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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03150316
Study type Interventional
Source Chong Kun Dang Pharmaceutical
Contact Minji Song
Phone 02-3149-7853
Email songmj@ckdpharm.com
Status Recruiting
Phase Phase 1
Start date May 10, 2017
Completion date September 30, 2021

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04009109 - Study of Lenalidomide/Ixazomib/Dexamethasone/Daratumumab in Transplant-Ineligible Patients With Newly Diagnosed MM Phase 2
Terminated NCT03910439 - Avelumab in Combination With Hypofractionated Radiotherapy in Patients With Relapsed Refractory Multiple Myeloma Phase 2
Recruiting NCT03966443 - Fluciclovine PET/CT in Multiple Myeloma Patients
Recruiting NCT03051841 - CKD-581 + Bortezomib + Dexamethasone in Patients With Previously Treated Multiple Myeloma Phase 1
Completed NCT02294487 - Study of the Immune Response After Vaccination in Multiple Myeloma Patients
Recruiting NCT04645199 - National Longitudinal Cohort of Hematological Diseases
Completed NCT02033928 - Comprehensive Frailty Assessment N/A