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    Clinical Trial Results:
    The role of apixaban, aspirin and enoxaparin as Thromboprophylaxis in patients newly diagnosed with Multiple Myeloma - an open label randomised control clinical trial

    Summary
    EudraCT number
    		 2015-002668-18
    Trial protocol
    		 GB  
    Global end of trial date
    27 Jun 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Mar 2019
    First version publication date
    15 Mar 2019
    Other versions
    Summary report(s)
    		 FINAL STUDY REPORT

    Trial information

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    Trial identification
    Sponsor protocol code
    TiMM
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 REC number: 15/LO/1319
    Sponsors
    Sponsor organisation name
    King's College Hospital NHS Foundation Trust
    Sponsor organisation address
    Denmark Hill, London, United Kingdom, SE5 9RS
    Public contact
    Professor Roopen Arya, King’s College Hospital NHS Foundation Trust, +44 02032993570, roopen.arya@nhs.net
    Scientific contact
    Professor Roopen Arya, King’s College Hospital NHS Foundation Trust, +44 02032993570, roopen.arya@nhs.net
    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
    27 Jun 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Jun 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Jun 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Safety of apixaban as a thromboprophylactic agent in the newly diagnosed myeloma population
    Protection of trial subjects
    Patients are free to withdraw consent for study treatment and/or consent to participate in the study at any time and without the prejudice to further treatment. Patients who withdraw from study treatment, but are willing to continue to participate in the follow-up visits should be followed according to the procedures outlined in the protocol.
    Background therapy
    		 For the low risk group, aspirin 75mg tablets (once tablet once a day) or apixaban 2.5mg tablets (one tablet twice a day) will be prescribed for patients, according to which arm they are randomised to. For the high risk group, enoxaparin 40mg daily* (by subcutaneous once a day) or apixaban 2.5mg tablets (one tablet twice a day) will be prescribed for patients, according to which arm they are randomised to.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 May 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    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)
    5
    From 65 to 84 years
    5
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited between 12/04/2016 and 21/04/2017. Participants were recruited from King's College Hospital NHS Foundation Trust

    Pre-assignment
    Screening details
    		 Patients with newly diagnosed with multiple myeloma requiring chemotherapy, age >18 years and able to give informed consent were recruited. 29 patients were screened.

    Pre-assignment period milestones
    Number of subjects started
    		 10
    Number of subjects completed
    		 10

    Period 1
    Period 1 title
    Overall trial period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 High risk apixaban
    Arm description
    		 Newly diagnosed multiple myeloma patients with a high risk of developing a venous thromboembolic event randomised to receive apixaban
    Arm type
    		 Experimental

    Investigational medicinal product name
    Apixaban
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5 mg milligram(s) per day

    Arm title
    		 Standard risk apixaban
    Arm description
    		 Newly diagnosed multiple myeloma patients with a standard risk of developing a venous thromboembolic event randomised to receive apixaban
    Arm type
    		 Experimental

    Investigational medicinal product name
    Apixaban
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5 mg milligram(s) per day

    Arm title
    		 Standard risk aspirin
    Arm description
    		 Newly diagnosed multiple myeloma patients with a standard risk of developing a venous thromboembolic event randomised to receive aspirin
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Aspirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    75 mg milligram(s) per day

    Number of subjects in period 1
    		High risk apixaban Standard risk apixaban Standard risk aspirin
    Started
    2
    4
    4
    Completed
    1
    3
    1
    Not completed
    1
    1
    3
         Adverse event, non-fatal
    1
    1
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial period
    Reporting group description
    		 Newly diagnosed multiple myeloma patients were recruited between the ages 50 and 79.

    Reporting group values
    		 Overall trial period Total
    Number of subjects
    		 10 10
    Age categorical
    Units: Subjects
        50-59 years
    		 3 3
        60-69 years
    		 4 4
        70-79 years
    		 3 3
    Gender categorical
    Both male and female subjects were recruited for this trial.
    Units: Subjects
        Female
    		 5 5
        Male
    		 5 5

    End points

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    End points reporting groups
    Reporting group title
    High risk apixaban
    Reporting group description
    		 Newly diagnosed multiple myeloma patients with a high risk of developing a venous thromboembolic event randomised to receive apixaban

    Reporting group title
    Standard risk apixaban
    Reporting group description
    		 Newly diagnosed multiple myeloma patients with a standard risk of developing a venous thromboembolic event randomised to receive apixaban

    Reporting group title
    Standard risk aspirin
    Reporting group description
    		 Newly diagnosed multiple myeloma patients with a standard risk of developing a venous thromboembolic event randomised to receive aspirin

    Primary: Safety of apixaban as a thromboprophylactic agent in the newly diagnosed myeloma population

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    End point title
    		 Safety of apixaban as a thromboprophylactic agent in the newly diagnosed myeloma population [1]
    End point description
    End point type
    Primary
    End point timeframe
    Bleeding events were captured from 1st dose of IMP until 10 days post last dose of IMP.
    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: No statistical tests were undertaken as the study is not powered to detect meaningful significance.
    End point values
    		 High risk apixaban Standard risk apixaban Standard risk aspirin
    Number of subjects analysed
    2
    4
    4
    Units: Bleeding events
    0
    2
    1
    No statistical analyses for this end point

    Secondary: Venous Thromboembolic events

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    End point title
    		 Venous Thromboembolic events
    End point description
    End point type
    Secondary
    End point timeframe
    Venous Thromboembolic events were captured from first dose of IMP until 10 days post last dose of IMP.
    End point values
    		 High risk apixaban Standard risk apixaban Standard risk aspirin
    Number of subjects analysed
    2
    4
    4
    Units: number of events
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Recruitment rate from eligible population to the stud

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    End point title
    		 Recruitment rate from eligible population to the stud
    End point description
    End point type
    Secondary
    End point timeframe
    12 month recruitment period
    End point values
    		 High risk apixaban Standard risk apixaban Standard risk aspirin
    Number of subjects analysed
    2
    4
    4
    Units: Number of patients recruited
    2
    4
    4
    Attachments
    		 FINAL STUDY REPORT
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs and SAEs were reported from consent until 10 days after administration of the last dose of study medication
    Adverse event reporting additional description
    Patients will be risked assessed for VTE, as soon as the treatment for the myeloma is initiated. For patients who consent to the study, they will be randomised to apixaban or aspirin and will continue this VTE preventative medication until they are deemed to be in remission.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    High risk apixaban
    Reporting group description
    		 Newly diagnosed multiple myeloma patients with a high risk of developing a venous thromboembolic event randomised to receive apixaban

    Reporting group title
    Standard risk apixaban
    Reporting group description
    		 Newly diagnosed multiple myeloma patients with a standard risk of developing a venous thromboembolic event randomised to receive apixaban

    Reporting group title
    Standard risk aspirin
    Reporting group description
    		 Newly diagnosed multiple myeloma patients with a standard risk of developing a venous thromboembolic event randomised to receive aspirin

    Serious adverse events
    		 High risk apixaban Standard risk apixaban Standard risk aspirin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 2 (50.00%)
    1 / 4 (25.00%)
    1 / 4 (25.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Cardiac disorders
    Myocardial infarction
    Additional description: Chest pain and raised troponin
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Sepsis syndrome
    Additional description: Non-neutropenic sepsis and toxic erythema
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    1 / 4 (25.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
    Additional description: Elevated blood glucose
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 High risk apixaban Standard risk apixaban Standard risk aspirin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 2 (100.00%)
    3 / 4 (75.00%)
    3 / 4 (75.00%)
    Blood and lymphatic system disorders
    Cephalic vein thrombosis
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    1
    1
    Bleeding
         subjects affected / exposed
    0 / 2 (0.00%)
    2 / 4 (50.00%)
    1 / 4 (25.00%)
         occurrences all number
    0
    2
    1
    General disorders and administration site conditions
    light headed
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Eye disorders
    Chromatopsia
         subjects affected / exposed
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 4 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Diarrhoea
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Redness
    Additional description: Red blotches on skin
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Back ache
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Bilateral calf tenderness
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Raised temperature
         subjects affected / exposed
    1 / 2 (50.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
         occurrences all number
    1
    0
    0

    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
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