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

Recruitment & Eligibility

Inclusion Criteria

must have received at least one prior lines of therapy and Diagnosis of symptomatic multiple myeloma(IMWG 2014)
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
- ANC(absolute neutrophil count) ≥ 1,500 mm3
- PLT(platelet count)≥ 100,000 mm3
- Hb ≥ 8.0g/dL
- AST(SGOT) and ALT (SGPT) ≤ 3 x UNL(upper limit of normal)
- Serum bilirubin ≤ 1.5 x ULN (but, Gilbert syndrome ≤ 3 x UNL)
- Serum Cr ≤ 1.5 x UNL
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 FLC level ≥ 100mg/L(≥10mg/dL)
more than 24 weeks prior to last bortezomib dose
must have signed the consent form

Exclusion Criteria

Patients with central neurological 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 active hepatitis, HIV positive(exception, non active hepatitis)
peripheral neuropathy ≥ CTCAE grade 2 or peripheral neuropathy ≥ CTCAE grade 1 with pain within 2 weeks prior to first dose of study drug
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
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 bortezomib or dexamethasone
patients without best overall response is above minimal response based on IMWG 2015 past all treatment for multiple myeloma
patients with refractory to past bortezomib treatment(ex; under minimal response) or progress within 60days prior to last bortezomib treatment

Study & Design

Arm && Interventions

Group	Intervention	Description
Treat Regimen	CKD-581	CKD-581(investigational Drug) Bortezomib Dexamethasone

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose(MTD)	Up to 21 days(for 1st cycle)

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics(Cmax)	1st Cycle day1, Day8: up to 24hr
Number of participants with toxicity as assessed by CTCAE v4.03 through study completion, an average of 1 year	through study completion, an average of 1 year
Duration of Response(DOR) of participants as assessed by IMWG uniform response criteria(2011) every 6weeks	Average time period between the day of first achievement of response and the day of first relapse or progression, up to 1year
Pharmacokinetics(CL)	1st Cycle day1, Day8: up to 24hr
Pharmacokinetics(AUClast)	1st Cycle day1, Day8: up to 24hr
Overall Survival(OS) of participants as assessed by IMWG uniform response criteria(2011) every 6weeks	Average time period between the start day of induction therapy and the day of death, due to any cause, up to 1year
Objective Response Rate(ORR) of participants as assessed by IMWG uniform response criteria(2011) every 6weeks	every 6weeks, up to 1year
Progression Free Survival(PFS) of participants as assessed by IMWG uniform response criteria(2011) every 6weeks	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
Pharmacokinetics(T1/2)	1st Cycle day1, Day8: up to 24hr
Pharmacokinetics(AUCinf)	1st Cycle day1, Day8: up to 24hr
Pharmacokinetics(Vd)	1st Cycle day1, Day8: up to 24hr
Pharmacokinetics( MRT)	1st Cycle day1, Day8: up to 24hr

Recruitment & Eligibility