UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Observational study of the correlation between the geriatric assessment tools and prognosis of the geriatric patients with multiple myeloma (prospective observational study)
Title of the study (Brief title)	Observational study of the correlation between the geriatric assessment tools and prognosis of the geriatric patients with multiple myeloma (prospective observational study)
Region	Japan

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

Objectives
Narrative objectives1	We confirm whether the geriatric assessment tool can be multiple myeloma patients prognostic prediction
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	5 years survival rate stratified by geriatric assessment tool
Key secondary outcomes	monthly hospital days stratified by geriatric assessment tool decrease rate of the score of EQ-5D-5L stratified by geriatric assessment tool remission rate by treatment intensity stratified by geriatric assessment tool survival rate by treatment intensity stratified by geriatric assessment tool

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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	65 years of age or older patients diagnosed with multiple myeloma patients who got written informed consent
Key exclusion criteria	patients who treat chemotherapy for hematological malignancy
Target sample size	80

Research contact person
Name of lead principal investigator	Suyama Takuya
Organization	Hitachi general hospital
Division name	hematology,oncology
Address	2-1-1 Jonan-cho,Hitachi City,Ibaraki prefecture
TEL	0294231111
Email	sutaku2468@yahoo.co.jp

Public contact
Name of contact person	Suyama Takuya
Organization	Hitachi general hospital
Division name	hematology,oncology
Address	2-1-1 Jonan-cho,Hitachi City,Ibaraki prefecture
TEL	0294231111
Homepage URL
Email	sutaku2468@yahoo.co.jp

Sponsor
Institute	Hitachi general hospital
Institute
Department

Funding Source
Organization	Hitachi general hospital
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	日立総合病院(茨城県)

Other administrative information
Date of disclosure of the study information	2018 Year 12 Month 15 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 11 Month 27 Day
Anticipated trial start date	2018 Year 12 Month 15 Day
Last follow-up date	2031 Year 12 Month 14 Day
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	observational study all patients who met the selection criteria in patients who visited our hospital forom December 2018 to December 2026 Items to be measured:age,sex,PS,G8,R-ISS, Charlson comobidity index,EQ-5D-5L(registration,Half a year, 1 year, 2 year, 3 year, 4 year, 5 year),serum Alb,hospital days,Chemotherapy, treatment effect, presence or absence of relapse, survival date, date of death

Management information
Registered date	2018 Year 11 Month 26 Day
Last modified on	2018 Year 12 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039903