Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-03-30 @ 2:36 AM
Study NCT ID:
NCT02628704
Status:
WITHDRAWN
Last Update Posted:
2023-01-26
First Post:
2015-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Selinexor, Carfilzomib, and Dexamethasone Versus Placebo, Carfilzomib, and Dexamethasone in 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'}, {'id': 'C524865', 'term': 'carfilzomib'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'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'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-24', 'studyFirstSubmitDate': '2015-12-02', 'studyFirstSubmitQcDate': '2015-12-09', 'lastUpdatePostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months'}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'Assessed from the date of first dose of blinded study treatment until the date that PD assessed up to 24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Karyopharm', 'selinexor', 'KPT-330', 'multiple myeloma', 'SCORE'], 'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'Double-blind study will compare the efficacy and assess safety of selinexor plus carfilzomib (Kyprolis®) plus low-dose dexamethasone versus placebo plus carfilzomib plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma.', 'detailedDescription': 'This is a Phase 2, two-arm, randomized, placebo-controlled, double-blind, multicenter study of relapsed/refractory multiple myeloma patients who have received at least two prior therapies, including a proteasome inhibitor and an IMiD.\n\nPatients who meet all the eligibility criteria will be randomized to one of two blinded treatment arms:\n\n* selinexor + carfilzomib + dexamethasone\n* placebo + carfilzomib + dexamethasone'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic, histologically confirmed MM, based on IMWG guidelines. Patients must have measurable disease as defined by at least one of the following:\n\n * Serum M-protein ≥ 1.0 g/dL by serum protein electrophoresis (SPEP) or for immunoglobulin (Ig) A myeloma, by quantitative IgA; or\n * Urinary M-protein excretion at least 200 mg/24 hours; or\n * Serum FLC ≥ 100 mg/L, provided that the serum FLC ratio is abnormal.\n * If serum protein electrophoresis is felt to be unreliable for routine M- protein measurement, then quantitative Ig levels by nephelometry or turbidometry are acceptable.\n* Must have received ≥ 2 prior anti-MM therapies including a proteasome inhibitor and an IMiD. The most recent proteasome inhibitor must not have been carfilzomib.\n* Patients previously treated with carfilzomib are eligible as long as they meet the following criteria:\n\n * Not received carfilzomib within 6 months (183 days) of Cycle 1 Day 1 (C1D1), and\n * Carfilzomib was not part of their most recent therapy for the treatment of MM, and\n * Did not discontinue carfilzomib treatment because of adverse effects.\n* MM that is refractory to the most recent treatment regimen. Refractory is defined as ≤ 25% response to therapy, or progression during therapy, or progression on or within 60 days after completion of therapy.\n\nExclusion Criteria:\n\n* Smoldering MM.\n* Active plasma cell leukemia.\n* MM that does not express M-protein or serum FLC (i.e., non-secretory MM is excluded; plasmacytomas without M-protein or serum FLC are excluded).\n* Documented active systemic amyloid light chain amyloidosis.\n* Active MM involving the central nervous system.\n* Active polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes (POEMS) syndrome.\n* Prior autologous stem cell transplantation \\< 1 month or allogenic stem cell transplantation \\< 3 months prior to C1D1.\n* Active graft versus host disease (after allogeneic stem cell transplantation) at C1D1.'}, 'identificationModule': {'nctId': 'NCT02628704', 'acronym': 'SCORE', 'briefTitle': 'Selinexor, Carfilzomib, and Dexamethasone Versus Placebo, Carfilzomib, and Dexamethasone in Multiple Myeloma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Karyopharm Therapeutics Inc'}, 'officialTitle': 'Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Selinexor (KPT-330), Carfilzomib, and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma Previously Treated With a Proteasome Inhibitor and an Immunomodulatory Drug', 'orgStudyIdInfo': {'id': 'KCP-330-015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Selinexor, carfilzomib and dexamethasone', 'description': '60 mg of selinexor and and 20 mg of dexamethasone will be taken twice weekly. On days coinciding with carfilzomib administration, selinexor will be given between 30 minutes and 4 hours after the end of the carfilzomib infusion.', 'interventionNames': ['Drug: Selinexor', 'Drug: carfilzomib', 'Drug: Dexamethasone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo, carfilzomib and dexamethasone', 'description': 'Placebo (for 60 mg of selinexor) and and 20 mg of dexamethasone will be taken twice weekly. On days coinciding with carfilzomib administration, Placebo (for 60 mg of selinexor) will be given between 30 minutes and 4 hours after the end of the carfilzomib infusion.', 'interventionNames': ['Drug: Placebo (for selinexor)', 'Drug: carfilzomib', 'Drug: Dexamethasone']}], 'interventions': [{'name': 'Selinexor', 'type': 'DRUG', 'otherNames': ['KCP-330'], 'description': 'The fixed dose of selinexor is 60 mg (three 20 mg tablets)', 'armGroupLabels': ['Selinexor, carfilzomib and dexamethasone']}, {'name': 'Placebo (for selinexor)', 'type': 'DRUG', 'description': 'sugar tablet manufactured to mimic selinexor tablet', 'armGroupLabels': ['Placebo, carfilzomib and dexamethasone']}, {'name': 'carfilzomib', 'type': 'DRUG', 'otherNames': ['Kyprolis'], 'description': 'Administered as an IV infusion on Days 1, 2, 8, 9, 15 and 16 of each 4-week cycle for Cycles 1-13 and then on Days 1, 2, 15, and 16 for Cycles ≥ 14.', 'armGroupLabels': ['Placebo, carfilzomib and dexamethasone', 'Selinexor, carfilzomib and dexamethasone']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Fixed oral dose of 20 mg will be given twice weekly (Days 1, 2, 8, 9, 15, 16, 22 and 23) in each cycle.', 'armGroupLabels': ['Placebo, carfilzomib and dexamethasone', 'Selinexor, carfilzomib and dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90069', 'city': 'West Hollywood', 'state': 'California', 'country': 'United States', 'facility': 'James R. Berenson MD, Inc', 'geoPoint': {'lat': 34.09001, 'lon': -118.36174}}, {'zip': '27518', 'city': 'Cary', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Waverly Hematology', 'geoPoint': {'lat': 35.79154, 'lon': -78.78112}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karyopharm Therapeutics Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}