UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010178 |
|---|---|
| Receipt number | R000011918 |
| Scientific Title | Investigation of the maximum optimal dosage and efficacy of lenalidomide for the treatment of relapsed and refractory multiple myeloma. |
| Date of disclosure of the study information | 2013/03/06 |
| Last modified on | 2013/03/06 15:28:04 |
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Basic information
Public title
Investigation of the maximum optimal dosage and efficacy of lenalidomide for the treatment of relapsed and refractory multiple myeloma.
Acronym
Investigation of the maximum optimal dosage and efficacy of lenalidomide for the treatment of relapsed and refractory multiple myeloma.
Scientific Title
Investigation of the maximum optimal dosage and efficacy of lenalidomide for the treatment of relapsed and refractory multiple myeloma.
Scientific Title:Acronym
Investigation of the maximum optimal dosage and efficacy of lenalidomide for the treatment of relapsed and 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 assess the efficacy and maximum optimal dose of
lenalidomide when combined with dexamethasone, and to
evaluate the efficacy of this combination therapy and quality of life (QoL).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
response rate
Key secondary outcomes
safety and quality of life
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
lemalidomide treatment
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
1) relapse and refractory multiple myeloma without previously treated lenalidomide
2) assessable M proteinemia or M proteinuira
3) preserved mail organ function and implement the following criteria
4) promising more than 3 months living
5) menopausal female and male and female are enable to prevent conception by the adequate methods, including the surgical conception
6) complete informed concent
Key exclusion criteria
1) previously administered lenalidomide
2) hypersensitive reaction for lenalidomide, thalidomide and dexamethazone
3) non-secretory myeloma, solitary plasmacytoma, plasmacell leukemia and POEMS syndrome
4) CTCAE more than grade 3 neutropenia, thrombocytopenia
5) HBsAg is positive
6) HCV is positive, HIV is positive
7) uncontrollable liver dysfunction, renal insufficiency, cardiac dysfunction, respiratory dysfunction, diabetus mellitus, hypertension and infection
8) double cancer
9) psychoneurotic disorder, depression state or history
10) a case for difficult to collect QoL score
11) pregnant female, possible pregnancy or durling lactation
12) pulomonary fibrosis and interstitial pneumonitis interstitial shadow on chest CT, even if no sympton
13) physicians' decision
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Okamura |
Organization
Kurume University Hospital
Division name
Hematology and Oncology
Zip code
Address
67, Asahi-machi, Kurume 830-0011, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Osaki |
Organization
Kurume University Hospital
Division name
Hematology and Oncology
Zip code
Address
TEL
Homepage URL
osaki_koichi@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University Hospital
Division of Hematology and Oncology
Institute
Department
Personal name
Funding Source
Organization
Kurume University Hospital
Division of Hematology and Oncology
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
| 2013 | Year | 03 | Month | 06 | 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
| 2013 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 06 | Day |
Last modified on
| 2013 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011918
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
