NCT03150316

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

A Phase I, Open-Label, Multi-Center Study of CKD-581 in Combination With Lenalidomide 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) and recommened phase 2 dose(RP2D) based on dose limiting toxicity(DLT), and to evaluate safety and pharmacokinetics(PK) profile of a single agent CKD-581 injection in Combination with Lenalidomide 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-516 until the maximum tolerated dose(MTD) is determined. The MTD is defined 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	Treat Regimen	CKD-581(investigational Drug): on days 1, 8, 15 of repeated 28day cycles Lenalidomide: on days 1\~21 of repeated 28 day cycles Dexamethasone: administrated once weekly every 28day cycles

Timeline

• Start date: 2017-05-10
• Primary completion: 2020-06-30
• Completion: 2021-09-30
• First posted: 2017-05-12
• Last updated: 2020-02-24

Locations

2 sites across 1 country: South Korea