Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-26 @ 4:42 PM
Study NCT ID:
NCT01058434
Status:
COMPLETED
Last Update Posted:
2020-12-19
First Post:
2010-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of TKI258 in Relapsed or Refractory Multiple Myeloma Patients, Who Are With or Without t(4;14) Chromosomal Translocation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Spain']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C500007', 'term': '4-amino-5-fluoro-3-(5-(4-methylpiperazin-1-yl)-1H-benzimidazol-2-yl)quinolin-2(1H)-one'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'dispFirstSubmitDate': '2020-08-20', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-11', 'studyFirstSubmitDate': '2010-01-26', 'dispFirstSubmitQcDate': '2020-08-28', 'studyFirstSubmitQcDate': '2010-01-26', 'dispFirstPostDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall response rate', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'frequency and severity of adverse events as per CTCAE', 'timeFrame': 'throughout the study'}, {'measure': 'Progression free survival (PFS)', 'timeFrame': 'every 4 weeks'}, {'measure': 'Plasma exposure of TKI258', 'timeFrame': 'during the first 3 cycles'}]}, 'conditionsModule': {'keywords': ['Multiple myeloma', 'relapsed', 'refractory', 't(4;14)', 'FGFR3'], 'conditions': ['Relapsed or Refractory Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '25402977', 'type': 'RESULT', 'citation': 'Scheid C, Reece D, Beksac M, Spencer A, Callander N, Sonneveld P, Kalimi G, Cai C, Shi M, Scott JW, Stewart AK. Phase 2 study of dovitinib in patients with relapsed or refractory multiple myeloma with or without t(4;14) translocation. Eur J Haematol. 2015 Oct;95(4):316-24. doi: 10.1111/ejh.12491. Epub 2015 Jan 22.'}], 'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=9317', 'label': 'CTKI258A2204 Results at Novartis Clinical Trials Results Website'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate safety and efficacy of TKI258 in patients with relapsed or refractory multiple myeloma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Cytopathologically or histologically confirmed diagnosis of multiple myeloma previously requiring systemic treatment.\n2. Evidence of relapsed or refractory disease as documented from the prior treatment history. (Refractory myeloma is defined as disease that is non-responsive while on salvage therapy, or progresses within 60 days of last therapy. Relapsed myeloma is defined as previously treated myeloma which after a period of being off-therapy requires the initiation of salvage therapy. Detailed definitions provided in the PTS-1)\n3. Have received at least 2 prior treatment regimens for multiple myeloma including chemotherapy, autologous transplantation, immunotherapy, or other investigational agents. Pre-planned induction, followed by transplant and maintenance should be considered as one regimen.\n4. Presence of measurable disease as defined by at least one of the following;\n\n * Serum M-protein ≥ 1g/dL (measurable disease)\n * Urine M-protein ≥ 200mg/24 hours by protein electrophoresis (measurable disease)\n\nExclusion Criteria:\n\n1. Patients with non-secretory, or oligosecretory, multiple myeloma.\n2. Patients with symptomatic amyloidosis, or with plasma cell leukemia.\n3. Patients who have received allogeneic stem cell transplantation and who show evidence of active graft-versus-host disease that requires immunosuppressive therapy.\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01058434', 'briefTitle': 'Safety and Efficacy of TKI258 in Relapsed or Refractory Multiple Myeloma Patients, Who Are With or Without t(4;14) Chromosomal Translocation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase II, Multi-center, Non-randomized, Open-label Study of TKI258 in Patients With Relapsed or Refractory Multiple Myeloma, Who Are With or Without t(4;14) Translocation', 'orgStudyIdInfo': {'id': 'CTKI258A2204'}, 'secondaryIdInfos': [{'id': '2009-012417-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TKI258', 'interventionNames': ['Drug: TKI258']}], 'interventions': [{'name': 'TKI258', 'type': 'DRUG', 'armGroupLabels': ['TKI258']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36688', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of South Alabama / Mitchell Cancer Institute Dept. of Mitchell Cancer Inst.', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '91801', 'city': 'Alhambra', 'state': 'California', 'country': 'United States', 'facility': 'Central Hematology Oncology Medical Group', 'geoPoint': {'lat': 34.09529, 'lon': -118.12701}}, {'zip': '93454', 'city': 'Santa Maria', 'state': 'California', 'country': 'United States', 'facility': 'Central Coast Medical Oncology Corporation', 'geoPoint': {'lat': 34.95303, 'lon': -120.43572}}, {'zip': '92886', 'city': 'Yorba Linda', 'state': 'California', 'country': 'United States', 'facility': 'St. Jude Heritage Medical Group Virginia Crosson Cancer Center', 'geoPoint': {'lat': 33.88863, 'lon': -117.81311}}, {'zip': '83814', 'city': "Coeur d'Alene", 'state': 'Idaho', 'country': 'United States', 'facility': 'Kootenai Medical Center Kootenai Medical Center', 'geoPoint': {'lat': 47.67768, 'lon': -116.78047}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Hematology and Oncology Specialists Dept of Hem&Onc Specialist - 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