Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-28 @ 5:36 AM
Study NCT ID:
NCT06237803
Status:
RECRUITING
Last Update Posted:
2025-12-03
First Post:
2024-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
European Myeloma Network (EMN) Sample Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D000075122', 'term': 'Smoldering Multiple Myeloma'}, {'id': 'D007952', 'term': 'Leukemia, Plasma Cell'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D006942', 'term': 'Hypergammaglobulinemia'}, {'id': 'D007938', 'term': 'Leukemia'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '* bone marrow aspirate, bone marrow biopsy, extramedullary disease (EMD) biopsy, peripheral blood and serum at baseline;\n* bone marrow aspirate, bone marrow biopsy, peripheral blood and serum pre-maintenance in TE patients or after 1 year of therapy in non transplant eligible patients;\n* bone marrow aspirate, bone marrow biopsy, peripheral blood and serum during maintenance therapy and only if performed as standard of care (SOC);\n* bone marrow aspirate, bone marrow biopsy, EMD biopsy peripheral blood and serum at 1st and later progressive disease (PD).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2037-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2024-01-15', 'studyFirstSubmitQcDate': '2024-01-25', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2037-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biobank', 'timeFrame': 'up to 30 years', 'description': 'Collect biological samples for research studies related to improving medicine and care to the patient'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Myeloma', 'Smoldering Multiple Myeloma', 'Plasma Cell Leukemia', 'Extramedullary Myeloma', 'MGUS']}, 'descriptionModule': {'briefSummary': "This is an observational, non-interventional, multicenter study for the prospective collection, storage and analysis of patients' biological samples.\n\nThis study establishes a common international infrastructure useful to collect standard clinical variables at baseline and during treatment and to uniformly collect and store biological samples"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in hospitals in countries that participate in European Myeloma Network (EMN) trials; these patients may be included in upfront trials or in maintenance or relapse trials later during their disease.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects with MGUS, smouldering Multiple Myeloma (SMM) , MM (Multiple Myeloma) (+/- EMD), plasma cell leukemia (PCL) (+/- EMD)\n* Subjects are ≥ 18 years old.\n* Subjects have provided written informed consent in accordance with federal, local, and institutional guidelines prior to initiation of any project-specific activities or procedures.\n\n 1. Subjects do not have kind of condition that, in the opinion of the Investigators, may compromise the ability of the subjects to give written informed consent and\n 2. subjects are, in the investigator's opinion, willing and able to comply with the protocol requirements.\n\nExclusion Criteria:\n\n* Previous treatment with anti-myeloma therapy (excluding one course of therapy in patients in which urgent therapy is deemed necessary according to physician's discretion, e.g. myeloma-related complications resistant to supportive care).\n* Subjects have had prior unforeseen (serious) adverse reactions to blood donation including, but not limited to fainting, angina, severe bruising, allergic reactions, or any other adverse events.\n* Any psychological, familial, sociological and geographical condition potentially hampering compliance with the protocol and follow-up schedule."}, 'identificationModule': {'nctId': 'NCT06237803', 'acronym': 'EMN36', 'briefTitle': 'European Myeloma Network (EMN) Sample Project', 'organization': {'class': 'NETWORK', 'fullName': 'European Myeloma Network B.V.'}, 'officialTitle': 'EMN Prospective Sample Collection Project', 'orgStudyIdInfo': {'id': 'EMN36'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subjects with MGUS, SMM, MM, PCL', 'description': 'Subjects with Monoclonal Gammopathy of Undetermined Significance (MGUS), smouldering Multiple Myeloma (SMM), Multiple Myeloma (MM), Plasma Cell Leukemia (PCL)\n\nTimepoints and samples to be collected are the following:\n\n* bone marrow aspirate, bone marrow biopsy, EMD biopsy, peripheral blood and serum at baseline;\n* bone marrow aspirate, bone marrow biopsy, peripheral blood and serum pre-maintenance in TE patients or after 1 year of therapy in Non-Transplant-Eligible (NTE) patients;\n* bone marrow aspirate, bone marrow biopsy, peripheral blood and serum during maintenance therapy and only if performed as SOC;\n* bone marrow aspirate, bone marrow biopsy, EMD biopsy peripheral blood and serum at 1st and later PD.', 'interventionNames': ['Other: storage of biological samples']}], 'interventions': [{'name': 'storage of biological samples', 'type': 'OTHER', 'description': 'collect and store biological samples', 'armGroupLabels': ['Subjects with MGUS, SMM, MM, PCL']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Melbourne', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Spencer', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Linz', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Schmitt', 'role': 'CONTACT'}], 'facility': 'KUK Linz', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Krauth', 'role': 'CONTACT'}], 'facility': 'Medical University Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Leuven', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Delforge', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Haematology UZ Leuven Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Havířov', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Mikula', 'role': 'CONTACT'}], 'facility': 'Nemocnice Havířov', 'geoPoint': {'lat': 49.77984, 'lon': 18.43688}}, {'city': 'Nový Jičín', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Wrobel', 'role': 'CONTACT'}], 'facility': 'Nemocnice Nový Jičín', 'geoPoint': {'lat': 49.59438, 'lon': 18.01028}}, {'city': 'Olomouc', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Minařík', 'role': 'CONTACT'}], 'facility': 'Fakultní nemocnice', 'geoPoint': {'lat': 49.59552, 'lon': 17.25175}}, {'city': 'Opava', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Stejskal', 'role': 'CONTACT'}], 'facility': 'Slezská nemocnice', 'geoPoint': {'lat': 49.93866, 'lon': 17.90257}}, {'city': 'Ostrava', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Hajek', 'role': 'CONTACT'}], 'facility': 'Fakutni nemocnice Ostrava', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'city': 'Pelhřimov', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Kessler', 'role': 'CONTACT'}], 'facility': 'Nemocnice Pelhrimov', 'geoPoint': {'lat': 49.43134, 'lon': 15.22336}}, {'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Pavlicek', 'role': 'CONTACT'}], 'facility': 'Všeobecná Fakultní nemocnice v Praz', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Terpos', 'role': 'CONTACT'}], 'facility': 'Regional General Hospital Alexandra Dept of Clinical Therapeutics', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Thessaloniki', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Katodrytou', 'role': 'CONTACT'}], 'facility': 'Theagenion Cancer Hospital', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'city': 'Galway', 'status': 'RECRUITING', 'country': 'Ireland', 'contacts': [{'name': 'Krawczyk', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beaumont Hospital, Dublin, Hematology Department', 'geoPoint': {'lat': 53.27245, 'lon': -9.05095}}, {'city': 'Alessandria', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Monaco', 'role': 'CONTACT'}], 'facility': "A.O. 'SS. Antonio e Biagio'", 'geoPoint': {'lat': 44.90924, 'lon': 8.61007}}, {'city': 'Ancona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Offidani', 'role': 'CONTACT'}], 'facility': 'AOU Ospedali Riuniti di Ancona', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'city': 'Bari', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Ria', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Bari-A.O.U. Consorziale Policlinico - Medicina Interna', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Zamagni', 'role': 'CONTACT'}], 'facility': 'Policlinico S Orsola Malpighi', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Brescia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Belotti', 'role': 'CONTACT'}], 'facility': 'A.O.Spedali Civili di Brescia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'city': 'Civitanova Marche', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Mirabile', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'A.S.U.R. Regione Marche', 'geoPoint': {'lat': 43.30491, 'lon': 13.72068}}, {'city': 'Florence', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonioli', 'role': 'CONTACT'}], 'facility': 'A.O.U. Careggi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Genova', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Cea', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'A.O.U. Policlinico S. Martino - Clinica Ematologica', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Genova', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Aquino', 'role': 'CONTACT'}, {'name': 'Aquino', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'A.O.U. Policlinico S. Martino - Ematologia', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Lecce', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Mele', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "A.O. 'Cardinale G.Panico'", 'geoPoint': {'lat': 40.35481, 'lon': 18.17244}}, {'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Palmieri', 'role': 'CONTACT'}], 'facility': 'A.O. di Rilievo Nazionale A. Cardarelli', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Novara', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Casaluci', 'role': 'CONTACT'}], 'facility': 'A.O.U. Maggiore della Carità', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}, {'city': 'Pavia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Mangiacavalli', 'role': 'CONTACT'}], 'facility': 'Policlinico S. Matteo Fondazione IRCCS - Pavia', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Garzia', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'A.O. San Camillo-Forlanini', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Ferraro', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale S. Eugenio', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'San Giovanni Rotondo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Falcone', 'role': 'CONTACT'}], 'facility': 'I.R.C.C.S. Ospedale Casa Sollievo della Sofferenza', 'geoPoint': {'lat': 41.70643, 'lon': 15.7277}}, {'city': 'Terni', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Liberati', 'role': 'CONTACT'}, {'name': 'Liso', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'A.O. S. Maria', 'geoPoint': {'lat': 42.56335, 'lon': 12.64329}}, {'city': 'Torino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': "D'Agostino", 'role': 'CONTACT'}], 'facility': 'A.O.U. Città della Salute e della Scienza di Torino - PO Molinette', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Udine', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesca Patriarca', 'role': 'CONTACT'}], 'facility': 'Azienda Ospedaliera Universitaria di Udine', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}, {'city': 'Vicenza', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Barillà', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'ULSS8 Berica Ospedale S.Bortolo', 'geoPoint': {'lat': 45.54672, 'lon': 11.5475}}, {'city': 'Coimbra', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Roque', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHUC', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}, {'city': 'Lisbon', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'João', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fundação Champalimaud', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'city': 'Porto', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Bergantim', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chsj - Hosp. Sao Joao', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'city': 'Porto', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Barreto', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IPOP Porto', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'city': 'Belgrade', 'status': 'RECRUITING', 'country': 'Serbia', 'contacts': [{'name': 'Bila', 'role': 'CONTACT'}], 'facility': 'Clinic of Hematology, University Clinical Center of Serbia', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}, {'city': 'Lausanne', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Auner', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHUV', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}, {'city': 'Sankt Gallen', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Driessen', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'HOCH Health Ostschweiz Kantonsspital St.Gallen', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}], 'centralContacts': [{'name': 'Chiara Del Pietro', 'role': 'CONTACT', 'email': 'chiara.delpietro@emn.org', 'phone': '+31 10702687065'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Myeloma Network B.V.', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Janssen, LP', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}