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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007945
Receipt No. 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

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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
Email

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
Email hanamoto@nara.med.kindai.ac.jp

Sponsor
Institute Nara Hospital Kinki University School Of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009358

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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