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ID

18232

Beskrivning

The Use of Dendritic Cell/Tumor Fusions as a Novel Tumor Vaccine in Patients With Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00459069

Länk

https://clinicaltrials.gov/show/NCT00459069

Nyckelord

Versioner (2)
  1. 2016-10-25 2016-10-25 -
  2. 2016-10-26 2016-10-26 -
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25 oktober 2016

DOI

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Creative Commons BY-NC 3.0
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    Eligibility Multiple Myeloma NCT00459069

    Engelsk

    Eligibility Multiple Myeloma NCT00459069

    1 Formulär  
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    confirmed diagnosis of multiple myeloma: stage i not requiring initiation of chemotherapy; stage i, ii or iii patients felt to be clinically stable and having received at least one prior chemotherapy regimen
    Beskrivning

    Multiple Myeloma | Staging | Patients Clinical Stable | Prior Chemotherapy Quantity

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0026764 (Multiple Myeloma)
    SNOMED
    55921005
    UMLS CUI [2]
    C0332305 (With staging)
    SNOMED
    72589006
    UMLS CUI [3,1]
    C0030705 (Patients)
    SNOMED
    116154003
    UMLS CUI [3,2]
    C0205210 (Clinical)
    SNOMED
    58147004
    UMLS CUI [3,3]
    C0205360 (Stable status)
    SNOMED
    58158008
    LOINC
    LP73394-6
    UMLS CUI [4,1]
    C1514457 (Prior Chemotherapy)
    UMLS CUI [4,2]
    C1265611 (Quantity)
    SNOMED
    246205007
    LOINC
    LP202968-6
    measurable disease as defined by a history of an elevated m component in plasma or urine or free kappa.lambda light chains in serum
    Beskrivning

    Measurable Disease | Plasma High M-component | High M-component In Urine | Serum Free kappa light chain | Serum Free lambda light chain

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1513041 (Measurable Disease)
    UMLS CUI [2,1]
    C0032105 (Plasma)
    SNOMED
    50863008
    LOINC
    LP7479-1
    UMLS CUI [2,2]
    C3151542 (High M-component)
    UMLS CUI [3,1]
    C3151542 (High M-component)
    UMLS CUI [3,2]
    C0042037 (In Urine)
    UMLS CUI [4,1]
    C0229671 (Serum)
    SNOMED
    67922002
    LOINC
    LP18698-8
    UMLS CUI [4,2]
    C0443743 (Free kappa light chain)
    SNOMED
    259811008
    UMLS CUI [5,1]
    C0229671 (Serum)
    SNOMED
    67922002
    LOINC
    LP18698-8
    UMLS CUI [5,2]
    C0443744 (Free lambda light chain)
    SNOMED
    259812001
    18 years of age or older
    Beskrivning

    Age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    ecog performance status of 0-1 with a greater than nine week life expectancy
    Beskrivning

    ECOG performance status | Life Expectancy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    UMLS CUI [2]
    C0023671 (Life Expectancy)
    > 20% bone marrow involvement or plasmacytoma amenable to resection under local anesthesia
    Beskrivning

    Bone Marrow Involvement Percentage | Plasmacytoma Amenable Excision Under anesthesia Local

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1517677 (Bone Marrow Involvement)
    UMLS CUI [1,2]
    C0439165 (Percent (qualifier value))
    SNOMED
    118582008
    UMLS CUI [2,1]
    C0032131 (Plasmacytoma)
    SNOMED
    10639003
    UMLS CUI [2,2]
    C3900053 (Amenable)
    UMLS CUI [2,3]
    C0728940 (Excision)
    SNOMED
    65801008
    LOINC
    LA17736-2
    UMLS CUI [2,4]
    C1720436 (Under anesthesia)
    SNOMED
    421642003
    UMLS CUI [2,5]
    C0205276 (Local)
    SNOMED
    255470001
    LOINC
    LA4583-6
    laboratory results within ranges outlined in protocol
    Beskrivning

    Laboratory Results Study Protocol Adequate

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1254595 (Laboratory Results)
    UMLS CUI [1,2]
    C2348563 (Study Protocol)
    UMLS CUI [1,3]
    C0205411 (Adequate)
    SNOMED
    88323005
    LOINC
    LA8913-1
    negative pregnancy test and adequate contraception method(s) must be documented
    Beskrivning

    Pregnancy test negative | Contraceptive methods

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0427780 (Pregnancy test negative)
    SNOMED
    250425007
    UMLS CUI [2]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    history of clinically significant venous thromboembolism
    Beskrivning

    Venous Thromboembolism Clinical Significance

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1861172 (Venous Thromboembolism)
    LOINC
    LA20775-5
    UMLS CUI [1,2]
    C2826293 (Clinical Significance)
    received other immunotherapy treatment in the past 4 weeks prior to the initiation of cell collections for vaccine generation
    Beskrivning

    Immunotherapy | Cell Collection Resulting in Vaccine Generation

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021083 (Immunotherapy)
    SNOMED
    76334006
    UMLS CUI [2,1]
    C0007634 (Cells)
    SNOMED
    4421005
    LOINC
    LP14738-6
    UMLS CUI [2,2]
    C0200345 (Specimen Collection)
    SNOMED
    17636008
    UMLS CUI [2,3]
    C0332294 (Resulting in)
    SNOMED
    79409006
    UMLS CUI [2,4]
    C0042210 (Vaccines)
    SNOMED
    787859002
    LOINC
    LA20283-0
    UMLS CUI [2,5]
    C3146294 (Generation (action))
    chemotherapy or radiation therapy 4 weeks prior to the first vaccine
    Beskrivning

    Chemotherapy Regimen | Therapeutic radiology procedure

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    UMLS CUI [2]
    C1522449 (Therapeutic radiology procedure)
    SNOMED
    53438000
    LOINC
    LA4351-8
    clinically significant autoimmune disease
    Beskrivning

    Autoimmune Disease Clinical Significance

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0004364 (Autoimmune Diseases)
    SNOMED
    85828009
    UMLS CUI [1,2]
    C2826293 (Clinical Significance)
    hiv positive
    Beskrivning

    HIV Seropositivity

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0019699 (HIV Seropositivity)
    SNOMED
    165816005
    serious intercurrent illness
    Beskrivning

    Illness Serious

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0221423 (Illness (finding))
    SNOMED
    39104002
    UMLS CUI [1,2]
    C0205404 (Serious)
    SNOMED
    42745003
    LOINC
    LA30751-4
    taking systemic corticosteroids within 4 weeks of treatment with study drug
    Beskrivning

    systemic steroids | Investigational New Drugs

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2825233 (systemic steroids)
    UMLS CUI [2]
    C0013230 (Investigational New Drugs)
    Tillbaka till toppen

    Similar models

    Eligibility Multiple Myeloma NCT00459069

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Multiple Myeloma | Staging | Patients Clinical Stable | Prior Chemotherapy Quantity
    Item
    confirmed diagnosis of multiple myeloma: stage i not requiring initiation of chemotherapy; stage i, ii or iii patients felt to be clinically stable and having received at least one prior chemotherapy regimen
    boolean
    C0026764 (UMLS CUI [1])
    C0332305 (UMLS CUI [2])
    C0030705 (UMLS CUI [3,1])
    C0205210 (UMLS CUI [3,2])
    C0205360 (UMLS CUI [3,3])
    C1514457 (UMLS CUI [4,1])
    C1265611 (UMLS CUI [4,2])
    Measurable Disease | Plasma High M-component | High M-component In Urine | Serum Free kappa light chain | Serum Free lambda light chain
    Item
    measurable disease as defined by a history of an elevated m component in plasma or urine or free kappa.lambda light chains in serum
    boolean
    C1513041 (UMLS CUI [1])
    C0032105 (UMLS CUI [2,1])
    C3151542 (UMLS CUI [2,2])
    C3151542 (UMLS CUI [3,1])
    C0042037 (UMLS CUI [3,2])
    C0229671 (UMLS CUI [4,1])
    C0443743 (UMLS CUI [4,2])
    C0229671 (UMLS CUI [5,1])
    C0443744 (UMLS CUI [5,2])
    Age
    Item
    18 years of age or older
    boolean
    C0001779 (UMLS CUI [1])
    ECOG performance status | Life Expectancy
    Item
    ecog performance status of 0-1 with a greater than nine week life expectancy
    boolean
    C1520224 (UMLS CUI [1])
    C0023671 (UMLS CUI [2])
    Bone Marrow Involvement Percentage | Plasmacytoma Amenable Excision Under anesthesia Local
    Item
    > 20% bone marrow involvement or plasmacytoma amenable to resection under local anesthesia
    boolean
    C1517677 (UMLS CUI [1,1])
    C0439165 (UMLS CUI [1,2])
    C0032131 (UMLS CUI [2,1])
    C3900053 (UMLS CUI [2,2])
    C0728940 (UMLS CUI [2,3])
    C1720436 (UMLS CUI [2,4])
    C0205276 (UMLS CUI [2,5])
    Laboratory Results Study Protocol Adequate
    Item
    laboratory results within ranges outlined in protocol
    boolean
    C1254595 (UMLS CUI [1,1])
    C2348563 (UMLS CUI [1,2])
    C0205411 (UMLS CUI [1,3])
    Pregnancy test negative | Contraceptive methods
    Item
    negative pregnancy test and adequate contraception method(s) must be documented
    boolean
    C0427780 (UMLS CUI [1])
    C0700589 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    Venous Thromboembolism Clinical Significance
    Item
    history of clinically significant venous thromboembolism
    boolean
    C1861172 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    Immunotherapy | Cell Collection Resulting in Vaccine Generation
    Item
    received other immunotherapy treatment in the past 4 weeks prior to the initiation of cell collections for vaccine generation
    boolean
    C0021083 (UMLS CUI [1])
    C0007634 (UMLS CUI [2,1])
    C0200345 (UMLS CUI [2,2])
    C0332294 (UMLS CUI [2,3])
    C0042210 (UMLS CUI [2,4])
    C3146294 (UMLS CUI [2,5])
    Chemotherapy Regimen | Therapeutic radiology procedure
    Item
    chemotherapy or radiation therapy 4 weeks prior to the first vaccine
    boolean
    C0392920 (UMLS CUI [1])
    C1522449 (UMLS CUI [2])
    Autoimmune Disease Clinical Significance
    Item
    clinically significant autoimmune disease
    boolean
    C0004364 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    HIV Seropositivity
    Item
    hiv positive
    boolean
    C0019699 (UMLS CUI [1])
    Illness Serious
    Item
    serious intercurrent illness
    boolean
    C0221423 (UMLS CUI [1,1])
    C0205404 (UMLS CUI [1,2])
    systemic steroids | Investigational New Drugs
    Item
    taking systemic corticosteroids within 4 weeks of treatment with study drug
    boolean
    C2825233 (UMLS CUI [1])
    C0013230 (UMLS CUI [2])
    Tillbaka till toppen 

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