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    Clinical Trial Results:
    Pomalidomide in relapsed and refractory multiple myeloma (RRMM)

    Summary
    EudraCT number
    2013-002101-62
    Trial protocol
    GB  
    Global end of trial date
    13 Oct 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    04 Jan 2020
    First version publication date
    04 Jan 2020
    Other versions
    Summary report(s)
    Never opened to recruitment statement

    Trial information

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    Trial identification
    Sponsor protocol code
    HM13/10758
    Additional study identifiers
    ISRCTN number
    ISRCTN24593488
    US NCT number
    NCT02406222
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    University of Leeds
    Sponsor organisation address
    Worsley Building, Leeds, United Kingdom, LS2 9JT
    Public contact
    Clare Skinner, University of Leeds, 0113 3434897, c.e.skinner@leeds.ac.uk
    Scientific contact
    Clare Skinner, University of Leeds, 0113 3434897, c.e.skinner@leeds.ac.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 Oct 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Oct 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine whether the addition of cyclophosphamide to pomalidomide and dexamethasone (CPD) improves progression-free survival in patients with relapsed refractory myeloma (RRMM) in the UK, compared to pomalidomide and dexamethasone (Pd) alone.
    Protection of trial subjects
    N/A
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Aug 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 99999
    Worldwide total number of subjects
    99999
    EEA total number of subjects
    99999
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    99999
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    n/a

    Pre-assignment
    Screening details
    N/A

    Period 1
    Period 1 title
    Main Trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    n/a

    Arms
    Arm title
    Pomalidomide, cyclophosphamide and dexamethasone
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    Pomalidomide, cyclophosphamide and dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Tablet, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    All IMP's in the arm would have been administered orally.

    Number of subjects in period 1
    Pomalidomide, cyclophosphamide and dexamethasone
    Started
    99999
    Completed
    99999

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pomalidomide, cyclophosphamide and dexamethasone
    Reporting group description
    -

    Reporting group values
    Pomalidomide, cyclophosphamide and dexamethasone Total
    Number of subjects
    99999 99999
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    99999 99999
        From 65-84 years
    0 0
        85 years and over
    0 0
    Gender categorical
    Units: Subjects
        Female
    99999 99999
        Male
    0 0

    End points

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    End points reporting groups
    Reporting group title
    Pomalidomide, cyclophosphamide and dexamethasone
    Reporting group description
    -

    Primary: addition of cyclophosphamide to pomalidomide and dexamethasone (CPD) improves progression-free survival

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    End point title
    addition of cyclophosphamide to pomalidomide and dexamethasone (CPD) improves progression-free survival [1]
    End point description
    this trial was discontinued with no participants enrolled in the trial.
    End point type
    Primary
    End point timeframe
    this trial was discontinued with no participants enrolled in the trial.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: this trial was discontinued with no participants enrolled in the trial.
    End point values
    Pomalidomide, cyclophosphamide and dexamethasone
    Number of subjects analysed
    0 [2]
    Units: yes/no
    Notes
    [2] - this trial was discontinued with no participants enrolled in the trial.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    n/a- trial never opened to recruitment
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    CTCAE
    Dictionary version
    4.0
    Frequency threshold for reporting non-serious adverse events: 5%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: this trial was discontinued with no participants enrolled in the trial.

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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