[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644114":3},{"organization":4,"outcomesModule":7,"designInfo":67,"detailedDescription":66,"studyPopulation":66,"armGroups":73,"interventions":89,"overallOfficials":111,"centralContacts":115,"locations":121,"responsibleParty":386,"collaborators":66,"id":388,"slug":389,"hasResults":390,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":394,"eligibilityCriteria":395,"healthyVolunteers":390,"sex":396,"minAge":397,"maxAge":66,"enrollmentInfo":398,"targetDuration":66,"studyType":401,"phases":402,"briefSummary":404,"conditions":405,"keywords":66,"overallStatus":124,"whyStopped":66,"lastUpdateSubmitDate":407,"lastUpdatePostDateStruct":408,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":416},{"fullName":5,"class":6},"Janssen Research & Development, LLC","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":66},[9,13],{"measure":10,"description":11,"timeFrame":12},"Progression-Free Survival (PFS)","PFS is defined as the duration from randomization to either confirmed progression of disease (PD) or death, whichever occurs first.","Up to approximately 62 months",{"measure":14,"description":15,"timeFrame":16},"Percentage of Participants Achieving 12-Month Minimal Residual Disease (MRD)-Negative Complete Response (CR)","12-month MRD-negative CR rate is defined as participants who achieve MRD-negative status at 12 months (+\u002F-3 months) from randomization, as determined by next-generation sequencing (NGS), prior to PD or subsequent antimyeloma therapy (including ASCT). Additionally, participant must achieve CR or better any time from randomization up to and including 12+3 months prior to PD or subsequent antimyeloma therapy, according to international myeloma working group (IMWG) criteria.","Up to 12 months",[18,22,26,29,32,35,38,41,44,47,51,54,57,60,63],{"measure":19,"description":20,"timeFrame":21},"Overall Survival (OS)","OS is defined as time from treatment assignment (that is, randomization in the trial) to date of death due to any cause.","Up to approximately 100 months",{"measure":23,"description":24,"timeFrame":25},"Percentage of Participants Achieving 24-Month Sustained MRD-Negative CR","24-month sustained MRD-negative CR is defined as participants who achieve MRD-negative CR status, as determined by NGS for at least 24 months without any examination showing MRD positive status or PD in between.","Up to 5 years",{"measure":27,"description":28,"timeFrame":25},"Percentage of Participants with Very Good Partial Response (VGPR) or Better","Percentage of participants achieving VGPR, CR, or stringent complete response (sCR) prior to subsequent antimyeloma therapy in accordance with IMWG criteria during or after the trial intervention will be reported.",{"measure":30,"description":31,"timeFrame":25},"Percentage of Participants with CR or Better","Percentage of participants achieving CR, or sCR prior to subsequent antimyeloma therapy in accordance with IMWG criteria during or after the trial intervention will be reported.",{"measure":33,"description":34,"timeFrame":25},"Percentage of Participants with Overall Response","Percentage of participants achieving PR or better prior to subsequent antimyeloma therapy in accordance with IMWG criteria during or after the trial intervention will be reported.",{"measure":36,"description":37,"timeFrame":25},"Percentage of Participants with Overall MRD-Negative CR","Percentage of participants who achieve MRD-negative status, as determined by NGS at any time point after randomization and prior to PD or subsequent antimyeloma therapy and who achieve CR or better will be reported.",{"measure":39,"description":40,"timeFrame":25},"Percentage of Participants with 12-Month Sustained MRD-Negative CR","Percentage of participants who achieve MRD-negative CR status, as determined by NGS, for at least 12 months without any examination showing MRD-positive status or PD in between will be reported.",{"measure":42,"description":43,"timeFrame":21},"Progression Free Survival After Subsequent Therapy (PFS2)","PFS2 is defined as the time interval between the date of randomization and date of event, which is defined as PD as assessed by investigator on the first subsequent line of antimyeloma therapy, or death from any cause, whichever occurs first.",{"measure":45,"description":46,"timeFrame":21},"Number of Participants with Adverse Events (AEs)","An AE is any untoward medical occurrence in a clinical trial participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention.",{"measure":48,"description":49,"timeFrame":50},"Change from Baseline in Health-Related Quality of Life (HRQoL) as Assessed by Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q) Scale Score","The MySIm-Q is a disease-specific PRO assessment complementary to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30). It includes 17 items with recall period of \"7 days\" and responses are reported on a 5-point verbal rating scale. Item responses are scored from 0 to 4. Higher scores indicate greater severity\u002Fimpact.","Baseline up to approximately 100 months",{"measure":52,"description":53,"timeFrame":50},"Change from Baseline in HRQoL as Assessed by EORTC-QLQ-C30 Scale Score","The EORTC QLQ-C30 Version 3 includes 30 items that make up 5 functional scales (physical, role, emotional, cognitive, and social), 1 global health status scale, 3 symptom scales (pain, fatigue, and nausea\u002Fvomiting), and 5 single symptom items (dyspnea, insomnia, appetite loss, constipation, and diarrhea) and a single impact item (financial difficulties). The item and scale scores are transformed to a 0 to 100 scale. A higher score represents greater HRQoL, better functioning, and more (worse) symptoms.",{"measure":55,"description":56,"timeFrame":50},"Change from Baseline in HRQoL as Assessed by European Quality of Life - 5 Dimensions-5 Levels (EQ-5D-5L) Scale Score","The EQ-5D-5L is a self-administered, generic health status measure, consisting of a descriptive system and a visual analog scale (EQ-VAS). The EQ-5D-5L descriptive system covers 5 dimensions of health (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression), each with 5 levels of severity (no problems, slight problems, moderate problems, severe problems, and unable to perform or extreme problems) with higher scores indicating worse HRQoL.",{"measure":58,"description":59,"timeFrame":50},"Change from Baseline in HRQoL as Assessed by Patient Global Impression of Symptom Severity (PGIS) Scale Score","The PGI-S is a 2-item questionnaire that assesses severity of the participant's symptoms and impacts of their symptoms, respectively, on a 5-point verbal rating scale, at the time of completing the PRO measure. Score ranges from 1 (None) to 5 (Very Severe). Higher scores indicate greater severity.",{"measure":61,"description":62,"timeFrame":50},"Change from Baseline in HRQoL as Assessed by European Organization for Research and Treatment of Cancer Item List (EORTC IL) 46","The EORTC IL46 consists of a single question that measures global impression of burden due to treatment-related symptoms. The response options range from \"not at all\" to \"very much\" on a 4 point scale where higher scores indicate more symptoms.",{"measure":64,"description":65,"timeFrame":21},"Percentage of Participants with Tolerability to Ramantamig-D Measured Through Patient Reported Outcomes (PROs)","Percentage of participants with tolerability to ramantamig-D measured through PROs will be reported.",null,{"allocation":68,"interventionModel":69,"interventionModelDescription":66,"primaryPurpose":70,"observationalModel":66,"timePerspective":66,"maskingInfo":71},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":72,"maskingDescription":66,"whoMasked":66},"NONE",[74,81],{"label":75,"type":76,"description":77,"interventionNames":78},"Arm A: Ramantamig plus Daratumumab (Ramantamig-D)","EXPERIMENTAL","Participants will receive ramantamig D subcutaneous injection.",[79,80],"Drug: Ramantamig","Drug: Daratumumab",{"label":82,"type":83,"description":84,"interventionNames":85},"Arm B: Investigator's Choice (DVRd or DRd)","ACTIVE_COMPARATOR","Participants will receive either daratumumab, bortezomib, lenalidomide, dexamethasone (DVRd) or daratumumab, lenalidomide, dexamethasone (DRd) as per investigator's choice.",[80,86,87,88],"Drug: Lenalidomide","Drug: Bortezomib","Drug: Dexamethasone",[90,95,99,103,107],{"type":91,"name":92,"description":93,"armGroupLabels":94,"otherNames":66},"DRUG","Ramantamig","Ramantamig will be administered subcutaneously.",[75],{"type":91,"name":96,"description":97,"armGroupLabels":98,"otherNames":66},"Daratumumab","Daratumumab will be administered subcutaneously.",[75,82],{"type":91,"name":100,"description":101,"armGroupLabels":102,"otherNames":66},"Lenalidomide","Lenalidomide will be administered orally.",[82],{"type":91,"name":104,"description":105,"armGroupLabels":106,"otherNames":66},"Bortezomib","Bortezomib will be administered subcutaneously or intravenously.",[82],{"type":91,"name":108,"description":109,"armGroupLabels":110,"otherNames":66},"Dexamethasone","Dexamethasone will be administered orally or intravenously.",[82],[112],{"name":113,"affiliation":5,"role":114},"Janssen Research & Development LLC Clinical trial","STUDY_DIRECTOR",[116],{"name":117,"role":118,"phone":119,"phoneExt":66,"email":120},"Study Contact","CONTACT","844-434-4210","Participate-In-This-Study1@its.jnj.com",[122,135,144,155,161,172,178,187,196,205,214,225,236,245,255,261,267,273,284,293,303,309,318,324,333,339,348,357,368,377],{"facility":123,"status":124,"city":125,"state":66,"zip":126,"country":127,"countryCode":128,"cosmosGeoPoint":129,"geoPoint":134,"contacts":66},"CHU Nantes","RECRUITING","Nantes","44000","France","FR",{"type":130,"coordinates":131},"Point",[132,133],-1.55336,47.21725,{"lat":133,"lon":132},{"facility":136,"status":124,"city":137,"state":66,"zip":138,"country":127,"countryCode":128,"cosmosGeoPoint":139,"geoPoint":143,"contacts":66},"CHU Lyon Sud","Pierre-Bénite","69495",{"type":130,"coordinates":140},[141,142],4.82424,45.70359,{"lat":142,"lon":141},{"facility":145,"status":124,"city":146,"state":66,"zip":147,"country":148,"countryCode":149,"cosmosGeoPoint":150,"geoPoint":154,"contacts":66},"Evangelismos S A","Athens","106 76","Greece","GR",{"type":130,"coordinates":151},[152,153],23.72784,37.98376,{"lat":153,"lon":152},{"facility":156,"status":124,"city":146,"state":66,"zip":157,"country":148,"countryCode":149,"cosmosGeoPoint":158,"geoPoint":160,"contacts":66},"Alexandra General Hospital of Athens","11528",{"type":130,"coordinates":159},[152,153],{"lat":153,"lon":152},{"facility":162,"status":124,"city":163,"state":66,"zip":164,"country":165,"countryCode":166,"cosmosGeoPoint":167,"geoPoint":171,"contacts":66},"Rambam Med.Center - Hematology Institute","Haifa","3109601","Israel","IL",{"type":130,"coordinates":168},[169,170],34.99928,32.81303,{"lat":170,"lon":169},{"facility":173,"status":124,"city":163,"state":66,"zip":174,"country":165,"countryCode":166,"cosmosGeoPoint":175,"geoPoint":177,"contacts":66},"Carmel Medical Center","3436212",{"type":130,"coordinates":176},[169,170],{"lat":170,"lon":169},{"facility":179,"status":124,"city":180,"state":66,"zip":181,"country":165,"countryCode":166,"cosmosGeoPoint":182,"geoPoint":186,"contacts":66},"Shaare Zedek Medical Center","Jerusalem","9103102",{"type":130,"coordinates":183},[184,185],35.21633,31.76904,{"lat":185,"lon":184},{"facility":188,"status":124,"city":189,"state":66,"zip":190,"country":165,"countryCode":166,"cosmosGeoPoint":191,"geoPoint":195,"contacts":66},"Rabin Medical Center","Petah Tikva","4941492",{"type":130,"coordinates":192},[193,194],34.88666,32.0888,{"lat":194,"lon":193},{"facility":197,"status":124,"city":198,"state":66,"zip":199,"country":165,"countryCode":166,"cosmosGeoPoint":200,"geoPoint":204,"contacts":66},"Sheba Medical Center","Ramat Gan","5262000",{"type":130,"coordinates":201},[202,203],34.81065,32.08227,{"lat":203,"lon":202},{"facility":206,"status":124,"city":207,"state":66,"zip":208,"country":165,"countryCode":166,"cosmosGeoPoint":209,"geoPoint":213,"contacts":66},"Tel Aviv Sourasky Medical Center","Tel Aviv","64239",{"type":130,"coordinates":210},[211,212],34.78057,32.08088,{"lat":212,"lon":211},{"facility":215,"status":124,"city":216,"state":66,"zip":217,"country":218,"countryCode":219,"cosmosGeoPoint":220,"geoPoint":224,"contacts":66},"Sint Antonius Ziekenhuis","Nieuwegein","3435CM","Netherlands","NL",{"type":130,"coordinates":221},[222,223],5.08056,52.02917,{"lat":223,"lon":222},{"facility":226,"status":124,"city":227,"state":66,"zip":228,"country":229,"countryCode":230,"cosmosGeoPoint":231,"geoPoint":235,"contacts":66},"Pratia Onkologia Katowice","Katowice","40 519","Poland","PL",{"type":130,"coordinates":232},[233,234],19.02173,50.2597,{"lat":234,"lon":233},{"facility":237,"status":124,"city":238,"state":66,"zip":239,"country":229,"countryCode":230,"cosmosGeoPoint":240,"geoPoint":244,"contacts":66},"Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie","Lublin","20 081",{"type":130,"coordinates":241},[242,243],22.57009,51.25058,{"lat":243,"lon":242},{"facility":246,"status":124,"city":247,"state":66,"zip":248,"country":249,"countryCode":66,"cosmosGeoPoint":250,"geoPoint":254,"contacts":66},"The Catholic University of Korea Eunpyeong St Marys Hospital","Seoul","03312","South Korea",{"type":130,"coordinates":251},[252,253],126.9784,37.566,{"lat":253,"lon":252},{"facility":256,"status":124,"city":247,"state":66,"zip":257,"country":249,"countryCode":66,"cosmosGeoPoint":258,"geoPoint":260,"contacts":66},"Asan Medical Center","05505",{"type":130,"coordinates":259},[252,253],{"lat":253,"lon":252},{"facility":262,"status":124,"city":247,"state":66,"zip":263,"country":249,"countryCode":66,"cosmosGeoPoint":264,"geoPoint":266,"contacts":66},"Samsung Medical Center","06351",{"type":130,"coordinates":265},[252,253],{"lat":253,"lon":252},{"facility":268,"status":124,"city":247,"state":66,"zip":269,"country":249,"countryCode":66,"cosmosGeoPoint":270,"geoPoint":272,"contacts":66},"The Catholic University of Korea Seoul St Mary s Hospital","06591",{"type":130,"coordinates":271},[252,253],{"lat":253,"lon":252},{"facility":274,"status":124,"city":275,"state":66,"zip":276,"country":277,"countryCode":278,"cosmosGeoPoint":279,"geoPoint":283,"contacts":66},"Hosp. Univ. Infanta Leonor","Madrid","28031","Spain","ES",{"type":130,"coordinates":280},[281,282],-3.70256,40.4165,{"lat":282,"lon":281},{"facility":285,"status":124,"city":286,"state":66,"zip":287,"country":277,"countryCode":278,"cosmosGeoPoint":288,"geoPoint":292,"contacts":66},"Hosp. Univ. Dr. Peset","Valencia","46017",{"type":130,"coordinates":289},[290,291],-0.37966,39.47391,{"lat":291,"lon":290},{"facility":294,"status":124,"city":295,"state":66,"zip":296,"country":297,"countryCode":66,"cosmosGeoPoint":298,"geoPoint":302,"contacts":66},"Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi","Ankara","06620","Turkey (Türkiye)",{"type":130,"coordinates":299},[300,301],32.85427,39.91987,{"lat":301,"lon":300},{"facility":304,"status":124,"city":295,"state":66,"zip":305,"country":297,"countryCode":66,"cosmosGeoPoint":306,"geoPoint":308,"contacts":66},"Liv Hospital Ankara","06680",{"type":130,"coordinates":307},[300,301],{"lat":301,"lon":300},{"facility":310,"status":124,"city":311,"state":66,"zip":312,"country":297,"countryCode":66,"cosmosGeoPoint":313,"geoPoint":317,"contacts":66},"Memorial Antalya Hastanesi","Antalya","07025",{"type":130,"coordinates":314},[315,316],30.69556,36.90812,{"lat":316,"lon":315},{"facility":319,"status":124,"city":311,"state":66,"zip":320,"country":297,"countryCode":66,"cosmosGeoPoint":321,"geoPoint":323,"contacts":66},"Akdeniz Universitesi Tip Fakultesi","07070",{"type":130,"coordinates":322},[315,316],{"lat":316,"lon":315},{"facility":325,"status":124,"city":326,"state":66,"zip":327,"country":297,"countryCode":66,"cosmosGeoPoint":328,"geoPoint":332,"contacts":66},"Medipol Mega University Hospital","Istanbul","34214",{"type":130,"coordinates":329},[330,331],28.94966,41.01384,{"lat":331,"lon":330},{"facility":334,"status":124,"city":326,"state":66,"zip":335,"country":297,"countryCode":66,"cosmosGeoPoint":336,"geoPoint":338,"contacts":66},"Istanbul Florence Nightingale Hastanesi","34381",{"type":130,"coordinates":337},[330,331],{"lat":331,"lon":330},{"facility":340,"status":124,"city":341,"state":66,"zip":342,"country":297,"countryCode":66,"cosmosGeoPoint":343,"geoPoint":347,"contacts":66},"Izmir Tinaztepe Universitesi Ozel Galen Hastanesi","Izmir","35001",{"type":130,"coordinates":344},[345,346],27.13838,38.41273,{"lat":346,"lon":345},{"facility":349,"status":124,"city":350,"state":66,"zip":351,"country":297,"countryCode":66,"cosmosGeoPoint":352,"geoPoint":356,"contacts":66},"Ondokuz Mayis University","Samsun","55139",{"type":130,"coordinates":353},[354,355],36.3361,41.27976,{"lat":355,"lon":354},{"facility":358,"status":124,"city":359,"state":66,"zip":360,"country":361,"countryCode":362,"cosmosGeoPoint":363,"geoPoint":367,"contacts":66},"Blackpool Victoria Hospital","Blackpool","FY3 8NR","United Kingdom","UK",{"type":130,"coordinates":364},[365,366],-3.05,53.81667,{"lat":366,"lon":365},{"facility":369,"status":124,"city":370,"state":66,"zip":371,"country":361,"countryCode":362,"cosmosGeoPoint":372,"geoPoint":376,"contacts":66},"Addenbrooke's Hospital","Cambridge","CB2 0QQ",{"type":130,"coordinates":373},[374,375],0.11667,52.2,{"lat":375,"lon":374},{"facility":378,"status":124,"city":379,"state":66,"zip":380,"country":361,"countryCode":362,"cosmosGeoPoint":381,"geoPoint":385,"contacts":66},"Kent and Canterbury Hospital","Canterbury","CT1 3NG",{"type":130,"coordinates":382},[383,384],1.07992,51.27904,{"lat":384,"lon":383},{"type":387,"investigatorFullName":66,"investigatorTitle":66,"investigatorAffiliation":66,"oldNameTitle":66,"oldOrganization":66},"SPONSOR","100644114","phase-3-a-study-of-ramantamig-plus-daratumumab-versus-daratumumab-bortezomib-lenalidomide-and-dexamethasone-dvrd-or-daratumumab-lenalidomide-and-dexamethasone-drd-in-participants-with-ndmm-for-whom-stem-cell-transplant-is-not-planned-100644114",false,"NCT07665450","A Study of Ramantamig Plus Daratumumab Versus Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd) or Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With NDMM For Whom Stem Cell Transplant is Not Planned","A Phase 3 Randomized Study Comparing Ramantamig Plus Daratumumab Versus Investigator's Choice of Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd) or Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy","TRIlogy-7","Inclusion criteria:\n\n* Documented diagnosis of multiple myeloma (MM) according to the IMWG diagnostic criteria\n* Not considered for high-dose chemotherapy with autologous stem cell transplantation (ASCT) due to: i. ineligible due to advanced age; or ii. ineligible due to presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT\n* Have an eastern cooperative oncology status (ECOG) performance status of 0 to 2\n* Must sign an informed consent form (ICF)\n* Measurable disease at screening as assessed by central laboratory as defined in the protocol\n\nExclusion criteria:\n\n* Myeloma Frailty Score of greater than or equal to (\\>=) 2 with the exception of participants who have a score of 2 based on age alone\n* Suspected or known allergies, hypersensitivity, intolerance or other contraindications to any trial intervention or its excipients\n* Had major surgery (for example, requiring general anesthesia) or had significant traumatic injury within 2 weeks prior to first dose of trial intervention or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the trial\n* Known active or prior CNS involvement or exhibits clinical signs of meningeal involvement of MM\n* Received any prior therapy(ies) for treatment of MM or smoldering myeloma, with the exception of emergency use of a short course of corticosteroids","ALL","18 Years",{"count":399,"type":400},1000,"ESTIMATED","INTERVENTIONAL",[403],"PHASE3","The main purpose of this study is to see how well a new treatment ramantamig-D works compared to standard treatments that is either DVRd or DRd on progression-free survival (PFS; time until a participant's disease worsens) and 12-month minimal residue disease (MRD)-negative complete response (CR) rate (percentage of participants in whom cancer cells are not detected) in participants with newly diagnosed multiple myeloma (NDMM; an initial stage of blood cancer that forms in a type of white blood cells \\[WBCs\\] called plasma cells) for whom stem cell transplant is not planned as initial therapy.",[406],"Multiple Myeloma","2026-10-02",{"date":409,"type":410},"2026-10-06","ACTUAL",{"date":412,"type":410},"2026-09-09",{"date":414,"type":400},"2035-02-02",{"name":5,"class":6},30]