0 Ratings
ID

18194

Description

Weekly Bortezomib (Velcade) in the Treatment of Patients With Refractory Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00193557

Link

https://clinicaltrials.gov/show/NCT00193557

Keywords

Versions (1)
  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 NCT00193557

    English

    Eligibility Multiple Myeloma NCT00193557

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    to be included in this study, you must meet the following criteria:
    Description

    Criteria Fulfill

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0243161 (criteria)
    UMLS CUI [1,2]
    C1550543 (Fulfill)
    multiple myeloma
    Description

    Multiple Myeloma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0026764 (Multiple Myeloma)
    SNOMED
    55921005
    received no more than 2 previous treatment regimens for multiple myeloma
    Description

    Prior Therapy Quantity Multiple Myeloma

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463 (Prior Therapy)
    UMLS CUI [1,2]
    C1265611 (Quantity)
    SNOMED
    246205007
    LOINC
    LP202968-6
    UMLS CUI [1,3]
    C0026764 (Multiple Myeloma)
    SNOMED
    55921005
    ecog performance status 0, 1, or 2
    Description

    ECOG performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    serum creatinine < 2.0mg/dl
    Description

    Creatinine measurement, serum

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0201976 (Creatinine measurement, serum (procedure))
    SNOMED
    113075003
    calculated or measured creatinine clearance > 30ml/minute
    Description

    Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine clearance measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2711451 (Estimation of creatinine clearance by Cockcroft-Gault formula)
    SNOMED
    442407001
    UMLS CUI [2]
    C0373595 (Creatinine clearance measurement)
    SNOMED
    167181009
    measurable or evaluable disease
    Description

    Measurable Disease | Evaluable Disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1513041 (Measurable Disease)
    UMLS CUI [2]
    C1516986 (Evaluable Disease)
    provide written informed consent prior to receiving protocol therapy.
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    you cannot participate in this study if any of the following apply to you:
    Description

    Study Subject Participation Status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568 (Study Subject Participation Status)
    moderate or severe peripheral neuropathy
    Description

    Peripheral Neuropathy | CTCAE Grades

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0031117 (Peripheral Neuropathy)
    UMLS CUI [2]
    C1516728 (National Cancer Institute common terminology criteria for adverse events)
    SNOMED
    446391000124101
    other serious medical conditions
    Description

    Other medical condition Serious

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3843040 (Other medical condition)
    LOINC
    LA16346-1
    UMLS CUI [1,2]
    C0205404 (Serious)
    SNOMED
    42745003
    LOINC
    LA30751-4
    other active malignancies
    Description

    Malignant Neoplasms

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    history of treatment for other invasive cancers
    Description

    Therapeutic procedure Invasive cancer

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111 (Therapeutic procedure)
    SNOMED
    277132007
    LOINC
    LP21090-3
    UMLS CUI [1,2]
    C0677898 (Invasive Malignant Neoplasm)
    women who are pregnant or lactating
    Description

    Pregnancy | Breast Feeding

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
    Description

    Clinical Trial Eligibility Criteria Additional

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1516637 (Clinical Trial Eligibility Criteria)
    UMLS CUI [1,2]
    C1524062 (Additional)
    LOINC
    LP35025-3
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    Similar models

    Eligibility Multiple Myeloma NCT00193557

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Criteria Fulfill
    Item
    to be included in this study, you must meet the following criteria:
    boolean
    C0243161 (UMLS CUI [1,1])
    C1550543 (UMLS CUI [1,2])
    Multiple Myeloma
    Item
    multiple myeloma
    boolean
    C0026764 (UMLS CUI [1])
    Prior Therapy Quantity Multiple Myeloma
    Item
    received no more than 2 previous treatment regimens for multiple myeloma
    boolean
    C1514463 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    C0026764 (UMLS CUI [1,3])
    ECOG performance status
    Item
    ecog performance status 0, 1, or 2
    boolean
    C1520224 (UMLS CUI [1])
    Creatinine measurement, serum
    Item
    serum creatinine < 2.0mg/dl
    boolean
    C0201976 (UMLS CUI [1])
    Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine clearance measurement
    Item
    calculated or measured creatinine clearance > 30ml/minute
    boolean
    C2711451 (UMLS CUI [1])
    C0373595 (UMLS CUI [2])
    Measurable Disease | Evaluable Disease
    Item
    measurable or evaluable disease
    boolean
    C1513041 (UMLS CUI [1])
    C1516986 (UMLS CUI [2])
    Informed Consent
    Item
    provide written informed consent prior to receiving protocol therapy.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Study Subject Participation Status
    Item
    you cannot participate in this study if any of the following apply to you:
    boolean
    C2348568 (UMLS CUI [1])
    Peripheral Neuropathy | CTCAE Grades
    Item
    moderate or severe peripheral neuropathy
    boolean
    C0031117 (UMLS CUI [1])
    C1516728 (UMLS CUI [2])
    Other medical condition Serious
    Item
    other serious medical conditions
    boolean
    C3843040 (UMLS CUI [1,1])
    C0205404 (UMLS CUI [1,2])
    Malignant Neoplasms
    Item
    other active malignancies
    boolean
    C0006826 (UMLS CUI [1])
    Therapeutic procedure Invasive cancer
    Item
    history of treatment for other invasive cancers
    boolean
    C0087111 (UMLS CUI [1,1])
    C0677898 (UMLS CUI [1,2])
    Pregnancy | Breast Feeding
    Item
    women who are pregnant or lactating
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Clinical Trial Eligibility Criteria Additional
    Item
    please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
    boolean
    C1516637 (UMLS CUI [1,1])
    C1524062 (UMLS CUI [1,2])
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