponsor or person
Institute
Kansai Medical University
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
| 2012 | Year | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 02 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 02 | Day |
Last modified on
| 2012 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008481
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
