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    Clinical Trial Results:
    A randomized phase III study on the effect of Bortezomib combined with Adriamycin, Dexamethasone (AD) for induction treatment, followed by High Dose Melphalan and Bortezomib alone during maintenance in patients with multiple myeloma

    Summary
    EudraCT number
    		 2004-000944-26
    Trial protocol
    		 BE  
    Global end of trial date
    30 Apr 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Apr 2023
    First version publication date
    12 Apr 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HOVON 65 MM / GMMG-HD4
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    HOVON
    Sponsor organisation address
    De Boelelaan 1117, Amsterdam, Netherlands,
    Public contact
    HOVON Data Center, HOVON, hdc@erasmusmc.nl
    Scientific contact
    HOVON Data Center, HOVON, hdc@erasmusmc.nl
    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 Apr 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Mar 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Apr 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of Bortezomib combined with intensive chemotherapy and in maintenance therapy in comparison with intensive therapy with Vincristine followed by thalidomide maintenance in patients with previously untreated multiple myeloma, as measured by the progression free survival as defined in chapter 14
    Protection of trial subjects
    Monitoring and Insurance.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Apr 2005
    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
    Belgium: 6
    Country: Number of subjects enrolled
    Germany: 399
    Country: Number of subjects enrolled
    Netherlands: 428
    Worldwide total number of subjects
    833
    EEA total number of subjects
    833
    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)
    803
    From 65 to 84 years
    30
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 All subjects gave written informed consent and were screened according to the inclusion- and exclusion criteria.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm1
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Vincristine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.4mg, al cycles, day 1-4

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    40mg at day 1,2,3,4,9,10,11,12,17,18,19,20 all cycles.

    Investigational medicinal product name
    Doxorubicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    9mg/m2, al cycles, day 1-4.

    Investigational medicinal product name
    Filgrastim
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    10 μg/kg (divided in 2 gifts daily, according to local rules), s.c., day 5 until last pheresis.

    Investigational medicinal product name
    Thalidomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50mg per day.

    Investigational medicinal product name
    Melphalan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    100mg/m2 cycle 1 (day -3,-2), 200mg/m2 cycle 2 (day -3,-2).

    Arm title
    		 Arm2
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dexamethasone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    40mg at day 1,2,3,4,9,10,11,12,17,18,19,20 all cycles.

    Investigational medicinal product name
    Doxorubicin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    9mg/m2, al cycles, day 1-4.

    Investigational medicinal product name
    Melphalan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    100mg/m2 cycle 1 (day -3,-2), 200mg/m2 cycle 2 (day -3,-2).

    Investigational medicinal product name
    Bortezomib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    1,3mg/m2 for 3 cycles, days 1,4, 8, 11. Maintenance is 1,3 mg/m2 every 2 weeks.

    Number of subjects in period 1
    		Arm1 Arm2
    Started
    416
    417
    Completed
    77
    115
    Not completed
    339
    302
         Adverse reactions
    111
    104
         Other
    110
    102
         Lack of efficacy
    118
    96

    Baseline characteristics

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

    Reporting group values
    		 Overall period Total
    Number of subjects
    		 833 833
    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)
    		 803 803
        From 65-84 years
    		 30 30
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 57 (25 to 65) -
    Gender categorical
    Units: Subjects
        Female
    		 328 328
        Male
    		 505 505

    End points

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    End points reporting groups
    Reporting group title
    Arm1
    Reporting group description
    		 -

    Reporting group title
    Arm2
    Reporting group description
    		 -

    Primary: Primary endpoint

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    End point title
    		 Primary endpoint [1]
    End point description
    End point type
    Primary
    End point timeframe
    See publication.
    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: See attached chart/documents for results.
    End point values
    		 Arm1 Arm2
    Number of subjects analysed
    414
    413
    Units: Whole
    414
    413
    Attachments
    		 Statistical data section from publication
    List of reported non-SAE's
    List of reported SAE's
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All AEs, with the exception of progression of multiple myeloma, will be reported from the first study-related procedure until 30 days following the last dose of study drug or until the start of subsequent systemic antimyeloma therapy, if earlier.
    Adverse event reporting additional description
    Adverse events occurring after 30 days should also be reported if considered related to study drug. All Grade 3 or 4 adverse events considered related to study drug must be followed until recovery to Grade 0 or 1. Neuropathic and cardiac adverse events of Grade 2 or higher will be followed until improvement to Grade 0 or 1.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 CTCAE
    Dictionary version
    3
    Reporting groups
    Reporting group title
    Arm1
    Reporting group description
    		 -

    Reporting group title
    Arm2
    Reporting group description
    		 -

    Serious adverse events
    		 Arm1 Arm2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    242 / 413 (58.60%)
    290 / 412 (70.39%)
         number of deaths (all causes)
    263
    246
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Neoplasm benign, malignant and unspecif. (inc. cysts/polyp)
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    9 / 413 (2.18%)
    5 / 412 (1.21%)
         occurrences causally related to treatment / all
    4 / 10
    1 / 5
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Vascular disorders
    Vasa praeviacular disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    34 / 413 (8.23%)
    36 / 412 (8.74%)
         occurrences causally related to treatment / all
    17 / 37
    21 / 38
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Surgical and medical procedures
    Surgical and medical procedures
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    6 / 413 (1.45%)
    4 / 412 (0.97%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    General disorders and administration site conditions
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    39 / 413 (9.44%)
    56 / 412 (13.59%)
         occurrences causally related to treatment / all
    35 / 48
    53 / 68
         deaths causally related to treatment / all
    0 / 0
    2 / 3
    Unknown
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    20 / 413 (4.84%)
    26 / 412 (6.31%)
         occurrences causally related to treatment / all
    12 / 20
    17 / 27
         deaths causally related to treatment / all
    0 / 1
    4 / 4
    Immune system disorders
    Immune system disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    1 / 413 (0.24%)
    3 / 412 (0.73%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Reproductive system and breast disorders
    Reproductive system and breast disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    1 / 413 (0.24%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory, thoracic and mediastinal disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    25 / 413 (6.05%)
    29 / 412 (7.04%)
         occurrences causally related to treatment / all
    13 / 25
    18 / 34
         deaths causally related to treatment / all
    1 / 2
    1 / 3
    Psychiatric disorders
    Psychiatric disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    6 / 413 (1.45%)
    6 / 412 (1.46%)
         occurrences causally related to treatment / all
    5 / 6
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Investigations
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    6 / 413 (1.45%)
    1 / 412 (0.24%)
         occurrences causally related to treatment / all
    5 / 6
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Injury, Poisoning and procedural complications
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    10 / 413 (2.42%)
    17 / 412 (4.13%)
         occurrences causally related to treatment / all
    0 / 10
    2 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    22 / 413 (5.33%)
    21 / 412 (5.10%)
         occurrences causally related to treatment / all
    11 / 25
    14 / 22
         deaths causally related to treatment / all
    1 / 1
    4 / 5
    Nervous system disorders
    Nervous system disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    23 / 413 (5.57%)
    74 / 412 (17.96%)
         occurrences causally related to treatment / all
    13 / 25
    90 / 98
         deaths causally related to treatment / all
    1 / 3
    0 / 0
    Blood and lymphatic system disorders
    Blood and lymphatic system disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    13 / 413 (3.15%)
    16 / 412 (3.88%)
         occurrences causally related to treatment / all
    10 / 13
    14 / 16
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Eye disorders
    Eye disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    1 / 413 (0.24%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    28 / 413 (6.78%)
    57 / 412 (13.83%)
         occurrences causally related to treatment / all
    21 / 34
    48 / 68
         deaths causally related to treatment / all
    3 / 3
    3 / 3
    Hepatobiliary disorders
    Hepatobiliary disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    4 / 413 (0.97%)
    5 / 412 (1.21%)
         occurrences causally related to treatment / all
    3 / 4
    2 / 5
         deaths causally related to treatment / all
    1 / 2
    0 / 1
    Skin and subcutaneous tissue disorders
    Skin and subcutaneous tissue disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    3 / 413 (0.73%)
    3 / 412 (0.73%)
         occurrences causally related to treatment / all
    3 / 3
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal and urinary disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    19 / 413 (4.60%)
    8 / 412 (1.94%)
         occurrences causally related to treatment / all
    5 / 20
    4 / 9
         deaths causally related to treatment / all
    1 / 1
    0 / 1
    Endocrine disorders
    Endocrine disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    3 / 413 (0.73%)
    0 / 412 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal and connective tissue disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    20 / 413 (4.84%)
    16 / 412 (3.88%)
         occurrences causally related to treatment / all
    1 / 22
    6 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Infections and infestations
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    117 / 413 (28.33%)
    120 / 412 (29.13%)
         occurrences causally related to treatment / all
    99 / 149
    112 / 142
         deaths causally related to treatment / all
    9 / 12
    9 / 13
    Metabolism and nutrition disorders
    Metabolism and nutrition disorders
    Additional description: All combined, see SAE chart for details.
         subjects affected / exposed
    15 / 413 (3.63%)
    11 / 412 (2.67%)
         occurrences causally related to treatment / all
    11 / 17
    8 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Arm1 Arm2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    408 / 413 (98.79%)
    408 / 412 (99.03%)
    Vascular disorders
    Vascular
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    51 / 413 (12.35%)
    58 / 412 (14.08%)
         occurrences all number
    62
    66
    Surgical and medical procedures
    Surgery/intra-operative injury
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    11 / 413 (2.66%)
    6 / 412 (1.46%)
         occurrences all number
    12
    8
    General disorders and administration site conditions
    Coagulation
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    81 / 413 (19.61%)
    73 / 412 (17.72%)
         occurrences all number
    245
    220
    Constitutional symptoms
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    326 / 413 (78.93%)
    315 / 412 (76.46%)
         occurrences all number
    1137
    1168
    Growth/development
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    1 / 413 (0.24%)
    2 / 412 (0.49%)
         occurrences all number
    1
    2
    Other
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    45 / 413 (10.90%)
    36 / 412 (8.74%)
         occurrences all number
    49
    46
    Pain
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    271 / 413 (65.62%)
    274 / 412 (66.50%)
         occurrences all number
    800
    781
    Secondary malignancy
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    1 / 413 (0.24%)
    1 / 412 (0.24%)
         occurrences all number
    1
    1
    Syndromes
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    21 / 413 (5.08%)
    31 / 412 (7.52%)
         occurrences all number
    26
    47
    Immune system disorders
    Allergy/immunology
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    67 / 413 (16.22%)
    51 / 412 (12.38%)
         occurrences all number
    88
    60
    Reproductive system and breast disorders
    Sexual/reproductive
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    16 / 413 (3.87%)
    20 / 412 (4.85%)
         occurrences all number
    18
    22
    Respiratory, thoracic and mediastinal disorders
    Pulmonary/upper respiratory
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    176 / 413 (42.62%)
    182 / 412 (44.17%)
         occurrences all number
    304
    327
    Cardiac disorders
    Cardiac arrhythmia
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    91 / 413 (22.03%)
    79 / 412 (19.17%)
         occurrences all number
    119
    134
    Cardiac general
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    139 / 413 (33.66%)
    157 / 412 (38.11%)
         occurrences all number
    276
    276
    Nervous system disorders
    Neurology
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    314 / 413 (76.03%)
    314 / 412 (76.21%)
         occurrences all number
    972
    917
    Blood and lymphatic system disorders
    Blood/bone marrow
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    319 / 413 (77.24%)
    325 / 412 (78.88%)
         occurrences all number
    2599
    3204
    Hemorrhage/bleeding
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    89 / 413 (21.55%)
    72 / 412 (17.48%)
         occurrences all number
    125
    99
    Lymphatics
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    110 / 413 (26.63%)
    127 / 412 (30.83%)
         occurrences all number
    181
    194
    Ear and labyrinth disorders
    Auditory/ear
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    30 / 413 (7.26%)
    27 / 412 (6.55%)
         occurrences all number
    33
    30
    Eye disorders
    Ocular/visual
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    61 / 413 (14.77%)
    73 / 412 (17.72%)
         occurrences all number
    83
    100
    Gastrointestinal disorders
    GI
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    377 / 413 (91.28%)
    379 / 412 (91.99%)
         occurrences all number
    2403
    2557
    Hepatobiliary disorders
    Hepatobiliary/pancreas
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    18 / 413 (4.36%)
    19 / 412 (4.61%)
         occurrences all number
    24
    23
    Skin and subcutaneous tissue disorders
    Dermatology/skin
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    256 / 413 (61.99%)
    265 / 412 (64.32%)
         occurrences all number
    567
    554
    Renal and urinary disorders
    Renal/genitourinary
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    76 / 413 (18.40%)
    61 / 412 (14.81%)
         occurrences all number
    98
    75
    Endocrine disorders
    Endocrine
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    49 / 413 (11.86%)
    51 / 412 (12.38%)
         occurrences all number
    64
    69
    Musculoskeletal and connective tissue disorders
    Musculoskeletal/soft tissue
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    149 / 413 (36.08%)
    127 / 412 (30.83%)
         occurrences all number
    258
    226
    Metabolism and nutrition disorders
    Metabolic/laboratory
    Additional description: All combined, see non-SAE chart for details.
         subjects affected / exposed
    307 / 413 (74.33%)
    303 / 412 (73.54%)
         occurrences all number
    4246
    4582

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Feb 2005
    Overall updates in the protocol.
    25 Mar 2005
    Overall updates in the protocol.
    15 Feb 2006
    Some errors in the protocol and patient information have been corrected.
    16 Nov 2007
    Overall updates in the protocol.
    29 Aug 2008
    Safety information for Bortezomib updated according to updated Investigator Drug Brochure (version 11). Administrative correction (new phone + fax numbers ErasmusMC and new contact address GMMG). Addition of mandatory serum M- and urine M-protein value at registration (to comply with already updated and implemented CRF of 9 July 2007).

    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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