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CKD-581 + Bortezomib + 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

CKD-581

About this trial

This is an interventional treatment trial for Myeloma, Multiple

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treat Regimen

Arm Description

CKD-581(investigational Drug) Bortezomib Dexamethasone

Outcomes

Primary Outcome Measures

Maximum Tolerated Dose(MTD)

Secondary Outcome Measures

Pharmacokinetics(Cmax)

Number of participants with toxicity as assessed by CTCAE v4.03 through study completion, an average of 1 year

Objective Response Rate(ORR) of participants as assessed by IMWG uniform response criteria(2011) every 6weeks

Progression Free Survival(PFS) of participants as assessed by IMWG uniform response criteria(2011) every 6weeks

Overall Survival(OS) of participants as assessed by IMWG uniform response criteria(2011) every 6weeks

Duration of Response(DOR) of participants as assessed by IMWG uniform response criteria(2011) every 6weeks

Pharmacokinetics(T1/2)

Pharmacokinetics(CL)

Pharmacokinetics(AUClast)

Pharmacokinetics(AUCinf)

Pharmacokinetics(Vd)

Pharmacokinetics( MRT)

Full Information

NCT ID

NCT03051841

First Posted

January 9, 2017

Last Updated

February 20, 2020

Sponsor

Chong Kun Dang Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT03051841

Brief Title

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

Official Title

A Phase I, Open-Label, Multi-Center Study of CKD-581 in Combination With Bortezomib 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

January 2017 (undefined)

Primary Completion Date

April 2021 (Anticipated)

Study Completion Date

November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chong Kun Dang Pharmaceutical

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study is to determine the maximum tolerated dose(MTD), dose limiting toxicity(DLT), safety and pharmacokinetics(PK) profile of a single agent CKD-581 injection in Combination with Bortezomib 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-581 until the maximum toleated dose(MTD) is determined. The MTD is defiend 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) Bortezomib Dexamethasone

Intervention Type

Drug

Intervention Name(s)

CKD-581

Other Intervention Name(s)

CKD-581 bortezomib dexamethasone regimen

Intervention Description

Intravenously on Days 1, 8 of each 21-day treatment cycle.

Primary Outcome Measure Information:

Title

Maximum Tolerated Dose(MTD)

Time Frame

Up to 21 days(for 1st cycle)

Secondary Outcome Measure Information:

Title

Pharmacokinetics(Cmax)

Time Frame

1st Cycle day1, Day8: up to 24hr

Title

Number of participants with toxicity as assessed by CTCAE v4.03 through study completion, an average of 1 year

Time Frame

through study completion, an average of 1 year

Title

Objective Response Rate(ORR) of participants as assessed by IMWG uniform response criteria(2011) every 6weeks

Time Frame

every 6weeks, up to 1year

Title

Progression Free Survival(PFS) of participants as assessed by IMWG uniform response criteria(2011) every 6weeks

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) of participants as assessed by IMWG uniform response criteria(2011) every 6weeks

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) of participants as assessed by IMWG uniform response criteria(2011) every 6weeks

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)

Time Frame

1st Cycle day1, Day8: up to 24hr

Title

Pharmacokinetics(CL)

Time Frame

1st Cycle day1, Day8: up to 24hr

Title

Pharmacokinetics(AUClast)

Time Frame

1st Cycle day1, Day8: up to 24hr

Title

Pharmacokinetics(AUCinf)

Time Frame

1st Cycle day1, Day8: up to 24hr

Title

Pharmacokinetics(Vd)

Time Frame

1st Cycle day1, Day8: up to 24hr

Title

Pharmacokinetics( MRT)

Time Frame

1st Cycle day1, Day8: up to 24hr

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Min Ji Song

Phone

+82-2-3149-7853

songmj@ckdpharm.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Min Ji Song

Organizational Affiliation

Chong Kun Dang Pharmaceutical Corp.

Official's Role

Study Director

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sung-Soo Yoon

Phone

+82-2-2072-3079

ssysmc@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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