Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2026-01-01 @ 11:19 AM
Study NCT ID:
NCT03850704
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2019-02-22
First Post:
2019-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Patient Use of Selinexor and Dexamethasone for a Patient With Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C585161', 'term': 'selinexor'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'statusVerifiedDate': '2019-02', 'lastUpdateSubmitDate': '2019-02-20', 'studyFirstSubmitDate': '2019-02-20', 'studyFirstSubmitQcDate': '2019-02-20', 'lastUpdatePostDateStruct': {'date': '2019-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-22', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['MM'], 'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'This is an individual patient, expanded access protocol using Selinexor and dexamethasone ("Sd") for the treatment of Relapsed, Refractory multiple myeloma in a 64 year old male, "19023-UMN-01" weighing 105.7 kg. 19023-UMN-01 has IgG kappa myeloma that has relapsed after numerous treatments.', 'detailedDescription': 'Selinexor is an oral, first in class, slowly reversible, potent and Selective Inhibitor of Nuclear Export (SINE) compound that specifically blocks Exportin 1 (XPO1). It is one of the most promising investigational drugs available for this patient with clear risk and benefit assessment favoring potential benefit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients having relapsed/refractory multiple myeloma and neuropathy (or who are otherwise unable to tolerate bortezomib)\n* Aged 18 years and older\n* Patient able to provide written, informed consent to participate in and follow the KEAP Treatment Plan\n\nExclusion Criteria:\n\n* Known hypersensitivity to selinexor or any excipients.\n* Patient receiving any other investigational agent.\n* Any concurrent uncontrolled and active medical condition or disease (e.g., uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, etc.).\n* Known intolerance, hypersensitivity, or contraindication to glucocorticoids.\n* Active graft versus host disease (after allogeneic stem cell transplantation).\n* Active, unstable cardiovascular function:\n\n * Symptomatic ischemia, or uncontrolled clinically significant conduction abnormalities (e.g., patients with ventricular tachycardia on antiarrhythmics)\n * Congestive heart failure of New York Heart Association Class ≥ 3 or known leftventricular ejection fraction \\< 40%, or\n * Myocardial infarction within 3 months prior to C1D1.\n* Significant renal impairment with ongoing dialysis treatment\n* Active gastrointestinal dysfunction interfering with the patient's ability to swallow tablets, or any active gastrointestinal dysfunction that could, in the treating physician's opinion, interfere with absorption of treatment.\n* Any active, serious psychiatric, medical, or other conditions/situations which, in the treating physician's opinion, could compromise the patient's safety."}, 'identificationModule': {'nctId': 'NCT03850704', 'briefTitle': 'Single Patient Use of Selinexor and Dexamethasone for a Patient With Multiple Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'Masonic Cancer Center, University of Minnesota'}, 'orgStudyIdInfo': {'id': '2019EX023'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Selinexor', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Erica Warlick, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Hematology, Oncology and Transplantation, University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masonic Cancer Center, University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}