UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009927 |
|---|---|
| Receipt number | R000011633 |
| Scientific Title | Analysis of efficacy and immunomodulatory activity of lenalidomide alone in relapse and refractory multiple myeloma |
| Date of disclosure of the study information | 2013/02/01 |
| Last modified on | 2017/02/13 09:13:40 |
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Basic information
Public title
Analysis of efficacy and immunomodulatory activity of lenalidomide alone in relapse and refractory multiple myeloma
Acronym
Immunomoduratory activity for MM treated with lenalidomide
Scientific Title
Analysis of efficacy and immunomodulatory activity of lenalidomide alone in relapse and refractory multiple myeloma
Scientific Title:Acronym
Immunomoduratory activity for MM treated with lenalidomide
Region
| Japan |
Condition
Condition
plasma cell myeloma
Classification by specialty
| Medicine in general | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the efficacy immunomodulatory activity for lenalidomide alone in relapse and refractory multiple myeloma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
progression free survival time
Key secondary outcomes
safety, overall survival time, exploratory of immunomodulatory marker
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
Treatment of 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
| 20 | years-old | <= |
Age-upper limit
| 81 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) relapse and refractory multiple myeloma without previously treated lenalidomide
2) Aged 20 to less than 81 years old
3) assessable M proteinemia or M proteinuira
4) ECOG PS 0-2
5) preserved mail organ function and implement the following criteria
a) neutrophil count is more than 1x10e9/L
b) platetel count is more than 5x10e10/L
c) Total bilirubin is less than three times-fold in upper limit
d) Serum AST and ALT are less than five times-fold in upper limit
e) Serum creatinine is less than 2.5mg/dl
f) ejection fraction in ultrasound cardiography is more than 50%
g) PaO2 is more than 60mmHg or SpO2 is more than 93%
6) promising more than 3 months living
7) menopausal female and male and female are enable to prevent conception by the adequate methods, including the surgical conception
8) 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) pregnant female, possible pregnancy or durling lactation
11) pulomonary fibrosis and interstitial pneumonitis interstitial shadow on chest CT, even if no sympton
12) physicians' decision
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinya Kimura |
Organization
Faculty of Medicine, Saga University
Division name
Hematology, Respiratory Medicine and Oncology
Zip code
Address
Nabeshima 5-1-1, Saga,Saga
TEL
0952-34-2366
shkimu@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriyasu Fukushima |
Organization
Faculty of Medicine, Saga University
Division name
Hematology, Respiratory Medicine and Oncology
Zip code
Address
Nabeshima 5-1-1, Saga,Saga
TEL
0952-34-2366
Homepage URL
fukushin@cc.saga-u.ac.jp
Sponsor or person
Institute
Hematology, Respiratory Medicine and Oncology,Faculty of Medicine, Saga University
Institute
Department
Personal name
Funding Source
Organization
Hematology, Respiratory Medicine and Oncology,Faculty of Medicine, Saga University
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
佐賀大学医学部血液・呼吸器・腫瘍内科(佐賀県)、高木病院(福岡県)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 01 | 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
Completed
Date of protocol fixation
| 2013 | Year | 01 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 01 | Day |
Last modified on
| 2017 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011633
