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    Clinical Trial Results:
    A MULTICENTER, OPEN LABEL STUDY OF VELCADE, MELPHALAN AND PREDNISONE (VMP) IN RELAPSED/REFRACTORY MULTIPLE MYELOMA PATIENTS

    Summary
    EudraCT number
    		 2007-006123-13
    Trial protocol
    		 IT  
    Global end of trial date
    01 Oct 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Mar 2023
    First version publication date
    28 Mar 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MM-07-07
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    FONDAZIONE EMN ITALY ONLUS
    Sponsor organisation address
    Via Saluzzo 1/A, Torino, Italy, 10125
    Public contact
    Data Center, Data Center, 011 0243236, clinicaltrialoffice@emn.org
    Scientific contact
    Data Center, Data Center, 011 0243236, clinicaltrialoffice@emn.org
    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
    01 Oct 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Oct 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Determine whether the association of VMP (with Melphalan at dose of 24 mg/28 days and Velcade 1.3 mg/m2, weekly) is safe and induces a significant rate of PR in patients with relapse/refractory myeloma.
    Protection of trial subjects
    Under approval of Local Etical Commitee
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Mar 2008
    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
    Italy: 42
    Worldwide total number of subjects
    42
    EEA total number of subjects
    42
    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)
    0
    From 65 to 84 years
    40
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Blood samples were collected at screening. During 28 days screeening incusion and excluson criteria was examinated

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 VMP ARM
    Arm description
    		 Velcade Melphalan Prednisione
    Arm type
    		 Experimental

    Investigational medicinal product name
    Velcade
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1,3 mg/m2 milligram(s)/square meter daily VMP: 4 cycles for 8 days Maximum treatment duration according to the protocol: 52 Days

    Investigational medicinal product name
    Alkeran
    Investigational medicinal product code
    Other name
    Melphalan
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    9 cycles 4mg daily

    Investigational medicinal product name
    DELTACORTENE
    Investigational medicinal product code
    Other name
    PREDNISONE
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    9 cycles 50mg daily

    Number of subjects in period 1
    		VMP ARM
    Started
    42
    Completed
    42

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 42 42
    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)
    		 0 0
        From 65-84 years
    		 40 40
        85 years and over
    		 2 2
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 73 (70 to 79) -
    Gender categorical
    Units: Subjects
        Female
    		 25 25
        Male
    		 17 17
    Median previous lines therapy
    Units: Subjects
        One
    		 31 31
        Two
    		 11 11
    Subject analysis sets

    Subject analysis set title
    VMP
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    In this trial, we started with a reduced dose of melphalan (24 mg for 28 days: 2 mg on Monday, Wednesday, and Friday every week), bortezomib (1.3 mg/m2 as a bolus intravenous injection on days 1, 8, 15, and 22), and prednisone (50 mg every other day) for a total of 9 cycles, as soon as the screening visits of the pretreatment period had been completed

    Subject analysis sets values
    		 VMP
    Number of subjects
    42
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    0
        From 65-84 years
    40
        85 years and over
    2
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    73 (70 to 79)
    Gender categorical
    Units: Subjects
        Female
    25
        Male
    17
    Median previous lines therapy
    Units: Subjects
        One
    31
        Two
    11

    End points

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    End points reporting groups
    Reporting group title
    VMP ARM
    Reporting group description
    		 Velcade Melphalan Prednisione

    Subject analysis set title
    VMP
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    In this trial, we started with a reduced dose of melphalan (24 mg for 28 days: 2 mg on Monday, Wednesday, and Friday every week), bortezomib (1.3 mg/m2 as a bolus intravenous injection on days 1, 8, 15, and 22), and prednisone (50 mg every other day) for a total of 9 cycles, as soon as the screening visits of the pretreatment period had been completed

    Primary: ORR Rate

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    End point title
    		 ORR Rate
    End point description
    Determine whether the association of VMP (with Melphalan at dose of 24 mg/28 days and VELCADE at 1.3 mg/m2, weekly) induces a significant rate of PR or better in patients with relapse/refractory myeloma.
    End point type
    Primary
    End point timeframe
    9 months
    End point values
    		 VMP ARM VMP
    Number of subjects analysed
    42
    42
    Units: number
    number (not applicable)
        Yes
    24
    24
        No
    18
    18
    Statistical analysis title
    		 only descriptive
    Statistical analysis description
    only descriptive
    Comparison groups
    VMP ARM v VMP
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0 [2]
    Method
    		 only descriptive
    Parameter type
    		 only descriptive
    Point estimate
    57
    Confidence interval
         level
    		 0%
         sides
    2-sided
         lower limit
    		 57
         upper limit
    		 57
    Notes
    [1] - only descriptive
    [2] - only descriptive

    Secondary: PFS

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    End point title
    		 PFS
    End point description
    Determine the durations of progression-free survival (PFS)
    End point type
    Secondary
    End point timeframe
    37 months
    End point values
    		 VMP ARM VMP
    Number of subjects analysed
    42
    42
    Units: month
        median (confidence interval 95%)
    18 (12.8 to 20.2)
    18 (12.8 to 20.2)
    Statistical analysis title
    		 only descriptive
    Statistical analysis description
    only descriptive
    Comparison groups
    VMP ARM v VMP
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0 [4]
    Method
    		 only descriptive
    Parameter type
    		 only descriptive
    Point estimate
    18
    Confidence interval
         level
    		 0%
         sides
    2-sided
         lower limit
    		 18
         upper limit
    		 18
    Notes
    [3] - only descriptive
    [4] - only descriptive

    Secondary: OS

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    End point title
    		 OS
    End point description
    Determine the OS
    End point type
    Secondary
    End point timeframe
    37 monhts
    End point values
    		 VMP ARM VMP
    Number of subjects analysed
    42
    42
    Units: month
        median (confidence interval 95%)
    30 (17.2 to 37)
    30 (17.2 to 37)
    Statistical analysis title
    		 only descriptive
    Statistical analysis description
    only descriptive
    Comparison groups
    VMP ARM v VMP
    Number of subjects included in analysis
    84
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 = 0 [6]
    Method
    		 only descriptive
    Parameter type
    		 only descriptive
    Point estimate
    30
    Confidence interval
         level
    		 0%
         sides
    2-sided
         lower limit
    		 30
         upper limit
    		 30
    Notes
    [5] - only descriptive
    [6] - only descriptive

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    37 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 no dictionary
    Dictionary version
    0
    Reporting groups
    Reporting group title
    VMP Arm
    Reporting group description
    		 -

    Serious adverse events
    		 VMP Arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 42 (19.05%)
         number of deaths (all causes)
    24
         number of deaths resulting from adverse events
    0
    Cardiac disorders
    Heart failure
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Angina pectoris
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Diarrhea
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Hemorrhagic erosive gastritis
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    COPD exacerbation
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Bronchopneumonia
         subjects affected / exposed
    2 / 42 (4.76%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    H1N1 influenza
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 42 (2.38%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 VMP Arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    42 / 42 (100.00%)
    Nervous system disorders
    Neuropathic pruritus
    Additional description: Real AE is Neuropathic Pain (10054095) by MedDRA. Not reported in this system
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    3
    Paraesthesia
         subjects affected / exposed
    7 / 42 (16.67%)
         occurrences all number
    7
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    28 / 42 (66.67%)
         occurrences all number
    28
    Neutropenia
         subjects affected / exposed
    14 / 42 (33.33%)
         occurrences all number
    14
    Thrombocytopenia
         subjects affected / exposed
    26 / 42 (61.90%)
         occurrences all number
    26
    General disorders and administration site conditions
    Haematoma
         subjects affected / exposed
    4 / 42 (9.52%)
         occurrences all number
    4
    Pyrexia
         subjects affected / exposed
    8 / 42 (19.05%)
         occurrences all number
    8
    Fatigue
         subjects affected / exposed
    4 / 42 (9.52%)
         occurrences all number
    4
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    8 / 42 (19.05%)
         occurrences all number
    8
    Diarrhoea
         subjects affected / exposed
    10 / 42 (23.81%)
         occurrences all number
    10
    Metabolism and nutrition disorders
    Hypocalcaemia
         subjects affected / exposed
    3 / 42 (7.14%)
         occurrences all number
    3

    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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