臨床研究等提出・公開システム

Date of registration	Jan. 30, 2012
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221706

Scientific Title	Phase I trial of YHI-1003 Added to the Combination of Bortezomib and Dexamethasone in Multiple Myeloma Patients Previously Treated with Bortezomib
Public Title	Phase I trial of YHI-1003 plus Bortezomib and Dexamethasone

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Yakult Honsha Co., Ltd.
	Address	TEL: +81-3-5550-8968
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		18
Study Type		Interventional
Study Design	Study Design	open-label, multicenter trial
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	(1)Patients were previously diagnosed with multiple myeloma (2)Patients must have relapsed after their last dose of bortezomib-based therapy (3)Patients must have received 1 to 4-myeloma therapies (4)ECOG performance status (PS) :0-2
	Exclusion Criteria	(1)Patients with uncontrolled intercurrent illness (2)Female patients who are pregnant or lactating (3)Patients with non-secretory multiple myeloma
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Relapsed Multiple Myeloma previously treated with Bortezomib
Intervention(s)		investigational material(s) Generic name etc : YHI-1003 INN of investigational material : Perifosine Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : oral
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety CTCAE v3.0
Secondary Outcome		efficacy and pharmacokinetic profile

Primary Sponsor	Yakult Honsha Co., Ltd.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-121748
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
5	Dec. 17, 2018	(this page)	Changes
4	Mar. 12, 2013	Detail	Changes
3	Mar. 12, 2013	Detail	Changes
2	Mar. 09, 2012	Detail	Changes
1	Jan. 30, 2012	Detail

List of change history