Spots Global Cancer Trial Database for CKD-581 + Bortezomib + Dexamethasone in Patients With Previously Treated Multiple Myeloma
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Trial Identification
Brief Title: CKD-581 + Bortezomib + Dexamethasone in Patients With Previously Treated Multiple Myeloma
Official Title: A Phase I, Open-Label, Multi-Center Study of CKD-581 in Combination With Bortezomib and Dexamethasone in Patients With Previously Treated Multiple Myeloma
Study ID: NCT03051841
Conditions
Interventions
Study Description
Brief Summary: This study is to determine the maximum tolerated dose(MTD), dose limiting toxicity(DLT), safety and pharmacokinetics(PK) profile of a single agent CKD-581 injection in Combination with Bortezomib and Dexamethasone in patients with Previously Treated Multiple Myeloma.
Detailed Description: This is an open label, dose escalation study. Cohort of 3\~6 patients receive escalation doses of CKD-581 until the maximum toleated dose(MTD) is determined. The MTD is defiend as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity.
Keywords
Eligibility
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Seoul National University Hospital, Seoul, , Korea, Republic of
Contact Details
Name: Min Ji Song
Affiliation: Chong Kun Dang Pharmaceutical Corp.
Role: STUDY_DIRECTOR
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