UMIN-CTR Clinical Trial

Basic information
Public title	The correlation between fatigue and reactivation of HHV-6 in the patients with multiple myeloma
Acronym	The correlation between fatigue and reactivation of HHV-6 in the patients with multiple myeloma
Scientific Title	The correlation between fatigue and reactivation of HHV-6 in the patients with multiple myeloma
Scientific Title:Acronym	The correlation between fatigue and reactivation of HHV-6 in the patients with multiple myeloma
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 correlation between fatigue and reactivation of HHV-6 in the multiple myeloma patients who receive chemotherapy.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the correlation between fatigue and several markers that represent fatigue, such as the level of HHV6 DNA in saliva, the level of HHV7 DNA in saliva, fatigue factor, fatigue recovery factor, and inflammatory cytokines.
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	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	harvest of saliva, and blood test.
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. Patients with multiple myeloma 2. To receive chemotherapy 3. ECOG PS = 0-2 4. The hemoglobin level >= a facilities standard value 5. To answer the questions to evaluate the degree of fatigue. 6. Harvest the adequate volume of saliva
Key exclusion criteria	1. Severe phycological disorder 2. Infection of HIV, HTLV=1, HBV, HCV 3. Congenital immunodeficiency 4. Severe complications, such as hypertension, congestive heart failure, coronary artery disease, liver cirrhosis, diabetes mellitus, and respiratory failure.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Kazuhito Middle name Last name Suzuki
Organization	The Jikei University School of Medicine
Division name	Devision of Clinical Oncology/ Hematology
Zip code	105-8567
Address	3-25-8 Nishi-shinbashi, Minato-ku, Tokyo.
TEL	03-3433-1111
Email	kaz-suzuki@jikei.ac.jp

Public contact
Name of contact person	1st name Kazuhito Middle name Last name Suzuki
Organization	The Jikei University School of Medicine
Division name	Devision of Clinical Oncology/ Hematology
Zip code	105-8567
Address	3-25-8 Nishi-shinbashi, Minato-ku, Tokyo
TEL	03-3433-1111
Homepage URL
Email	kaz-suzuki@jikei.ac.jp

Sponsor
Institute	The Jikei University School of Medicine
Institute
Department

Funding Source
Organization	None
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	The Jikei University School of Medicine
Address	3-25-8 Nishi-sihmbashi, Minato-ku, Tokyo
Tel	03-3433-1111
Email	kaz-suzuki@jikei.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	2013 Year 03 Month 28 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	2013 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date	2013 Year 02 Month 01 Day
Last follow-up date	2016 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 03 Month 28 Day
Last modified on	2019 Year 10 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012113