ID

18246

Description

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

Link

https://clinicaltrials.gov/show/NCT00459069

Keywords

  1. 10/25/16 10/25/16 -
  2. 10/26/16 10/26/16 -
Uploaded on

October 26, 2016

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :


    No comments

    In order to download data models you must be logged in. Please log in or register for free.

    Eligibility Multiple Myeloma NCT00459069

    Eligibility Multiple Myeloma NCT00459069

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    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
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0026764
    UMLS CUI [2]
    C0332305
    UMLS CUI [3,1]
    C0030705
    UMLS CUI [3,2]
    C0205210
    UMLS CUI [3,3]
    C0205360
    UMLS CUI [4,1]
    C1514457
    UMLS CUI [4,2]
    C1265611
    measurable disease as defined by a history of an elevated m component in plasma or urine or free kappa.lambda light chains in serum
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1513041
    UMLS CUI [2,1]
    C0032105
    UMLS CUI [2,2]
    C3151542
    UMLS CUI [3,1]
    C3151542
    UMLS CUI [3,2]
    C0042037
    UMLS CUI [4,1]
    C0229671
    UMLS CUI [4,2]
    C0443743
    UMLS CUI [5,1]
    C0229671
    UMLS CUI [5,2]
    C0443744
    18 years of age or older
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    ecog performance status of 0-1 with a greater than nine week life expectancy
    Description

    ECOG performance status | Life Expectancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    UMLS CUI [2]
    C0023671
    > 20% bone marrow involvement or plasmacytoma amenable to resection under local anesthesia
    Description

    Bone Marrow Involvement Percentage | Plasmacytoma Amenable Excision Under anesthesia Local

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1517677
    UMLS CUI [1,2]
    C0439165
    UMLS CUI [2,1]
    C0032131
    UMLS CUI [2,2]
    C3900053
    UMLS CUI [2,3]
    C0728940
    UMLS CUI [2,4]
    C1720436
    UMLS CUI [2,5]
    C0205276
    laboratory results within ranges outlined in protocol
    Description

    Laboratory Results Study Protocol Adequate

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1254595
    UMLS CUI [1,2]
    C2348563
    UMLS CUI [1,3]
    C0205411
    negative pregnancy test and adequate contraception method(s) must be documented
    Description

    Pregnancy test negative | Contraceptive methods

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0427780
    UMLS CUI [2]
    C0700589
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    history of clinically significant venous thromboembolism
    Description

    Venous Thromboembolism Clinical Significance

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1861172
    UMLS CUI [1,2]
    C2826293
    received other immunotherapy treatment in the past 4 weeks prior to the initiation of cell collections for vaccine generation
    Description

    Immunotherapy | Cell Collection Related Vaccine Generation

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021083
    UMLS CUI [2,1]
    C0007634
    UMLS CUI [2,2]
    C0200345
    UMLS CUI [2,3]
    C0439849
    UMLS CUI [2,4]
    C0042210
    UMLS CUI [2,5]
    C3146294
    chemotherapy or radiation therapy 4 weeks prior to the first vaccine
    Description

    Chemotherapy Regimen | Therapeutic radiology procedure

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    UMLS CUI [2]
    C1522449
    clinically significant autoimmune disease
    Description

    Autoimmune Disease Clinical Significance

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0004364
    UMLS CUI [1,2]
    C2826293
    hiv positive
    Description

    HIV Seropositivity

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019699
    serious intercurrent illness
    Description

    Illness Serious

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0221423
    UMLS CUI [1,2]
    C0205404
    taking systemic corticosteroids within 4 weeks of treatment with study drug
    Description

    systemic steroids | Investigational New Drugs

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2825233
    UMLS CUI [2]
    C0013230

    Similar models

    Eligibility Multiple Myeloma NCT00459069

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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 Related 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])
    C0439849 (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])

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial