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

NCT ID: NCT03150316

Last Updated: 2020-02-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-10
• Study Completion Date: 2021-09-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treat Regimen

CKD-581(investigational Drug) Lenalidomide Dexamethasone

Group Type: EXPERIMENTAL

Treat Regimen

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

CKD-581 lenalidomide dexamethasone regimen

Eligibility Criteria

Inclusion Criteria

• must have received at least two prior lines of therapy and Diagnosis of symptomatic multiple myeloma(IMWG 2015)
• Eastern Cooperative Oncology Group performance status ≤ 2
• Life expectancy 12 weeks
• must have the following laboratory values within 3 weeks prior to first dose of study drug

• absolute neutrophil count(ANC) ≥ 1,500 mm3
• platelet count(PLT)≥ 100,000 mm3
• Hb ≥ 9.0g/dL
• AST(SGOT) and ALT(SGPT) ≤ 3 x upper limit of normal(UNL)
• Serum bilirubin ≤ 1.5 x ULN (but, Gilbert syndrome ≤ 3 x UNL)
• Creatinin Clearance(CrCl) ≤ 50mL/min
• One more measureable disease following values

• Serum M-protein ≥ 1g/dL
• Urine M-Protein ≥ 200mg/24hr
• in that case serum M-protein, urine M-Protein nonmeasurable and FLC ratio abnormal, Serum free light chain(FLC) level ≥ 100mg/L(≥10mg/dL)
• more than 24 weeks prior to last lenalidomide dose
• must have signed the consent form

Exclusion Criteria

• Patients with CNS disease
• Patients with clinically significant heart disease within 24weeks prior to first dose of study drug
• patients with clinically significans abnormal EKG, echocardiography at screening
• patients with patients with embolism within 24 weeks
• patients with active hepatitis, HIV positive(exception, non active hepatitis)
• peripheral neuropathy ≥ CTCAE grade 2 within 2 weeks prior to first dose of study drug
• Patients with clinically significant disease
• Patients with a prior malignancy with in the last 3 years except adequately treated basal cell or squamous cell or skin cancer, in situ cervical cancer
• Patients who have received surgery, chemotherapy, radiation therapy or immunotherapy or any other investigational drugs ≤ 4 weeks prior to first dose of study drug and during treatment period
• Patients who can not anticoagulate
• Patients who have received dexamethasone >10mg/day within 2week prior to first dose of study drug and during treatment period
• Women who are pregnant or breast feeding or women of childbearing potential not using an effective method of birth control. Male patients whose sexual partners are not using effective birth control.
• patients with hypersensitive reaction of lenalidomide or dexamethasone

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chanki Min

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea

Locations

Samsung Hospital

Seoul, Gangnam-gu, South Korea

Site Status: RECRUITING

the catholic university of korea, Seoul ST. Mary's Hospital

Seoul, Seocho, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Minji Song

Role: CONTACT

songmj@ckdpharm.com

02-3149-7853

Facility Contacts

Ki Hyun Kim, PI

Role: primary

Chang-ki Min, PI

Role: primary

Other Identifiers

133MM16016

Identifier Type: -

Identifier Source: org_study_id