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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03051841
Recruitment Status : Recruiting
First Posted : February 14, 2017
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

Study Description
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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.

Condition or disease Intervention/treatment Phase
Myeloma, Multiple Drug: CKD-581 Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2017
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treat Regimen
CKD-581(investigational Drug) Bortezomib Dexamethasone
 Drug: CKD-581
Intravenously on Days 1, 8 of each 21-day treatment cycle.
Other Name: CKD-581 bortezomib dexamethasone regimen


Outcome Measures
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Primary Outcome Measures :
  1. Maximum Tolerated Dose(MTD) [ Time Frame: Up to 21 days(for 1st cycle) ]

Secondary Outcome Measures :
  1. Pharmacokinetics(Cmax) [ Time Frame: 1st Cycle day1, Day8: up to 24hr ]
  2. 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 ]
  3. Objective Response Rate(ORR) of participants as assessed by IMWG uniform response criteria(2011) every 6weeks [ Time Frame: every 6weeks, up to 1year ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. Pharmacokinetics(T1/2) [ Time Frame: 1st Cycle day1, Day8: up to 24hr ]
  8. Pharmacokinetics(CL) [ Time Frame: 1st Cycle day1, Day8: up to 24hr ]
  9. Pharmacokinetics(AUClast) [ Time Frame: 1st Cycle day1, Day8: up to 24hr ]
  10. Pharmacokinetics(AUCinf) [ Time Frame: 1st Cycle day1, Day8: up to 24hr ]
  11. Pharmacokinetics(Vd) [ Time Frame: 1st Cycle day1, Day8: up to 24hr ]
  12. Pharmacokinetics( MRT) [ Time Frame: 1st Cycle day1, Day8: up to 24hr ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03051841


Contacts
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Contact: Min Ji Song +82-2-3149-7853 songmj@ckdpharm.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Sung-Soo Yoon    +82-2-2072-3079    ssysmc@gmail.com   
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
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Study Director: Min Ji Song Chong Kun Dang Pharmaceutical Corp.
More Information
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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT03051841    
Other Study ID Numbers: 133MM16010
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
 Dexamethasone
Bortezomib
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents