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

Myeloma, Multiple Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03150316
• Other study ID #: 133MM16016
• Status: Recruiting
• Phase: Phase 1
• Start date: May 10, 2017
• Est. completion date: September 30, 2021

Study information

• Verified date: February 2020
• Source: Chong Kun Dang Pharmaceutical
• Contact: Minji Song
• Phone: 02-3149-7853
• Email: songmj[@]ckdpharm.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: September 30, 2021
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Myeloma, Multiple
• Neoplasms, Plasma Cell

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Hospital	Seoul	Gangnam-gu
Korea, Republic of	the catholic university of korea, Seoul ST. Mary's Hospital	Seoul	Seocho

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Objective Response Rate(ORR)	Objective Response Rate(ORR) of participants as assessed by IMWG uniform response criteria(2011) every 4weeks	Average time period between the start day of induction therapy and the day of relapse or progression or death, whichever occurs firstly, up to 1year
Other	Progression Free Survival(PFS)	Progression Free Survival(PFS) of participants as assessed by IMWG uniform response criteria(2011) every 4weeks	Average time period between the start day of induction therapy and the day of relapse or progression or death, whichever occurs firstly, up to 1year
Other	Overall Survival(OS)	Overall Survival(OS) of participants as assessed by IMWG uniform response criteria(2011) every 4weeks	Average time period between the start day of induction therapy and the day of death, due to any cause, up to 1year
Other	Duration of Response(DOR)	Duration of Response(DOR) of participants as assessed by IMWG uniform response criteria(2011) every 4weeks	Average time period between the day of first achievement of response and the day of first relapse or progression, up to 1year
Other	Pharmacokinetics(T1/2)	Pharmacokinetics	1st Cycle day1: up to 24hr
Other	Pharmacokinetics(CL)	Pharmacokinetics	1st Cycle day1: up to 24hr
Other	Pharmacokinetics(AUClast)	Pharmacokinetics	1st Cycle day1: up to 24hr
Other	Pharmacokinetics(AUCinf)	Pharmacokinetics	1st Cycle day1: up to 24hr
Other	Pharmacokinetics(Vd)	Pharmacokinetics	1st Cycle day1: up to 24hr
Other	Pharmacokinetics( MRT)	Pharmacokinetics	1st Cycle day1: up to 24hr
Other	Adverse events	Adverse events will be assessed using CTCAE criteria.	through study completion, an average of 1 year
Primary	MTD	Maximum Tolerated Dose	Up to 28 days(for 1st cycle)
Secondary	Pharmacokinetics(Cmax)	Pharmacokinetics	1st Cycle day1: up to 24hr