[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589403":3},{"organization":4,"outcomesModule":7,"designInfo":40,"detailedDescription":39,"studyPopulation":39,"armGroups":46,"interventions":86,"overallOfficials":106,"centralContacts":110,"locations":116,"responsibleParty":609,"collaborators":39,"id":611,"slug":612,"hasResults":613,"nctId":614,"briefTitle":615,"officialTitle":616,"acronym":39,"eligibilityCriteria":617,"healthyVolunteers":613,"sex":618,"minAge":619,"maxAge":39,"enrollmentInfo":620,"targetDuration":39,"studyType":623,"phases":624,"briefSummary":627,"conditions":628,"keywords":630,"overallStatus":119,"whyStopped":39,"lastUpdateSubmitDate":633,"lastUpdatePostDateStruct":634,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":641,"locationsCount":642},{"fullName":5,"class":6},"AbbVie","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":39},[9,13],{"measure":10,"description":11,"timeFrame":12},"Dose-Limiting Toxicities (DLT)s of ABBV-453","DLT events are defined as specific clinically significant adverse events or abnormal laboratory values assessed as events regardless of attribution to ABBV-453, except those clearly and incontrovertibly associated with underlying disease or extraneous causes.","Up to Approximately 45 Months",{"measure":14,"description":15,"timeFrame":16},"Number of Participants with Adverse Events (AE)s","An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.","Up to Approximately 4.5 Years",[18,21,24,27,30,33,36],{"measure":19,"description":20,"timeFrame":16},"Overall Response Rate (ORR)","ORR is defined as the percentage of participants with a confirmed partial response (PR), very good partial response (VGPR), complete response (CR) or stringent complete response (sCR) per Investigator review according to International Myeloma Working Group (IMWG) 2016 criteria.",{"measure":22,"description":23,"timeFrame":16},"Progression-Free Survival (PFS)","PFS is defined as time from first study treatment to the earliest documented disease progression according to IMWG 2016 criteria, as determined by the investigator, or death due to any cause, whichever occurs earlier.",{"measure":25,"description":26,"timeFrame":16},"Duration of Response (DOR)","DOR is defined as the time from the date of achieving the first confirmed sCR\u002FCR\u002FVGPR\u002FPR to the date of recurrence, disease progression according to IMWG 2016 criteria, as determined by the investigator, or death of any cause, whichever occurs earlier.",{"measure":28,"description":29,"timeFrame":16},"Time-to-Progression (TTP)","TTP will be defined as the number of days from the date of first dose to the date of earliest disease progression.",{"measure":31,"description":32,"timeFrame":16},"Time to Next Treatment","Time to next treatment will be defined as the number of days from the date of first dose to the date of next treatment.",{"measure":34,"description":35,"timeFrame":16},"Minimal Residual Disease (MRD) Negativity","MRD negativity is defined as having less than 1 myeloma cell that may remain in the bone marrow aspirate per 10\\^5 nucleated cells. Rate of MRD negativity will be determined.",{"measure":37,"description":38,"timeFrame":16},"Overall Survival (OS)","OS is defined as time from first study treatment to death due to any cause.",null,{"allocation":41,"interventionModel":42,"interventionModelDescription":39,"primaryPurpose":43,"observationalModel":39,"timePerspective":39,"maskingInfo":44},"RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":45,"maskingDescription":39,"whoMasked":39},"NONE",[47,55,59,65,69,74,78,82],{"label":48,"type":49,"description":50,"interventionNames":51},"Substudy 1: Dose Escalation Surzetoclax Combination","EXPERIMENTAL","Participants will receive various doses of surzetoclax in combination with daratumumab + dexamethasone, to determine the best dose of surzetoclax, as part of the total 4.5 year study duration.",[52,53,54],"Drug: Surzetoclax","Drug: Daratumumab","Drug: Dexamethasone",{"label":56,"type":49,"description":57,"interventionNames":58},"Substudy 1: Dose Optimization & Selection ABBV-453 Combination","Participants will receive 1 of 2 doses of ABBV-453 in combination with daratumumab + dexamethasone, as part of the total 4.5 year study duration.",[52,53,54],{"label":60,"type":61,"description":62,"interventionNames":63},"Substudy 1: Dose Optimization & Selection Control","ACTIVE_COMPARATOR","Participants will receive daratumumab, dexamethasone, and pomalidomide, as part of the total 4.5 year study duration.",[53,54,64],"Drug: Pomalidomide",{"label":66,"type":49,"description":67,"interventionNames":68},"Substudy 2: Dose Escalation ABBV-453 Monotherapy","Japanese participants will receive various doses of ABBV-453 as a monotherapy, to determine the best dose of ABBV-453, as part of the total 4.5 year study duration.",[52],{"label":70,"type":49,"description":71,"interventionNames":72},"Substudy 3: Dose Escalation Surzetoclax + Etentamig","Participants will receive various doses of both surzetoclax and etentamig, to determine the best dose of surzetoclax and etentamig, as part of the total 4.5 year study duration.",[52,73],"Drug: Etentamig",{"label":75,"type":49,"description":76,"interventionNames":77},"Substudy 3: Dose Optimization Etentamig Dose A Combination","Participants will receive etentamig dose A in combination with surzetoclax, as part of the total 4.5 year study duration.",[52,73],{"label":79,"type":49,"description":80,"interventionNames":81},"Substudy 3: Dose Optimization Etentamig Dose B Combination","Participants will receive etentamig dose B in combination with surzetoclax, as part of the total 4.5 year study duration.",[52,73],{"label":83,"type":49,"description":84,"interventionNames":85},"Substudy 3: Dose Optimization Etentamig Monotherapy","Participants will receive etentamig, as part of the total 4.5 year study duration.",[52,73],[87,92,96,99,102],{"type":88,"name":89,"description":90,"armGroupLabels":91,"otherNames":39},"DRUG","Surzetoclax","Oral",[48,56,66,70,75,79,83],{"type":88,"name":93,"description":94,"armGroupLabels":95,"otherNames":39},"Daratumumab","Subcutaneous (SC) Injection",[48,56,60],{"type":88,"name":97,"description":90,"armGroupLabels":98,"otherNames":39},"Dexamethasone",[48,56,60],{"type":88,"name":100,"description":90,"armGroupLabels":101,"otherNames":39},"Pomalidomide",[60],{"type":88,"name":103,"description":104,"armGroupLabels":105,"otherNames":39},"Etentamig","Intravenous Infusion",[70,75,79,83],[107],{"name":108,"affiliation":5,"role":109},"ABBVIE INC.","STUDY_DIRECTOR",[111],{"name":112,"role":113,"phone":114,"phoneExt":39,"email":115},"ABBVIE CALL CENTER","CONTACT","844-663-3742","abbvieclinicaltrials@abbvie.com",[117,131,141,151,161,170,180,189,198,208,218,228,238,250,259,269,278,290,300,309,321,331,341,351,361,373,383,392,401,413,423,431,440,449,460,472,481,486,491,499,511,521,527,537,549,558,567,579,589,598],{"facility":118,"status":119,"city":120,"state":121,"zip":122,"country":123,"countryCode":124,"cosmosGeoPoint":125,"geoPoint":130,"contacts":39},"University of Southern California \u002FID# 272414","RECRUITING","Los Angeles","California","90033","United States","US",{"type":126,"coordinates":127},"Point",[128,129],-118.24368,34.05223,{"lat":129,"lon":128},{"facility":132,"status":119,"city":133,"state":134,"zip":135,"country":123,"countryCode":124,"cosmosGeoPoint":136,"geoPoint":140,"contacts":39},"Smilow Cancer Center At Yale-New Haven \u002FID# 272447","New Haven","Connecticut","06511",{"type":126,"coordinates":137},[138,139],-72.92816,41.30815,{"lat":139,"lon":138},{"facility":142,"status":119,"city":143,"state":144,"zip":145,"country":123,"countryCode":124,"cosmosGeoPoint":146,"geoPoint":150,"contacts":39},"Dana-Farber Cancer Institute \u002FID# 271846","Boston","Massachusetts","02215",{"type":126,"coordinates":147},[148,149],-71.05977,42.35843,{"lat":149,"lon":148},{"facility":152,"status":119,"city":153,"state":154,"zip":155,"country":123,"countryCode":124,"cosmosGeoPoint":156,"geoPoint":160,"contacts":39},"University of Michigan Health System - Ann Arbor \u002FID# 271536","Ann Arbor","Michigan","48109",{"type":126,"coordinates":157},[158,159],-83.74088,42.27756,{"lat":159,"lon":158},{"facility":162,"status":119,"city":163,"state":163,"zip":164,"country":123,"countryCode":124,"cosmosGeoPoint":165,"geoPoint":169,"contacts":39},"Memorial Sloan Kettering Cancer Center - New York - York Avenue \u002FID# 271214","New York","10065",{"type":126,"coordinates":166},[167,168],-74.00597,40.71427,{"lat":168,"lon":167},{"facility":171,"status":119,"city":172,"state":173,"zip":174,"country":123,"countryCode":124,"cosmosGeoPoint":175,"geoPoint":179,"contacts":39},"University of North Carolina at Chapel Hill \u002FID# 272454","Chapel Hill","North Carolina","27514",{"type":126,"coordinates":176},[177,178],-79.05584,35.9132,{"lat":178,"lon":177},{"facility":181,"status":119,"city":182,"state":173,"zip":183,"country":123,"countryCode":124,"cosmosGeoPoint":184,"geoPoint":188,"contacts":39},"Atrium Health Levine Cancer Institute \u002FID# 271510","Charlotte","28204",{"type":126,"coordinates":185},[186,187],-80.84313,35.22709,{"lat":187,"lon":186},{"facility":190,"status":119,"city":191,"state":173,"zip":192,"country":123,"countryCode":124,"cosmosGeoPoint":193,"geoPoint":197,"contacts":39},"Wake Forest Baptist Health \u002FID# 271294","Winston-Salem","27103",{"type":126,"coordinates":194},[195,196],-80.24422,36.09986,{"lat":196,"lon":195},{"facility":199,"status":119,"city":200,"state":201,"zip":202,"country":123,"countryCode":124,"cosmosGeoPoint":203,"geoPoint":207,"contacts":39},"Oregon Health and Science University \u002FID# 272282","Portland","Oregon","97239",{"type":126,"coordinates":204},[205,206],-122.67621,45.52345,{"lat":206,"lon":205},{"facility":209,"status":119,"city":210,"state":211,"zip":212,"country":123,"countryCode":124,"cosmosGeoPoint":213,"geoPoint":217,"contacts":39},"University of Texas - Southwestern Medical Center \u002FID# 271914","Dallas","Texas","75235",{"type":126,"coordinates":214},[215,216],-96.80667,32.78306,{"lat":216,"lon":215},{"facility":219,"status":119,"city":220,"state":221,"zip":222,"country":123,"countryCode":124,"cosmosGeoPoint":223,"geoPoint":227,"contacts":39},"Huntsman Cancer Institute \u002FID# 271618","Salt Lake City","Utah","84112",{"type":126,"coordinates":224},[225,226],-111.89105,40.76078,{"lat":226,"lon":225},{"facility":229,"status":119,"city":230,"state":231,"zip":232,"country":123,"countryCode":124,"cosmosGeoPoint":233,"geoPoint":237,"contacts":39},"Northwest Medical Specialties Tacoma \u002FID# 272506","Tacoma","Washington","98405",{"type":126,"coordinates":234},[235,236],-122.44429,47.25288,{"lat":236,"lon":235},{"facility":239,"status":119,"city":240,"state":241,"zip":242,"country":243,"countryCode":244,"cosmosGeoPoint":245,"geoPoint":249,"contacts":39},"Liverpool Hospital \u002FID# 272002","Liverpool","New South Wales","2170","Australia","AU",{"type":126,"coordinates":246},[247,248],150.92588,-33.91938,{"lat":248,"lon":247},{"facility":251,"status":119,"city":252,"state":241,"zip":253,"country":243,"countryCode":244,"cosmosGeoPoint":254,"geoPoint":258,"contacts":39},"Calvary Mater Newcastle \u002FID# 272498","Waratah","2298",{"type":126,"coordinates":255},[256,257],151.72647,-32.90667,{"lat":257,"lon":256},{"facility":260,"status":119,"city":261,"state":262,"zip":263,"country":243,"countryCode":244,"cosmosGeoPoint":264,"geoPoint":268,"contacts":39},"St Vincent's Hospital - Melbourne \u002FID# 271997","Fitzroy","Victoria","3065",{"type":126,"coordinates":265},[266,267],144.97833,-37.79839,{"lat":267,"lon":266},{"facility":270,"status":119,"city":271,"state":262,"zip":272,"country":243,"countryCode":244,"cosmosGeoPoint":273,"geoPoint":277,"contacts":39},"Epworth HealthCare \u002FID# 272497","Richmond","3121",{"type":126,"coordinates":274},[275,276],145.00176,-37.81819,{"lat":276,"lon":275},{"facility":279,"status":119,"city":280,"state":281,"zip":282,"country":283,"countryCode":284,"cosmosGeoPoint":285,"geoPoint":289,"contacts":39},"UZ Gent \u002FID# 271432","Ghent","Oost-Vlaanderen","9000","Belgium","BE",{"type":126,"coordinates":286},[287,288],3.71667,51.05,{"lat":288,"lon":287},{"facility":291,"status":119,"city":292,"state":293,"zip":294,"country":283,"countryCode":284,"cosmosGeoPoint":295,"geoPoint":299,"contacts":39},"Universitair Ziekenhuis Leuven \u002FID# 272382","Leuven","Vlaams-Brabant","3000",{"type":126,"coordinates":296},[297,298],4.70093,50.87959,{"lat":298,"lon":297},{"facility":301,"status":119,"city":302,"state":39,"zip":303,"country":283,"countryCode":284,"cosmosGeoPoint":304,"geoPoint":308,"contacts":39},"CHU de Liege \u002FID# 271430","Liège","4000",{"type":126,"coordinates":305},[306,307],5.56749,50.63373,{"lat":307,"lon":306},{"facility":310,"status":119,"city":311,"state":312,"zip":313,"country":314,"countryCode":315,"cosmosGeoPoint":316,"geoPoint":320,"contacts":39},"CHU de Montpellier - Hopital Saint Eloi \u002FID# 275570","Montpellier","Herault","34295","France","FR",{"type":126,"coordinates":317},[318,319],3.87635,43.61093,{"lat":319,"lon":318},{"facility":322,"status":119,"city":323,"state":324,"zip":325,"country":314,"countryCode":315,"cosmosGeoPoint":326,"geoPoint":330,"contacts":39},"Centre Hospitalier Universitaire de Poitiers \u002FID# 275563","Poitiers","New Aquitaine","86021",{"type":126,"coordinates":327},[328,329],0.34348,46.58261,{"lat":329,"lon":328},{"facility":332,"status":119,"city":333,"state":334,"zip":335,"country":314,"countryCode":315,"cosmosGeoPoint":336,"geoPoint":340,"contacts":39},"IUCT Oncopole \u002FID# 275568","Toulouse","Occitanie","31059",{"type":126,"coordinates":337},[338,339],1.44367,43.60426,{"lat":339,"lon":338},{"facility":342,"status":119,"city":343,"state":344,"zip":345,"country":314,"countryCode":315,"cosmosGeoPoint":346,"geoPoint":350,"contacts":39},"Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME \u002FID# 275562","Nantes","Pays de la Loire Region","44000",{"type":126,"coordinates":347},[348,349],-1.55336,47.21725,{"lat":349,"lon":348},{"facility":352,"status":119,"city":353,"state":354,"zip":355,"country":314,"countryCode":315,"cosmosGeoPoint":356,"geoPoint":360,"contacts":39},"Hopital Universitaire Necker Enfants Malades \u002FID# 275571","Paris","Île-de-France Region","75015",{"type":126,"coordinates":357},[358,359],2.3488,48.85341,{"lat":359,"lon":358},{"facility":362,"status":119,"city":363,"state":364,"zip":365,"country":366,"countryCode":367,"cosmosGeoPoint":368,"geoPoint":372,"contacts":39},"Universitaetsklinikum Heidelberg \u002FID# 275598","Heidelberg","Baden-Wurttemberg","69120","Germany","DE",{"type":126,"coordinates":369},[370,371],8.69079,49.40768,{"lat":371,"lon":370},{"facility":374,"status":119,"city":375,"state":376,"zip":377,"country":366,"countryCode":367,"cosmosGeoPoint":378,"geoPoint":382,"contacts":39},"Klinikum der Universitaet Muenchen Grosshadern \u002FID# 276658","Munich","Bavaria","81337",{"type":126,"coordinates":379},[380,381],11.57549,48.13743,{"lat":381,"lon":380},{"facility":384,"status":119,"city":385,"state":376,"zip":386,"country":366,"countryCode":367,"cosmosGeoPoint":387,"geoPoint":391,"contacts":39},"Universitaetsklinikum Wuerzburg \u002FID# 276657","Würzburg","97080",{"type":126,"coordinates":388},[389,390],9.95121,49.79391,{"lat":390,"lon":389},{"facility":393,"status":119,"city":394,"state":39,"zip":395,"country":366,"countryCode":367,"cosmosGeoPoint":396,"geoPoint":400,"contacts":39},"Universitaetsklinikum Hamburg-Eppendorf \u002FID# 275803","Hamburg","20246",{"type":126,"coordinates":397},[398,399],9.99302,53.55073,{"lat":399,"lon":398},{"facility":402,"status":119,"city":403,"state":404,"zip":405,"country":406,"countryCode":407,"cosmosGeoPoint":408,"geoPoint":412,"contacts":39},"Rabin Medical Center. \u002FID# 272073","Petah Tikva","Central District","4941492","Israel","IL",{"type":126,"coordinates":409},[410,411],34.88747,32.08707,{"lat":411,"lon":410},{"facility":414,"status":119,"city":415,"state":416,"zip":417,"country":406,"countryCode":407,"cosmosGeoPoint":418,"geoPoint":422,"contacts":39},"The Chaim Sheba Medical Center \u002FID# 271251","Ramat Gan","Tel Aviv","5265601",{"type":126,"coordinates":419},[420,421],34.81065,32.08227,{"lat":421,"lon":420},{"facility":424,"status":119,"city":416,"state":416,"zip":425,"country":406,"countryCode":407,"cosmosGeoPoint":426,"geoPoint":430,"contacts":39},"Tel Aviv Sourasky Medical Center \u002FID# 271252","6423906",{"type":126,"coordinates":427},[428,429],34.78057,32.08088,{"lat":429,"lon":428},{"facility":432,"status":119,"city":433,"state":39,"zip":434,"country":406,"countryCode":407,"cosmosGeoPoint":435,"geoPoint":439,"contacts":39},"Rambam Health Care Campus- Haifa \u002FID# 271256","Haifa","3109601",{"type":126,"coordinates":436},[437,438],34.99928,32.81303,{"lat":438,"lon":437},{"facility":441,"status":119,"city":442,"state":39,"zip":443,"country":406,"countryCode":407,"cosmosGeoPoint":444,"geoPoint":448,"contacts":39},"Hadassah Medical Center-Hebrew University \u002FID# 271253","Jerusalem","91120",{"type":126,"coordinates":445},[446,447],35.21633,31.76904,{"lat":447,"lon":446},{"facility":450,"status":119,"city":451,"state":39,"zip":452,"country":453,"countryCode":454,"cosmosGeoPoint":455,"geoPoint":459,"contacts":39},"Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico \u002FID# 276306","Milan","20122","Italy","IT",{"type":126,"coordinates":456},[457,458],12.59836,42.78235,{"lat":458,"lon":457},{"facility":461,"status":119,"city":462,"state":463,"zip":464,"country":465,"countryCode":466,"cosmosGeoPoint":467,"geoPoint":471,"contacts":39},"Nagoya City University Hospital \u002FID# 271427","Nagoya","Aichi-ken","467-8602","Japan","JP",{"type":126,"coordinates":468},[469,470],136.90641,35.18147,{"lat":470,"lon":469},{"facility":473,"status":119,"city":474,"state":474,"zip":475,"country":465,"countryCode":466,"cosmosGeoPoint":476,"geoPoint":480,"contacts":39},"University Hospital Kyoto Prefectural University of Medicine \u002FID# 271911","Kyoto","602-8566",{"type":126,"coordinates":477},[478,479],135.75385,35.02107,{"lat":479,"lon":478},{"facility":482,"status":119,"city":483,"state":484,"zip":485,"country":465,"countryCode":466,"cosmosGeoPoint":39,"geoPoint":39,"contacts":39},"The University of Osaka Hospital \u002FID# 271636","Suita-shi","Osaka","565-0871",{"facility":487,"status":119,"city":488,"state":489,"zip":490,"country":465,"countryCode":466,"cosmosGeoPoint":39,"geoPoint":39,"contacts":39},"Japanese Red Cross Medical Center \u002FID# 272018","Shibuya-ku","Tokyo","150-8935",{"facility":492,"status":119,"city":489,"state":39,"zip":493,"country":465,"countryCode":466,"cosmosGeoPoint":494,"geoPoint":498,"contacts":39},"The Jikei University Hospital \u002FID# 272091","105-8461",{"type":126,"coordinates":495},[496,497],139.69171,35.6895,{"lat":497,"lon":496},{"facility":500,"status":119,"city":501,"state":502,"zip":503,"country":504,"countryCode":505,"cosmosGeoPoint":506,"geoPoint":510,"contacts":39},"Uniwersytecki Szpital Kliniczny W Poznaniu - Przybyszewskiego \u002FID# 276237","Poznan","Greater Poland Voivodeship","60-355","Poland","PL",{"type":126,"coordinates":507},[508,509],16.92993,52.40692,{"lat":509,"lon":508},{"facility":512,"status":119,"city":513,"state":514,"zip":515,"country":504,"countryCode":505,"cosmosGeoPoint":516,"geoPoint":520,"contacts":39},"Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie \u002FID# 276052","Lublin","Lublin Voivodeship","20-081",{"type":126,"coordinates":517},[518,519],22.57009,51.25058,{"lat":519,"lon":518},{"facility":522,"status":119,"city":513,"state":514,"zip":523,"country":504,"countryCode":505,"cosmosGeoPoint":524,"geoPoint":526,"contacts":39},"Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie \u002FID# 276352","20-090",{"type":126,"coordinates":525},[518,519],{"lat":519,"lon":518},{"facility":528,"status":119,"city":529,"state":530,"zip":531,"country":504,"countryCode":505,"cosmosGeoPoint":532,"geoPoint":536,"contacts":39},"Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada \u002FID# 276263","Warsaw","Masovian Voivodeship","02-781",{"type":126,"coordinates":533},[534,535],21.01178,52.22977,{"lat":535,"lon":534},{"facility":538,"status":119,"city":539,"state":540,"zip":541,"country":542,"countryCode":543,"cosmosGeoPoint":544,"geoPoint":548,"contacts":39},"Instituto Portugues de Oncologia de Lisboa Francisco Gentil \u002FID# 275873","Lisbon","Lisbon District","1099-023","Portugal","PT",{"type":126,"coordinates":545},[546,547],-9.1498,38.72509,{"lat":547,"lon":546},{"facility":550,"status":119,"city":551,"state":39,"zip":552,"country":542,"countryCode":543,"cosmosGeoPoint":553,"geoPoint":557,"contacts":39},"Unidade Local de Saude de Braga, EPE \u002FID# 275853","Braga","4710-243",{"type":126,"coordinates":554},[555,556],-8.42311,41.5514,{"lat":556,"lon":555},{"facility":559,"status":119,"city":560,"state":39,"zip":561,"country":542,"countryCode":543,"cosmosGeoPoint":562,"geoPoint":566,"contacts":39},"Instituto Portugues de Oncologia do Porto Francisco Gentil \u002FID# 275851","Porto","4200-072",{"type":126,"coordinates":563},[564,565],-8.61097,41.1485,{"lat":565,"lon":564},{"facility":568,"status":119,"city":569,"state":570,"zip":571,"country":572,"countryCode":573,"cosmosGeoPoint":574,"geoPoint":578,"contacts":39},"Karolinska University Hospital Solna \u002FID# 271674","Solna","Stockholm County","171 64","Sweden","SE",{"type":126,"coordinates":575},[576,577],18.00086,59.36004,{"lat":577,"lon":576},{"facility":580,"status":119,"city":581,"state":582,"zip":583,"country":572,"countryCode":573,"cosmosGeoPoint":584,"geoPoint":588,"contacts":39},"Sodra Alvsborgs sjukhus \u002FID# 271822","Borås","Västra Götaland County","501 82",{"type":126,"coordinates":585},[586,587],12.9401,57.72101,{"lat":587,"lon":586},{"facility":590,"status":119,"city":591,"state":582,"zip":592,"country":572,"countryCode":573,"cosmosGeoPoint":593,"geoPoint":597,"contacts":39},"Sahlgrenska Universitetssjukhuset \u002FID# 272448","Gothenburg","413 46",{"type":126,"coordinates":594},[595,596],11.96679,57.70716,{"lat":596,"lon":595},{"facility":599,"status":119,"city":600,"state":39,"zip":601,"country":602,"countryCode":603,"cosmosGeoPoint":604,"geoPoint":608,"contacts":39},"The Christie NHS Foundation Trust - Christie Hospital \u002FID# 276276","Manchester","M20 4BX","United Kingdom","UK",{"type":126,"coordinates":605},[606,607],-2.23743,53.48095,{"lat":607,"lon":606},{"type":610,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100589403","phase-1-a-study-to-assess-adverse-events-and-change-in-disease-activity-of-oral-surzetoclax-alone-or-in-combination-with-subcutaneous-andor-oral-antimyeloma-agents-in-adult-participants-with-multiple-myeloma-mm-100589403",false,"NCT06953960","A Study to Assess Adverse Events and Change in Disease Activity of Oral Surzetoclax Alone or in Combination With Subcutaneous and\u002For Oral Antimyeloma Agents in Adult Participants With Multiple Myeloma (MM)","A Phase 1\u002F2, Open-Label, Platform Study to Evaluate Safety and Efficacy of the BCL-2 Inhibitor Surzetoclax (ABBV-453) Given as Monotherapy or in Combination With Antimyeloma Regimens in Subjects With Multiple Myeloma","Inclusion Criteria:\n\n* Documented diagnosis of multiple myeloma (MM) based on standard international myeloma working group (IMWG) diagnostic criteria.\n* All participants must have measurable disease per central laboratory with at least 1 of the following assessed within 28 days prior to enrollment:\n\n  * Serum M-protein \\>= 0.5 g\u002FdL (\\>= 5g\u002FL); OR\n  * Urine M-protein \\>= 200 mg\u002F24 hours; OR\n  * For participants without measurable serum and urine M-protein: Serum free light chain (sFLC) \\>= 10 mg\u002FdL (100 mg\u002FL), provided sFLC ratio is abnormal.\n* B-cell lymphoma (BCL)-2 inhibitor treatment naïve.\n* t(11;14) positive status and\u002For BCL2 high status.\n* Must have confirmed diagnosis of relapsed or refractory (R\u002FR) multiple myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen, based on the investigator's determination of the international myeloma working group (IMWG) 2016 criteria.\n\nExclusion Criteria:\n\n* Major surgery within 4 weeks of study treatment or planned during study participation.\n* Recent infection requiring systemic treatment that was completed \\\u003C= 14 days before first dose of study treatment and\u002For uncontrolled active systemic infection.","ALL","18 Years",{"count":621,"type":622},325,"ESTIMATED","INTERVENTIONAL",[625,626],"PHASE1","PHASE2","Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the safety and change in disease activity of surzetoclax in adult participants with relapsed\u002Frefractory (R\u002FR) MM. Adverse events and change in disease activity will be assessed.\n\nSurzetoclax is an investigational drug being developed for the treatment of R\u002FR MM. In Substudy 1 there will be dose escalation and dose expansion phases where participants will receive various doses (escalation) or 1 of 2 doses (expansion) of surzetoclax in combination with daratumumab + dexamethasone, to determine the best dose of surzetoclax. In Substudy 2, there will be a dose escalation phase where participants will receive various doses of surzetoclax alone. In Substudy 3 there will be dose escalation and optimization phases where participants will receive various doses (escalation) or 1 of 2 doses (optimization) of of surzetoclax and etentamig to determine the best dose of surzetoclax and etentamig. Optimization will also include etentamig received alone. Approximately 325 adult participants with R\u002FR MM will be enrolled in the study in approximately 55 sites worldwide.\n\nIn Substudy 1 escalation phase, participants will receive oral surzetoclax tablets in combination with subcutaneous (SC) daratumumab injections + oral dexamethasone tablets and in the expansion phase, will receive 1 of 2 doses oral surzetoclax tablets in combination with SC daratumumab injections + oral dexamethasone tablets or daratumumab injections + oral pomalidomide + oral dexamethasone tablets. In Substudy 2, Japanese participants will receive oral surzetoclax tablets. In Substudy 3 escalation phase, participants will receive oral surzetoclax tablets in combination with IV etentamig and in the expansion phase, will receive 1 of 2 doses of both oral surzetoclax tablets in combination with of IV etentamig, or IV etentamig alone. The total study duration is approximately 4.5 years.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution. The effect of the treatment will be frequently checked by medical assessments, blood tests, and side effects.",[629],"Multiple Myeloma",[629,631,89,93,97,100,632],"ABBV-453","Cancer","2026-09-10",{"date":635,"type":636},"2026-09-14","ACTUAL",{"date":638,"type":636},"2025-07-23",{"date":640,"type":622},"2030-12",{"name":5,"class":6},50]