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ID

13912

Description

A randomised comparison of daily 25 mg versus 5 mg lenalidomide as maintenance therapy after high-dose therapy and autologous stem cell transplantation in patients with multiple myeloma. Protocol-Code: RV-MM-PI-280 EudraCT-Number: 2007-003945-33 Author: Claus Schreiber Review: Gerd Felder Approval of CRF: Prof. Dr. med. G. Kobbe (LKP) Release for MDM: Prof. Gattermann, Düsseldorf (26.1.2016) Principal Investigator „LenaMain“-Studie: Prof. Roland Fenk, Düsseldorf Coordinating center for clinical trial Medical faculty of University Hospital Heinrich-Heine-University Scientific Director: Herr Dr. J. Grebe Moorenstrasse 5 40225 Düsseldorf Tel.: +49 (0) 211-81-19701 Fax: +49 (0) 211-81-19702

Keywords

  1. 3/16/16 3/16/16 -
Uploaded on

March 16, 2016

DOI

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License

Creative Commons BY-NC 3.0

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    First Consolidation Cycle 2.week LenaMain-Study

    First Consolidation Cycle

    2. Weekly control visit (large)
    Description

    2. Weekly control visit (large)

    Date of visit
    Description

    Date

    Data type

    date

    Alias
    UMLS CUI [1]
    C0011008
    Medication dosage of last cycle
    Description

    Cumulative dosage of trial substance during last cycle in mg

    Data type

    float

    Measurement units
    • mg
    Alias
    UMLS CUI [1]
    C3174092
    mg
    Prior trial substance dosage
    Description

    Trial substance dosage

    Data type

    integer

    Measurement units
    • mg
    Alias
    UMLS CUI [1,1]
    C0013230
    UMLS CUI [1,2]
    C0178602
    New trial substance dosage
    Description

    Trial substance dosage

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0013230
    UMLS CUI [1,2]
    C0178602
    Please specify reason for dose reduction
    Description

    Dosage reduction

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0178602
    UMLS CUI [1,2]
    C0547047
    Did any Adverse Events occur?
    Description

    Adverse Events

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0877248
    Laboratory:Hematology
    Description

    Laboratory:Hematology

    Erythrocytes
    Description

    Erythrocytes

    Data type

    float

    Measurement units
    • Mio/μl
    Alias
    UMLS CUI [1]
    C0014772
    Mio/μl
    Hemoglobin
    Description

    Hemoglobin

    Data type

    float

    Measurement units
    • g/dL
    Alias
    UMLS CUI [1]
    C0019046
    g/dL
    Hematocrit
    Description

    Hematocrit

    Data type

    float

    Measurement units
    • %
    Alias
    UMLS CUI [1]
    C0518014
    %
    Mean Corpuscular Volume
    Description

    MCV

    Data type

    float

    Measurement units
    • fl
    Alias
    UMLS CUI [1]
    C1948043
    fl
    MCH
    Description

    MCH

    Data type

    float

    Measurement units
    • pg
    Alias
    UMLS CUI [1]
    C0369183
    pg
    Mean corpuscular hemoglobin concentration
    Description

    MCHC

    Data type

    float

    Measurement units
    • g Hb/dL Ery
    Alias
    UMLS CUI [1]
    C0474535
    g Hb/dL Ery
    Leukocytes
    Description

    Leukocytes

    Data type

    float

    Measurement units
    • 1000/μl
    Alias
    UMLS CUI [1]
    C0023508
    1000/μl
    Leukocytes (total)
    Description

    Leukocytes

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1271681
    Platelet count
    Description

    Platelets

    Data type

    float

    Measurement units
    • 1000/uL
    Alias
    UMLS CUI [1]
    C0005821
    1000/uL
    Neutrophils percentage
    Description

    Neutrophils percentage

    Data type

    float

    Measurement units
    • %
    Alias
    UMLS CUI [1]
    C2238207
    %
    Neutrophils
    Description

    Neutrophils

    Data type

    float

    Measurement units
    • abs.
    Alias
    UMLS CUI [1]
    C0948762
    abs.
    Eosinophils percentage
    Description

    Eosinophils percentage

    Data type

    float

    Measurement units
    • %
    Alias
    UMLS CUI [1]
    C2228144
    %
    Basophils percentage
    Description

    Basophils percentage

    Data type

    float

    Measurement units
    • %
    Alias
    UMLS CUI [1]
    C2237945
    %
    Monocytes percentage
    Description

    Monocytes percentage

    Data type

    float

    Measurement units
    • %
    Alias
    UMLS CUI [1]
    C2237144
    %
    Lymphocytes percentage
    Description

    Lymphocytes percentage

    Data type

    float

    Measurement units
    • %
    Alias
    UMLS CUI [1]
    C2200256
    %
    Neutrophils
    Description

    Neutrophils

    Data type

    float

    Measurement units
    • 1000/μl
    Alias
    UMLS CUI [1]
    C0200633
    1000/μl
    Laboratory:serum chemistry
    Description

    Laboratory:serum chemistry

    Sodium
    Description

    Sodium

    Data type

    float

    Measurement units
    • mmol/L
    Alias
    UMLS CUI [1]
    C0337443
    mmol/L
    Potassium
    Description

    Potassium

    Data type

    float

    Measurement units
    • mmol/l
    Alias
    UMLS CUI [1]
    C0202194
    mmol/l
    Calcium
    Description

    Calcium

    Data type

    float

    Measurement units
    • mmol/l
    Alias
    UMLS CUI [1]
    C0201925
    mmol/l
    Glucose
    Description

    Glucose

    Data type

    float

    Measurement units
    • mg/dl
    Alias
    UMLS CUI [1]
    C0202042
    mg/dl
    Alkaline Phosphatase
    Description

    Alkaline Phosphatase

    Data type

    float

    Measurement units
    • U/L
    Alias
    UMLS CUI [1]
    C0201850
    U/L
    Bilirubin
    Description

    Bilirubin

    Data type

    float

    Measurement units
    • mg/dL
    Alias
    UMLS CUI [1]
    C0005437
    mg/dL
    AST (SGOT)
    Description

    AST

    Data type

    float

    Measurement units
    • U/L
    Alias
    UMLS CUI [1]
    C0201899
    U/L
    ALT
    Description

    ALT

    Data type

    float

    Measurement units
    • U/L
    Alias
    UMLS CUI [1]
    C0201836
    U/L
    Gamma GT
    Description

    Gamma GT

    Data type

    float

    Measurement units
    • U/l
    Alias
    UMLS CUI [1]
    C0202035
    U/l
    Lactate Dehydrogenase (LDH)
    Description

    LDH

    Data type

    float

    Measurement units
    • U/L
    Alias
    UMLS CUI [1]
    C0202113
    U/L
    Urea
    Description

    Urea

    Data type

    float

    Measurement units
    • mg/dl
    Alias
    UMLS CUI [1]
    C0523961
    mg/dl
    CRP
    Description

    CRP

    Data type

    float

    Measurement units
    • md/dl
    Alias
    UMLS CUI [1]
    C0201657
    md/dl
    Serum creatinine
    Description

    Creatinine, Serum

    Data type

    float

    Measurement units
    • mg/dL
    Alias
    UMLS CUI [1]
    C0201976
    mg/dL
    Creatinine Clearance
    Description

    Creatinine Clearance

    Data type

    float

    Measurement units
    • mL/min
    Alias
    UMLS CUI [1]
    C0373595
    mL/min
    Laboratory:pregnancy test
    Description

    Laboratory:pregnancy test

    Is the subject of childbearing potential?
    Description

    Childbearing potential

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3831118
    Pregnancy test result
    Description

    Pregnancy test

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0032976
    Has the patient experienced irregularities with her menstrual period since her last pregnancy test?
    Description

    Menstruation

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0025344

    Similar models

    First Consolidation Cycle

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    2. Weekly control visit (large)
    Date
    Item
    Date of visit
    date
    C0011008 (UMLS CUI [1])
    Medication dosage
    Item
    Medication dosage of last cycle
    float
    C3174092 (UMLS CUI [1])
    Item
    Prior trial substance dosage
    integer
    C0013230 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    Code List
    Prior trial substance dosage
    CL Item
    25 mg (1)
    CL Item
    15 mg (2)
    CL Item
    10 mg (3)
    CL Item
    5 mg (4)
    CL Item
    20 mg (5)
    Item
    New trial substance dosage
    integer
    C0013230 (UMLS CUI [1,1])
    C0178602 (UMLS CUI [1,2])
    Code List
    New trial substance dosage
    CL Item
    25 mg (1)
    CL Item
    15 mg (2)
    CL Item
    10 mg (3)
    CL Item
    5 mg (4)
    CL Item
    20 mg (5)
    Dosage reduction
    Item
    Please specify reason for dose reduction
    text
    C0178602 (UMLS CUI [1,1])
    C0547047 (UMLS CUI [1,2])
    Adverse Events
    Item
    Did any Adverse Events occur?
    boolean
    C0877248 (UMLS CUI [1])
    Item Group
    Laboratory:Hematology
    Erythrocytes
    Item
    Erythrocytes
    float
    C0014772 (UMLS CUI [1])
    Hemoglobin
    Item
    Hemoglobin
    float
    C0019046 (UMLS CUI [1])
    Hematocrit
    Item
    Hematocrit
    float
    C0518014 (UMLS CUI [1])
    MCV
    Item
    Mean Corpuscular Volume
    float
    C1948043 (UMLS CUI [1])
    MCH
    Item
    MCH
    float
    C0369183 (UMLS CUI [1])
    MCHC
    Item
    Mean corpuscular hemoglobin concentration
    float
    C0474535 (UMLS CUI [1])
    Leukocytes
    Item
    Leukocytes
    float
    C0023508 (UMLS CUI [1])
    Leukocytes
    Item
    Leukocytes (total)
    integer
    C1271681 (UMLS CUI [1])
    Platelets
    Item
    Platelet count
    float
    C0005821 (UMLS CUI [1])
    Neutrophils percentage
    Item
    Neutrophils percentage
    float
    C2238207 (UMLS CUI [1])
    Neutrophils
    Item
    Neutrophils
    float
    C0948762 (UMLS CUI [1])
    Eosinophils percentage
    Item
    Eosinophils percentage
    float
    C2228144 (UMLS CUI [1])
    Basophils percentage
    Item
    Basophils percentage
    float
    C2237945 (UMLS CUI [1])
    Monocytes percentage
    Item
    Monocytes percentage
    float
    C2237144 (UMLS CUI [1])
    Lymphocytes percentage
    Item
    Lymphocytes percentage
    float
    C2200256 (UMLS CUI [1])
    Neutrophils
    Item
    Neutrophils
    float
    C0200633 (UMLS CUI [1])
    Item Group
    Laboratory:serum chemistry
    Sodium
    Item
    Sodium
    float
    C0337443 (UMLS CUI [1])
    Potassium
    Item
    Potassium
    float
    C0202194 (UMLS CUI [1])
    Calcium
    Item
    Calcium
    float
    C0201925 (UMLS CUI [1])
    Glucose
    Item
    Glucose
    float
    C0202042 (UMLS CUI [1])
    Alkaline Phosphatase
    Item
    Alkaline Phosphatase
    float
    C0201850 (UMLS CUI [1])
    Bilirubin
    Item
    Bilirubin
    float
    C0005437 (UMLS CUI [1])
    AST
    Item
    AST (SGOT)
    float
    C0201899 (UMLS CUI [1])
    ALT
    Item
    ALT
    float
    C0201836 (UMLS CUI [1])
    Gamma GT
    Item
    Gamma GT
    float
    C0202035 (UMLS CUI [1])
    LDH
    Item
    Lactate Dehydrogenase (LDH)
    float
    C0202113 (UMLS CUI [1])
    Urea
    Item
    Urea
    float
    C0523961 (UMLS CUI [1])
    CRP
    Item
    CRP
    float
    C0201657 (UMLS CUI [1])
    Creatinine, Serum
    Item
    Serum creatinine
    float
    C0201976 (UMLS CUI [1])
    Creatinine Clearance
    Item
    Creatinine Clearance
    float
    C0373595 (UMLS CUI [1])
    Item Group
    Laboratory:pregnancy test
    Childbearing potential
    Item
    Is the subject of childbearing potential?
    boolean
    C3831118 (UMLS CUI [1])
    Item
    Pregnancy test result
    integer
    C0032976 (UMLS CUI [1])
    Code List
    Pregnancy test result
    CL Item
    positive (1)
    CL Item
    negative (2)
    Item
    Has the patient experienced irregularities with her menstrual period since her last pregnancy test?
    integer
    C0025344 (UMLS CUI [1])
    Code List
    Has the patient experienced irregularities with her menstrual period since her last pregnancy test?
    CL Item
    No menstruation (0)
    CL Item
    Yes (1)
    CL Item
    No (2)

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