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35310

Description

Study ID: 113222 Clinical Study ID: 113222 Study Title: A Phase II, Open Label, Clinical Study to Assess the Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00920556 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name:5.0g SRT501 Trade Name: Bortezomib Study Indication: Multiple Myeloma

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Versions (1)
  1. 2/27/19 2/27/19 -
Copyright Holder

GlaxoSmithKline

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February 27, 2019

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Creative Commons BY-NC 3.0
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    Safety and Activity of SRT501 Alone or in Combination with Bortezomib in Patients with Multiple Myeloma NCT00920556

    English

    Screening - Medical and Surgical History; Disease Stage at Study Entry; Classification of Disease at Study Entry; Cancer related Surgical History; Previous Anti-Neoplastic Therapy

    1 forms  
    Adminstrative
    Description

    Adminstrative

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Description

    Subject Number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2348585
    Does the subject have any clinically significant medical or surgical history?
    Description

    Does the subject have any clinically significant medical or surgical history?

    Alias
    UMLS CUI-1
    C0262926
    UMLS CUI-2
    C2826293
    UMLS CUI-3
    C0489540
    UMLS CUI-4
    C2826293
    Does the subject have any clinically significant medical or surgical history?
    Description

    If yes, please record details below (please record any new medical conditions occurring after the signing of the Informed Consent Form on the Adverse Events page)

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C2826293
    UMLS CUI [1,3]
    C0489540
    UMLS CUI [1,4]
    C2826293
    Medical and Surgical History
    Description

    Medical and Surgical History

    Alias
    UMLS CUI-1
    C0262926
    UMLS CUI-2
    C0489540
    Seq #
    Description

    Seq #

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0237753
    Description of medical condition or abnormality
    Description

    Description of medical condition or abnormality

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0678257
    UMLS CUI [2,1]
    C1704258
    UMLS CUI [2,2]
    C0678257
    Year of first diagnosis
    Description

    Year of first diagnosis

    Data type

    partialDate

    Alias
    UMLS CUI [1,1]
    C0439234
    UMLS CUI [1,2]
    C0011900
    Ongoing
    Description

    Ongoing

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0549178
    Currently being treated with Concomitant Medication?
    Description

    Currently being treated with Concomitant Medication?

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2347852
    Disease Stage at Study Entry
    Description

    Disease Stage at Study Entry

    Alias
    UMLS CUI-1
    C0699749
    UMLS CUI-2
    C0008976
    UMLS CUI-3
    C1301880
    Was Disease Stage assessed?
    Description

    If Yes, complete below

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0699749
    Date of Assessment
    Description

    Date of Assessment

    Data type

    date

    Alias
    UMLS CUI [1]
    C2985720
    Stage
    Description

    Check one box only

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0699749
    Classification of Disease at Study Entry
    Description

    Classification of Disease at Study Entry

    Alias
    UMLS CUI-1
    C0683326
    UMLS CUI-2
    C0008976
    UMLS CUI-3
    C1301880
    Was Classification of Disease performed?
    Description

    If Yes, complete below

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0683326
    Disease Classification
    Description

    Check one box only

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0683326
    Did the subject have previous cancer related surgical history?
    Description

    Did the subject have previous cancer related surgical history?

    Alias
    UMLS CUI-1
    C0489540
    UMLS CUI-2
    C2826292
    Did the subject have previous cancer related surgical history?
    Description

    Did the subject have previous cancer related surgical history?

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0489540
    UMLS CUI [1,2]
    C2826292
    Cancer related Surgical History
    Description

    Cancer related Surgical History

    Alias
    UMLS CUI-1
    C0489540
    UMLS CUI-2
    C2826292
    Seq #
    Description

    Seq #

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0237753
    Surgery Description (ex. Mastectomy, right breast)
    Description

    Surgery Description (ex. Mastectomy, right breast)

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0543467
    UMLS CUI [1,2]
    C0678257
    UMLS CUI [2]
    C0024881
    Surgery Date
    Description

    Surgery Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C1628561
    Previous Anti-Neoplastic Therapy
    Description

    Previous Anti-Neoplastic Therapy

    Alias
    UMLS CUI-1
    C0003392
    UMLS CUI-2
    C1514463
    Did the subject have previous chemotherapy, hormone therapy, immunotherapy, antibody therapy, gene therapy and/or other systemic therapy for multiple myeloma or any malignancy?
    Description

    If Yes, complete below

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0392920
    UMLS CUI [1,2]
    C1514463
    UMLS CUI [2,1]
    C0279025
    UMLS CUI [2,2]
    C1514463
    UMLS CUI [3,1]
    C0021083
    UMLS CUI [3,2]
    C1514463
    UMLS CUI [4,1]
    C0281176
    UMLS CUI [4,2]
    C1514463
    UMLS CUI [5,1]
    C0017296
    UMLS CUI [5,2]
    C1514463
    UMLS CUI [6,1]
    C1515119
    UMLS CUI [6,2]
    C0026764
    UMLS CUI [6,3]
    C1514463
    UMLS CUI [7,1]
    C1515119
    UMLS CUI [7,2]
    C0006826
    UMLS CUI [7,3]
    C1514463
    Please tick the box if this is the last Previous Anti-Neoplastic Therapy page
    Description

    Last Previous Anti-Neoplastic Therapy page

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0003392
    UMLS CUI [1,2]
    C1514463
    UMLS CUI [2,1]
    C1704732
    UMLS CUI [2,2]
    C1517741
    Previous Anti-Neoplastic Therapy
    Description

    Previous Anti-Neoplastic Therapy

    Alias
    UMLS CUI-1
    C0003392
    UMLS CUI-2
    C1514463
    Seq #
    Description

    Seq #

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0237753
    Type of Therapy
    Description

    Type of Therapy

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0332307
    UMLS CUI [1,2]
    C0087111
    If other Type of Therapy, please specify.
    Description

    If other Type of Therapy, please specify

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0332307
    UMLS CUI [1,2]
    C0087111
    UMLS CUI [1,3]
    C0205394
    UMLS CUI [1,4]
    C2348235
    Treatment
    Description

    Treatment

    Data type

    text

    Alias
    UMLS CUI [1]
    C0087111
    Indication
    Description

    Indication

    Data type

    text

    Alias
    UMLS CUI [1]
    C3146298
    Date First Dose
    Description

    Date First Dose

    Data type

    date

    Alias
    UMLS CUI [1]
    C3173309
    Date Last Dose
    Description

    Date Last Dose

    Data type

    date

    Alias
    UMLS CUI [1]
    C1762893
    Best Response
    Description

    Best Response

    Data type

    integer

    Alias
    UMLS CUI [1]
    C2986560
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    Similar models

    Screening - Medical and Surgical History; Disease Stage at Study Entry; Classification of Disease at Study Entry; Cancer related Surgical History; Previous Anti-Neoplastic Therapy

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Adminstrative
    C1320722 (UMLS CUI-1)
    Subject Number
    Item
    Subject Number
    integer
    C2348585 (UMLS CUI [1])
    Item Group
    Does the subject have any clinically significant medical or surgical history?
    C0262926 (UMLS CUI-1)
    C2826293 (UMLS CUI-2)
    C0489540 (UMLS CUI-3)
    C2826293 (UMLS CUI-4)
    Does the subject have any clinically significant medical or surgical history?
    Item
    Does the subject have any clinically significant medical or surgical history?
    boolean
    C0262926 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    C0489540 (UMLS CUI [1,3])
    C2826293 (UMLS CUI [1,4])
    Item Group
    Medical and Surgical History
    C0262926 (UMLS CUI-1)
    C0489540 (UMLS CUI-2)
    Seq #
    Item
    Seq #
    integer
    C0237753 (UMLS CUI [1])
    Description of medical condition or abnormality
    Item
    Description of medical condition or abnormality
    text
    C0012634 (UMLS CUI [1,1])
    C0678257 (UMLS CUI [1,2])
    C1704258 (UMLS CUI [2,1])
    C0678257 (UMLS CUI [2,2])
    Year of first diagnosis
    Item
    Year of first diagnosis
    partialDate
    C0439234 (UMLS CUI [1,1])
    C0011900 (UMLS CUI [1,2])
    Ongoing
    Item
    Ongoing
    boolean
    C0549178 (UMLS CUI [1])
    Currently being treated with Concomitant Medication?
    Item
    Currently being treated with Concomitant Medication?
    boolean
    C2347852 (UMLS CUI [1])
    Item Group
    Disease Stage at Study Entry
    C0699749 (UMLS CUI-1)
    C0008976 (UMLS CUI-2)
    C1301880 (UMLS CUI-3)
    Was Disease Stage assessed?
    Item
    Was Disease Stage assessed?
    boolean
    C0699749 (UMLS CUI [1])
    Date of Assessment
    Item
    Date of Assessment
    date
    C2985720 (UMLS CUI [1])
    Item
    Stage
    integer
    C0699749 (UMLS CUI [1])
    Stage
    Code List
    Stage
    CL Item
    1 (Durie-Salmon Criteria: All of the following: Hemoglobin value >10 g/dL; Serum calcium value normal or ≤12 mg/dL; Bone x-ray, normal bone structure (scale 0) or solitary bone plasmacytoma only; Low M-component production rate; IgG value <5 g/dL; IgA value <3 g/dL; Bence Jones protein <4 g/24 h; ISS Criteria: ß2-M <3.5 and Albumin ≥3.5 ) (1)
    CL Item
    2 (Durie-Salmon Criteria: Neither stage I nor stage III; ISS Criteria: Neither stage I nor stage III) (2)
    CL Item
    3 (Durie-Salmon Criteria: One or more of the following: Hemoglobin value <8.5 g/dL; Serum calcium value >12 mg/dL; Advanced lytic bone lesions (scale 3); High M-component production rate; IgG value >7 g/dL; IgA value >5 g/dL; Bence Jones protein >12 g/24 h; ISS Criteria: ß2-M >5.5) (3)
    Item Group
    Classification of Disease at Study Entry
    C0683326 (UMLS CUI-1)
    C0008976 (UMLS CUI-2)
    C1301880 (UMLS CUI-3)
    Was Classification of Disease performed?
    Item
    Was Classification of Disease performed?
    boolean
    C0683326 (UMLS CUI [1])
    Item
    Disease Classification
    integer
    C0683326 (UMLS CUI [1])
    Disease Classification
    Code List
    Disease Classification
    CL Item
    Asymptomatic Multiple Myeloma (MM)  (1)
    CL Item
    Symptomatic Multiple Myeloma (MM) (2)
    Item Group
    Did the subject have previous cancer related surgical history?
    C0489540 (UMLS CUI-1)
    C2826292 (UMLS CUI-2)
    Did the subject have previous cancer related surgical history?
    Item
    Did the subject have previous cancer related surgical history?
    boolean
    C0489540 (UMLS CUI [1,1])
    C2826292 (UMLS CUI [1,2])
    Item Group
    Cancer related Surgical History
    C0489540 (UMLS CUI-1)
    C2826292 (UMLS CUI-2)
    Seq #
    Item
    Seq #
    integer
    C0237753 (UMLS CUI [1])
    Surgery Description (ex. Mastectomy, right breast)
    Item
    Surgery Description (ex. Mastectomy, right breast)
    text
    C0543467 (UMLS CUI [1,1])
    C0678257 (UMLS CUI [1,2])
    C0024881 (UMLS CUI [2])
    Surgery Date
    Item
    Surgery Date
    date
    C1628561 (UMLS CUI [1])
    Item Group
    Previous Anti-Neoplastic Therapy
    C0003392 (UMLS CUI-1)
    C1514463 (UMLS CUI-2)
    Did the subject have previous chemotherapy, hormone therapy, immunotherapy, antibody therapy, gene therapy and/or other systemic therapy for multiple myeloma or any malignancy?
    Item
    Did the subject have previous chemotherapy, hormone therapy, immunotherapy, antibody therapy, gene therapy and/or other systemic therapy for multiple myeloma or any malignancy?
    boolean
    C0392920 (UMLS CUI [1,1])
    C1514463 (UMLS CUI [1,2])
    C0279025 (UMLS CUI [2,1])
    C1514463 (UMLS CUI [2,2])
    C0021083 (UMLS CUI [3,1])
    C1514463 (UMLS CUI [3,2])
    C0281176 (UMLS CUI [4,1])
    C1514463 (UMLS CUI [4,2])
    C0017296 (UMLS CUI [5,1])
    C1514463 (UMLS CUI [5,2])
    C1515119 (UMLS CUI [6,1])
    C0026764 (UMLS CUI [6,2])
    C1514463 (UMLS CUI [6,3])
    C1515119 (UMLS CUI [7,1])
    C0006826 (UMLS CUI [7,2])
    C1514463 (UMLS CUI [7,3])
    Item
    Please tick the box if this is the last Previous Anti-Neoplastic Therapy page
    integer
    C0003392 (UMLS CUI [1,1])
    C1514463 (UMLS CUI [1,2])
    C1704732 (UMLS CUI [2,1])
    C1517741 (UMLS CUI [2,2])
    undefined item
    Code List
    Please tick the box if this is the last Previous Anti-Neoplastic Therapy page
    CL Item
    Last Previous Anti-Neoplastic Therapy page (1)
    Item Group
    Previous Anti-Neoplastic Therapy
    C0003392 (UMLS CUI-1)
    C1514463 (UMLS CUI-2)
    Seq #
    Item
    Seq #
    integer
    C0237753 (UMLS CUI [1])
    Item
    Type of Therapy
    integer
    C0332307 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    Type of Therapy
    Code List
    Type of Therapy
    CL Item
    Chemotherapy (1)
    CL Item
    Hormone therapy (2)
    CL Item
    Immunotherapy (3)
    CL Item
    Antibody therapy (4)
    CL Item
    Gene therapy (5)
    CL Item
    Other, specify (6)
    If other Type of Therapy, please specify
    Item
    If other Type of Therapy, please specify.
    text
    C0332307 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    C0205394 (UMLS CUI [1,3])
    C2348235 (UMLS CUI [1,4])
    Treatment
    Item
    Treatment
    text
    C0087111 (UMLS CUI [1])
    Indication
    Item
    Indication
    text
    C3146298 (UMLS CUI [1])
    Date First Dose
    Item
    Date First Dose
    date
    C3173309 (UMLS CUI [1])
    Date Last Dose
    Item
    Date Last Dose
    date
    C1762893 (UMLS CUI [1])
    Item
    Best Response
    integer
    C2986560 (UMLS CUI [1])
    Best Response
    Code List
    Best Response
    CL Item
    CR (1)
    CL Item
    PR (2)
    CL Item
    MR (3)
    CL Item
    SD (4)
    CL Item
    PD (5)
    CL Item
    Unknown (6)
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