UMIN-CTR Clinical Trial

Basic information
Public title	A cluster randomized controlled trial on a procedure to ensure appropriate management of medications with strong teratogenicity.
Acronym	A cluster randomized controlled trial on a procedure to ensure appropriate management of medications with strong teratogenicity.
Scientific Title	A cluster randomized controlled trial on a procedure to ensure appropriate management of medications with strong teratogenicity.
Scientific Title:Acronym	A cluster randomized controlled trial on a procedure to ensure appropriate management of medications with strong teratogenicity.
Region	Japan

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

Objectives
Narrative objectives1	This study scientifically proves whether there is a difference in the patient's awareness of compliance regardless of the confirmation period of the "periodic confirmation form" and considers a more appropriate drug safety management procedure. Since the introduction of drug safety management procedures, while safety has been emphasized, we will study the ideal way of appropriate drug safety management procedures for reducing the burden on patients in cluster randomized trials, which have not been done so far.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Confirmation that all subjects and their partners do not report pregnancy Percentage of correct answers (correct answers to all questions of questionnaire 7 questions) of the understanding questionnaire (Appendix) at 24 weeks
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Medicine
Interventions/Control_1	Understanding the Noveltability of Thalidmid(Non-extended groups)
Interventions/Control_2	Understanding the Noveltability of Thalidmid(extended groups)
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	Men over 20 years of age and pregnant women treating thalidmid drugs in patients with multiple myeloma
Key exclusion criteria	Female patients with no possibility of pregnancy
Target sample size	900

Research contact person
Name of lead principal investigator	1st name kenshi Middle name Last name suzuki
Organization	Japanese Red Cross Medical Center
Division name	Myeloma Amyloidosis Center
Zip code	1508935
Address	Hiroo 4-1-22, Shibuya-ku, Tokyo
TEL	03-3400-1311
Email	ken-suzuki@mtb.biglobe.ne.jp

Public contact
Name of contact person	1st name rena Middle name Last name tazawa
Organization	Japanese Red Cross Medical Center
Division name	Medical Secretary's Division
Zip code	1508935
Address	Hiroo 4-1-22, Shibuya-ku, Tokyo
TEL	03-3400-1311
Homepage URL
Email	iryohisyoka2@med.jrc.or.jp

Sponsor
Institute	Ministry of Health, Labou Safety Measures Section
Institute
Department

Funding Source
Organization	AMED
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Japanese Red Cross Medical Center
Address	Hiroo 4-1-22, Shibuya-ku, Tokyo
Tel	03-3400-1311
Email	ken-suzuki@mtb.biglobe.ne.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	2020 Year 10 Month 19 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	900
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	2020 Year 03 Month 29 Day
Date of IRB	2018 Year 11 Month 21 Day
Anticipated trial start date	2020 Year 07 Month 01 Day
Last follow-up date	2021 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 10 Month 19 Day
Last modified on	2020 Year 10 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048131