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    Clinical Trial Results:
    Magnolia Study Prolonged Protection from Bone Disease in Multiple Myeloma. An open label phase 4 multicenter international randomised trial

    Summary
    EudraCT number
    		 2014-002494-12
    Trial protocol
    		 DK   SE   NO  
    Global end of trial date
    15 Mar 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Nov 2024
    First version publication date
    30 Nov 2024
    Other versions
    Summary report(s)
    		 summary magnolia

    Trial information

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    Trial identification
    Sponsor protocol code
    NMSG22/14
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02286830
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    OdenseOUH
    Sponsor organisation address
    J. B. Winsløws Vej 4, Odense, Denmark, 5000
    Public contact
    Thomas Lund, Odense University Hospital, +45 21450256, Thomas.lund2@rsyd.dk
    Scientific contact
    Thomas Lund, Odense University Hospital, +45 21450256, Thomas.lund2@rsyd.dk
    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 Nov 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Mar 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Mar 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the time to PBD from year 2 to year 4 in patients treated with monthly zoledronic acid in two consecutive years compared to patients treated with monthly zoledronic acid in four consecutive years.
    Protection of trial subjects
    done according to the ethical committee approval
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 2014
    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
    Norway: 82
    Country: Number of subjects enrolled
    Denmark: 111
    Worldwide total number of subjects
    193
    EEA total number of subjects
    193
    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)
    81
    From 65 to 84 years
    112
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 recruited either at diagnosis or after 2 years of zoledronic acid treatment

    Pre-assignment
    Screening details
    		 Patients with MM in recruiting hospitals

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 2 years treatment
    Arm description
    		 2 years of treatment
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 4 years treatment
    Arm description
    		 4 years of treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    zoledronic acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Injection
    Dosage and administration details
    4-3 mg ever fouth week

    Number of subjects in period 1
    		2 years treatment 4 years treatment
    Started
    94
    99
    Completed
    94
    99

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    2 years treatment
    Reporting group description
    		 2 years of treatment

    Reporting group title
    4 years treatment
    Reporting group description
    		 4 years of treatment

    Reporting group values
    		 2 years treatment 4 years treatment Total
    Number of subjects
    		 94 99 193
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 46 35 81
        From 65-84 years
    		 48 64 112
    Gender categorical
    Units: Subjects
        Female
    		 39 39 78
        Male
    		 55 60 115
    Subject analysis sets

    Subject analysis set title
    number of osteolysis in each group
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    9 in the intervention arm 21 in the control arm

    Subject analysis sets values
    		 number of osteolysis in each group
    Number of subjects
    193
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    81
        From 65-84 years
    112
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    Gender categorical
    Units: Subjects
        Female
    78
        Male
    115

    End points

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    End points reporting groups
    Reporting group title
    2 years treatment
    Reporting group description
    		 2 years of treatment

    Reporting group title
    4 years treatment
    Reporting group description
    		 4 years of treatment

    Subject analysis set title
    number of osteolysis in each group
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    9 in the intervention arm 21 in the control arm

    Primary: Bone disease

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    End point title
    		 Bone disease
    End point description
    End point type
    Primary
    End point timeframe
    LPLV
    End point values
    		 2 years treatment 4 years treatment number of osteolysis in each group
    Number of subjects analysed
    94
    99
    193
    Units: Number
        Number
    21
    9
    30
    Statistical analysis title
    		 Cox regression analysis of PBD
    Comparison groups
    4 years treatment v 2 years treatment
    Number of subjects included in analysis
    193
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Regression, Cox
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from start of trial til end of trial
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    2 years treatment
    Reporting group description
    		 2 years of treatment

    Reporting group title
    4 years treatment
    Reporting group description
    		 4 years of treatment

    Serious adverse events
    		 2 years treatment 4 years treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 94 (2.13%)
    6 / 99 (6.06%)
         number of deaths (all causes)
    3
    2
         number of deaths resulting from adverse events
    Renal and urinary disorders
    Creatinine increase
         subjects affected / exposed
    0 / 94 (0.00%)
    2 / 99 (2.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Hypercalcaemia
         subjects affected / exposed
    2 / 94 (2.13%)
    0 / 99 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteonecrosis of jaw
         subjects affected / exposed
    0 / 94 (0.00%)
    4 / 99 (4.04%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 2 years treatment 4 years treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    74 / 94 (78.72%)
    83 / 99 (83.84%)
    Renal and urinary disorders
    Creatinine increase
         subjects affected / exposed
    24 / 94 (25.53%)
    39 / 99 (39.39%)
         occurrences all number
    24
    39
    Endocrine disorders
    Hypercalcaemia
         subjects affected / exposed
    10 / 94 (10.64%)
    15 / 99 (15.15%)
         occurrences all number
    10
    15
    Hypocalcaemia
         subjects affected / exposed
    39 / 94 (41.49%)
    47 / 99 (47.47%)
         occurrences all number
    39
    47
    Musculoskeletal and connective tissue disorders
    Osteonecrosis of jaw
         subjects affected / exposed
    1 / 94 (1.06%)
    2 / 99 (2.02%)
         occurrences all number
    1
    2

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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