Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2026-03-13 @ 2:30 PM
Study NCT ID:
NCT02419118
Status:
COMPLETED
Last Update Posted:
2017-11-07
First Post:
2015-02-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"Monoclonal Antibodies for Treatment of Multiple Myeloma. Emphasis on the CD38 Antibody Daratumumab "
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C556306', 'term': 'daratumumab'}, {'id': 'D000077269', 'term': 'Lenalidomide'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2015-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-06', 'studyFirstSubmitDate': '2015-02-12', 'studyFirstSubmitQcDate': '2015-04-13', 'lastUpdatePostDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response by IMWG criteria', 'timeFrame': '4 weeks', 'description': 'Assessed by M-component in blood and urine samples'}], 'secondaryOutcomes': [{'measure': 'T cell subset numbers', 'timeFrame': '4 weeks', 'description': 'Measured in bood and bone marrow aspirates'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Myeloma', 'monoclonal antibody', 'Daratumumab'], 'conditions': ['Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '25798669', 'type': 'RESULT', 'citation': 'Franssen LE, van de Donk NW, Emmelot ME, Roeven MW, Schaap N, Dolstra H, Hobo W, Lokhorst HM, Mutis T. The impact of circulating suppressor cells in multiple myeloma patients on clinical outcome of DLIs. Bone Marrow Transplant. 2015 Jun;50(6):822-8. doi: 10.1038/bmt.2015.48. Epub 2015 Mar 23.'}, {'pmid': '25760767', 'type': 'RESULT', 'citation': 'Overdijk MB, Verploegen S, Bogels M, van Egmond M, Lammerts van Bueren JJ, Mutis T, Groen RW, Breij E, Martens AC, Bleeker WK, Parren PW. Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma. MAbs. 2015;7(2):311-21. doi: 10.1080/19420862.2015.1007813.'}]}, 'descriptionModule': {'briefSummary': 'Daratumumab is a new treatment for patients with myeloma. While many patients benefit from this treatment some do not and the mechanism(s) of failure are poorly understood. This study aims to clarify aspects of resistance to treatment with daratumumab in order to improve patient outcomes in the future.', 'detailedDescription': "The effector mechanisms of daratumumab have been extensively studied in vitro, but the in vivo correlates and key determinants of success or failure when daratumumab is used alone or in combination with lenalidomide for treatment of patients with myeloma have not been clarified.\n\nThere is potentially a wide spectrum of factors that may influence the quality and duration of response following treatment with daratumumab. The integrity of the patient's immune system may be important. Prior lines of chemotherapy or the myeloma disease itself may impair humural (i.e. complement) or cellular (i.e. ADCC) effector mechanisms that are of importance for the response to daratumumab. Also intrinsic properties of the tumor cells or interactions between myeloma cells and the bone marrow microenvironment could make the myeloma cells refractory to daratumumab.\n\nA better understanding of these variables may enable us to improve the quality and duration of daratumumab-induced responses and make daratumumab-based therapies more effective in the near future."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Accepted for a clinical trial with Daratumumab for myeloma\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02419118', 'acronym': 'DARA', 'briefTitle': '"Monoclonal Antibodies for Treatment of Multiple Myeloma. Emphasis on the CD38 Antibody Daratumumab "', 'organization': {'class': 'OTHER', 'fullName': 'Vejle Hospital'}, 'officialTitle': '"Monoclonal Antibodies for Treatment of Multiple Myeloma. Present Status and Aspects of Effector Mechanisms With Emphasis on the CD38 Antibody Daratumumab "', 'orgStudyIdInfo': {'id': '181114'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dara len dex', 'description': 'Daratumumab in combination with lenalidomide and dexamethasone', 'interventionNames': ['Drug: Daratumumab', 'Drug: Lenalidomide', 'Drug: Dexamethasone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Len dex', 'description': 'Lenalidomide in combination with dexamethasone', 'interventionNames': ['Drug: Lenalidomide', 'Drug: Dexamethasone']}], 'interventions': [{'name': 'Daratumumab', 'type': 'DRUG', 'otherNames': ['CD38 monoclonal antibody', 'HuMax CD38'], 'description': 'Treatment of myeloma patients with Daratumumab', 'armGroupLabels': ['Dara len dex']}, {'name': 'Lenalidomide', 'type': 'DRUG', 'description': 'Treatment of myeloma patients', 'armGroupLabels': ['Dara len dex', 'Len dex']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Treatment of myeloma patients', 'armGroupLabels': ['Dara len dex', 'Len dex']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7100', 'city': 'Vejle', 'country': 'Denmark', 'facility': 'Department of Hematology Vejle Hospital', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}], 'overallOfficials': [{'name': 'Torben Plesner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vejle Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vejle Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}