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    Clinical Trial Results:
    A phase 3, prospective, randomized clinical study with Velcade-Thalidomide- Dexamethasone versus Thalidomide-Dexamethasone for previously untreated patients with symptomatic multiple myeloma who are candidates to receive double autologous transplantation. 26866138-MMY-3006

    Summary
    EudraCT number
    		 2005-003723-39
    Trial protocol
    		 IT  
    Global end of trial date
    02 Mar 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 May 2022
    First version publication date
    08 May 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    123/2005/U/Sper-26866138-MMY-3006
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    IRCCS Azienda Ospedaliero-Universitaria di Bologna
    Sponsor organisation address
    Via Albertoni, 15, Bologna, Italy, 40138
    Public contact
    Prof. Michele Cavo, IRCCS Azienda Ospedaliero-Universitaria di Bologna, +39 051 214 3680, michele.cavo@unibo.it
    Scientific contact
    Prof. Michele Cavo, IRCCS Azienda Ospedaliero-Universitaria di Bologna, +39 051 214 3680, michele.cavo@unibo.it
    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 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Mar 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Mar 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the probability of answer to VELCADE-thalidomide-dexamethasone (the group of A treatment) or thalidomide-dexamethasone (group of B treatment) like primary therapy of induction of the answer.
    Protection of trial subjects
    Written informed consent
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Apr 2006
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 10 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Italy: 480
    Worldwide total number of subjects
    480
    EEA total number of subjects
    480
    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)
    480
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between May 10, 2006, and April 30, 2008, 480 patients, aged 18–65 years with previously untreated symptomatic multiple myeloma and a Karnofsky Performance Status of 60% or higher were enrolled at 73 centres in Italy.

    Pre-assignment
    Screening details
    		 Key inclusion criteria were aged 18–65 years, previously untreated symptomatic and measurable multiple myeloma, Karnofsky Performance Status of 60% or higher, and adequate haematological, renal, cardiac, and hepatic functions.

    Pre-assignment period milestones
    Number of subjects started
    		 480
    Number of subjects completed
    		 474

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Consent withdrawn by subject: 6
    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment with VTD
    Arm description
    		 1) VELCADE-THALIDOMIDE-DEXAMETHASONE induction (3 21-day cycles); 2) mobilization with CYCLOPHOSPHAMIDE; 3) double autologous HSCT; 4) VELCADE-THALIDOMIDE-DEXAMETHASONE consolidation (2 35-day cycles); 5) DEXAMETHASONE maintenance until disease progression or intolerance.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BORTEZOMIB
    Investigational medicinal product code
    ATC CODE: L01XG01
    Other name
    VELCADE
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1.3mg/m2 on days 1-4-8-11 (induction phase, 3 21-day cyles) 1.3mg/m2 on days 1-8-15-22 (consolidation phase, 2 35-day cyles, 3 months after second autologous HSCT)

    Investigational medicinal product name
    THALIDOMIDE
    Investigational medicinal product code
    ATC CODE: L04AX02
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    100mg/die (first 14 days), then 200mg/die thereafter (induction phase, 3 21-day cyles) 100-200mg/die (bridging therapy from induction to second autologous HSCT) 100mg/die (consolidation phase, 2 35-day cyles, 3 months after second autologous HSCT)

    Investigational medicinal product name
    DEXAMETHASONE
    Investigational medicinal product code
    ATC CODE: S01BA01
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    40mg/die on days 1-2, 4-5, 8-9 and 11-12 (total dose 320mg/cycle, induction phase, 3 21-day cycles) 40mg/die on days 1-4 (total dose 320mg/cycle, maintenance phase, 2 35-day cycles) 40mg/die on days 1-4 (total dose 320mg/cycle, maintenance phase, 28-day cycles until disease progression or intolerance)

    Arm title
    		 Treatment with TD
    Arm description
    		 - THALIDOMIDE-DEXAMETHASONE induction (3 21-day cycles); - mobilization with CYCLOPHOSPHAMIDE; double autologous HSCT; - THALIDOMIDE-DEXAMETHASONE consolidation (2 35-day cycles); - DEXAMETHASONE maintenance until disease progression or intolerance.
    Arm type
    		 Experimental

    Investigational medicinal product name
    THALIDOMIDE
    Investigational medicinal product code
    ATC CODE: L04AX02
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    100mg/die (first 14 days), then 200mg/die thereafter (induction phase, 3 21-day cyles) 100-200mg/die (bridging therapy from induction to second autologous HSCT) 100mg/die (consolidation phase, 2 35-day cyles, 3 months after second autologous HSCT)

    Investigational medicinal product name
    DEXAMETHASONE
    Investigational medicinal product code
    ATC CODE: S01BA01
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    40mg/die on days 1-2, 4-5, 8-9 and 11-12 (total dose 320mg/cycle, induction phase, 3 21-day cycles) 40mg/die on days 1-4 (total dose 320mg/cycle, maintenance phase, 2 35-day cycles) 40mg/die on days 1-4 (total dose 320mg/cycle, maintenance phase, 28-day cycles until disease progression or intolerance)

    Number of subjects in period 1 [1]
    		Treatment with VTD Treatment with TD
    Started
    236
    238
    Completed
    163
    168
    Not completed
    73
    70
         Adverse event, serious fatal
    4
    5
         Melanoma
    1
    -
         Consent withdrawn by subject
    11
    8
         Physician decision
    2
    4
         Adverse event, non-fatal
    34
    22
         Allogeneic stem-cell transplantation
    8
    7
         Lost to follow-up
    3
    1
         Lack of efficacy
    10
    23
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Between May 10, 2006, and April 30, 2008, 480 patients were enrolled and randomly assigned to receive VTD (241 patients) or TD (239 patients). Six patients withdrew consent before start of treatment. 236 patients in the VTD group and 238 patients in the TD group were included in the intention-to-treat analysis.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment with VTD
    Reporting group description
    		 1) VELCADE-THALIDOMIDE-DEXAMETHASONE induction (3 21-day cycles); 2) mobilization with CYCLOPHOSPHAMIDE; 3) double autologous HSCT; 4) VELCADE-THALIDOMIDE-DEXAMETHASONE consolidation (2 35-day cycles); 5) DEXAMETHASONE maintenance until disease progression or intolerance.

    Reporting group title
    Treatment with TD
    Reporting group description
    		 - THALIDOMIDE-DEXAMETHASONE induction (3 21-day cycles); - mobilization with CYCLOPHOSPHAMIDE; double autologous HSCT; - THALIDOMIDE-DEXAMETHASONE consolidation (2 35-day cycles); - DEXAMETHASONE maintenance until disease progression or intolerance.

    Reporting group values
    		 Treatment with VTD Treatment with TD Total
    Number of subjects
    		 236 238 474
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 236 238 474
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 56.3 ± 6.9 55.9 ± 7.4 -
    Gender categorical
    Units: Subjects
        Female
    		 99 102 201
        Male
    		 137 136 273
    Myeloma subtype
    Secernent/non secernent MM
    Units: Subjects
        IgA
    		 41 54 95
        IgG
    		 154 147 301
        Light chain
    		 40 34 74
        Other
    		 1 3 4
    ISS stage (International Staging System)
    ISS 1-2-3
    Units: Subjects
        Category title 1
    		 107 107 214
        Category title 2
    		 91 92 183
        Category title 3
    		 38 39 77
    Cytogenetic abnormalities at baseline
    FISH analysis for Cytogenetic abnormalities
    Units: Subjects
        del(13), del(17) and t(4;14) NEGATIVE
    		 101 108 209
        del(13) POSITIVE; del(17) and t(4;14) NEGATIVE
    		 66 59 125
        del(13) and t(4;14) POSITIVE; del(17) NEGATIVE
    		 26 30 56
        del(13) and del(17) NEGATIVE; t(4;14) POSITIVE
    		 14 10 24
        del(13) and del(17) POSITIVE; t(4;14) NEGATIVE
    		 11 10 21
        del(13), del(17) and t(4;14) POSITIVE
    		 3 5 8
        del(17) POSITIVE; del(13) and t(4;14) NEGATIVE
    		 2 1 3
        del(17) and t(4;14) POSITIVE; del(13) NEGATIVE
    		 0 1 1
        Not evaluable
    		 13 14 27
    Subject analysis sets

    Subject analysis set title
    Final analysis
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Randomly assigned patients who effectively started therapy.

    Subject analysis sets values
    		 Final analysis
    Number of subjects
    474
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    474
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ±
    Gender categorical
    Units: Subjects
        Female
    201
        Male
    273
    Myeloma subtype
    Secernent/non secernent MM
    Units: Subjects
        IgA
    95
        IgG
    301
        Light chain
    74
        Other
    1
    ISS stage (International Staging System)
    ISS 1-2-3
    Units: Subjects
        Category title 1
    214
        Category title 2
    183
        Category title 3
    77
    Cytogenetic abnormalities at baseline
    FISH analysis for Cytogenetic abnormalities
    Units: Subjects
        del(13), del(17) and t(4;14) NEGATIVE
    209
        del(13) POSITIVE; del(17) and t(4;14) NEGATIVE
    125
        del(13) and t(4;14) POSITIVE; del(17) NEGATIVE
    56
        del(13) and del(17) NEGATIVE; t(4;14) POSITIVE
    24
        del(13) and del(17) POSITIVE; t(4;14) NEGATIVE
    21
        del(13), del(17) and t(4;14) POSITIVE
    8
        del(17) POSITIVE; del(13) and t(4;14) NEGATIVE
    3
        del(17) and t(4;14) POSITIVE; del(13) NEGATIVE
    1
        Not evaluable
    27

    End points

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    End points reporting groups
    Reporting group title
    Treatment with VTD
    Reporting group description
    		 1) VELCADE-THALIDOMIDE-DEXAMETHASONE induction (3 21-day cycles); 2) mobilization with CYCLOPHOSPHAMIDE; 3) double autologous HSCT; 4) VELCADE-THALIDOMIDE-DEXAMETHASONE consolidation (2 35-day cycles); 5) DEXAMETHASONE maintenance until disease progression or intolerance.

    Reporting group title
    Treatment with TD
    Reporting group description
    		 - THALIDOMIDE-DEXAMETHASONE induction (3 21-day cycles); - mobilization with CYCLOPHOSPHAMIDE; double autologous HSCT; - THALIDOMIDE-DEXAMETHASONE consolidation (2 35-day cycles); - DEXAMETHASONE maintenance until disease progression or intolerance.

    Subject analysis set title
    Final analysis
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Randomly assigned patients who effectively started therapy.

    Primary: Rate of CR/nCR to induction therapy

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    End point title
    		 Rate of CR/nCR to induction therapy
    End point description
    Rate of ≥ nCR to primary remission induction therapy with either Vel-Thal-Dex or Thal-Dex, as determined by EBMT/IBMTR criteria (with the addition of a nCR category) and calculated on an intent-to-treat basis.
    End point type
    Primary
    End point timeframe
    Evaluated 28 days after end of induction therapy.
    End point values
    		 Treatment with VTD Treatment with TD
    Number of subjects analysed
    236
    238
    Units: Number
    number (not applicable)
        CR
    44
    11
        >=nCR
    73
    27
    Statistical analysis title
    		 Rate of CR/nCR to induction therapy
    Statistical analysis description
    The trial was designed to detect a significant increase in the complete response and near complete response rate from 15% to 27% upon an induction therapy with TD or VTD (with a statistical power of 80% and an α error of 0.05)
    Comparison groups
    Treatment with VTD v Treatment with TD
    Number of subjects included in analysis
    474
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 ≤ 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Rate of CR/nCR after consolidation therapy

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    End point title
    		 Rate of CR/nCR after consolidation therapy
    End point description
    Rate of  nCR after consolidation therapy with either Vel-Thal-Dex or Thal-Dex, as determined by EBMT/IBMTR criteria (with the addition of a nCR category) and calculated on an intent-to-treat basis.
    End point type
    Secondary
    End point timeframe
    Evaluated 28 days after end of consolidation therapy.
    End point values
    		 Treatment with VTD Treatment with TD
    Number of subjects analysed
    236
    238
    Units: Number
    number (not applicable)
        CR
    116
    82
        >=nCR
    147
    108
    Statistical analysis title
    		 CR/nCR after consolidation therapy analysis
    Statistical analysis description
    The trial was designed to detect a significant increase in the complete response and near complete response rate from 15% to 27% upon an induction therapy with TD or VTD (with a statistical power of 80% and an α error of 0.05)
    Comparison groups
    Treatment with VTD v Treatment with TD
    Number of subjects included in analysis
    474
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 ≤ 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Safety and toxicity

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    End point title
    		 Safety and toxicity
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 30 days after the last dose of treatment
    End point values
    		 Treatment with VTD Treatment with TD
    Number of subjects analysed
    236
    238
    Units: Number of patients
        Peripheral neuropathy grade >=2
    83
    24
        Peripheral neuropathy grade >=3
    35
    6
        any grade 3 or 4 adverse event
    132
    79
        any grade 3 or 4 adverse event (non-hematological)
    120
    73
    Statistical analysis title
    		 Safety and toxicity analysis
    Statistical analysis description
    The trial was designed to detect a significant increase in the complete response and near complete response rate from 15% to 27% upon an induction therapy with TD or VTD (with a statistical power of 80% and an α error of 0.05)
    Comparison groups
    Treatment with VTD v Treatment with TD
    Number of subjects included in analysis
    474
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 ≤ 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: Safety and toxicity

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    End point title
    		 Safety and toxicity
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 30 days after the last dose of treatment
    End point values
    		 Treatment with VTD Treatment with TD
    Number of subjects analysed
    236
    238
    Units: Days
    median (full range (min-max))
        Time of onset of Peripheral neuropathy grade >=2
    83 (41 to 133)
    37.5 (24 to 142.5)
        Time of onset of Peripheral neuropathy grade >=3
    72 (28 to 109)
    37.5 (30 to 72)
    Statistical analysis title
    		 Safety and toxicity analysis
    Statistical analysis description
    The trial was designed to detect a significant increase in the complete response and near complete response rate from 15% to 27% upon an induction therapy with TD or VTD (with a statistical power of 80% and an α error of 0.05)
    Comparison groups
    Treatment with VTD v Treatment with TD
    Number of subjects included in analysis
    474
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 ≤ 0.05
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From start of induction therapy to 30 days after last dose treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    8.0
    Reporting groups
    Reporting group title
    Treatment with VTD
    Reporting group description
    		 1) VELCADE-THALIDOMIDE-DEXAMETHASONE induction (3 21-day cycles); 2) mobilization with CYCLOPHOSPHAMIDE; 3) double autologous HSCT; 4) VELCADE-THALIDOMIDE-DEXAMETHASONE consolidation (2 35-day cycles); 5) DEXAMETHASONE maintenance until disease progression or intolerance.

    Reporting group title
    Treatment with TD
    Reporting group description
    		 - THALIDOMIDE-DEXAMETHASONE induction (3 21-day cycles); - mobilization with CYCLOPHOSPHAMIDE; double autologous HSCT; - THALIDOMIDE-DEXAMETHASONE consolidation (2 35-day cycles); - DEXAMETHASONE maintenance until disease progression or intolerance.

    Serious adverse events
    		 Treatment with VTD Treatment with TD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    34 / 236 (14.41%)
    22 / 238 (9.24%)
         number of deaths (all causes)
    4
    5
         number of deaths resulting from adverse events
    2
    3
    Cardiac disorders
    Cardiac toxicity
    Additional description: Grade ≥3
         subjects affected / exposed
    5 / 236 (2.12%)
    5 / 238 (2.10%)
         occurrences causally related to treatment / all
    1 / 7
    3 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nervous system disorders
    Peripheral neuropathy
    Additional description: Grade ≥3
         subjects affected / exposed
    23 / 236 (9.75%)
    5 / 238 (2.10%)
         occurrences causally related to treatment / all
    48 / 48
    6 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Deep vein thrombosis
    Additional description: Grade ≥3
         subjects affected / exposed
    8 / 236 (3.39%)
    12 / 238 (5.04%)
         occurrences causally related to treatment / all
    6 / 8
    12 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Constipation
    Additional description: Grade ≥3
         subjects affected / exposed
    10 / 236 (4.24%)
    7 / 238 (2.94%)
         occurrences causally related to treatment / all
    14 / 14
    8 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal events (excluding constipation)
         subjects affected / exposed
    5 / 236 (2.12%)
    1 / 238 (0.42%)
         occurrences causally related to treatment / all
    4 / 5
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Liver toxicity
    Additional description: Grade ≥3
         subjects affected / exposed
    4 / 236 (1.69%)
    7 / 238 (2.94%)
         occurrences causally related to treatment / all
    4 / 5
    6 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin rash
    Additional description: Grade ≥3
         subjects affected / exposed
    24 / 236 (10.17%)
    4 / 238 (1.68%)
         occurrences causally related to treatment / all
    19 / 24
    8 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Infections (excluding Herpe Zoster)
    Additional description: Grade ≥3
         subjects affected / exposed
    7 / 236 (2.97%)
    11 / 238 (4.62%)
         occurrences causally related to treatment / all
    3 / 8
    9 / 13
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Treatment with VTD Treatment with TD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    132 / 236 (55.93%)
    79 / 238 (33.19%)
    Nervous system disorders
    Peripheral neuropathy
         subjects affected / exposed
    57 / 236 (24.15%)
    29 / 238 (12.18%)
         occurrences all number
    62
    43
    Blood and lymphatic system disorders
    Oedema
         subjects affected / exposed
    23 / 236 (9.75%)
    11 / 238 (4.62%)
         occurrences all number
    48
    31
    Immune system disorders
    Fever
    Additional description: Grade 1-2
         subjects affected / exposed
    25 / 236 (10.59%)
    21 / 238 (8.82%)
         occurrences all number
    87
    85
    Gastrointestinal disorders
    Constipation
    Additional description: Grade 1-2
         subjects affected / exposed
    89 / 236 (37.71%)
    60 / 238 (25.21%)
         occurrences all number
    169
    103
    Gastrointestinal events (excluding constipation)
         subjects affected / exposed
    41 / 236 (17.37%)
    18 / 238 (7.56%)
         occurrences all number
    46
    26
    Skin and subcutaneous tissue disorders
    Skin rash
    Additional description: Grade 1-2
         subjects affected / exposed
    43 / 236 (18.22%)
    13 / 238 (5.46%)
         occurrences all number
    46
    21
    Infections and infestations
    Infections
         subjects affected / exposed
    17 / 236 (7.20%)
    24 / 238 (10.08%)
         occurrences all number
    41
    38

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Dec 2005
    • A more detailed description of the substudy on prevention of thromboembolic complications. • Modification of some inclusion/exclusion criteria in the substudy. • Inclusion of Thalidomide in the chapter on information on investigational drugs. • Revision of bibliography.
    18 Apr 2006
    • Update of the VELCADE safety section, according to the most recent data provided by the manufacturer (protocol, patient and doctor information form). • Study synopsis: revised and expanded in many sections to allow easier and more correct application of study procedures.

    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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