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ID

18143

Description

Safety and Efficacy of Atiprimod for Patients With Refractory Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT00086216

Lien

https://clinicaltrials.gov/show/NCT00086216

Mots-clés

  1. 23/10/2016 23/10/2016 -
  2. 20/09/2021 20/09/2021 -
Téléchargé le

23 octobre 2016

DOI

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Licence

Creative Commons BY 4.0

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    Eligibility Multiple Myeloma NCT00086216

    Eligibility Multiple Myeloma NCT00086216

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    documented history of multiple myeloma,
    Description

    Multiple Myeloma

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0026764
    failed at least two prior regimens for multiple myeloma,
    Description

    Multiple Myeloma | Regimen Quantity failed

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0026764
    UMLS CUI [2,1]
    C0040808
    UMLS CUI [2,2]
    C1265611
    UMLS CUI [2,3]
    C0231175
    18 years of age or older,
    Description

    Age

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    ecog(zubrod)ps of 0 to 2,
    Description

    Zubrod Performance Status

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C3714786
    screening evaluation for determining eligibility prior to enrollment,
    Description

    Screening Evaluation Eligibility Determination

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1409616
    UMLS CUI [1,2]
    C0220825
    UMLS CUI [1,3]
    C0013893
    signed informed consent form,
    Description

    Informed Consent

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    concomitant therapy medications including corticosteroids or other chemotherapy that is or may be active against myeloma ,
    Description

    Pharmacotherapy Against Multiple Myeloma | Adrenal Cortex Hormones Against Multiple Myeloma | Chemotherapy Against Multiple Myeloma

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0013216
    UMLS CUI [1,2]
    C0521124
    UMLS CUI [1,3]
    C0026764
    UMLS CUI [2,1]
    C0001617
    UMLS CUI [2,2]
    C0521124
    UMLS CUI [2,3]
    C0026764
    UMLS CUI [3,1]
    C0392920
    UMLS CUI [3,2]
    C0521124
    UMLS CUI [3,3]
    C0026764
    renal insufficiency (serum creatinine levels of > 2mg/dl),
    Description

    Renal Insufficiency | Creatinine measurement, serum

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1565489
    UMLS CUI [2]
    C0201976
    mucosal bleeding,
    Description

    Mucosal bleeding

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2748540
    any condition which in the opinion of the investigator, places the patient at unacceptable risk if he/she were to participate in the study.
    Description

    Condition At risk Study Subject Participation Status

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0348080
    UMLS CUI [1,2]
    C1444641
    UMLS CUI [1,3]
    C2348568
    clinically relevant active infection or co-morbid medical conditions.
    Description

    Communicable Disease Relevant Clinical | Comorbidity Relevant Clinical

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C2347946
    UMLS CUI [1,3]
    C0205210
    UMLS CUI [2,1]
    C0009488
    UMLS CUI [2,2]
    C2347946
    UMLS CUI [2,3]
    C0205210
    prior malignancy(within the last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient is has been disease-free for at least 3 years.
    Description

    Malignant Neoplasms | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | Carcinoma in situ of uterine cervix Treated

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    UMLS CUI [2,1]
    C0007117
    UMLS CUI [2,2]
    C1522326
    UMLS CUI [3,1]
    C0553723
    UMLS CUI [3,2]
    C1522326
    UMLS CUI [4,1]
    C0851140
    UMLS CUI [4,2]
    C1522326
    patients with non-secretory myeloma.
    Description

    Non-secretory myeloma

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0456845
    as atiprimod is a potent inhibitor or cyp2d6, patients taking drugs that are substrates of cyp2d6(e.g. beta blockers, antidepressants and antipsychotics) will be excluded.
    Description

    antiprimod | CYP2D6 | Adrenergic beta-Antagonists | Antidepressive Agents | Antipsychotic Agents

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0754307
    UMLS CUI [2]
    C0057223
    UMLS CUI [3]
    C0001645
    UMLS CUI [4]
    C0003289
    UMLS CUI [5]
    C0040615

    Similar models

    Eligibility Multiple Myeloma NCT00086216

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Multiple Myeloma
    Item
    documented history of multiple myeloma,
    boolean
    C0026764 (UMLS CUI [1])
    Multiple Myeloma | Regimen Quantity failed
    Item
    failed at least two prior regimens for multiple myeloma,
    boolean
    C0026764 (UMLS CUI [1])
    C0040808 (UMLS CUI [2,1])
    C1265611 (UMLS CUI [2,2])
    C0231175 (UMLS CUI [2,3])
    Age
    Item
    18 years of age or older,
    boolean
    C0001779 (UMLS CUI [1])
    Zubrod Performance Status
    Item
    ecog(zubrod)ps of 0 to 2,
    boolean
    C3714786 (UMLS CUI [1])
    Screening Evaluation Eligibility Determination
    Item
    screening evaluation for determining eligibility prior to enrollment,
    boolean
    C1409616 (UMLS CUI [1,1])
    C0220825 (UMLS CUI [1,2])
    C0013893 (UMLS CUI [1,3])
    Informed Consent
    Item
    signed informed consent form,
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Pharmacotherapy Against Multiple Myeloma | Adrenal Cortex Hormones Against Multiple Myeloma | Chemotherapy Against Multiple Myeloma
    Item
    concomitant therapy medications including corticosteroids or other chemotherapy that is or may be active against myeloma ,
    boolean
    C0013216 (UMLS CUI [1,1])
    C0521124 (UMLS CUI [1,2])
    C0026764 (UMLS CUI [1,3])
    C0001617 (UMLS CUI [2,1])
    C0521124 (UMLS CUI [2,2])
    C0026764 (UMLS CUI [2,3])
    C0392920 (UMLS CUI [3,1])
    C0521124 (UMLS CUI [3,2])
    C0026764 (UMLS CUI [3,3])
    Renal Insufficiency | Creatinine measurement, serum
    Item
    renal insufficiency (serum creatinine levels of > 2mg/dl),
    boolean
    C1565489 (UMLS CUI [1])
    C0201976 (UMLS CUI [2])
    Mucosal bleeding
    Item
    mucosal bleeding,
    boolean
    C2748540 (UMLS CUI [1])
    Condition At risk Study Subject Participation Status
    Item
    any condition which in the opinion of the investigator, places the patient at unacceptable risk if he/she were to participate in the study.
    boolean
    C0348080 (UMLS CUI [1,1])
    C1444641 (UMLS CUI [1,2])
    C2348568 (UMLS CUI [1,3])
    Communicable Disease Relevant Clinical | Comorbidity Relevant Clinical
    Item
    clinically relevant active infection or co-morbid medical conditions.
    boolean
    C0009450 (UMLS CUI [1,1])
    C2347946 (UMLS CUI [1,2])
    C0205210 (UMLS CUI [1,3])
    C0009488 (UMLS CUI [2,1])
    C2347946 (UMLS CUI [2,2])
    C0205210 (UMLS CUI [2,3])
    Malignant Neoplasms | Basal cell carcinoma Treated | Squamous cell carcinoma of skin Treated | Carcinoma in situ of uterine cervix Treated
    Item
    prior malignancy(within the last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient is has been disease-free for at least 3 years.
    boolean
    C0006826 (UMLS CUI [1])
    C0007117 (UMLS CUI [2,1])
    C1522326 (UMLS CUI [2,2])
    C0553723 (UMLS CUI [3,1])
    C1522326 (UMLS CUI [3,2])
    C0851140 (UMLS CUI [4,1])
    C1522326 (UMLS CUI [4,2])
    Non-secretory myeloma
    Item
    patients with non-secretory myeloma.
    boolean
    C0456845 (UMLS CUI [1])
    antiprimod | CYP2D6 | Adrenergic beta-Antagonists | Antidepressive Agents | Antipsychotic Agents
    Item
    as atiprimod is a potent inhibitor or cyp2d6, patients taking drugs that are substrates of cyp2d6(e.g. beta blockers, antidepressants and antipsychotics) will be excluded.
    boolean
    C0754307 (UMLS CUI [1])
    C0057223 (UMLS CUI [2])
    C0001645 (UMLS CUI [3])
    C0003289 (UMLS CUI [4])
    C0040615 (UMLS CUI [5])

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