Back to resultsCKD-581 + Lenalidomide + Dexamethasone in Patients With Previously Treated Multiple Myeloma
Primary Purpose
Myeloma, Multiple
Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Treat Regimen
Sponsored by
About this trial
This is an interventional treatment trial for Myeloma, Multiple
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
Sites / Locations
- Samsung HospitalRecruiting
- the catholic university of korea, Seoul ST. Mary's HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treat Regimen
Arm Description
CKD-581(investigational Drug) Lenalidomide Dexamethasone
Outcomes
Primary Outcome Measures
MTD
Maximum Tolerated Dose
Secondary Outcome Measures
Pharmacokinetics(Cmax)
Pharmacokinetics
Full Information
NCT ID
NCT03150316
First Posted
May 10, 2017
Last Updated
February 20, 2020
Sponsor
Chong Kun Dang Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT03150316
Brief Title
CKD-581 + Lenalidomide + Dexamethasone in Patients With Previously Treated Multiple Myeloma
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 10, 2017 (Actual)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
September 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myeloma, Multiple
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treat Regimen
Arm Type
Experimental
Arm Description
CKD-581(investigational Drug) Lenalidomide Dexamethasone
Intervention Type
Drug
Intervention Name(s)
Treat Regimen
Other Intervention Name(s)
CKD-581 lenalidomide dexamethasone regimen
Intervention Description
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
Primary Outcome Measure Information:
Title
MTD
Description
Maximum Tolerated Dose
Time Frame
Up to 28 days(for 1st cycle)
Secondary Outcome Measure Information:
Title
Pharmacokinetics(Cmax)
Description
Pharmacokinetics
Time Frame
1st Cycle day1: up to 24hr
Other Pre-specified Outcome Measures:
Title
Objective Response Rate(ORR)
Description
Objective Response Rate(ORR) of participants as assessed by IMWG uniform response criteria(2011) every 4weeks
Time Frame
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
Title
Progression Free Survival(PFS)
Description
Progression Free Survival(PFS) of participants as assessed by IMWG uniform response criteria(2011) every 4weeks
Time Frame
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
Title
Overall Survival(OS)
Description
Overall Survival(OS) of participants as assessed by IMWG uniform response criteria(2011) every 4weeks
Time Frame
Average time period between the start day of induction therapy and the day of death, due to any cause, up to 1year
Title
Duration of Response(DOR)
Description
Duration of Response(DOR) of participants as assessed by IMWG uniform response criteria(2011) every 4weeks
Time Frame
Average time period between the day of first achievement of response and the day of first relapse or progression, up to 1year
Title
Pharmacokinetics(T1/2)
Description
Pharmacokinetics
Time Frame
1st Cycle day1: up to 24hr
Title
Pharmacokinetics(CL)
Description
Pharmacokinetics
Time Frame
1st Cycle day1: up to 24hr
Title
Pharmacokinetics(AUClast)
Description
Pharmacokinetics
Time Frame
1st Cycle day1: up to 24hr
Title
Pharmacokinetics(AUCinf)
Description
Pharmacokinetics
Time Frame
1st Cycle day1: up to 24hr
Title
Pharmacokinetics(Vd)
Description
Pharmacokinetics
Time Frame
1st Cycle day1: up to 24hr
Title
Pharmacokinetics( MRT)
Description
Pharmacokinetics
Time Frame
1st Cycle day1: up to 24hr
Title
Adverse events
Description
Adverse events will be assessed using CTCAE criteria.
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Minji Song
Phone
02-3149-7853
Email
songmj@ckdpharm.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chanki Min
Organizational Affiliation
The Catholic University of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Hospital
City
Seoul
State/Province
Gangnam-gu
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ki Hyun Kim, PI
Facility Name
the catholic university of korea, Seoul ST. Mary's Hospital
City
Seoul
State/Province
Seocho
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang-ki Min, PI
12. IPD Sharing Statement
Plan to Share IPD
No
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CKD-581 + Lenalidomide + Dexamethasone in Patients With Previously Treated Multiple Myeloma
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