ID

18144

Beskrivning

Study of Oral SCIO-469 in Relapsed, Refractory Patients With Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00087867

Länk

https://clinicaltrials.gov/show/NCT00087867

Nyckelord

  1. 2016-10-23 2016-10-23 -
Uppladdad den

23 oktober 2016

DOI

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Licens

Creative Commons BY 4.0

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    Eligibility Multiple Myeloma NCT00087867

    Eligibility Multiple Myeloma NCT00087867

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    life expectancy more than three months
    Beskrivning

    Life Expectancy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    diagnosed with multiple myeloma (mm)
    Beskrivning

    Multiple Myeloma

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0026764
    relapsed following a response to any conventional mm therapy, and refractory to their most recent mm therapy
    Beskrivning

    Conventional Treatment Multiple Myeloma Response | Recurrent disease | Therapeutic procedure Recent Multiple Myeloma Unresponsive to Treatment

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2945704
    UMLS CUI [1,2]
    C0026764
    UMLS CUI [1,3]
    C1704632
    UMLS CUI [2]
    C0277556
    UMLS CUI [3,1]
    C0087111
    UMLS CUI [3,2]
    C0332185
    UMLS CUI [3,3]
    C0026764
    UMLS CUI [3,4]
    C0205269
    karnofsky performance status = 60
    Beskrivning

    Karnofsky Performance Status

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0206065
    no electrocardiographic evidence of acute ischemia or new conduction system abnormalities
    Beskrivning

    Ischemia | Conduction system abnormalities New | Electrocardiography Evidence

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0022116
    UMLS CUI [2,1]
    C0151236
    UMLS CUI [2,2]
    C0205314
    UMLS CUI [3,1]
    C1623258
    UMLS CUI [3,2]
    C3887511
    no history of myocardial infarction within last 6 months
    Beskrivning

    Myocardial Infarction

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0027051
    serum concentrations of aspartate aminotransferase (ast) and alanine aminotransferase (alt) = 3x upper limit of normal (uln)
    Beskrivning

    Aspartate aminotransferase measurement | Alanine aminotransferase measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0201899
    UMLS CUI [2]
    C0201836
    total serum bilirubin = 2x uln
    Beskrivning

    Serum total bilirubin measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1278039
    calculated or measured creatinine clearance >30 ml/min
    Beskrivning

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

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2711451
    UMLS CUI [2]
    C0373595
    platelet count = 30 x 10(9)/l
    Beskrivning

    Platelet Count measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032181
    hemoglobin concentration = 8 g/dl
    Beskrivning

    Hemoglobin

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0019046
    white blood cell count = 2.0 x 10(9)/l
    Beskrivning

    White Blood Cell Count procedure

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023508
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    patients with non-secretory myeloma, plasma cell leukemia, or poems syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, m-protein and skin changes)
    Beskrivning

    Non-secretory myeloma | Leukemia, Plasma Cell | POEMS Syndrome | Plasma cell dyscrasia with polyneuropathy | Organomegaly | Endocrine System Diseases | M Protein Change | skin; change

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0456845
    UMLS CUI [2]
    C0023484
    UMLS CUI [3]
    C0085404
    UMLS CUI [4]
    C0272255
    UMLS CUI [5]
    C4054315
    UMLS CUI [6]
    C0014130
    UMLS CUI [7,1]
    C0700271
    UMLS CUI [7,2]
    C0392747
    UMLS CUI [8]
    C1399787
    major surgery within four weeks of enrollment
    Beskrivning

    major surgery

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0679637
    severe elevated serum calcium
    Beskrivning

    Serum calcium increased Severe

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0595928
    UMLS CUI [1,2]
    C0205082
    heart failure
    Beskrivning

    Heart failure

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0018801
    receipt of chemotherapy within 21 days before enrollment, receiving immunotherapy, radiation therapy, or other investigational agents
    Beskrivning

    Chemotherapy | Immunotherapy | Therapeutic radiology procedure | Investigational New Drugs

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    UMLS CUI [2]
    C0021083
    UMLS CUI [3]
    C1522449
    UMLS CUI [4]
    C0013230
    receipt of corticosteroids equivalent to more than 10 mg/day of prednisone within two weeks before enrollment
    Beskrivning

    Adrenal Cortex Hormones | Prednisone

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001617
    UMLS CUI [2]
    C0032952
    known allergies to agents used in bortezomib (e.g., boron or mannitol)
    Beskrivning

    Hypersensitivity bortezomib | Hypersensitivity Boron | Mannitol allergy

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C1176309
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0006030
    UMLS CUI [3]
    C0571922
    poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol
    Beskrivning

    Poor hypertension control | poorly controlled diabetes mellitus | Illness Serious Interferes with Protocol Compliance | Serious mental illness Interferes with Protocol Compliance

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0421190
    UMLS CUI [2]
    C0554876
    UMLS CUI [3,1]
    C0221423
    UMLS CUI [3,2]
    C0205404
    UMLS CUI [3,3]
    C0521102
    UMLS CUI [3,4]
    C0525058
    UMLS CUI [4,1]
    C3841614
    UMLS CUI [4,2]
    C0521102
    UMLS CUI [4,3]
    C0525058

    Similar models

    Eligibility Multiple Myeloma NCT00087867

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Life Expectancy
    Item
    life expectancy more than three months
    boolean
    C0023671 (UMLS CUI [1])
    Multiple Myeloma
    Item
    diagnosed with multiple myeloma (mm)
    boolean
    C0026764 (UMLS CUI [1])
    Conventional Treatment Multiple Myeloma Response | Recurrent disease | Therapeutic procedure Recent Multiple Myeloma Unresponsive to Treatment
    Item
    relapsed following a response to any conventional mm therapy, and refractory to their most recent mm therapy
    boolean
    C2945704 (UMLS CUI [1,1])
    C0026764 (UMLS CUI [1,2])
    C1704632 (UMLS CUI [1,3])
    C0277556 (UMLS CUI [2])
    C0087111 (UMLS CUI [3,1])
    C0332185 (UMLS CUI [3,2])
    C0026764 (UMLS CUI [3,3])
    C0205269 (UMLS CUI [3,4])
    Karnofsky Performance Status
    Item
    karnofsky performance status = 60
    boolean
    C0206065 (UMLS CUI [1])
    Ischemia | Conduction system abnormalities New | Electrocardiography Evidence
    Item
    no electrocardiographic evidence of acute ischemia or new conduction system abnormalities
    boolean
    C0022116 (UMLS CUI [1])
    C0151236 (UMLS CUI [2,1])
    C0205314 (UMLS CUI [2,2])
    C1623258 (UMLS CUI [3,1])
    C3887511 (UMLS CUI [3,2])
    Myocardial Infarction
    Item
    no history of myocardial infarction within last 6 months
    boolean
    C0027051 (UMLS CUI [1])
    Aspartate aminotransferase measurement | Alanine aminotransferase measurement
    Item
    serum concentrations of aspartate aminotransferase (ast) and alanine aminotransferase (alt) = 3x upper limit of normal (uln)
    boolean
    C0201899 (UMLS CUI [1])
    C0201836 (UMLS CUI [2])
    Serum total bilirubin measurement
    Item
    total serum bilirubin = 2x uln
    boolean
    C1278039 (UMLS CUI [1])
    Estimation of creatinine clearance by Cockcroft-Gault formula | Creatinine clearance measurement
    Item
    calculated or measured creatinine clearance >30 ml/min
    boolean
    C2711451 (UMLS CUI [1])
    C0373595 (UMLS CUI [2])
    Platelet Count measurement
    Item
    platelet count = 30 x 10(9)/l
    boolean
    C0032181 (UMLS CUI [1])
    Hemoglobin
    Item
    hemoglobin concentration = 8 g/dl
    boolean
    C0019046 (UMLS CUI [1])
    White Blood Cell Count procedure
    Item
    white blood cell count = 2.0 x 10(9)/l
    boolean
    C0023508 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Non-secretory myeloma | Leukemia, Plasma Cell | POEMS Syndrome | Plasma cell dyscrasia with polyneuropathy | Organomegaly | Endocrine System Diseases | M Protein Change | skin; change
    Item
    patients with non-secretory myeloma, plasma cell leukemia, or poems syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, m-protein and skin changes)
    boolean
    C0456845 (UMLS CUI [1])
    C0023484 (UMLS CUI [2])
    C0085404 (UMLS CUI [3])
    C0272255 (UMLS CUI [4])
    C4054315 (UMLS CUI [5])
    C0014130 (UMLS CUI [6])
    C0700271 (UMLS CUI [7,1])
    C0392747 (UMLS CUI [7,2])
    C1399787 (UMLS CUI [8])
    major surgery
    Item
    major surgery within four weeks of enrollment
    boolean
    C0679637 (UMLS CUI [1])
    Serum calcium increased Severe
    Item
    severe elevated serum calcium
    boolean
    C0595928 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    Heart failure
    Item
    heart failure
    boolean
    C0018801 (UMLS CUI [1])
    Chemotherapy | Immunotherapy | Therapeutic radiology procedure | Investigational New Drugs
    Item
    receipt of chemotherapy within 21 days before enrollment, receiving immunotherapy, radiation therapy, or other investigational agents
    boolean
    C0392920 (UMLS CUI [1])
    C0021083 (UMLS CUI [2])
    C1522449 (UMLS CUI [3])
    C0013230 (UMLS CUI [4])
    Adrenal Cortex Hormones | Prednisone
    Item
    receipt of corticosteroids equivalent to more than 10 mg/day of prednisone within two weeks before enrollment
    boolean
    C0001617 (UMLS CUI [1])
    C0032952 (UMLS CUI [2])
    Hypersensitivity bortezomib | Hypersensitivity Boron | Mannitol allergy
    Item
    known allergies to agents used in bortezomib (e.g., boron or mannitol)
    boolean
    C0020517 (UMLS CUI [1,1])
    C1176309 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0006030 (UMLS CUI [2,2])
    C0571922 (UMLS CUI [3])
    Poor hypertension control | poorly controlled diabetes mellitus | Illness Serious Interferes with Protocol Compliance | Serious mental illness Interferes with Protocol Compliance
    Item
    poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol
    boolean
    C0421190 (UMLS CUI [1])
    C0554876 (UMLS CUI [2])
    C0221423 (UMLS CUI [3,1])
    C0205404 (UMLS CUI [3,2])
    C0521102 (UMLS CUI [3,3])
    C0525058 (UMLS CUI [3,4])
    C3841614 (UMLS CUI [4,1])
    C0521102 (UMLS CUI [4,2])
    C0525058 (UMLS CUI [4,3])

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