UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of efficacy and immunomodulatory activity of lenalidomide alone in relapse and refractory multiple myeloma
Title of the study (Brief title)	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	Shinya Kimura
Organization	Faculty of Medicine, Saga University
Division name	Hematology, Respiratory Medicine and Oncology
Address	Nabeshima 5-1-1, Saga,Saga
TEL	0952-34-2366
Email	shkimu@cc.saga-u.ac.jp

Public contact
Name of contact person	Noriyasu Fukushima
Organization	Faculty of Medicine, Saga University
Division name	Hematology, Respiratory Medicine and Oncology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 01 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000011633