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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009927
Receipt No. 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

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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
Email 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
Email fukushin@cc.saga-u.ac.jp

Sponsor
Institute Hematology, Respiratory Medicine and Oncology,Faculty of Medicine, Saga University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011633

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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