UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008918 |
|---|---|
| Receipt number | R000010460 |
| Scientific Title | Low dose of lenalidomide and dexamethasone therapy for eldery multiple myeloma |
| Date of disclosure of the study information | 2012/09/14 |
| Last modified on | 2012/09/14 14:32:48 |
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Basic information
Public title
Low dose of lenalidomide and dexamethasone therapy for eldery multiple myeloma
Acronym
Mini-Rd for eldery multiple myeloma
Scientific Title
Low dose of lenalidomide and dexamethasone therapy for eldery multiple myeloma
Scientific Title:Acronym
Mini-Rd for eldery multiple myeloma
Region
| Japan |
Condition
Condition
Refractory or relapsed symptomatic multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy of low dose of lenalidomide and dexamethasone therapy for elderly refractory multiple myeloma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Partial remission rate within a year after the therapy
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients were administrated with lenalidomide of 5 mg per day for 21 days and dexamethasone of 8 mg per day weekly for a cycle of 28 days. Numbers of cycle are not determined.
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
*Refractory or relapsed symptomatic multiple myeloma
*patient must be 70 or more than 70 years old at registration, or patients age of lower than 70 are also included if they are considered to be intolerable for ordinary treatment of lenalidomide because of the comorbidities such as previously infectious disease.
*Patient must be informed consent with their signature.
Key exclusion criteria
*Patients who have allergy for the drugs used in this study
*Patients who have active infectious disease
*Patients who are decided as inappropriate by corresponding doctor.
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sachiko Kimura |
Organization
Nishiwaki municipal hospital
Division name
Internal medicine
Zip code
Address
652-1, shimotoda, nishiwaki , Hyogo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chiho Kinugasa |
Organization
Nishiwaki municipal hospital
Division name
management division
Zip code
Address
TEL
Homepage URL
kminagaw@med.kobe-u.ac.jp
Sponsor or person
Institute
Nishiwaki municipal hospital
Institute
Department
Personal name
Funding Source
Organization
N.A.
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 | 09 | Month | 14 | 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
| 2012 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | 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 | 09 | Month | 14 | Day |
Last modified on
| 2012 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010460
