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   43865   clinical trials with a EudraCT protocol, of which   7286   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:
    Safety And Efficacy Of Lenalidomide As Maintenance Therapy In Patients With Newly Diagnosed Multiple Myeloma Following A Tandem Autologous-Allogeneic Transplant

    Summary
    EudraCT number
    		 2008-004529-41
    Trial protocol
    		 IT  
    Global end of trial date
    24 Aug 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Oct 2023
    First version publication date
    21 Oct 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    RV-MM-GITMO-413
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01264315
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fondazione EMN Italy Onlus
    Sponsor organisation address
    Via Nizza, 52, Turin, Italy, 10126
    Public contact
    Fondazione EMN Italy Onlus, Fondazione EMN Italy Onlus, 0039 0110243236, clinicaltrialoffice@emnitaly.org
    Scientific contact
    Fondazione EMN Italy Onlus, 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
    24 Aug 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Aug 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1. To evaluate toxicity and tolerability of lenalidomide after allografting 2. To evaluate efficacy of lenalidomide in inducing complete remission, defined as negative immunofixation, 12 months after allografting.
    Protection of trial subjects
    Under approval of Local Etical Commitee
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Aug 2008
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Italy: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    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)
    11
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The pre-treatment period includes screening visits, performed at study entry. After providing written informed consent to participate in the study, patients will be evaluated for study eligibility. The screening period includes the availability of inclusion criteria.

    Pre-assignment
    Screening details
    		 A conference will be held with the patient, donor and family to explain option of a tandem auto/allo approach. Inclusion and exclusion criteria will be evaluated.

    Period 1
    Period 1 title
    Lenalidomide and Tandem Auto-Allo SCT (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    NA

    Arms
    Arm title
    		 Lenalidomide Tandem Auto-Allo SCT
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lenalidomide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Lenalidomide will be given orally at the dose of 25 mg/day for 21 days followed by a 7 day rest period (day 22 to 28)

    Number of subjects in period 1
    		Lenalidomide Tandem Auto-Allo SCT
    Started
    12
    Completed
    0
    Not completed
    12
         Adverse event, serious fatal
    1
         Lost to follow-up
    9
         Lack of efficacy
    2

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Lenalidomide and Tandem Auto-Allo SCT
    Reporting group description
    		 -

    Reporting group values
    		 Lenalidomide and Tandem Auto-Allo SCT Total
    Number of subjects
    		 12 12
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 11 11
        From 65-84 years
    		 1 1
    Age continuous
    Units: years
        median (full range (min-max))
    		 56 (51 to 65) -
    Gender categorical
    Units: Subjects
        Female
    		 6 6
        Male
    		 6 6
    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
    12
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    11
        From 65-84 years
    1
    Age continuous
    Units: years
        median (full range (min-max))
    56 (51 to 65)
    Gender categorical
    Units: Subjects
        Female
    6
        Male
    6

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Lenalidomide Tandem Auto-Allo SCT
    Reporting group description
    		 -

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

    Primary: CR Rate

    		 Close Top of page
    End point title
    		 CR Rate
    End point description
    End point type
    Primary
    End point timeframe
    12 months
    End point values
    		 Lenalidomide Tandem Auto-Allo SCT ITT
    Number of subjects analysed
    12
    12
    Units: Patients
    1
    1
    Statistical analysis title
    		 No statistical analysis
    Statistical analysis description
    No statistical analysis
    Comparison groups
    Lenalidomide Tandem Auto-Allo SCT v ITT
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0 [2]
    Method
    		 No statistical analysis
    Parameter type
    		 No statistical analysis
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 0
    Variability estimate
    Standard deviation
    Dispersion value
    0
    Notes
    [1] - No statistical analysis
    [2] - No statistical analysis

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Per protocol
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26
    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
    0 / 11 (0.00%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    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
    4 / 11 (36.36%)
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    4 / 11 (36.36%)
         occurrences all number
    4
    Thrombocytopenia
         subjects affected / exposed
    4 / 11 (36.36%)
         occurrences all number
    4
    Anaemia
         subjects affected / exposed
    3 / 11 (27.27%)
         occurrences all number
    3
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 11 (27.27%)
         occurrences all number
    3
    Mucosal inflammation
         subjects affected / exposed
    2 / 11 (18.18%)
         occurrences all number
    2

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Jan 2010
    Given the current availability of immunomodulatory drugs that can be used in induction before transplantation, this amendment intends to extend the enrollment in the protocol to patients who have used therapeutic regimens containing alternatively thalidomide, bortezomib or lenalidomide in the induction phase, based on the preferences and availability of the individual centre.

    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-Mon Apr 29 00:30:53 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA