NCT03051841

CKD-581 + Bortezomib + Dexamethasone in Patients With Previously Treated Multiple Myeloma

A Phase I, Open-Label, Multi-Center Study of CKD-581 in Combination With Bortezomib and Dexamethasone in Patients With Previously Treated Multiple Myeloma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myeloma, Multiple

Interventions

Type	Name	Description
DRUG	CKD-581	Intravenously on Days 1, 8 of each 21-day treatment cycle.

Timeline

• Start date: 2017-01-01
• Primary completion: 2021-04-01
• Completion: 2022-11-01
• First posted: 2017-02-14
• Last updated: 2020-02-24

Locations

1 site across 1 country: South Korea