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Clinical trials for Dira

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   44336   clinical trials with a EudraCT protocol, of which   7366   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.
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    3 result(s) found for: Dira. Displaying page 1 of 1.
    EudraCT Number: 2016-000287-42 Sponsor Protocol Number: I15015 Start Date*: 2016-05-18
    Sponsor Name:CHU de Limoges
    Full Title: A Multicentre Open label Phase II study of Daratumumab in AL Amyloidosis Patients not in VGPR or Better
    Medical condition: AL Amyloidosis
    Disease: Version SOC Term Classification Code Term Level
    19.0 10005329 - Blood and lymphatic system disorders 10035227 Plasma cell neoplasms HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-003535-30 Sponsor Protocol Number: 2018_16 Start Date*: 2019-05-03
    Sponsor Name:CHRU de Lille
    Full Title: A Phase 3 Study Comparing Lenalidomide and Daratumumab Subcutaneous Injection (R-Dara SC) vs Lenalidomide and Dexamethasone (Rd) in Frail Subjects with Previously Untreated Multiple Myeloma who are...
    Medical condition: A Phase III Study Comparing Lenalidomide and Daratumumab (R-Dara) vs Lenalidomide and Dexamethasone (Rd) in Frail Subjects with Previously Untreated Multiple Myeloma who are Ineligible for High Dos...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10028228 Multiple myeloma LLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-001737-27 Sponsor Protocol Number: 54767414AMY3001 Start Date*: 2018-04-16
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnos...
    Medical condition: AL Amyloidosis (Newly Diagnosed Systemic AL Amyloidosis )
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021428 - Immune system disorders 10002022 Amyloidosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) BE (Trial now transitioned) SE (Trial now transitioned) ES (Ongoing) HU (Trial now transitioned) NL (Trial now transitioned) GB (GB - no longer in EU/EEA) GR (Trial now transitioned) DK (Trial now transitioned) PL (Trial now transitioned) IT (Trial now transitioned) RO (Ongoing)
    Trial results: (No results available)
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    Query did not match any studies.
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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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