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Trial record 75 of 376 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 : Unknown
Verified June 2017 by Chong Kun Dang Pharmaceutical.
Recruitment status was:  Recruiting
First Posted : May 12, 2017
Last Update Posted : June 9, 2017
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

Tracking Information
First Submitted Date  ICMJE May 10, 2017
First Posted Date  ICMJE May 12, 2017
Last Update Posted Date June 9, 2017
Actual Study Start Date  ICMJE May 10, 2017
Estimated Primary Completion Date June 29, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2017)
MTD [ Time Frame: Up to 28 days(for 1st cycle) ]
Maximum Tolerated Dose
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03150316 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2017)
Pharmacokinetics(Cmax) [ Time Frame: 1st Cycle day1: up to 24hr ]
Pharmacokinetics
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 10, 2017)
  • 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
  • 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
  • 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
  • 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
  • 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
  • Pharmacokinetics(T1/2) [ Time Frame: 1st Cycle day1: up to 24hr ]
    Pharmacokinetics
  • Pharmacokinetics(CL) [ Time Frame: 1st Cycle day1: up to 24hr ]
    Pharmacokinetics
  • Pharmacokinetics(AUClast) [ Time Frame: 1st Cycle day1: up to 24hr ]
    Pharmacokinetics
  • Pharmacokinetics(AUCinf) [ Time Frame: 1st Cycle day1: up to 24hr ]
    Pharmacokinetics
  • Pharmacokinetics(Vd) [ Time Frame: 1st Cycle day1: up to 24hr ]
    Pharmacokinetics
  • Pharmacokinetics( MRT) [ Time Frame: 1st Cycle day1: up to 24hr ]
    Pharmacokinetics
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE CKD-581 + Lenalidomide + Dexamethasone in Patients With Previously Treated Multiple Myeloma
Official Title  ICMJE A Phase I, Open-Label, Multi-Center Study of CKD-581 in Combination With Lenalidomide and Dexamethasone in Patients With Previously Treated Multiple Myeloma
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Myeloma, Multiple
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Treat Regimen
CKD-581(investigational Drug) Lenalidomide Dexamethasone
Intervention: Drug: Treat Regimen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 10, 2017)
18
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 19, 2019
Estimated Primary Completion Date June 29, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03150316
Other Study ID Numbers  ICMJE 133MM16016
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Chong Kun Dang Pharmaceutical
Study Sponsor  ICMJE Chong Kun Dang Pharmaceutical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chanki Min The Catholic University of Korea
PRS Account Chong Kun Dang Pharmaceutical
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP