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Clinical trials for Risk mitigation

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   44334   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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    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.
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    8 result(s) found for: Risk mitigation. Displaying page 1 of 1.
    EudraCT Number: 2016-003517-95 Sponsor Protocol Number: OP-103 Start Date*: 2017-01-31
    Sponsor Name:Oncopeptides AB
    Full Title: A Randomized, Controlled, Open-Label, Phase 3 Study of Melflufen/ Dexamethasone Compared with Pomalidomide/Dexamethasone for Patients with Relapsed Refractory Multiple Myeloma who are Refractory to...
    Medical condition: Patients with Relapsed Refractory Multiple Myeloma who are Refractory to Lenalidomide
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004851 10028229 Multiple myelomas HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) ES (Ongoing) CZ (Completed) GB (GB - no longer in EU/EEA) GR (Temporarily Halted) BE (Completed) DK (Completed) NL (Completed) NO (Completed) FR (Completed) PL (Completed) AT (Completed) EE (Completed) LT (Completed) IT (Completed) RO (Temporarily Halted)
    Trial results: View results
    EudraCT Number: 2018-003411-21 Sponsor Protocol Number: FEDR-MF-002 Start Date*: 2019-05-14
    Sponsor Name:Impact Biomedicines, Inc., a Wholly Owned Subsidiary of Celgene Corporation
    Full Title: A Phase 3, multicenter, open-label, randomized study to evaluate the efficacy and safety of fedratinib compared to best available therapy in subjects with DIPSS - intermediate or high-risk primary ...
    Medical condition: Primary myelofibrosis, post-polycythemia vera myelofibrosis , or post-essential thrombocythemia myelofibrosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028537 Myelofibrosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) DE (Trial now transitioned) GB (GB - no longer in EU/EEA) ES (Ongoing) IE (Trial now transitioned) NL (Completed) AT (Ongoing) HU (Trial now transitioned) BE (Trial now transitioned) PL (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-001242-35 Sponsor Protocol Number: 68284528MMY3004 Start Date*: 2021-08-02
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd) followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA...
    Medical condition: Multiple Myeloma
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028228 Multiple myeloma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Trial now transitioned) SE (Trial now transitioned) DK (Trial now transitioned) FR (Trial now transitioned) PL (Trial now transitioned) NO (Trial now transitioned) DE (Trial now transitioned) PT (Trial now transitioned) FI (Trial now transitioned) NL (Ongoing) CZ (Trial now transitioned) ES (Ongoing) HU (Ongoing) AT (Trial now transitioned) IE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-003650-23 Sponsor Protocol Number: KKSH178 Start Date*: 2022-07-29
    Sponsor Name:Martin-Luther-Universität Halle-Wittenberg
    Full Title: Fedratinib in Combination with CC-486, a Hypomethylating Agent, in Patients with Accelerated Phase Myelofibrosis
    Medical condition: Myeloproliferative neoplasm in accelerated phase (MPN-AP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10077465 Myeloproliferative neoplasm PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-000450-21 Sponsor Protocol Number: MONS4STRAT Start Date*: 2018-04-09
    Sponsor Name:Fundación Investigación Biomédica Hospital Ramón y Cajal
    Full Title: Prospective, Randomized, Open, Controlled, Multicenter Study to Evaluate the Safety and Efficacy of the MON4STRAT Approach for Optimizing Meropenem Therapy in Intubated and Mechanically-Ventilated,...
    Medical condition: Nosocomial pneumonia or severe tracheobronchitis caused by Gram-negative pathogens in subjects that requiring mechanical ventilation.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) FR (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2018-003287-31 Sponsor Protocol Number: M16-104 Start Date*: 2019-06-05
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: A Phase 2, Multicenter, Single Arm, Open Label Study of Venetoclax Plus Lenalidomide and Dexamethasone for the Treatment of Newly Diagnosed t(11;14)-Positive Multiple Myeloma in Subjects Who Are In...
    Medical condition: Multiple Myeloma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10028228 Multiple myeloma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-001618-27 Sponsor Protocol Number: EMN14/54767414MMY3013 Start Date*: 2017-05-19
    Sponsor Name:Stichting European Myeloma Network (EMN)
    Full Title: A Phase 3 Study Comparing Pomalidomide and Dexamethasone With or Without Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy Wi...
    Medical condition: Relapsed or Refractory Multiple Myeloma
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028228 Multiple myeloma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed) ES (Ongoing) BE (Completed) DE (Completed) CZ (Completed) DK (Completed) FR (Completed) NL (Completed) PL (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-004124-10 Sponsor Protocol Number: 68284528MMY2003 Start Date*: 2020-08-07
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 2, Multicohort Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA in Subjects with Multiple Myeloma
    Medical condition: Multiple Myeloma
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10028228 Multiple myeloma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) DE (Trial now transitioned) BE (Trial now transitioned) ES (Ongoing) NL (Trial now transitioned)
    Trial results: (No results available)
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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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