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Clinical trials for Immunoglobulin light chains

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 ).  
     
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    17 result(s) found for: Immunoglobulin light chains. Displaying page 1 of 1.
    EudraCT Number: 2021-000037-14 Sponsor Protocol Number: NEOD001-301 Start Date*: 2021-09-01
    Sponsor Name:Prothena Biosciences Limited
    Full Title: A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects with ...
    Medical condition: AL amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in both soluble, a...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021428 - Immune system disorders 10036673 Primary amyloidosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Trial now transitioned) HU (Trial now transitioned) DE (Trial now transitioned) PT (Trial now transitioned) FR (Trial now transitioned) PL (Trial now transitioned) ES (Ongoing) CZ (Trial now transitioned) GR (Trial now transitioned) NL (Trial now transitioned) IT (Trial now transitioned) IE (Trial now transitioned) BE (Trial now transitioned) AT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-004318-14 Sponsor Protocol Number: NEOD001-201 Start Date*: 2016-06-13
    Sponsor Name:Prothena Therapeutics Limited
    Full Title: A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects with Light Chain (AL) Amyloidosis who have Persistent Cardiac Dysfunction
    Medical condition: Light chain (AL) amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in bo...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021428 - Immune system disorders 10036673 Primary amyloidosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) GB (Completed) GR (Completed) ES (Prematurely Ended) AT (Completed)
    Trial results: View results
    EudraCT Number: 2015-005384-16 Sponsor Protocol Number: FLORAMICAR Start Date*: 2016-04-26
    Sponsor Name:FONDAZIONE TOSCANA GABRIELE MONASTERIO
    Full Title: A prospective single-arm, monocentric, phase-II explorative study on evaluation of diagnostic use of the PET tracer (18F)-florbetaben (Neuraceq®) in patient with patient with suspected cardiac amyl...
    Medical condition: Patients with high clinical suspicion of cardiac amyloidosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10007541 - Cardiac disorders 10007509 Cardiac amyloidosis PT
    20.0 10007541 - Cardiac disorders 10007509 Cardiac amyloidosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-003865-11 Sponsor Protocol Number: NEOD001-CL002 Start Date*: 2015-11-27
    Sponsor Name:Prothena Therapeutics Limited
    Full Title: A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy and Safety Study of NEOD001 Plus Standard of Care vs. Placebo Plus Standard of Care in Subjects with Light Chai...
    Medical condition: Light chain (AL) amyloidosis involves a hematologic disorder caused by clonal plasma cells that produce misfolded immunoglobulin light chains. Overproduction of misfolded light chains results in bo...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021428 - Immune system disorders 10036673 Primary amyloidosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) AT (Prematurely Ended) ES (Completed) BE (Prematurely Ended) NL (Prematurely Ended) FR (Prematurely Ended) GB (Prematurely Ended) GR (Completed) PL (Prematurely Ended) DK (Prematurely Ended) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-002187-49 Sponsor Protocol Number: EB-CLIN-1001-03 Start Date*: 2021-08-16
    Sponsor Name:Eden Biologics, Inc., Taiwan
    Full Title: A Multinational, Randomized, Double-Blind, Active-Controlled Phase 3 Study to Compare the Clinical Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of EB1001 Biosimilar With EU-Licensed Pro...
    Medical condition: Osteoporosis is a disorder of impaired bone strength that results in skeletal fragility and increased fracture risk. It is a common and costly disorder, and is associated with significant morbidity...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10031285 Osteoporosis postmenopausal PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: HU (Prematurely Ended) EE (Prematurely Ended) BG (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-004664-18 Sponsor Protocol Number: NEOD001-OLE251 Start Date*: 2017-08-08
    Sponsor Name:Prothena Therapeutics Limited
    Full Title: A Phase 2b Open-label Extension Study to Evaluate the Long-term Safety and Efficacy of NEOD001 in Subjects with Light Chain (AL) Amyloidosis who were previously enrolled in Study NEOD001-201 (PRONTO)
    Medical condition: The objective of this study is to evaluate the long-term safety and efficacy of NEOD001 in subjects with AL amyloidosis who completed Study NEOD001 201
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021428 - Immune system disorders 10036673 Primary amyloidosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) DE (Prematurely Ended) ES (Prematurely Ended) GR (Completed) AT (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-005769-42 Sponsor Protocol Number: WUM-KH-AL1 Start Date*: 2023-04-13
    Sponsor Name:Warsaw Medical University/ Warszawski Uniwersytet Medyczny
    Full Title: PHASE II, MULTICENTER STUDY TO ASSESS SAFETY AND EFFICACY OF COMBINATION OF SARGRAMOSTIM WITH D-VCD THERAPY (DARATUMUMAB, CYCLOPHOSPHAMIDE, BORTEZOMIB, DEXAMETHASONE) IN UNTREATED PATIENTS WITH LIG...
    Medical condition: LIGHT CHAIN AMYLOIDOSIS (Amyloidosis AL)
    Disease: Version SOC Term Classification Code Term Level
    24.1 10021428 - Immune system disorders 10086183 AL amyloidosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2013-002340-90 Sponsor Protocol Number: HPV-Xneutra-001 Start Date*: 2013-06-26
    Sponsor Name:Ghent University Hospital
    Full Title: Study of the molecular mechanisms underlying the cross-neutralizing capacity of AS04-adjuvanted HPV vaccine (Cervarix®) in comparison with the aluminiumhydroxyphosphate sulphate adjuvanted HPV vacc...
    Medical condition: vaccin against the human papillomavirus
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004865 10046859 Vaccination LLT
    Population Age: Children, Adolescents, Under 18 Gender: Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-004476-35 Sponsor Protocol Number: CCFZ533B2201 Start Date*: 2019-08-19
    Sponsor Name:Novartis Pharma AG
    Full Title: A 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations o...
    Medical condition: Sjögren syndrome
    Disease: Version SOC Term Classification Code Term Level
    21.0 10028395 - Musculoskeletal and connective tissue disorders 10040767 Sjogren's syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PT (Completed) HU (Completed) GB (GB - no longer in EU/EEA) NL (Completed) GR (Completed) FR (Completed) DE (Completed) SE (Completed) AT (Completed) SI (Completed) IT (Completed) RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2012-004884-29 Sponsor Protocol Number: 12-BI-505-02 Start Date*: 2013-01-16
    Sponsor Name:BioInvent International AB
    Full Title: A single-arm, Open-label, Phase 2 Clinical Trial Evaluating Disease Response Following Treatment With BI-505, a Human Anti–Intercellular Adhesion Molecule 1 Monoclonal Antibody, In Patients With Sm...
    Medical condition: Smoldering (asymptomatic) multiple myeloma
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028228 Multiple myeloma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-002829-28 Sponsor Protocol Number: B8011011 Start Date*: 2021-06-01
    Sponsor Name:Pfizer Inc.
    Full Title: A Phase 1b/2 Open Label Umbrella Study of Sasanlimab Combined with Anti-Cancer Therapies Targeting Multiple Molecular Mechanisms in Participants with Non-Small Cell Lung Cancer (NSCLC)
    Medical condition: locally advanced or metastatic NSCLC
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029521 Non-small cell lung cancer stage IIIB PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10029522 Non-small cell lung cancer stage IV PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10059515 Non-small cell lung cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2013-001418-13 Sponsor Protocol Number: TED10893 Start Date*: 2014-11-04
    Sponsor Name:Sanofi-aventis recherche & développement
    Full Title: A Phase I Dose Escalation Safety and Pharmacokinetic Study of Multiple Intravenous Administrations of a Humanized Monoclonal Antibody (SAR650984) Against CD38 In Patients with Selected CD38+ Hemat...
    Medical condition: Haematological malignancy
    Disease: Version SOC Term Classification Code Term Level
    17.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066476 Haematological malignancy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) GR (Completed) GB (GB - no longer in EU/EEA) FI (Completed) BE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2019-003375-19 Sponsor Protocol Number: B8011006 Start Date*: 2020-07-20
    Sponsor Name:Pfizer Inc.
    Full Title: A Phase 3, Multinational, Randomized, Open-Label, Three Parallel-Arm Study of PF-06801591, an anti-PD-1 antibody, in Combination with Bacillus Calmette-Guerin (BCG Induction With or Without BCG Mai...
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10022877 Invasive bladder cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) GB (GB - no longer in EU/EEA) PT (Completed) BE (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-000620-34 Sponsor Protocol Number: Imatinib-MS Start Date*: 2018-04-24
    Sponsor Name:Department of Clinical Neuroscience, Karolinska Institutet
    Full Title: Imatinib for Multiple Sclerosis (MS) Relapses - a Phase II, Randomised Study
    Medical condition: Patients with clinically definite Multiple Sclerosis (MS) according to the McDonald Criteria, or possible MS (also named clinically isolated syndrome-CIS, as a first manifestation of MS, where ther...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10048393 Multiple sclerosis relapse PT
    20.0 10029205 - Nervous system disorders 10028247 Multiple sclerosis like syndrome LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) NO (Prematurely Ended) DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-004031-68 Sponsor Protocol Number: PMC010 Start Date*: 2019-10-24
    Sponsor Name:Polish Myeloma Consortium
    Full Title: A Randomized, Open-label Phase 3 Study of Carfilzomib, Lenalidomide, and Dexamethasone Versus Bortezomib, Lenalidomide and Dexamethasone (KRd vs. VRd) in Patients With Newly Diagnosed Multiple Myel...
    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: PL (Trial now transitioned) NO (Trial now transitioned) FI (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-004333-20 Sponsor Protocol Number: IFM2020-01 Start Date*: 2021-10-21
    Sponsor Name:Intergroupe Francophone du Myélome
    Full Title: A phase 2, open label, multisite, single-stage study to evaluate the efficacy of isatuximab plus pomalidomide and dexamethasone (IPd), in patients with AL amyloidosis not in VGPR or better after an...
    Medical condition: Previously treated 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: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-005108-89 Sponsor Protocol Number: VHIO17002 Start Date*: 2019-01-25
    Sponsor Name:Vall d’Hebron Institute of Oncology (VHIO)
    Full Title: Basket of Baskets: A Modular, Open-label, Phase II, Multicentre Study To Evaluate Targeted Agents in Molecularly Selected Populations With Advanced Solid Tumors.
    Medical condition: Subjects with advanced solid tumor
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065147 Malignant solid tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) SE (Trial now transitioned) DE (Trial now transitioned) GB (GB - no longer in EU/EEA) FR (Trial now transitioned) ES (Ongoing) IT (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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