0 Ratings

ID

18189

Description

A Multiple Myeloma Trial in Patients With Bone Metastases; ODM derived from: https://clinicaltrials.gov/show/NCT00104104

Link

https://clinicaltrials.gov/show/NCT00104104

Keywords

  1. 10/24/16 10/24/16 -
Uploaded on

October 24, 2016

DOI

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License

Creative Commons BY 4.0

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    Eligibility Multiple Myeloma NCT00104104

    Eligibility Multiple Myeloma NCT00104104

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    patients 18 years of age or older
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    confirmed diagnosis of multiple myeloma
    Description

    Multiple Myeloma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0026764
    stable renal function defined as two serum creatinine determinations of < 3 mg/dl
    Description

    Renal function Stable | Serum creatinine measurement Quantity

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0232804
    UMLS CUI [1,2]
    C0205360
    UMLS CUI [2,1]
    C0201976
    UMLS CUI [2,2]
    C1265611
    calculated creatinine clearance of greater than or equal to 30 ml/min
    Description

    Estimation of creatinine clearance by Cockcroft-Gault formula

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2711451
    ecog performance status of 0 or 1
    Description

    ECOG performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    life expectancy of greater than or equal to 9 months
    Description

    Life Expectancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    if the patient is of child-bearing potential, a negative pregnancy test is required at screening, while postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
    Description

    Childbearing Potential Pregnancy test negative | Postmenopausal | Amenorrhea Duration

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0427780
    UMLS CUI [2]
    C0232970
    UMLS CUI [3,1]
    C0002453
    UMLS CUI [3,2]
    C0449238
    ability to comply with trial requirements and give informed consent.
    Description

    Protocol Compliance | Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0525058
    UMLS CUI [2]
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    iv bisphosphonate therapy for more than 3 years.
    Description

    Diphosphonates Intravenous

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0012544
    UMLS CUI [1,2]
    C1522726
    patients with a diagnosis of amyloidosis.
    Description

    amyloidosis

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0002726
    known hypersensitivity to zoledronic acid or other bisphosphonates
    Description

    Hypersensitivity zoledronic acid | Hypersensitivity Diphosphonates

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0257685
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0012544
    pregnant patients or lactating patients.
    Description

    Pregnancy | Breast Feeding

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    women of childbearing potential not on a medically recognized form of contraception
    Description

    Childbearing Potential Contraceptive methods

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0700589
    patients with uncontrolled cardiovascular disease, hypertension, and type 2 diabetes mellitus.
    Description

    Cardiovascular Disease Uncontrolled | Uncontrolled hypertension | DIABETES MELLITUS NON INSULIN DEPENDENT UNCONTROLLED

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0007222
    UMLS CUI [1,2]
    C0205318
    UMLS CUI [2]
    C1868885
    UMLS CUI [3]
    C0743118

    Similar models

    Eligibility Multiple Myeloma NCT00104104

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    patients 18 years of age or older
    boolean
    C0001779 (UMLS CUI [1])
    Multiple Myeloma
    Item
    confirmed diagnosis of multiple myeloma
    boolean
    C0026764 (UMLS CUI [1])
    Renal function Stable | Serum creatinine measurement Quantity
    Item
    stable renal function defined as two serum creatinine determinations of < 3 mg/dl
    boolean
    C0232804 (UMLS CUI [1,1])
    C0205360 (UMLS CUI [1,2])
    C0201976 (UMLS CUI [2,1])
    C1265611 (UMLS CUI [2,2])
    Estimation of creatinine clearance by Cockcroft-Gault formula
    Item
    calculated creatinine clearance of greater than or equal to 30 ml/min
    boolean
    C2711451 (UMLS CUI [1])
    ECOG performance status
    Item
    ecog performance status of 0 or 1
    boolean
    C1520224 (UMLS CUI [1])
    Life Expectancy
    Item
    life expectancy of greater than or equal to 9 months
    boolean
    C0023671 (UMLS CUI [1])
    Childbearing Potential Pregnancy test negative | Postmenopausal | Amenorrhea Duration
    Item
    if the patient is of child-bearing potential, a negative pregnancy test is required at screening, while postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
    boolean
    C3831118 (UMLS CUI [1,1])
    C0427780 (UMLS CUI [1,2])
    C0232970 (UMLS CUI [2])
    C0002453 (UMLS CUI [3,1])
    C0449238 (UMLS CUI [3,2])
    Protocol Compliance | Informed Consent
    Item
    ability to comply with trial requirements and give informed consent.
    boolean
    C0525058 (UMLS CUI [1])
    C0021430 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    Diphosphonates Intravenous
    Item
    iv bisphosphonate therapy for more than 3 years.
    boolean
    C0012544 (UMLS CUI [1,1])
    C1522726 (UMLS CUI [1,2])
    amyloidosis
    Item
    patients with a diagnosis of amyloidosis.
    boolean
    C0002726 (UMLS CUI [1])
    Hypersensitivity zoledronic acid | Hypersensitivity Diphosphonates
    Item
    known hypersensitivity to zoledronic acid or other bisphosphonates
    boolean
    C0020517 (UMLS CUI [1,1])
    C0257685 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0012544 (UMLS CUI [2,2])
    Pregnancy | Breast Feeding
    Item
    pregnant patients or lactating patients.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Childbearing Potential Contraceptive methods
    Item
    women of childbearing potential not on a medically recognized form of contraception
    boolean
    C3831118 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    Cardiovascular Disease Uncontrolled | Uncontrolled hypertension | DIABETES MELLITUS NON INSULIN DEPENDENT UNCONTROLLED
    Item
    patients with uncontrolled cardiovascular disease, hypertension, and type 2 diabetes mellitus.
    boolean
    C0007222 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    C1868885 (UMLS CUI [2])
    C0743118 (UMLS CUI [3])

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