UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007945 |
|---|---|
| Receipt number | R000009358 |
| Scientific Title | Safety and efficacy of lenalidomide and prednisone therapy in Japanese elderly patients with multiple myeloma, a phase II study |
| Date of disclosure of the study information | 2012/05/20 |
| Last modified on | 2012/05/14 14:26:01 |
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Basic information
Public title
Safety and efficacy of lenalidomide and prednisone therapy in Japanese elderly patients with multiple myeloma, a phase II study
Acronym
Safety and efficacy of lenalidomide and prednisone therapy in Japanese elderly patients with multiple myeloma, a phase II study
Scientific Title
Safety and efficacy of lenalidomide and prednisone therapy in Japanese elderly patients with multiple myeloma, a phase II study
Scientific Title:Acronym
Safety and efficacy of lenalidomide and prednisone therapy in Japanese elderly patients with multiple myeloma, a phase II 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 investigate efficacy and safety of lenalidomide and prednisone therapy in Japanese multiple myeloma patients who are over 70 years old.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Best response rate
Key secondary outcomes
Rate of adverse events
Duration of response
Progression-free survival
Overall survival
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 15mg/day days1-21, prednisone 15mg/day three times a week, in a 28-day cycle
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
.Multiple myeloma patient who is over 70 years old
.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 prednisone
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | kazuo tsubaki |
Organization
Nara Hospital Kinki University School Of Medicine
Division name
Department of Hematology
Zip code
Address
1248-1 Otsuda, Nara, 630-0293 JAPAN
TEL
0743-77-0880
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | hitoshi hanamoto |
Organization
Nara Hospital Kinki University School Of Medicine
Division name
Department of Hematology
Zip code
Address
1248-1 Otsuda, Nara, 630-0293 JAPAN
TEL
0743-77-0880
Homepage URL
hanamoto@nara.med.kindai.ac.jp
Sponsor or person
Institute
Nara Hospital Kinki University School Of Medicine
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 | 05 | Month | 20 | 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
| 2011 | Year | 04 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | 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
| 2012 | Year | 05 | Month | 14 | Day |
Last modified on
| 2012 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009358
