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Trial record 75 of 372 for:    LENALIDOMIDE AND Dexamethasone

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

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ClinicalTrials.gov Identifier: NCT03150316
Recruitment Status : Recruiting
First Posted : May 12, 2017
Last Update Posted : June 9, 2017
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

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.

Condition or disease Intervention/treatment Phase
Myeloma, Multiple Drug: Treat Regimen Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
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 Lenalidomide and Dexamethasone in Patients With Previously Treated Multiple Myeloma
Actual Study Start Date : May 10, 2017
Estimated Primary Completion Date : June 29, 2018
Estimated Study Completion Date : November 19, 2019


Arm Intervention/treatment
Experimental: Treat Regimen
CKD-581(investigational Drug) Lenalidomide Dexamethasone
Drug: Treat Regimen
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
Other Name: CKD-581 lenalidomide dexamethasone regimen




Primary Outcome Measures :
  1. MTD [ Time Frame: Up to 28 days(for 1st cycle) ]
    Maximum Tolerated Dose


Secondary Outcome Measures :
  1. Pharmacokinetics(Cmax) [ Time Frame: 1st Cycle day1: up to 24hr ]
    Pharmacokinetics


Other Outcome Measures:
  1. toxicity [ Time Frame: through study completion, an average of 1 year ]
    Number of participants with toxicity as assessed by CTCAE v4.03 through study completion, an average of 1 year

  2. Objective Response Rate(ORR) [ 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 ]
    Objective Response Rate(ORR) of participants as assessed by IMWG uniform response criteria(2011) every 4weeks

  3. Progression Free Survival(PFS) [ 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 ]
    Progression Free Survival(PFS) of participants as assessed by IMWG uniform response criteria(2011) every 4weeks

  4. Overall Survival(OS) [ Time Frame: Average time period between the start day of induction therapy and the day of death, due to any cause, up to 1year ]
    Overall Survival(OS) of participants as assessed by IMWG uniform response criteria(2011) every 4weeks

  5. Duration of Response(DOR) [ Time Frame: Average time period between the day of first achievement of response and the day of first relapse or progression, up to 1year ]
    Duration of Response(DOR) of participants as assessed by IMWG uniform response criteria(2011) every 4weeks

  6. Pharmacokinetics(T1/2) [ Time Frame: 1st Cycle day1: up to 24hr ]
    Pharmacokinetics

  7. Pharmacokinetics(CL) [ Time Frame: 1st Cycle day1: up to 24hr ]
    Pharmacokinetics

  8. Pharmacokinetics(AUClast) [ Time Frame: 1st Cycle day1: up to 24hr ]
    Pharmacokinetics

  9. Pharmacokinetics(AUCinf) [ Time Frame: 1st Cycle day1: up to 24hr ]
    Pharmacokinetics

  10. Pharmacokinetics(Vd) [ Time Frame: 1st Cycle day1: up to 24hr ]
    Pharmacokinetics

  11. Pharmacokinetics( MRT) [ Time Frame: 1st Cycle day1: up to 24hr ]
    Pharmacokinetics



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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 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

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): NCT03150316


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

Locations
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Korea, Republic of
Samsung Hospital Recruiting
Soul, Gangnam-gu, Korea, Republic of, 06351
Contact: Ki Hyun Kim, PI    +82-2-3410-3456    kihyunkimk@gmail.com   
the catholic university of korea, Seoul ST. Mary's Hospital Enrolling by invitation
Seoul, Seocho, Korea, Republic of, 06591
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
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Principal Investigator: Chanki Min The Catholic University of Korea

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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT03150316     History of Changes
Other Study ID Numbers: 133MM16016
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: June 9, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dexamethasone
Dexamethasone acetate
Lenalidomide
BB 1101
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
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
Protease Inhibitors