UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prediction of the lenalidomide toxicity and its therapeutic efficacy in multiple myeloma patients by measuring its plasma concentration
Title of the study (Brief title)	Prediction of the lenalidomide toxicity by measuring its plasma concentration
Region	Japan

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

Objectives
Narrative objectives1	Lenalidomide (Len) has significant clinical activity in patients with multiple myeloma (MM) and it is usually administered at a dose of 25 mg daily. However, it is important to determine the most suitable dosage on patient individually. The aim of this study is to investigate the relationship between pharmacokinetic variability of lenalidomide and its toxicity and therapeutic efficacy.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hematological and non-hematological adverse event
Key secondary outcomes	Continuity of initial dosage, Hematological response

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Multiple myeloma patient who received lenalidomide and dexamethasone
Key exclusion criteria	Multiple myeloma patient who recieved anti-cancer drugs in additon to lenalidomide
Target sample size	30

Research contact person
Name of lead principal investigator	Chihiro Shimazaki
Organization	Japan Community Health care Organization Kyoto Kuramaguchi Medical Center
Division name	Department of Hematology
Address	27 koyamashimohusa-cho, Kita-ku, Kyoto
TEL	075-441-6101
Email	shimazaki-chihiro@kyoto.jcho.go.jp

Public contact
Name of contact person	Shin-ichi Fuchida
Organization	Japan Community Health care Organization Kyoto Kuramaguchi Medical Center
Division name	Department of Hematology
Address	27 koyamashimohusa-cho, Kita-ku, Kyoto
TEL	075-441-6101
Homepage URL
Email	sfuch0614@gaia.eonet.ne.jp

Sponsor
Institute	Japan Community Health care Organization Kyoto Kuramaguchi Medical Center
Institute
Department

Funding Source
Organization	Japan Community Health care Organization Kyoto Kuramaguchi Medical Center
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Division of Biological Sciences Department of Clinical and Translational Physiology, Kyoto Pharmaceutical University
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	独立行政法人地域医療機能推進機構京都鞍馬口医療センター

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 03 Month 01 Day
Anticipated trial start date	2013 Year 07 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	This study was started on October 24, 2011. All multiple myeloma patients treated in Kyoto Kuramaguchi Medical Center and compatible to eligibility criterion are included in this study. Plasma concentration of lenalidomide is evaluated.

Management information
Registered date	2016 Year 05 Month 10 Day
Last modified on	2017 Year 05 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025509