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

NCT03051841 | Unknown Phase 1

• 1 other identifier: 133MM16010
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Myeloma, Multiple

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose(MTD)

  Up to 21 days(for 1st cycle)

Secondary Outcomes (12)

• 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

• 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

• 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

Study Arms (1)

Treat Regimen

EXPERIMENTAL

CKD-581(investigational Drug) Bortezomib Dexamethasone

Drug: CKD-581

Interventions

CKD-581 DRUG

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

Also known as: CKD-581 bortezomib dexamethasone regimen

Treat Regimen

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

CKD-581

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Min Ji Song

  Chong Kun Dang Pharmaceutical Corp.

  STUDY DIRECTOR

Central Study Contacts

Min Ji Song

CONTACT

+82-2-3149-7853; songmj@ckdpharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2017
• First Posted: February 14, 2017
• Study Start: January 1, 2017
• Primary Completion: April 1, 2021
• Study Completion: November 1, 2022
• Last Updated: February 24, 2020

Record last verified: 2020-02

Locations

KR (1)