[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530130":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":37,"centralContacts":42,"locations":48,"responsibleParty":412,"collaborators":414,"id":421,"slug":422,"hasResults":423,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":11,"eligibilityCriteria":427,"healthyVolunteers":423,"sex":428,"minAge":429,"maxAge":11,"enrollmentInfo":430,"targetDuration":11,"studyType":433,"phases":434,"briefSummary":436,"conditions":437,"keywords":11,"overallStatus":51,"whyStopped":11,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":447,"locationsCount":448},{"fullName":5,"class":6},"Canadian Cancer Trials Group","NETWORK",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Lenalidomide & Dexamethasone","EXPERIMENTAL",null,[13,14],"Drug: Lenalidomide","Drug: Dexamethasone",{"label":16,"type":17,"description":18,"interventionNames":19},"Daratumumab, Lenalidomide, Dexamethasone & Isatuximab","ACTIVE_COMPARATOR","Standard of Care",[20,13,14,21],"Drug: Daratumumab","Drug: Isatuximab",[23,28,31,34],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"DRUG","Daratumumab","Dose determined at enrollment",[16],{"type":24,"name":29,"description":26,"armGroupLabels":30,"otherNames":11},"Lenalidomide",[16,9],{"type":24,"name":32,"description":26,"armGroupLabels":33,"otherNames":11},"Dexamethasone",[16,9],{"type":24,"name":35,"description":26,"armGroupLabels":36,"otherNames":11},"Isatuximab",[16],[38],{"name":39,"affiliation":40,"role":41},"Hira Mian","Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario Canada","STUDY_CHAIR",[43],{"name":44,"role":45,"phone":46,"phoneExt":11,"email":47},"Annette Hay","CONTACT","613-533-6430","ahay@ctg.queensu.ca",[49,66,80,92,106,120,133,147,160,173,185,197,210,223,236,249,262,276,290,303,312,326,341,351,361,371,385,399],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Cross Cancer Institute","RECRUITING","Edmonton","Alberta","T6G 1Z2","Canada","CA",{"type":58,"coordinates":59},"Point",[60,61],-113.46871,53.55014,{"lat":61,"lon":60},[64],{"name":65,"role":45,"phone":11,"phoneExt":11,"email":11},"Steven Shih",{"facility":67,"status":51,"city":68,"state":69,"zip":70,"country":55,"countryCode":56,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"BCCA - Kelowna","Kelowna","British Columbia","V1Y 5L3",{"type":58,"coordinates":72},[73,74],-119.48568,49.88307,{"lat":74,"lon":73},[77],{"name":78,"role":45,"phone":79,"phoneExt":11,"email":11},"Erma Gardner","250 712-3900",{"facility":81,"status":51,"city":82,"state":69,"zip":83,"country":55,"countryCode":56,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"BCCA - Vancouver","Vancouver","V5Z 4E6",{"type":58,"coordinates":85},[86,87],-123.11934,49.24966,{"lat":87,"lon":86},[90],{"name":91,"role":45,"phone":11,"phoneExt":11,"email":11},"Christopher Venner",{"facility":93,"status":51,"city":94,"state":95,"zip":96,"country":55,"countryCode":56,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"CancerCare Manitoba","Winnipeg","Manitoba","R3E 0V9",{"type":58,"coordinates":98},[99,100],-97.14704,49.8844,{"lat":100,"lon":99},[103],{"name":104,"role":45,"phone":105,"phoneExt":11,"email":11},"Rami R. Kotb","204 787-2108",{"facility":107,"status":51,"city":108,"state":109,"zip":110,"country":55,"countryCode":56,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"The Moncton Hospital","Moncton","New Brunswick","E1C 6Z8",{"type":58,"coordinates":112},[113,114],-64.7965,46.09454,{"lat":114,"lon":113},[117],{"name":118,"role":45,"phone":119,"phoneExt":11,"email":11},"Nizar Abdel-Samad","506 870-2404",{"facility":121,"status":51,"city":122,"state":109,"zip":123,"country":55,"countryCode":56,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Regional Health Authority B, Zone 2","Saint John","E2L 4L2",{"type":58,"coordinates":125},[126,127],-66.05616,45.27076,{"lat":127,"lon":126},[130],{"name":131,"role":45,"phone":132,"phoneExt":11,"email":11},"Anthony J. Reiman","506 648-6884",{"facility":134,"status":51,"city":135,"state":136,"zip":137,"country":55,"countryCode":56,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Dr. H. Bliss Murphy Cancer Centre","St. John's","Newfoundland and Labrador","A1B 3V6",{"type":58,"coordinates":139},[140,141],-52.70931,47.56494,{"lat":141,"lon":140},[144],{"name":145,"role":45,"phone":146,"phoneExt":11,"email":11},"Debra Bergstrom","709 777-7557",{"facility":148,"status":51,"city":149,"state":150,"zip":151,"country":55,"countryCode":56,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"Royal Victoria Regional Health Centre","Barrie","Ontario","L4M 6M2",{"type":58,"coordinates":153},[154,155],-79.66634,44.40011,{"lat":155,"lon":154},[158],{"name":159,"role":45,"phone":11,"phoneExt":11,"email":11},"Rouslan Kotchetkov",{"facility":161,"status":51,"city":162,"state":150,"zip":163,"country":55,"countryCode":56,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"William Osler Health System","Brampton","L6R 3J7",{"type":58,"coordinates":165},[166,167],-79.76633,43.68341,{"lat":167,"lon":166},[170],{"name":171,"role":45,"phone":172,"phoneExt":11,"email":11},"Savannah Norman","416 494-2120",{"facility":174,"status":51,"city":175,"state":150,"zip":176,"country":55,"countryCode":56,"cosmosGeoPoint":177,"geoPoint":181,"contacts":182},"Juravinski Cancer Centre at Hamilton Health Sciences","Hamilton","L8V 5C2",{"type":58,"coordinates":178},[179,180],-79.84963,43.25011,{"lat":180,"lon":179},[183],{"name":39,"role":45,"phone":184,"phoneExt":11,"email":11},"905 387-9495",{"facility":186,"status":51,"city":187,"state":150,"zip":188,"country":55,"countryCode":56,"cosmosGeoPoint":189,"geoPoint":193,"contacts":194},"Kingston Health Sciences Centre","Kingston","K7L 2V7",{"type":58,"coordinates":190},[191,192],-76.48098,44.22976,{"lat":192,"lon":191},[195],{"name":196,"role":45,"phone":11,"phoneExt":11,"email":11},"Bethany Monteith",{"facility":198,"status":51,"city":199,"state":150,"zip":200,"country":55,"countryCode":56,"cosmosGeoPoint":201,"geoPoint":205,"contacts":206},"Waterloo Regional Health Network (WRHN)","Kitchener","N2G 1G3",{"type":58,"coordinates":202},[203,204],-80.5112,43.42537,{"lat":204,"lon":203},[207],{"name":208,"role":45,"phone":209,"phoneExt":11,"email":11},"Armela Dicu","519 749-4370",{"facility":211,"status":51,"city":212,"state":150,"zip":213,"country":55,"countryCode":56,"cosmosGeoPoint":214,"geoPoint":218,"contacts":219},"London Health Sciences Centre Research Inc.","London","N6A 5W9",{"type":58,"coordinates":215},[216,217],-81.23304,42.98339,{"lat":217,"lon":216},[220],{"name":221,"role":45,"phone":222,"phoneExt":11,"email":11},"Martha Louzada","519 685-2391",{"facility":224,"status":51,"city":225,"state":150,"zip":226,"country":55,"countryCode":56,"cosmosGeoPoint":227,"geoPoint":231,"contacts":232},"Stronach Regional Health Centre at Southlake","Newmarket","L3Y 2P9",{"type":58,"coordinates":228},[229,230],-79.46631,44.05011,{"lat":230,"lon":229},[233],{"name":234,"role":45,"phone":235,"phoneExt":11,"email":11},"Peter James Anglin","905 895-4521",{"facility":237,"status":51,"city":238,"state":150,"zip":239,"country":55,"countryCode":56,"cosmosGeoPoint":240,"geoPoint":244,"contacts":245},"Lakeridge Health Oshawa","Oshawa","L1G 2B9",{"type":58,"coordinates":241},[242,243],-78.84957,43.90012,{"lat":243,"lon":242},[246],{"name":247,"role":45,"phone":248,"phoneExt":11,"email":11},"Ariah Joshua Schattner","905 576-8711",{"facility":250,"status":51,"city":251,"state":150,"zip":252,"country":55,"countryCode":56,"cosmosGeoPoint":253,"geoPoint":257,"contacts":258},"Ottawa Hospital Research Institute","Ottawa","K1H 8L6",{"type":58,"coordinates":254},[255,256],-75.69812,45.41117,{"lat":256,"lon":255},[259],{"name":260,"role":45,"phone":261,"phoneExt":11,"email":11},"Arleigh B. Robertson McCurdy","613 737-7700",{"facility":263,"status":51,"city":264,"state":150,"zip":265,"country":55,"countryCode":56,"cosmosGeoPoint":266,"geoPoint":270,"contacts":271},"Algoma District Cancer Program","Sault Ste. Marie","P6B 0A8",{"type":58,"coordinates":267},[268,269],-84.33325,46.51677,{"lat":269,"lon":268},[272],{"name":273,"role":45,"phone":274,"phoneExt":275,"email":11},"Danny Hill","705 759-3434","4450",{"facility":277,"status":51,"city":278,"state":150,"zip":279,"country":55,"countryCode":56,"cosmosGeoPoint":280,"geoPoint":284,"contacts":285},"Niagara Health System","St. Catharines","L2S 0A9",{"type":58,"coordinates":281},[282,283],-79.24267,43.17126,{"lat":283,"lon":282},[286],{"name":287,"role":45,"phone":288,"phoneExt":289,"email":11},"Huma Qawi","905 684-7271","43801",{"facility":291,"status":51,"city":292,"state":150,"zip":293,"country":55,"countryCode":56,"cosmosGeoPoint":294,"geoPoint":298,"contacts":299},"St. Michael's Hospital","Toronto","M5B 1W8",{"type":58,"coordinates":295},[296,297],-79.39864,43.70643,{"lat":297,"lon":296},[300],{"name":301,"role":45,"phone":302,"phoneExt":11,"email":11},"Martina Trinkaus","416 864-5632",{"facility":304,"status":51,"city":292,"state":150,"zip":305,"country":55,"countryCode":56,"cosmosGeoPoint":306,"geoPoint":308,"contacts":309},"St. Joseph's Health Centre","M6R 1B5",{"type":58,"coordinates":307},[296,297],{"lat":297,"lon":296},[310],{"name":311,"role":45,"phone":11,"phoneExt":11,"email":11},"Christie Kim",{"facility":313,"status":51,"city":314,"state":150,"zip":315,"country":55,"countryCode":56,"cosmosGeoPoint":316,"geoPoint":320,"contacts":321},"Windsor Regional Cancer Centre","Windsor","N8W 2X3",{"type":58,"coordinates":317},[318,319],-83.01654,42.30008,{"lat":319,"lon":318},[322],{"name":323,"role":45,"phone":324,"phoneExt":325,"email":11},"Sindu Mary Kanjeekal","519 253-5253","58616",{"facility":327,"status":51,"city":328,"state":329,"zip":330,"country":55,"countryCode":56,"cosmosGeoPoint":331,"geoPoint":335,"contacts":336},"CIUSSS de l'Est-de-I'lle-de-Montreal","Montreal","Quebec","H1T 2M4",{"type":58,"coordinates":332},[333,334],-73.58781,45.50884,{"lat":334,"lon":333},[337],{"name":338,"role":45,"phone":339,"phoneExt":340,"email":11},"Richard LeBlanc","514 252-3400","3404",{"facility":342,"status":51,"city":328,"state":329,"zip":343,"country":55,"countryCode":56,"cosmosGeoPoint":344,"geoPoint":346,"contacts":347},"The Jewish General Hospital","H3T 1E2",{"type":58,"coordinates":345},[333,334],{"lat":334,"lon":333},[348],{"name":349,"role":45,"phone":350,"phoneExt":11,"email":11},"Rayan Kaedbey","614 340-8222",{"facility":352,"status":51,"city":328,"state":329,"zip":353,"country":55,"countryCode":56,"cosmosGeoPoint":354,"geoPoint":356,"contacts":357},"St. Mary's Hospital","H3T 1M5",{"type":58,"coordinates":355},[333,334],{"lat":334,"lon":333},[358],{"name":359,"role":45,"phone":360,"phoneExt":11,"email":11},"Tanya Skamene","514 340-8222",{"facility":362,"status":51,"city":328,"state":329,"zip":363,"country":55,"countryCode":56,"cosmosGeoPoint":364,"geoPoint":366,"contacts":367},"The Research Institute of the McGill University","H4A 3J1",{"type":58,"coordinates":365},[333,334],{"lat":334,"lon":333},[368],{"name":369,"role":45,"phone":370,"phoneExt":11,"email":11},"Michael Sebag","514 398-8307",{"facility":372,"status":51,"city":373,"state":329,"zip":374,"country":55,"countryCode":56,"cosmosGeoPoint":375,"geoPoint":379,"contacts":380},"CHU de Quebec-Hopital l'Enfant-Jesus (HEJ)","Québec","G1J 1Z4",{"type":58,"coordinates":376},[377,378],-71.21454,46.81228,{"lat":378,"lon":377},[381],{"name":382,"role":45,"phone":383,"phoneExt":384,"email":11},"Julie Cote","418 525-4444","63115",{"facility":386,"status":51,"city":387,"state":388,"zip":389,"country":55,"countryCode":56,"cosmosGeoPoint":390,"geoPoint":394,"contacts":395},"Allan Blair Cancer Centre","Regina","Saskatchewan","S4T 7T1",{"type":58,"coordinates":391},[392,393],-104.6178,50.45008,{"lat":393,"lon":392},[396],{"name":397,"role":45,"phone":398,"phoneExt":11,"email":11},"Ibraheem Mohammed Othman","306 766-2691",{"facility":400,"status":51,"city":401,"state":388,"zip":402,"country":55,"countryCode":56,"cosmosGeoPoint":403,"geoPoint":407,"contacts":408},"Saskatoon Cancer Centre","Saskatoon","S7N 4H4",{"type":58,"coordinates":404},[405,406],-106.66892,52.13238,{"lat":406,"lon":405},[409],{"name":410,"role":45,"phone":411,"phoneExt":11,"email":11},"Julie Stakiw","306 655-2980",{"type":413,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[415,418],{"name":416,"class":417},"Canadian Institutes of Health Research (CIHR)","OTHER_GOV",{"name":419,"class":420},"Myeloma Canada","UNKNOWN","100530130","phase-3-fixed-duration-vs-continuous-anti-cd38-antibody-therapy-among-transplant-ineligible-older-adults-with-newly-diagnosed-multiple-myeloma-100530130",false,"NCT06182774","Fixed Duration vs Continuous Anti-CD38 Antibody Therapy Among Transplant Ineligible Older Adults With Newly-Diagnosed Multiple Myeloma","A Phase III Non-Inferiority Randomized Controlled Trial of Fixed Duration Versus Continuous Anti-CD38 Antibody Therapy Among Transplant Ineligible Older Adults With Newly-Diagnosed Multiple Myeloma","Inclusion Criteria:\n\n* Participants with newly diagnosed multiple myeloma that are transplant-ineligible\n* Measurable disease at the time of diagnosis, as defined by at least one of the following criteria: Serum monoclonal protein (M-protein) ≥ 5 g\u002FL; Urine M-protein ≥ 200 mg\u002F24 hours; Involved serum free light chain measurement ≥ 100 mg\u002FL, provided serum FLC ration is abnormal; For IgA patients whose disease can only be reliably measured by serum quantitative immunoglobulin ≥ 750 mg\u002FdL\n* Completed 18-20 cycles of daratumumab-lenalidomide-dexamethasone or isatuximab-lenalidomide-dexamethasone.\n* Obtained at least a partial response per the standard 2016 IMWG criteria\n* ECOG performance status 0-3\n* Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and\u002For health utility questionnaires in English, French, or a provided validated language.\n* Participant consent must be appropriately obtained in accordance with applicable local and regulatory requirements.\n* Participants must be accessible for treatment and follow-up.\n* In accordance with CCTG policy, protocol treatment is to begin within 2 working days of participant enrollment.\n* Participants of childbearing potential must have agreed to use a highly effective contraceptive method.\n\nExclusion Criteria:\n\n* Known history of concurrent amyloid light chain amyloidosis, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), and Waldenstrom's macroglobulinemia.\n* Patients receiving concurrent treatment with other anti-cancer therapy that would impact the ability to comply with protocol treatment are ineligible. Note: Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of protocol treatment are eligible for this trial\n* Active, uncontrolled bacterial, fungal, or viral infection within 7 days prior to enrollment.\n* Known human immunodeficiency virus (HIV) with CD4 count \\\u003C 350 cells\u002Fmicroliter. Note that patients who are HIV positive are eligible, provided:\n\n  * They are under treatment with antiretroviral therapy for at least 4 weeks prior to enrollment, with acceptable pharmacokinetic interactions and minimal overlapping toxicity with protocol therapy AND\n  * HIV viral load must be \\\u003C 400 copies\u002Fml within 16 weeks prior to enrollment AND\n  * No history of opportunistic infections within the past year.","ALL","18 Years",{"count":431,"type":432},570,"ESTIMATED","INTERVENTIONAL",[435],"PHASE3","Currently, daratumumab or isatuximab are given continuously (non-stop), along side lenalidomide, and dexamethasone as part of multiple myeloma treatment. are given continuously (non-stop). Recent observations suggest that stopping daratumumab or isatuximb after about a year and a half of treatment may work just as well as giving them continuously with lenalidomide and dexamethasone. Sometimes, bortezomib is also given. This study is being done to answer the question: is less daratumumab or isatuximab treatment as good as more?",[438],"Multiple Myeloma","2026-07-13",{"date":441,"type":442},"2026-07-14","ACTUAL",{"date":444,"type":442},"2024-04-10",{"date":446,"type":432},"2032-07-31",{"name":5,"class":6},28]