ID

41484

Description

Clarithromycin Plus CTd Regimen for Patients With Newly Diagnosed Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT02248428

Link

https://clinicaltrials.gov/show/NCT02248428

Keywords

Versions (1)
  1. 10/26/20 10/26/20 -
Copyright Holder

see on clinicaltrials.gov

Uploaded on

October 26, 2020

DOI

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License

Creative Commons BY 4.0
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    Eligibility Multiple Myeloma NCT02248428

    English

    Eligibility Multiple Myeloma NCT02248428

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    signed informed consent form
    Description

    Signed informed consent form

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    adhere to the study visit schedule and other protocol requirements
    Description

    Ability to meet study requirements

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0525058
    diagnosed with active multiple myeloma
    Description

    active multiple myeloma

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0205177
    UMLS CUI [1,2]
    C0026764
    myeloma previously untreated
    Description

    previously untreated

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0332155
    UMLS CUI [1,2]
    C0026764
    karnofsky performance status(kps) ≥50
    Description

    karnofsky performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0206065
    karnofsky performance status (kps) <50 related to bony disease
    Description

    karnofsky performance status

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0206065
    UMLS CUI [1,2]
    C0439849
    UMLS CUI [1,3]
    C0005940
    new york heart association (nyha) functional ≤ class iii
    Description

    new york heart association

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1275491
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    hypersensitivity to clarithromycin or any of its excipients, erythromycin, or any of the macrolide antibiotics;
    Description

    hypersensitivity to clarithromycin or any of its excipients, erythromycin, or any of the macrolide antibiotics

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0055856
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0055856
    UMLS CUI [2,3]
    C0015237
    UMLS CUI [3,1]
    C0020517
    UMLS CUI [3,2]
    C0014806
    UMLS CUI [4,1]
    C0020517
    UMLS CUI [4,2]
    C0003240
    concomitant administration of cisapride, pimozide, astemizole, terfenadine, ergotamine or dihydroergotamine, simvastatin, lovastatin, and atorvastatin;
    Description

    concomitant administration of cisapride, pimozide, astemizole, terfenadine, ergotamine or dihydroergotamine, simvastatin, lovastatin, and atorvastatin

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2347852
    UMLS CUI [1,2]
    C0072916
    UMLS CUI [2,1]
    C2347852
    UMLS CUI [2,2]
    C0031935
    UMLS CUI [3,1]
    C2347852
    UMLS CUI [3,2]
    C0085170
    UMLS CUI [4,1]
    C2347852
    UMLS CUI [4,2]
    C0085173
    UMLS CUI [5,1]
    C2347852
    UMLS CUI [5,2]
    C0014710
    UMLS CUI [6,1]
    C2347852
    UMLS CUI [6,2]
    C0012291
    UMLS CUI [7,1]
    C2347852
    UMLS CUI [7,2]
    C0074554
    UMLS CUI [8,1]
    C2347852
    UMLS CUI [8,2]
    C0024027
    UMLS CUI [9,1]
    C2347852
    UMLS CUI [9,2]
    C0286651
    a history of cholestatic jaundice/hepatic dysfunction associated with prior use of clarithromycin
    Description

    previous cholestatic jaundice/hepatic dysfunction linked to use of clarithromycin

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0205156
    UMLS CUI [1,2]
    C0008370
    UMLS CUI [1,3]
    C0022346
    UMLS CUI [1,4]
    C0332281
    UMLS CUI [1,5]
    C0055856
    UMLS CUI [2,1]
    C0205156
    UMLS CUI [2,2]
    C0086565
    UMLS CUI [2,3]
    C0332281
    UMLS CUI [2,4]
    C0055856
    impaired renal function,creatinine ≥221umol/l；
    Description

    abnormal renal function, creatinine

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    UMLS CUI [2]
    C0151746
    pregnant or breast feeding females
    Description

    pregnant or breast feeding

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    any condition which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
    Description

    condition placing the subject at unacceptable risk in case of study participation or confounds the study's data interpretation

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C2348568
    UMLS CUI [1,3]
    C1883420
    UMLS CUI [1,4]
    C0035647
    UMLS CUI [2,1]
    C0012634
    UMLS CUI [2,2]
    C0392760
    UMLS CUI [2,3]
    C0681873
    UMLS CUI [2,4]
    C0459471
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    Similar models

    Eligibility Multiple Myeloma NCT02248428

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Signed informed consent form
    Item
    signed informed consent form
    boolean
    C0021430 (UMLS CUI [1])
    Ability to meet study requirements
    Item
    adhere to the study visit schedule and other protocol requirements
    boolean
    C0525058 (UMLS CUI [1])
    active multiple myeloma
    Item
    diagnosed with active multiple myeloma
    boolean
    C0205177 (UMLS CUI [1,1])
    C0026764 (UMLS CUI [1,2])
    previously untreated
    Item
    myeloma previously untreated
    boolean
    C0332155 (UMLS CUI [1,1])
    C0026764 (UMLS CUI [1,2])
    karnofsky performance status
    Item
    karnofsky performance status(kps) ≥50
    boolean
    C0206065 (UMLS CUI [1])
    karnofsky performance status
    Item
    karnofsky performance status (kps) <50 related to bony disease
    boolean
    C0206065 (UMLS CUI [1,1])
    C0439849 (UMLS CUI [1,2])
    C0005940 (UMLS CUI [1,3])
    new york heart association
    Item
    new york heart association (nyha) functional ≤ class iii
    boolean
    C1275491 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    hypersensitivity to clarithromycin or any of its excipients, erythromycin, or any of the macrolide antibiotics
    Item
    hypersensitivity to clarithromycin or any of its excipients, erythromycin, or any of the macrolide antibiotics;
    boolean
    C0020517 (UMLS CUI [1,1])
    C0055856 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0055856 (UMLS CUI [2,2])
    C0015237 (UMLS CUI [2,3])
    C0020517 (UMLS CUI [3,1])
    C0014806 (UMLS CUI [3,2])
    C0020517 (UMLS CUI [4,1])
    C0003240 (UMLS CUI [4,2])
    concomitant administration of cisapride, pimozide, astemizole, terfenadine, ergotamine or dihydroergotamine, simvastatin, lovastatin, and atorvastatin
    Item
    concomitant administration of cisapride, pimozide, astemizole, terfenadine, ergotamine or dihydroergotamine, simvastatin, lovastatin, and atorvastatin;
    boolean
    C2347852 (UMLS CUI [1,1])
    C0072916 (UMLS CUI [1,2])
    C2347852 (UMLS CUI [2,1])
    C0031935 (UMLS CUI [2,2])
    C2347852 (UMLS CUI [3,1])
    C0085170 (UMLS CUI [3,2])
    C2347852 (UMLS CUI [4,1])
    C0085173 (UMLS CUI [4,2])
    C2347852 (UMLS CUI [5,1])
    C0014710 (UMLS CUI [5,2])
    C2347852 (UMLS CUI [6,1])
    C0012291 (UMLS CUI [6,2])
    C2347852 (UMLS CUI [7,1])
    C0074554 (UMLS CUI [7,2])
    C2347852 (UMLS CUI [8,1])
    C0024027 (UMLS CUI [8,2])
    C2347852 (UMLS CUI [9,1])
    C0286651 (UMLS CUI [9,2])
    previous cholestatic jaundice/hepatic dysfunction linked to use of clarithromycin
    Item
    a history of cholestatic jaundice/hepatic dysfunction associated with prior use of clarithromycin
    boolean
    C0205156 (UMLS CUI [1,1])
    C0008370 (UMLS CUI [1,2])
    C0022346 (UMLS CUI [1,3])
    C0332281 (UMLS CUI [1,4])
    C0055856 (UMLS CUI [1,5])
    C0205156 (UMLS CUI [2,1])
    C0086565 (UMLS CUI [2,2])
    C0332281 (UMLS CUI [2,3])
    C0055856 (UMLS CUI [2,4])
    abnormal renal function, creatinine
    Item
    impaired renal function,creatinine ≥221umol/l；
    boolean
    C0201976 (UMLS CUI [1])
    C0151746 (UMLS CUI [2])
    pregnant or breast feeding
    Item
    pregnant or breast feeding females
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    condition placing the subject at unacceptable risk in case of study participation or confounds the study's data interpretation
    Item
    any condition which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
    boolean
    C0012634 (UMLS CUI [1,1])
    C2348568 (UMLS CUI [1,2])
    C1883420 (UMLS CUI [1,3])
    C0035647 (UMLS CUI [1,4])
    C0012634 (UMLS CUI [2,1])
    C0392760 (UMLS CUI [2,2])
    C0681873 (UMLS CUI [2,3])
    C0459471 (UMLS CUI [2,4])
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