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ID

15583

Description

CyBorD vs. PAD in the Treatment of Newly Diagnosed Multiple Myeloma; ODM derived from: https://clinicaltrials.gov/show/NCT02362165

Link

https://clinicaltrials.gov/show/NCT02362165

Keywords

Versions (1)
  1. 6/3/16 6/3/16 -
Uploaded on

June 3, 2016

DOI

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License

Creative Commons BY 4.0
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    Eligibility Multiple Myeloma NCT02362165

    English

    Eligibility Multiple Myeloma NCT02362165

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    newly diagnosis of multiple myeloma
    Description

    Multiple Myeloma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0026764
    eastern cooperative oncology group (ecog) status 0-3,
    Description

    ECOG performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    estimated survival time > 3 months
    Description

    Survival time Estimated

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C2919552
    UMLS CUI [1,2]
    C0750572
    acceptable liver function (bilirubin＜2.5×uln, alanine transaminase (alt) or aspartate aminotransferase (ast)＜2.5×uln)
    Description

    Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232741
    UMLS CUI [2]
    C1278039
    UMLS CUI [3]
    C0201836
    UMLS CUI [4]
    C0201899
    no history of other malignancies
    Description

    Malignant Neoplasms Other

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0006826
    UMLS CUI [1,2]
    C0205394
    no previous treatments including chemotherapy, radiotherapy, targeted therapy or stem cell transplantation
    Description

    Prior Therapy | Chemotherapy Regimen | Therapeutic radiology procedure | Targeted Therapy | Stem cell transplant

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1514463
    UMLS CUI [2]
    C0392920
    UMLS CUI [3]
    C1522449
    UMLS CUI [4]
    C2985566
    UMLS CUI [5]
    C1504389
    no other serious diseases which conflict with the treatment in the present trial
    Description

    Disease Interferes with Clinical Trial Therapeutic procedure

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0521102
    UMLS CUI [1,3]
    C0008976
    UMLS CUI [1,4]
    C0087111
    no concurrent treatments that conflict with the treatments in the present trial
    Description

    Therapeutic procedure Interferes with Clinical Trial Therapeutic procedure

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C0521102
    UMLS CUI [1,3]
    C0008976
    UMLS CUI [1,4]
    C0087111
    voluntary participation and signed the informed consent.
    Description

    voluntary participation | Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0680274
    UMLS CUI [2]
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    the patients had the conditions below: clinically significant ventricular tachycardia (vt), atrial fibrillation (af), heart block, myocardial infarction (mi), congestive heart failure (chf), symptomatic coronary artery heart disease requiring medication;
    Description

    Tachycardia, Ventricular | Atrial Fibrillation | Heart Block | Myocardial Infarction | Congestive heart failure | Coronary heart disease Symptomatic

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0042514
    UMLS CUI [2]
    C0004238
    UMLS CUI [3]
    C0018794
    UMLS CUI [4]
    C0027051
    UMLS CUI [5]
    C0018802
    UMLS CUI [6,1]
    C0010068
    UMLS CUI [6,2]
    C0231220
    the patients participated in other clinical trials within the 30 days before enrollment or who are participating in other clinical studies
    Description

    Study Subject Participation Status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    the patients with neuropathy
    Description

    Neuropathy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0442874
    the patients with mentally ill / unable to obtain informed consent
    Description

    Mental disorders Informed Consent Unable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0004936
    UMLS CUI [1,2]
    C0021430
    UMLS CUI [1,3]
    C1299582
    the patients with drug addiction, alcohol abuse which affects the long-term evaluation of test results
    Description

    Substance Use Disorders Affecting Evaluation of test results Long-term

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0038586
    UMLS CUI [1,2]
    C0392760
    UMLS CUI [1,3]
    C1285276
    UMLS CUI [1,4]
    C0443252
    the patients in pregnancy, lactation and women of childbearing age who do not want to take contraceptive measures subjects
    Description

    Pregnancy | Breast Feeding | Childbearing Potential Age | Contraceptive methods Unwilling

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3,1]
    C3831118
    UMLS CUI [3,2]
    C0001779
    UMLS CUI [4,1]
    C0700589
    UMLS CUI [4,2]
    C0558080
    the patients with a history of allergy to test drug
    Description

    Hypersensitivity Investigational New Drugs

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0013230
    the patients not suitable to participate in the investigator judged by researchers.
    Description

    Study Subject Participation Status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2348568
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    Similar models

    Eligibility Multiple Myeloma NCT02362165

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Multiple Myeloma
    Item
    newly diagnosis of multiple myeloma
    boolean
    C0026764 (UMLS CUI [1])
    ECOG performance status
    Item
    eastern cooperative oncology group (ecog) status 0-3,
    boolean
    C1520224 (UMLS CUI [1])
    Survival time Estimated
    Item
    estimated survival time > 3 months
    boolean
    C2919552 (UMLS CUI [1,1])
    C0750572 (UMLS CUI [1,2])
    Liver function | Serum total bilirubin measurement | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
    Item
    acceptable liver function (bilirubin＜2.5×uln, alanine transaminase (alt) or aspartate aminotransferase (ast)＜2.5×uln)
    boolean
    C0232741 (UMLS CUI [1])
    C1278039 (UMLS CUI [2])
    C0201836 (UMLS CUI [3])
    C0201899 (UMLS CUI [4])
    Malignant Neoplasms Other
    Item
    no history of other malignancies
    boolean
    C0006826 (UMLS CUI [1,1])
    C0205394 (UMLS CUI [1,2])
    Prior Therapy | Chemotherapy Regimen | Therapeutic radiology procedure | Targeted Therapy | Stem cell transplant
    Item
    no previous treatments including chemotherapy, radiotherapy, targeted therapy or stem cell transplantation
    boolean
    C1514463 (UMLS CUI [1])
    C0392920 (UMLS CUI [2])
    C1522449 (UMLS CUI [3])
    C2985566 (UMLS CUI [4])
    C1504389 (UMLS CUI [5])
    Disease Interferes with Clinical Trial Therapeutic procedure
    Item
    no other serious diseases which conflict with the treatment in the present trial
    boolean
    C0012634 (UMLS CUI [1,1])
    C0521102 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    C0087111 (UMLS CUI [1,4])
    Therapeutic procedure Interferes with Clinical Trial Therapeutic procedure
    Item
    no concurrent treatments that conflict with the treatments in the present trial
    boolean
    C0087111 (UMLS CUI [1,1])
    C0521102 (UMLS CUI [1,2])
    C0008976 (UMLS CUI [1,3])
    C0087111 (UMLS CUI [1,4])
    voluntary participation | Informed Consent
    Item
    voluntary participation and signed the informed consent.
    boolean
    C0680274 (UMLS CUI [1])
    C0021430 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    Tachycardia, Ventricular | Atrial Fibrillation | Heart Block | Myocardial Infarction | Congestive heart failure | Coronary heart disease Symptomatic
    Item
    the patients had the conditions below: clinically significant ventricular tachycardia (vt), atrial fibrillation (af), heart block, myocardial infarction (mi), congestive heart failure (chf), symptomatic coronary artery heart disease requiring medication;
    boolean
    C0042514 (UMLS CUI [1])
    C0004238 (UMLS CUI [2])
    C0018794 (UMLS CUI [3])
    C0027051 (UMLS CUI [4])
    C0018802 (UMLS CUI [5])
    C0010068 (UMLS CUI [6,1])
    C0231220 (UMLS CUI [6,2])
    Study Subject Participation Status
    Item
    the patients participated in other clinical trials within the 30 days before enrollment or who are participating in other clinical studies
    boolean
    C2348568 (UMLS CUI [1])
    Neuropathy
    Item
    the patients with neuropathy
    boolean
    C0442874 (UMLS CUI [1])
    Mental disorders Informed Consent Unable
    Item
    the patients with mentally ill / unable to obtain informed consent
    boolean
    C0004936 (UMLS CUI [1,1])
    C0021430 (UMLS CUI [1,2])
    C1299582 (UMLS CUI [1,3])
    Substance Use Disorders Affecting Evaluation of test results Long-term
    Item
    the patients with drug addiction, alcohol abuse which affects the long-term evaluation of test results
    boolean
    C0038586 (UMLS CUI [1,1])
    C0392760 (UMLS CUI [1,2])
    C1285276 (UMLS CUI [1,3])
    C0443252 (UMLS CUI [1,4])
    Pregnancy | Breast Feeding | Childbearing Potential Age | Contraceptive methods Unwilling
    Item
    the patients in pregnancy, lactation and women of childbearing age who do not want to take contraceptive measures subjects
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C3831118 (UMLS CUI [3,1])
    C0001779 (UMLS CUI [3,2])
    C0700589 (UMLS CUI [4,1])
    C0558080 (UMLS CUI [4,2])
    Hypersensitivity Investigational New Drugs
    Item
    the patients with a history of allergy to test drug
    boolean
    C0020517 (UMLS CUI [1,1])
    C0013230 (UMLS CUI [1,2])
    Study Subject Participation Status
    Item
    the patients not suitable to participate in the investigator judged by researchers.
    boolean
    C2348568 (UMLS CUI [1])
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