Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43870   clinical trials with a EudraCT protocol, of which   7289   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A MULTICENTER, OPEN LABEL STUDY OF ORAL REVLIMID AND PREDNISONE (RP) FOLLOWED BY ORAL REVLIMID MELPHALAN AND PREDNISONE (MPR) IN NEWLY DIAGNOSED ELDERLY MULTIPLE MYELOMA PATIENTS

    Summary
    EudraCT number
    		 2007-007616-28
    Trial protocol
    		 IT  
    Global end of trial date
    21 Dec 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Jan 2024
    First version publication date
    12 Jan 2024
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    RV-MM-PI-302
    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
    Clinical trial office, Fondazione EMN Italy Onlus, 0039 0110243236, clinicaltrialoffice@emnitaly.org
    Scientific contact
    Clinical trial office, Fondazione EMN Italy Onlus, 0039 0110243236, clinicaltrialoffice@emnitaly.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
    22 Jun 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Dec 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine whether the association of RP as induction followed by MPR as consolidation treatment is safe and induce a significant rate of PR (and CR) in elderly patients with newly diagnosed multiple myeloma.
    Protection of trial subjects
    The protocol for this study has been designed in accordance with the general ethical principles outlined in the Declaration of Helsinki. The review of this protocol by the IRB/EC and the performance of all aspects of the study, including the methods used for obtaining informed consent, must also be in accordance with principles enunciated in the declaration, as well as ICH Guidelines, Title 21 of the Code of Federal Regulations (CFR), Part 50 Protection of Human Subjects and Part 56 Institutional Review Boards.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Jul 2008
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 2 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Italy: 46
    Worldwide total number of subjects
    46
    EEA total number of subjects
    46
    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
    44
    85 years and over
    2

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 This protocol is a multicenter two-stage phase II, non comparative, open label study, designed according to Bryant and Day method (5). Potential study subjects will sign an informed consent prior to undergoing any study related procedure. This study consists of 3 phases for each study subject: Pre-treatment, Treatment, long-term follow-up

    Pre-assignment
    Screening details
    		 after providing written informed consent, patients will undergo screening for protocol eligibility as outlined in the Schedule of Study Assessments.

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

    Arms
    Arm title
    		 RP-MPR
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lenalidomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Induction Lenalidomide will be given orally at the dose of 25 mg/die for 21 days followed by a 7 days rest period (day 22 to 28) for 4 cycles. Consolidation Lenalidomide will be delivered orally at the dose of 15 mg/die for 21 days followed by a 7 days rest period (day 22 to 28), for 6 cycles. maintenance 10 mg/day from day 1 to 21, followed by a 7-day rest period (days 22 through 28). Each cycle will be repeated every 28 days, until PD.

    Investigational medicinal product name
    Prednisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Induction Prednisone will be given orally at the dose of 50 mg three times a week continuously for a total of 4 months. Consolidation Prednisone will be given orally at the dose of 50 mg three times a week, for 6 months maintenance Prednisone will be given orally at the dose of 25 mg three times a week

    Investigational medicinal product name
    Melphalan
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Consolidation Melphalan will be given orally at the dose of 2 mg three times a week (total dose 24 mg/28 days), for 6 cycles.

    Number of subjects in period 1
    		RP-MPR
    Started
    46
    Completed
    0
    Not completed
    46
         Adverse event, serious fatal
    4
         Adverse event, non-fatal
    20
         Protocol deviation
    1
         Lack of efficacy
    21

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    RP-MPR
    Reporting group description
    		 -

    Reporting group values
    		 RP-MPR Total
    Number of subjects
    		 46 46
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 44 44
        85 years and over
    		 2 2
    Age continuous
    Units: years
        median (full range (min-max))
    		 75 (65 to 88) -
    Gender categorical
    Units: Subjects
        Female
    		 16 16
        Male
    		 30 30
    ISS Stage
    Units: Subjects
        ISS I
    		 6 6
        ISS II
    		 14 14
        ISS III
    		 8 8
        Missing
    		 18 18
    ECOG
    Units: Subjects
        ECOG 0
    		 7 7
        ECOG 1
    		 18 18
        ECOG 2
    		 10 10
        ECOG 3
    		 2 2
        Missing
    		 9 9
    Subject analysis sets

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    ITT

    Subject analysis sets values
    		 ITT
    Number of subjects
    46
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    0
        From 65-84 years
    44
        85 years and over
    2
    Age continuous
    Units: years
        median (full range (min-max))
    75 (65 to 88)
    Gender categorical
    Units: Subjects
        Female
    16
        Male
    30
    ISS Stage
    Units: Subjects
        ISS I
    6
        ISS II
    14
        ISS III
    8
        Missing
    18
    ECOG
    Units: Subjects
        ECOG 0
    7
        ECOG 1
    18
        ECOG 2
    10
        ECOG 3
    2
        Missing
    9

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    RP-MPR
    Reporting group description
    		 -

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    ITT

    Primary: PR Rate

    		 Close Top of page
    End point title
    		 PR Rate
    End point description
    End point type
    Primary
    End point timeframe
    ITT
    End point values
    		 RP-MPR ITT
    Number of subjects analysed
    46
    46
    Units: subject
    37
    37
    Statistical analysis title
    		 No statistical analysis
    Statistical analysis description
    No statistical analysis
    Comparison groups
    RP-MPR v ITT
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0 [2]
    Method
    		 No statistical analysis
    Parameter type
    		 No statistical analysis
    Point estimate
    37
    Confidence interval
         level
    		 0%
         sides
    2-sided
         lower limit
    		 37
         upper limit
    		 37
    Variability estimate
    Standard deviation
    Dispersion value
    0
    Notes
    [1] - No statistical analysis
    [2] - No statistical analysis

    Secondary: Progression free survival

    		 Close Top of page
    End point title
    		 Progression free survival
    End point description
    End point type
    Secondary
    End point timeframe
    Progression free survival
    End point values
    		 RP-MPR ITT
    Number of subjects analysed
    46
    46
    Units: month
        median (confidence interval 95%)
    21.2 (17.1 to 34.8)
    21.2 (17.1 to 34.8)
    Statistical analysis title
    		 No statistical analysis
    Statistical analysis description
    No statistical analysis
    Comparison groups
    RP-MPR v ITT
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0 [4]
    Method
    		 No statistical analysis
    Parameter type
    		 No statistical analysis
    Point estimate
    21.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 21.2
         upper limit
    		 21.2
    Variability estimate
    Standard deviation
    Dispersion value
    0
    Notes
    [3] - No statistical analysis
    [4] - No statistical analysis

    Secondary: Time to progression

    		 Close Top of page
    End point title
    		 Time to progression
    End point description
    End point type
    Secondary
    End point timeframe
    Time to progression
    End point values
    		 RP-MPR ITT
    Number of subjects analysed
    46
    46
    Units: month
        median (confidence interval 95%)
    29.9 (18.2 to 57.6)
    29.9 (18.2 to 57.6)
    Statistical analysis title
    		 No statistical analysis
    Statistical analysis description
    No statistical analysis
    Comparison groups
    RP-MPR v ITT
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 = 0 [6]
    Method
    		 No statistical analysis
    Parameter type
    		 No statistical analysis
    Point estimate
    29.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 29.9
         upper limit
    		 29.9
    Variability estimate
    Standard deviation
    Dispersion value
    0
    Notes
    [5] - No statistical analysis
    [6] - No statistical analysis

    Secondary: Overall survival

    		 Close Top of page
    End point title
    		 Overall survival
    End point description
    End point type
    Secondary
    End point timeframe
    Overall survival
    End point values
    		 RP-MPR ITT
    Number of subjects analysed
    46
    46
    Units: month
        median (confidence interval 95%)
    60.4 (49 to 81.3)
    60.4 (49 to 81.3)
    Statistical analysis title
    		 No statistical analysis
    Statistical analysis description
    No statistical analysis
    Comparison groups
    RP-MPR v ITT
    Number of subjects included in analysis
    92
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    P-value
    		 = 0 [8]
    Method
    		 No statistical analysis
    Parameter type
    		 No statistical analysis
    Point estimate
    60.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 60.4
         upper limit
    		 60.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    0
    Notes
    [7] - No statistical analysis
    [8] - No statistical analysis

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    ITT
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24
    Reporting groups
    Reporting group title
    Per Protocol
    Reporting group description
    		 -

    Serious adverse events
    		 Per Protocol
    Total subjects affected by serious adverse events
         subjects affected / exposed
    27 / 46 (58.70%)
         number of deaths (all causes)
    26
         number of deaths resulting from adverse events
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Myelodysplastic syndrome
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    1 / 1
    Prostate cancer
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hepatic cancer
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bladder cancer
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Astringent therapy
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Hyperthermia
         subjects affected / exposed
    2 / 46 (4.35%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Hyperpyrexia
         subjects affected / exposed
    2 / 46 (4.35%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Asthenia
         subjects affected / exposed
    2 / 46 (4.35%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Oedema
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Emphysema
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchopulmonary disease
         subjects affected / exposed
    2 / 46 (4.35%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Dyspnoea
         subjects affected / exposed
    3 / 46 (6.52%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    3 / 46 (6.52%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Investigations
    Urogram
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    2 / 46 (4.35%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Carotid artery occlusion
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 46 (8.70%)
         occurrences causally related to treatment / all
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    3 / 46 (6.52%)
         occurrences causally related to treatment / all
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Neutropenia
         subjects affected / exposed
    5 / 46 (10.87%)
         occurrences causally related to treatment / all
    7 / 7
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Rectal haemorrhage
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 46 (4.35%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis exfoliative generalised
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Rash
         subjects affected / exposed
    5 / 46 (10.87%)
         occurrences causally related to treatment / all
    4 / 7
         deaths causally related to treatment / all
    0 / 0
    Angioedema
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Cervical spinal stenosis
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Bronchopulmonary disease
         subjects affected / exposed
    2 / 46 (4.35%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    3 / 46 (6.52%)
         occurrences causally related to treatment / all
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    Septic shock
         subjects affected / exposed
    2 / 46 (4.35%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infection
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dehydration
         subjects affected / exposed
    2 / 46 (4.35%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 46 (2.17%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Per Protocol
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    43 / 46 (93.48%)
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    13 / 46 (28.26%)
         occurrences all number
    46
    Thrombocytopenia
         subjects affected / exposed
    8 / 46 (17.39%)
         occurrences all number
    46
    Anaemia
         subjects affected / exposed
    4 / 46 (8.70%)
         occurrences all number
    46
    Asthenia
         subjects affected / exposed
    4 / 46 (8.70%)
         occurrences all number
    46
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    5 / 46 (10.87%)
         occurrences all number
    46
    Pain
         subjects affected / exposed
    5 / 46 (10.87%)
         occurrences all number
    46
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    4 / 46 (8.70%)
         occurrences all number
    46

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Jan 2009
    The amendments concern the revision by updating (deletion and/or replacement) of certain paragraphs of the ICF This amendment also includes changes made following the new 'Guidelines for the processing of personal data in the context of clinical trials of medicinal products - 24 July 2008 - Official Gazette No. 190 of 14 August 2008 Submission of Lenalidomide IMP dossier as a required doument to be attached to the application for authorisation according to the directive of 21 December 2007.
    08 Jun 2011
    Amendment to the information sheet/informed consent, for an update on the risks related to the use of Lenalidomide,Following the AIFA communication of 6 April 2011 on the "Safety Lenalidomde" emergency, it was necessary to to inform patients about risks of increased incidence of second malignancies highlighted by the EMA in some clinical trials.
    22 May 2017
    Protocol: some administrative information was changed and some criteria on disease response were corrected - Information/Informed Consent Sheet: the risks associated with lenalidomide treatment were updated and the Information on the Processing of Personal Data was updated. - Pregnancy Prevention Programme (PPG):documents are sent to subjects and the physician, which are part of the Pregnancy Prevention Programme (PPG), prepared by the pharmaceutical company Celgene Corporation - Drugs Melfalan, Lenalidomide: the "Summary of Product Characteristics" document is submitted for the aforementioned drugs, downloadable from the AIFA database system. - Promoter data: change of address of the promoter's registered office - IB Lenalidomide: the updated version of the document and relative Summary of Changes
    15 Jan 2019
    a new site for the importation and release of the drug Lenalidomide was added Submitted: - Supply Chain Letter dated 21.12.2018 - Certificate of GMP compliance of manufacturer dated 06.04.2018
    17 Jun 2019
    submission of new version of the IB Lenalidomide; the new version of the Informed Consent updated with the new side effects relating to the drug Lenalidomide was released.
    26 Jun 2020
    submission of new version of the IB Lenalidomide; the new version of the Informed Consent updated with the new side effects relating to the drug Lenalidomide was released.

    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.

    European Medicines Agency © 1995-Tue Apr 30 18:50:35 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA