Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-30 @ 7:37 PM
Study NCT ID:
NCT01838369
Status:
TERMINATED
Last Update Posted:
2023-01-11
First Post:
2013-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Study of BI-505 in Smoldering Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000075122', 'term': 'Smoldering Multiple Myeloma'}], 'ancestors': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006942', 'term': 'Hypergammaglobulinemia'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': "Sponsor's decision", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-10', 'studyFirstSubmitDate': '2013-03-26', 'studyFirstSubmitQcDate': '2013-04-23', 'lastUpdatePostDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the change in disease activity measured as M-protein levels in serum/urine following BI-505 treatment compared to base line according to the International Myeloma Working Group (IMWG) uniform response criteria', 'timeFrame': 'M-protein will be measured at screening, prior to each dose and at end of study visit, for up to 19 weeks.'}], 'secondaryOutcomes': [{'measure': 'The clinical safety of BI-505 will be assessed by reporting the numbers of AEs, the severity and the relationship to IMP.', 'timeFrame': 'At each visit and up to 28 days after the last dose.', 'description': 'Safety will be assessed by measuring the following clinical safety parameters; Adverse events, vital signs, clinical laboratory tests, ECG and immunogenicity.'}, {'measure': 'The pharmacokinetic profile of BI-505 will be determined by calculating the following pharmacokinetic parameters: AUC, % AUCex, Cmax, Tmax, CL, Vss and T1/2.', 'timeFrame': 'Up to 28 days after the last dose.'}, {'measure': 'The pharmacodynamics of BI-505 will be assessed by measuring soluble biomarkers and ICAM-1 saturation on bone marrow plasma cells.', 'timeFrame': 'Up to 28 days after the last dose.'}, {'measure': 'The immunogenicity profile of BI-505 will be assessed by measuring antibodies towards BI-505.', 'timeFrame': 'Prior to first dose and at 28 days after the final dose.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Smoldering Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '28158311', 'type': 'DERIVED', 'citation': 'Wichert S, Juliusson G, Johansson A, Sonesson E, Teige I, Wickenberg AT, Frendeus B, Korsgren M, Hansson M. 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 smoldering multiple myeloma. PLoS One. 2017 Feb 3;12(2):e0171205. doi: 10.1371/journal.pone.0171205. eCollection 2017.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect of BI-505 on tumor burden in patients diagnosed with smoldering multiple myeloma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Smoldering multiple myeloma based on the International Myeloma Working Group criteria:\n\n * Serum M-protein greater than or equal to 3 g/dL and/or bone marrow plasma cells greater than or equal to 10 percent.\n * Absence of end-organ damage such as lytic bone lesions, anemia, hypercalcemia or renal failure that can be attributed to a plasma cell proliferative disorder.\n* Male or female, 18 years or older.\n* Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1.\n\nExclusion Criteria:\n\n* Patients with a diagnosis of symptomatic multiple myeloma or a clinical suspicion of an ongoing progression into symptomatic multiple myeloma.\n* Prior or current treatment having a proven or potential impact on myeloma cell proliferation or survival (including conventional chemotherapies, biological therapies, immunomodulatory drugs, or proteasome inhibitors), as judged by the Investigator.\n* Severe other conditions.'}, 'identificationModule': {'nctId': 'NCT01838369', 'briefTitle': 'A Phase II Study of BI-505 in Smoldering Multiple Myeloma', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioInvent International AB'}, 'officialTitle': '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 Smoldering Multiple Myeloma', 'orgStudyIdInfo': {'id': '12-BI-505-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BI-505', 'interventionNames': ['Drug: BI-505']}], 'interventions': [{'name': 'BI-505', 'type': 'DRUG', 'armGroupLabels': ['BI-505']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE-22185', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Department of Hemtaology, Skåne University Hospital', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'overallOfficials': [{'name': 'Markus Hansson, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Hematology,Skåne University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioInvent International AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}