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    Clinical Trial Results:
    A Phase 2, Randomized Study of VELCADE® (Bortezomib), Dexamethasone, and Thalidomide Versus VELCADE® (Bortezomib), Dexamethasone, Thalidomide, and Cyclophosphamide in Subjects With Previously Untreated Multiple Myeloma Who Are Candidates for Autologous Transplantation

    Summary
    EudraCT number
    		 2006-006050-10
    Trial protocol
    		 FR   AT   HU   PT   CZ   IT  
    Global end of trial date
    16 Oct 2013

    Results information
    Results version number
    		 v2(current)
    This version publication date
    23 Jun 2016
    First version publication date
    06 Aug 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Review of data

    Trial information

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    Trial identification
    Sponsor protocol code
    26866138MMY2043
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00531453
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International NV
    Sponsor organisation address
    Turnhoutseweg 30, Beerse, Belgium, 2340
    Public contact
    Clinical Registry Group,, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
    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
    16 Oct 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to determine the overall combined complete response rate (CR rate) (defined in this protocol as the combination of complete response [CR, including sCR and nCR]) following induction treatment with VDT or VDTC in subjects with newly diagnosed symptomatic multiple myeloma who are candidates for HDT/SCT.
    Protection of trial subjects
    All participating subjects received full supportive care and were followed closely for safety throughout the study. Safety assessments occur through regular clinic visits including laboratory analyses. Special attention was given to the early detection of neurotoxicity (through the FACT/GOG -Ntx questionnaire checklist, investigator assessment, and possibly assessments by a neurologist).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Oct 2007
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 20
    Country: Number of subjects enrolled
    Czech Republic: 16
    Country: Number of subjects enrolled
    France: 14
    Country: Number of subjects enrolled
    Hungary: 9
    Country: Number of subjects enrolled
    Israel: 7
    Country: Number of subjects enrolled
    Italy: 6
    Country: Number of subjects enrolled
    Poland: 10
    Country: Number of subjects enrolled
    Portugal: 16
    Worldwide total number of subjects
    98
    EEA total number of subjects
    91
    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)
    90
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 98 patients were enrolled between October 2007 and September 2008

    Pre-assignment
    Screening details
    		 All enrolled patients received at least one dose of study drug.

    Period 1
    Period 1 title
    Induction Cycles 1-4 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Four Drug Regimen (VDTC)
    Arm description
    		 Treatment Group B (VDTC) - Cyclophosphamide 400 mg/m2 IV on Days 1 and 8 in addition to the therapies described for Treatment Group A.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Velcade (bortezomib)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants will receive velcade 1.3 milligram per meter square [mg/m2] as an intravenous (i.v.) bolus injection on Days 1,4,8, and 11, followed by a 10 day rest period (Days 12 to 21).

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dexamethasone 40 milligram per day (mg/day) was given orally by mouth (p.o.) on Days 1-4 and Days 9-12 in each of 4 cycles.

    Investigational medicinal product name
    Thalidomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Thalidomide 100 milligram (mg) orally Every day, starting on Day 1 of Cycle 1 (e.g. the same day of the first dose of Velcade) and continuing until Day 21 of Cycle 4.

    Investigational medicinal product name
    Cyclophosphamide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    400 milligram per meter square [mg/m2] on Day 1 and Day 8 of each 3-week cycle, for a total of 4 cycles.

    Arm title
    		 Three Drug Regimen (VDT): Bortezomib, Dexamethasone, and Thali
    Arm description
    		 VELCADE (bortezomib) twice weekly for 4 cycles (4 doses per cycle), prior to high-dose chemotherapy (HDT) and stem cell transplantation(SCT). Subjects will receive VELCADE 1.3 mg/m^2 as an intravenous (i.v.) bolus injection on Days 1, 4, 8, and 11, followed by a 10 day rest period (Days 12 to 21). Dexamethasone 40 mg/day given by mouth on Days 1-4 and Days 9-12 in each of 4 cycles. Thalidomide given by mouth every day, starting on Day 1 of Cycle 1 (e.g. the same day of the first dose of VELCADE) and continuing until Day 21 of Cycle 4 at a dose of 100 mg/day (bedtime).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Velcade (bortezomib)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    VELCADE (bortezomib) twice weekly for 4 cycles (4 doses per cycle), prior to high-dose chemotherapy (HDT) and stem cell transplantation(SCT). Subjects received VELCADE 1.3 mg/m^2 as an intravenous (i.v.) bolus injection on Days 1, 4, 8, and 11, followed by a 10 day rest period (Days 12 to 21).

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Dexamethasone 40 milligram per day (mg/day) was given orally by mouth (p.o.) on Days 1-4 and Days 9-12 in each of 4 cycles.

    Investigational medicinal product name
    Thalidomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Thalidomide 100 milligram (mg) orally Every day, starting on Day 1 of Cycle 1 (e.g. the same day of the first dose of Velcade) and continuing until Day 21 of Cycle 4.

    Number of subjects in period 1
    		Four Drug Regimen (VDTC) Three Drug Regimen (VDT): Bortezomib, Dexamethasone, and Thali
    Started
    49
    49
    Completed
    45
    46
    Not completed
    4
    3
         Adverse event, serious fatal
    1
    -
         Adverse event, non-fatal
    -
    1
         Adverse event, serious non-fatal
    2
    2
         Lack of efficacy
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Four Drug Regimen (VDTC)
    Reporting group description
    		 Treatment Group B (VDTC) - Cyclophosphamide 400 mg/m2 IV on Days 1 and 8 in addition to the therapies described for Treatment Group A.

    Reporting group title
    Three Drug Regimen (VDT): Bortezomib, Dexamethasone, and Thali
    Reporting group description
    		 VELCADE (bortezomib) twice weekly for 4 cycles (4 doses per cycle), prior to high-dose chemotherapy (HDT) and stem cell transplantation(SCT). Subjects will receive VELCADE 1.3 mg/m^2 as an intravenous (i.v.) bolus injection on Days 1, 4, 8, and 11, followed by a 10 day rest period (Days 12 to 21). Dexamethasone 40 mg/day given by mouth on Days 1-4 and Days 9-12 in each of 4 cycles. Thalidomide given by mouth every day, starting on Day 1 of Cycle 1 (e.g. the same day of the first dose of VELCADE) and continuing until Day 21 of Cycle 4 at a dose of 100 mg/day (bedtime).

    Reporting group values
    		 Four Drug Regimen (VDTC) Three Drug Regimen (VDT): Bortezomib, Dexamethasone, and Thali Total
    Number of subjects
    		 49 49 98
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 44 46 90
        From 65 to 84 years
    		 5 3 8
        85 years and over
    		 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 55.8 ( 8.27 ) 55.1 ( 7.04 ) -
    Title for Gender
    Units: subjects
        Female
    		 24 23 47
        Male
    		 25 26 51

    End points

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    End points reporting groups
    Reporting group title
    Four Drug Regimen (VDTC)
    Reporting group description
    		 Treatment Group B (VDTC) - Cyclophosphamide 400 mg/m2 IV on Days 1 and 8 in addition to the therapies described for Treatment Group A.

    Reporting group title
    Three Drug Regimen (VDT): Bortezomib, Dexamethasone, and Thali
    Reporting group description
    		 VELCADE (bortezomib) twice weekly for 4 cycles (4 doses per cycle), prior to high-dose chemotherapy (HDT) and stem cell transplantation(SCT). Subjects will receive VELCADE 1.3 mg/m^2 as an intravenous (i.v.) bolus injection on Days 1, 4, 8, and 11, followed by a 10 day rest period (Days 12 to 21). Dexamethasone 40 mg/day given by mouth on Days 1-4 and Days 9-12 in each of 4 cycles. Thalidomide given by mouth every day, starting on Day 1 of Cycle 1 (e.g. the same day of the first dose of VELCADE) and continuing until Day 21 of Cycle 4 at a dose of 100 mg/day (bedtime).

    Primary: Percentage of Particpants Achieving Overall Combined Complete Response (CR) Following Induction

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    End point title
    		 Percentage of Particpants Achieving Overall Combined Complete Response (CR) Following Induction
    End point description
    Percent of Particpants Achieving Overall combined complete response (CR w/normalized serum kappa: lambda ratio + CR + near complete response [nCR]) following induction therapy: CR criteria: negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and less tha <5 percent (%) plasma cells in bone marrow; kappa: lambda ratio: normal free light chain (FLC) ratio; nCR criteria: positive immunofixation analysis of serum or urine as the only evidence of disease; disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow.
    End point type
    Primary
    End point timeframe
    Cycle 1 up to Cycle 4/8 up to End-of-Induction Treatment Visit/ End-of–Extension Treatment Visit (30 days after the last dose of study drugs )
    End point values
    		 Four Drug Regimen (VDTC) Three Drug Regimen (VDT): Bortezomib, Dexamethasone, and Thali
    Number of subjects analysed
    49
    48
    Units: percentage of participants
        number (confidence interval 95%)
    43.75 (29.5 to 58.8)
    51.02 (36.3 to 65.6)
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    Four Drug Regimen (VDTC) v Three Drug Regimen (VDT): Bortezomib, Dexamethasone, and Thali
    Number of subjects included in analysis
    97
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.5056
    Method
    		 Stratified Log rank test
    Confidence interval

    Secondary: Percentage of Participants Achieving Overall Combined Complete Response (CR) Following High-dose Chemotherapy (HDT)/Stem Cell Transplantation (SCT)

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    End point title
    		 Percentage of Participants Achieving Overall Combined Complete Response (CR) Following High-dose Chemotherapy (HDT)/Stem Cell Transplantation (SCT)
    End point description
    Percent of Participants Achieving Overall Combined Complete Response (CR) (CR w/normalized serum kappa: lambda ratio + CR + Near Complete Response [nCR]) following stem cell transplantation. CR criteria: negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow. kappa:lambda ratio: normal free light chain (FLC) ratio. nCR criteria: positive immunofixation analysis of serum or urine as the only evidence of disease; disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow.
    End point type
    Secondary
    End point timeframe
    Cycle 1 up to Cycle 4/8 up to End-of-Induction Treatment Visit/ End-of–Extension Treatment Visit (30 days after the last dose of study drugs )
    End point values
    		 Four Drug Regimen (VDTC) Three Drug Regimen (VDT): Bortezomib, Dexamethasone, and Thali
    Number of subjects analysed
    38
    27
    Units: Percentage of Participants
        number (confidence interval 95%)
    77.78 (57.7 to 91.4)
    76.32 (59.8 to 88.6)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose to 30 days post last dose
    Adverse event reporting additional description
    Treatment emergent
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.1
    Reporting groups
    Reporting group title
    VDTC (Treatment Group B)
    Reporting group description
    		 Treatment Group B (VDTC) - Cyclophosphamide 400 mg/m2 IV on Days 1 and 8 in addition to the therapies described for Treatment Group A.

    Reporting group title
    VDT (Treatment Group A)
    Reporting group description
    		 Treatment Group A (VDT) - VELCADE 1.3 mg/m2 intravenously (IV) on Days 1, 4, 8, and 11, Dexamethasone 40 mg orally on Days 1 to 4 and Days 9 to 12, and Thalidomide 100 mg orally every day beginning on Day 1 of Cycle 1 until Day 21 of Cycle 4.

    Serious adverse events
    		 VDTC (Treatment Group B) VDT (Treatment Group A)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    20 / 49 (40.82%)
    11 / 49 (22.45%)
         number of deaths (all causes)
    2
    2
         number of deaths resulting from adverse events
    1
    0
    Vascular disorders
    Thrombosis
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Acute Phase Reaction
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest Pain
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    2 / 49 (4.08%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised Oedema
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema Peripheral
         subjects affected / exposed
    1 / 49 (2.04%)
    2 / 49 (4.08%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 49 (2.04%)
    2 / 49 (4.08%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Disorder
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Infiltration
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural Effusion
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Panic Attack
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femoral Neck Fracture
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pubic Rami Fracture
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Fracture
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina Pectoris
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial Fibrillation
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-Respiratory Arrest
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Nervous system disorders
    Autonomic Neuropathy
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathy Peripheral
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Sensory Neuropathy
         subjects affected / exposed
    0 / 49 (0.00%)
    2 / 49 (4.08%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 49 (4.08%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    2 / 49 (4.08%)
    2 / 49 (4.08%)
         occurrences causally related to treatment / all
    1 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faecal Vomiting
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Toxic Skin Eruption
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urinary Incontinence
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back Pain
         subjects affected / exposed
    3 / 49 (6.12%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 6
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone Pain
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal Pain
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neck Pain
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in Extremity
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchopneumonia
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium Difficile Colitis
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopulmonary Aspergillosis
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia Sepsis
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fungal Sepsis
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes Zoster
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 49 (4.08%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Fluid Retention
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 49 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 49 (2.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 VDTC (Treatment Group B) VDT (Treatment Group A)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    44 / 49 (89.80%)
    48 / 49 (97.96%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    6 / 49 (12.24%)
    3 / 49 (6.12%)
         occurrences all number
    6
    3
    Hypotension
         subjects affected / exposed
    4 / 49 (8.16%)
    1 / 49 (2.04%)
         occurrences all number
    5
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    7 / 49 (14.29%)
    10 / 49 (20.41%)
         occurrences all number
    8
    15
    Face Oedema
         subjects affected / exposed
    0 / 49 (0.00%)
    3 / 49 (6.12%)
         occurrences all number
    0
    3
    Fatigue
         subjects affected / exposed
    10 / 49 (20.41%)
    5 / 49 (10.20%)
         occurrences all number
    27
    8
    Oedema
         subjects affected / exposed
    6 / 49 (12.24%)
    4 / 49 (8.16%)
         occurrences all number
    7
    5
    Oedema Peripheral
         subjects affected / exposed
    17 / 49 (34.69%)
    16 / 49 (32.65%)
         occurrences all number
    25
    20
    Pyrexia
         subjects affected / exposed
    12 / 49 (24.49%)
    6 / 49 (12.24%)
         occurrences all number
    15
    8
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    3 / 49 (6.12%)
    4 / 49 (8.16%)
         occurrences all number
    3
    4
    Dyspnoea
         subjects affected / exposed
    2 / 49 (4.08%)
    3 / 49 (6.12%)
         occurrences all number
    2
    3
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    3 / 49 (6.12%)
    5 / 49 (10.20%)
         occurrences all number
    3
    8
    Anxiety
         subjects affected / exposed
    0 / 49 (0.00%)
    5 / 49 (10.20%)
         occurrences all number
    0
    5
    Investigations
    Weight Increased
         subjects affected / exposed
    3 / 49 (6.12%)
    2 / 49 (4.08%)
         occurrences all number
    4
    2
    Nervous system disorders
    Dysgeusia
         subjects affected / exposed
    3 / 49 (6.12%)
    1 / 49 (2.04%)
         occurrences all number
    4
    1
    Paraesthesia
         subjects affected / exposed
    11 / 49 (22.45%)
    11 / 49 (22.45%)
         occurrences all number
    15
    16
    Neuropathy Peripheral
         subjects affected / exposed
    0 / 49 (0.00%)
    4 / 49 (8.16%)
         occurrences all number
    0
    5
    Peripheral Motor Neuropathy
         subjects affected / exposed
    3 / 49 (6.12%)
    3 / 49 (6.12%)
         occurrences all number
    10
    4
    Somnolence
         subjects affected / exposed
    0 / 49 (0.00%)
    4 / 49 (8.16%)
         occurrences all number
    0
    4
    Peripheral Sensory Neuropathy
         subjects affected / exposed
    12 / 49 (24.49%)
    11 / 49 (22.45%)
         occurrences all number
    16
    19
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    17 / 49 (34.69%)
    7 / 49 (14.29%)
         occurrences all number
    37
    16
    Leukopenia
         subjects affected / exposed
    4 / 49 (8.16%)
    0 / 49 (0.00%)
         occurrences all number
    11
    0
    Lymphopenia
         subjects affected / exposed
    5 / 49 (10.20%)
    7 / 49 (14.29%)
         occurrences all number
    25
    16
    Neutropenia
         subjects affected / exposed
    8 / 49 (16.33%)
    7 / 49 (14.29%)
         occurrences all number
    17
    8
    Thrombocytopenia
         subjects affected / exposed
    7 / 49 (14.29%)
    4 / 49 (8.16%)
         occurrences all number
    14
    8
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    3 / 49 (6.12%)
    2 / 49 (4.08%)
         occurrences all number
    4
    2
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    3 / 49 (6.12%)
    2 / 49 (4.08%)
         occurrences all number
    4
    2
    Vision Blurred
         subjects affected / exposed
    3 / 49 (6.12%)
    1 / 49 (2.04%)
         occurrences all number
    3
    1
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    0 / 49 (0.00%)
    3 / 49 (6.12%)
         occurrences all number
    0
    5
    Constipation
         subjects affected / exposed
    24 / 49 (48.98%)
    27 / 49 (55.10%)
         occurrences all number
    30
    34
    Abdominal Pain Upper
         subjects affected / exposed
    2 / 49 (4.08%)
    4 / 49 (8.16%)
         occurrences all number
    2
    4
    Diarrhoea
         subjects affected / exposed
    8 / 49 (16.33%)
    4 / 49 (8.16%)
         occurrences all number
    12
    5
    Nausea
         subjects affected / exposed
    9 / 49 (18.37%)
    5 / 49 (10.20%)
         occurrences all number
    16
    8
    Dyspepsia
         subjects affected / exposed
    3 / 49 (6.12%)
    3 / 49 (6.12%)
         occurrences all number
    3
    4
    Stomatitis
         subjects affected / exposed
    4 / 49 (8.16%)
    1 / 49 (2.04%)
         occurrences all number
    4
    1
    Vomiting
         subjects affected / exposed
    4 / 49 (8.16%)
    2 / 49 (4.08%)
         occurrences all number
    6
    2
    Hepatobiliary disorders
    Hepatic Function Abnormal
         subjects affected / exposed
    2 / 49 (4.08%)
    5 / 49 (10.20%)
         occurrences all number
    2
    9
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    3 / 49 (6.12%)
    9 / 49 (18.37%)
         occurrences all number
    5
    12
    Musculoskeletal and connective tissue disorders
    Bone Pain
         subjects affected / exposed
    6 / 49 (12.24%)
    4 / 49 (8.16%)
         occurrences all number
    7
    4
    Back Pain
         subjects affected / exposed
    2 / 49 (4.08%)
    4 / 49 (8.16%)
         occurrences all number
    2
    4
    Pain in Extremity
         subjects affected / exposed
    5 / 49 (10.20%)
    4 / 49 (8.16%)
         occurrences all number
    5
    4
    Muscle Spasms
         subjects affected / exposed
    1 / 49 (2.04%)
    3 / 49 (6.12%)
         occurrences all number
    1
    5
    Infections and infestations
    Oral Candidiasis
         subjects affected / exposed
    0 / 49 (0.00%)
    3 / 49 (6.12%)
         occurrences all number
    0
    3
    Nasopharyngitis
         subjects affected / exposed
    3 / 49 (6.12%)
    3 / 49 (6.12%)
         occurrences all number
    5
    4
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    6 / 49 (12.24%)
    3 / 49 (6.12%)
         occurrences all number
    8
    3
    Enzyme Abnormality
         subjects affected / exposed
    3 / 49 (6.12%)
    5 / 49 (10.20%)
         occurrences all number
    9
    15
    Hyperglycaemia
         subjects affected / exposed
    2 / 49 (4.08%)
    5 / 49 (10.20%)
         occurrences all number
    18
    27
    Hyperuricaemia
         subjects affected / exposed
    0 / 49 (0.00%)
    4 / 49 (8.16%)
         occurrences all number
    0
    4
    Hypoalbuminaemia
         subjects affected / exposed
    3 / 49 (6.12%)
    1 / 49 (2.04%)
         occurrences all number
    6
    1
    Hypocalcaemia
         subjects affected / exposed
    6 / 49 (12.24%)
    1 / 49 (2.04%)
         occurrences all number
    13
    1
    Hyponatraemia
         subjects affected / exposed
    3 / 49 (6.12%)
    2 / 49 (4.08%)
         occurrences all number
    7
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Jun 2010
    The overall reason for the amendment was : Tto stop central testing of efficacy assessments, but continue to collect data related to time to progression and other efficacy parameters as routinely done by the investigator.

    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
    For support, Contact us.
    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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