UMIN-CTR Clinical Trial

Basic information
Public title	The association of Cytokine /chemokine profiles with the clinical outcome and safety in relapsed/refractory multiple myeloma patients treated with lenalidomide plus dexamethasone
Acronym	Cytokine /chemokine profiles in relapsed/refractory multiple myeloma patients treated with lenalidomide plus dexamethasone
Scientific Title	The association of Cytokine /chemokine profiles with the clinical outcome and safety in relapsed/refractory multiple myeloma patients treated with lenalidomide plus dexamethasone
Scientific Title:Acronym	Cytokine /chemokine profiles in relapsed/refractory multiple myeloma patients treated with lenalidomide plus dexamethasone
Region	Japan

Condition
Condition	Multiple myeloma
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the association of Cytokine /chemokine profiles with the clinical outcome and safety in relapsed/refractory multiple myeloma patients treated with lenalidomide plus dexamethasone
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The serum cytokine level,chemokine level and the counts of peripheral lymphocytes.
Key secondary outcomes

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	Patients will receive Lenalidomide(25mg on days 1-21) and dexamethazone(40mg on days1,8,15,22 in patinets aged between 20 to 74 and 20mg on days 1,8,15,22 in patinets aged 75 years or more) on 28-day cycle. The dose of lenalidomide is adjusted based on the guideline.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Multiple myeloma diagnosed aged 20 years or more 2.Relapsed or refractory multiple myeloma without lenalidemide and medical history over the past 1 or 2 regimen 3.ECOG of Performance Status between 0 and 2 4.M protein in serum or urine is assessable. 5.Preserved function of major organs 6.Predicting survival time is more than 3 months. 7.Menopausal female or male and female who are enable to prevent conception by the adequate methods, including the surgical conception. 8.Informed consent in writing
Key exclusion criteria	1.Previous treatment with lenalidomide 2.Hypersensitivity to lenalidomide and/or dexamethasone 3.non-secretory myeloma, solitary plasmacytoma, plasma cell leukemia, of POEMS syndrome 4.Positivity of HBs antigen or, HCV or HIV antibody 5.Uncontrollable liver dysfunction, renal dysfunction, cardiac dysfunction, respiratory dysfunction, diabetes mellitus, hypertension and infection 6.Double cancer requiring treatments 7.Psychoneurotic disorder, depression state or history 8.Patients with pregnancy, patients who may be pregnant, or patients during lactation 9.Pulomonary fibrosis, interstitial pneumonitis or interstitial shadow on chest CT, even if no symptom 10.Ineligible patient by physicians decision
Target sample size	20

Research contact person
Last name of lead principal investigator	1st name Takaaki Middle name Last name Ono
Organization	Hamamatsu University School of Medicine
Division name	Department of Internal Medicine III (Division of hematology)
Zip code	431-3192
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL	+81-53-435-2267
Email	takaono@hama-med.ac.jp

Public contact
1st name of contact person	1st name Yasuyuki Middle name Last name Nagata
Organization	Hamamatsu University School of Medicine
Division name	Department of Internal Medicine III (Division of hematology)
Zip code	431-3192
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
TEL	+81-53-435-2267
Homepage URL
Email	yasu@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Celgene
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Division of Center for Clinical research, Hamamatsu University School of Medicine
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, Japan
Tel	+81-53-435-2676
Email	yamoto@hama-med.ac.jp

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	2016 Year 05 Month 11 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	No longer recruiting
Date of protocol fixation	2015 Year 06 Month 09 Day
Date of IRB	2015 Year 09 Month 01 Day
Anticipated trial start date	2015 Year 09 Month 01 Day
Last follow-up date	2019 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	2016 Year 05 Month 05 Day
Last modified on	2019 Year 05 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025587