Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-26 @ 2:05 AM
Study NCT ID:
NCT00911105
Status:
COMPLETED
Last Update Posted:
2018-06-06
First Post:
2009-05-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Non -Interventional Study-Palliative Therapy of Multiple Myeloma With a Combination of Lenalidomide and Dexamethasone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D010954', 'term': 'Plasmacytoma'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-04', 'studyFirstSubmitDate': '2009-05-28', 'studyFirstSubmitQcDate': '2009-05-28', 'lastUpdatePostDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to progression (TTP)', 'timeFrame': 'maximum 3 years per Patient'}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate', 'timeFrame': 'maximum 3 years per Patient'}, {'measure': 'Time to Treatment Discontinuation (TTD)', 'timeFrame': 'maximum 3 years per Patient'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'maximum 3 years per Patient'}, {'measure': 'Safety Profile', 'timeFrame': 'maximum 3 years per Patient'}, {'measure': 'Dosage of Lenalidomide and Dexamethasone', 'timeFrame': 'maximum 3 years per Patient'}, {'measure': 'Kidney Function', 'timeFrame': 'maximum 3 years per Patient'}, {'measure': 'Neutropenia / Infection (Concomitant Medication)', 'timeFrame': 'maximum 3 years per Patient'}, {'measure': 'Thrombosis Prophylaxis', 'timeFrame': 'maximum 3 years per Patient'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multiple Myeloma', 'Non-interventional study', 'Lenalidomide', 'Dexamethasone', 'Observational', 'Time to progression', 'Clinical routine', 'Germany', 'Plasmacytoma'], 'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'Purpose of this non-interventional study is the documentation of efficacy and safety data of multiple myeloma therapy with a combined treatment of Lenalidomide and Dexamethasone in daily routine practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with mutiple myeloma receiving a combination therapy with Lenalidomide and Dexamethasone.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with multiple myeloma with at least one previous therapy.\n* 18 years or older\n* Signed, written informed consent\n\nExclusion Criteria:\n\n* Pregnancy or nursing\n* All other exclusion criteria listed in SmPC (summary of product characteristics)'}, 'identificationModule': {'nctId': 'NCT00911105', 'acronym': 'REVLIMID-NIS', 'briefTitle': 'Non -Interventional Study-Palliative Therapy of Multiple Myeloma With a Combination of Lenalidomide and Dexamethasone', 'organization': {'class': 'INDUSTRY', 'fullName': 'iOMEDICO AG'}, 'officialTitle': 'Combined Application of Lenalidomide and Desamethasone in the Palliative Therapy of Patients With Multiple Myeloma', 'orgStudyIdInfo': {'id': 'IOM-0810'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with multiple myeloma', 'description': 'Patients with multiple myeloma receiving second line therapy or higher.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '61348', 'city': 'Bad Homburg', 'country': 'Germany', 'facility': 'Onkologische Schwerpunktpraxis', 'geoPoint': {'lat': 50.22683, 'lon': 8.61816}}, {'zip': '10365', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Onkologische Schwerpunktpraxis', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10407', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Onkologisches Versorgungszentrum Friedrichshain', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13439', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Onkologische Praxis', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '60389', 'city': 'Frankfurt am Main', 'country': 'Germany', 'facility': 'Onkologische Gemeinschaftspraxis', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '82110', 'city': 'Germering', 'country': 'Germany', 'facility': 'Praxis für Innere Medizin', 'geoPoint': {'lat': 48.13392, 'lon': 11.3765}}, {'zip': '04539', 'city': 'Groitzsch', 'country': 'Germany', 'facility': 'MedResearch - Medizinisches Studien- und Dokumentationszentrum Leipziger Land', 'geoPoint': {'lat': 51.15536, 'lon': 12.28279}}, {'zip': '18273', 'city': 'Güstrow', 'country': 'Germany', 'facility': 'Internistische Gemeinschaftspraxis', 'geoPoint': {'lat': 53.7972, 'lon': 12.17337}}, {'zip': '22587', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Praxis für Innere Medizin, Haematologie und Internistische Onkologie', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '89518', 'city': 'Heidenheim', 'country': 'Germany', 'facility': 'Tumorpraxis Heidenheim', 'geoPoint': {'lat': 48.67798, 'lon': 10.15162}}, {'zip': '47805', 'city': 'Krefeld', 'country': 'Germany', 'facility': 'Onkol. Gem.praxis Dr. M. Neise & Dr. A. Lollert', 'geoPoint': {'lat': 51.33645, 'lon': 6.55381}}, {'zip': '66822', 'city': 'Lebach', 'country': 'Germany', 'facility': 'Onkologisches Zentrum Lebach', 'geoPoint': {'lat': 49.41122, 'lon': 6.90988}}, {'zip': '31275', 'city': 'Lehrte', 'country': 'Germany', 'facility': 'Onkologische Gemeinschaftspraxis', 'geoPoint': {'lat': 52.37193, 'lon': 9.97919}}, {'zip': '04289', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis Dr. Aldaoud - Dr. Schwarzer', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '45468', 'city': 'Mühlheim', 'country': 'Germany', 'facility': 'Praxis für Haematologie und Onkologie', 'geoPoint': {'lat': 53.52318, 'lon': 9.17204}}, {'zip': '92318', 'city': 'Neumarkt I. D. O.', 'country': 'Germany', 'facility': 'Praxis fuer Innere Medizin'}, {'zip': '41462', 'city': 'Neuss', 'country': 'Germany', 'facility': 'Praxis fuer Onkologie und Haematologie', 'geoPoint': {'lat': 51.19807, 'lon': 6.68504}}, {'zip': '48527', 'city': 'Nordhorn', 'country': 'Germany', 'facility': 'Haematologisch-Onkologische Gemeinschaftspraxis', 'geoPoint': {'lat': 52.43081, 'lon': 7.06833}}, {'zip': '26121', 'city': 'Oldenburg', 'country': 'Germany', 'facility': 'Onkologische Praxis Oldenburg', 'geoPoint': {'lat': 53.14039, 'lon': 8.21479}}, {'zip': '52146', 'city': 'Würselen', 'country': 'Germany', 'facility': 'Onkologische Gemeinschaftspraxis', 'geoPoint': {'lat': 50.81809, 'lon': 6.1347}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'iOMEDICO AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}