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    Clinical Trial Results:
    A PHASE II,MULTI-CENTER, OPEN LABEL STUDY OF ORAL LBH589 PLUS MELPHALAN, PREDNISONE AND THALIDOMIDE (LB-MPT)IN ADVANCED, REFRACTORY MULTIPLE MYELOMA PATIENTS.

    Summary
    EudraCT number
    		 2007-007939-29
    Trial protocol
    		 IT  
    Global end of trial date
    11 Apr 2017

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

    Trial information

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    Trial identification
    Sponsor protocol code
    CLBH589BIT01T
    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, Fondazione EMN Italy Onlus, 011 0243236, clinicaltrialoffice@emn.org
    Scientific contact
    Data Center, Fondazione EMN Italy Onlus, 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
    31 May 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Apr 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Determine whether the combination LB-MPT (with escalating dose of LB589) is safe and effective in advanced/refractory MM patients.
    Protection of trial subjects
    Under approval of Local Etical Commitee
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 May 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: 31
    Worldwide total number of subjects
    31
    EEA total number of subjects
    31
    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
    31
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The pre-treatment period includes the screening visit, performed at study entry. After providing written informed consent to participate in the study, patients will be evaluated for study eligibility

    Pre-assignment period milestones
    Number of subjects started
    		 31
    Number of subjects completed
    		 31

    Period 1
    Period 1 title
    Treatment
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 LB-MPT
    Arm description
    		 LBH589, melphalan, prednisone, thalidomide
    Arm type
    		 Experimental

    Investigational medicinal product name
    LBH589
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Level 0 = starting dose LBH589 = 15 mg once daily on days 1, 3, 5, 8, 10, 12, 15, 17, 19 followed by 9-day rest period (day 20 through 28). Level – 1 LBH589 = 10 mg once daily on days 1, 3, 5, 8, 10, 12, 15, 17, 19 followed by 9-day rest period (day 20 through 28). Level + 1 LBH589 = 20 mg once daily on days 1, 3, 5, 8, 10, 12, 15, 17, 19 followed by 9-day rest period (day 20 through 28).

    Investigational medicinal product name
    Melphalan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Melphalan will be given orally at the dose of 0.18 mg/Kg for 4 days. Each cycle will be repeated every 28 days for a total of 6 courses.

    Investigational medicinal product name
    Thalidomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Thalidomide will be given orally at the dose of 50 mg/day continuously.

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Prednisone will be given orally at the dose of 1,5 mg/Kg for 4 days followed by a 24-day rest period (days 5 through 28). Each cycle will be repeated every 28 days for a total of 6 courses.

    Number of subjects in period 1
    		LB-MPT
    Started
    31
    Completed
    10
    Not completed
    21
         Adverse event, serious fatal
    1
         Consent withdrawn by subject
    1
         Adverse event, non-fatal
    8
         Lack of efficacy
    11
    Period 2
    Period 2 title
    Maintenance
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 LB-P
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    LBH589
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    LBH589 at the dose used for LB-MPT daily on days 1, 3, 5, 8, 10, 12, 15, 17, 19 followed by 9-day rest period (day 20 through 28) continuously until development of PD.

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Prednisone 25 mg daily, on days 1, 3, 5 every week continuously until development of PD.

    Number of subjects in period 2
    		LB-P
    Started
    10
    Completed
    0
    Not completed
    10
         Adverse event, serious fatal
    1
         Adverse event, non-fatal
    1
         Lack of efficacy
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LB-MPT
    Reporting group description
    		 LBH589, melphalan, prednisone, thalidomide

    Reporting group values
    		 LB-MPT Total
    Number of subjects
    		 31 31
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 9 9
        From 65-84 years
    		 22 22
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 70 (40 to 81) -
    Gender categorical
    Units: Subjects
        Female
    		 15 15
        Male
    		 16 16
    ISS Stage
    Units: Subjects
        ISS I
    		 17 17
        ISS II
    		 10 10
        ISS III
    		 4 4
    Disease status
    Units: Subjects
        Untested relapse
    		 22 22
        Refractory
    		 9 9
    Performance status (WHO)
    Units: Subjects
        0-1
    		 20 20
        2-4
    		 11 11
    Myeloma type
    Units: Subjects
        IgG
    		 22 22
        IgA
    		 6 6
        Light chain only
    		 3 3
    Subject analysis sets

    Subject analysis set title
    LB-MPT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patient that are eligible

    Subject analysis sets values
    		 LB-MPT
    Number of subjects
    31
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    9
        From 65-84 years
    22
        85 years and over
    0
    Age continuous
    Units: years
        median (full range (min-max))
    70 (40 to 81)
    Gender categorical
    Units: Subjects
        Female
    15
        Male
    16
    ISS Stage
    Units: Subjects
        ISS I
    17
        ISS II
    10
        ISS III
    4
    Disease status
    Units: Subjects
        Untested relapse
    22
        Refractory
    9
    Performance status (WHO)
    Units: Subjects
        0-1
    20
        2-4
    11
    Myeloma type
    Units: Subjects
        IgG
    22
        IgA
    6
        Light chain only
    3

    End points

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    End points reporting groups
    Reporting group title
    LB-MPT
    Reporting group description
    		 LBH589, melphalan, prednisone, thalidomide
    Reporting group title
    LB-P
    Reporting group description
    		 -

    Subject analysis set title
    LB-MPT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Patient that are eligible

    Primary: grade 3-4 non-hematologic toxicity

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    End point title
    		 grade 3-4 non-hematologic toxicity
    End point description
    End point type
    Primary
    End point timeframe
    4 years
    End point values
    		 LB-MPT LB-MPT
    Number of subjects analysed
    31
    31
    Units: Patients
        Yes
    6
    6
        No
    25
    25
    Statistical analysis title
    		 No statistical analysis
    Statistical analysis description
    No statistical analysis
    Comparison groups
    LB-MPT v LB-MPT
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0 [2]
    Method
    		 No statistical analysis
    Parameter type
    		 No statistical analysis
    Point estimate
    6
    Confidence interval
         level
    		 0%
         sides
    2-sided
         lower limit
    		 6
         upper limit
    		 6
    Variability estimate
    Standard deviation
    Dispersion value
    0
    Notes
    [1] - No statistical analysis
    [2] - No statistical analysis

    Primary: PR Rate

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    End point title
    		 PR Rate
    End point description
    End point type
    Primary
    End point timeframe
    4 years
    End point values
    		 LB-MPT LB-MPT
    Number of subjects analysed
    31
    31 [3]
    Units: Patients
        >= PR
    12
    12
        < PR
    19
    19
    Notes
    [3] - 31
    Statistical analysis title
    		 No statistical analysis
    Comparison groups
    LB-MPT v LB-MPT
    Number of subjects included in analysis
    62
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    P-value
    		 = 0.001 [5]
    Method
    		 No statistical analysis
    Parameter type
    		 No statistical analysis
    Point estimate
    12
    Confidence interval
         level
    		 0%
         sides
    2-sided
         lower limit
    		 12
         upper limit
    		 12
    Variability estimate
    Standard error of the mean
    Dispersion value
    0
    Notes
    [4] - No statistical analysis
    [5] - No statistical analysis

    Secondary: PFS

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    End point title
    		 PFS
    End point description
    End point type
    Secondary
    End point timeframe
    1 year
    End point values
    		 LB-MPT
    Number of subjects analysed
    Units: percent
        number (not applicable)
    59
    No statistical analyses for this end point

    Secondary: OS

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    End point title
    		 OS
    End point description
    End point type
    Secondary
    End point timeframe
    1 year
    End point values
    		 LB-MPT
    Number of subjects analysed
    Units: percent
        number (not applicable)
    63
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    End of trial
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    LB-MPT
    Reporting group description
    		 LBH589, melphalan, prednisone, thalidomide

    Serious adverse events
    		 LB-MPT
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 31 (45.16%)
         number of deaths (all causes)
    29
         number of deaths resulting from adverse events
    2
    Investigations
    Blood pressure decreased
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Ischaemia
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Presyncope
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Neutropenia
         subjects affected / exposed
    7 / 31 (22.58%)
         occurrences causally related to treatment / all
    6 / 14
         deaths causally related to treatment / all
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    7 / 31 (22.58%)
         occurrences causally related to treatment / all
    5 / 10
         deaths causally related to treatment / all
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    2 / 31 (6.45%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Pulmonary alveolar haemorrhage
         subjects affected / exposed
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    1 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 LB-MPT
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 31 (96.77%)
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    28 / 31 (90.32%)
         occurrences all number
    31
    Thrombocytopenia
         subjects affected / exposed
    27 / 31 (87.10%)
         occurrences all number
    31
    Neutropenia
         subjects affected / exposed
    25 / 31 (80.65%)
         occurrences all number
    31
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    10 / 31 (32.26%)
         occurrences all number
    31
    Asthenia
         subjects affected / exposed
    9 / 31 (29.03%)
         occurrences all number
    31
    Pain
         subjects affected / exposed
    5 / 31 (16.13%)
         occurrences all number
    31
    Oedema
         subjects affected / exposed
    3 / 31 (9.68%)
         occurrences all number
    31
    Fatigue
         subjects affected / exposed
    3 / 31 (9.68%)
         occurrences all number
    31
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    6 / 31 (19.35%)
         occurrences all number
    31
    Nausea
         subjects affected / exposed
    5 / 31 (16.13%)
         occurrences all number
    31
    Diarrhoea
         subjects affected / exposed
    4 / 31 (12.90%)
         occurrences all number
    31
    Vomiting
         subjects affected / exposed
    3 / 31 (9.68%)
         occurrences all number
    31
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    4 / 31 (12.90%)
         occurrences all number
    31
    Dyspnoea
         subjects affected / exposed
    3 / 31 (9.68%)
         occurrences all number
    31
    Metabolism and nutrition disorders
    Hypocalcaemia
         subjects affected / exposed
    5 / 31 (16.13%)
         occurrences all number
    31
    Hyperkalaemia
         subjects affected / exposed
    5 / 31 (16.13%)
         occurrences all number
    31
    Decreased appetite
         subjects affected / exposed
    4 / 31 (12.90%)
         occurrences all number
    31
    Hyperglycaemia
         subjects affected / exposed
    3 / 31 (9.68%)
         occurrences all number
    31

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/22335534
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