[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100543492":3},{"organization":4,"outcomesModule":7,"designInfo":51,"detailedDescription":57,"studyPopulation":16,"armGroups":58,"interventions":71,"overallOfficials":16,"centralContacts":102,"locations":109,"responsibleParty":431,"collaborators":16,"id":433,"slug":434,"hasResults":435,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":439,"eligibilityCriteria":440,"healthyVolunteers":435,"sex":441,"minAge":442,"maxAge":16,"enrollmentInfo":443,"targetDuration":16,"studyType":446,"phases":447,"briefSummary":449,"conditions":450,"keywords":452,"overallStatus":112,"whyStopped":16,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":464},{"fullName":5,"class":6},"Sanofi","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Overall response rate (ORR)","ORR, defined as the proportion of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR), according to IMWG criteria assessed by investigator.","6 months after the Last Participant In (LPI) i.e., approximately 32 months",[14,18,20,22,26,29,32,35,38,42,46,49],{"measure":15,"description":16,"timeFrame":17},"Number of participants with infusion reactions (IRs)",null,"From the signing of informed consent to 30 days after the date of the last study treatment administration i.e., approximately 38 months",{"measure":19,"description":16,"timeFrame":17},"Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and laboratory abnormalities (per NCI-CTCAE grade or PCSA if NCI-CTCAE scale is not applicable)",{"measure":21,"description":16,"timeFrame":17},"Number of participants with injection site reactions (ISRs)",{"measure":23,"description":24,"timeFrame":25},"CR or better","CR or better assessed according to International Myeloma Working Group (IMWG) criteria assessed by investigator. CR is defined as negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, \\\u003C5% plasma cells in bone marrow aspirates, and a normal FLC ratio of 0.26-1.65 is required for FLC disease only. Two consecutive assessments are needed. No known evidence of progressive disease or new bone\u002Fsoft tissue lesions if radiographic studies were performed.","12 months after the Last Participant In (LPI) i.e., approximately 38 months",{"measure":27,"description":28,"timeFrame":25},"VGPR or better","VGPR or better assessed according to IMWG criteria assessed by investigator. VGPR is defined as Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level \\\u003C100 mg\u002F24 h, or ≥90% decrease in the sum of maximal perpendicular diameter compared to baseline in soft tissue plasmacytoma. FLC only: a ≥90% decrease in the difference between involved and uninvolved FLC levels. Two consecutive assessments are needed. No known evidence of progressive disease or new bone\u002Fsoft tissue lesions if radiographic studies were performed.",{"measure":30,"description":31,"timeFrame":25},"Duration of response (DOR)","DOR, defined as the time from date of first investigator determined response for achieving PR or better to first documentation of progressive disease (PD) determined by investigator or death, whichever occurred first.",{"measure":33,"description":34,"timeFrame":25},"Time to first response (TT1R)","TT1R, defined as the time from first isatuximab administration to first investigator-determined response (PR or better) that is subsequently confirmed.",{"measure":36,"description":37,"timeFrame":25},"Time to best response (TTBR)","TTBR, defined as the time from first isatuximab administration to first occurrence of investigator-determined best response (PR or better) that is subsequently confirmed.",{"measure":39,"description":40,"timeFrame":41},"Patient experience and Satisfaction Questionnaire v2 (PESQ v2)","The PESQ v2 has been designed to follow up on participant experience and satisfaction regarding the treatment (side effects and recommendation) and the administration method (comfortability, pain, side effects and overall satisfaction). This questionnaire has been developed using industry standard for instrument development and has been debriefed and adapted based on qualitative interviews with oncology patients. The more general treatment expectations instrument (v1) was further adapted and debriefed with patients to assess manual and OBDS subcutaneous delivery (v2). The trial specific version of the PESQ v2 contains of items administered for the duration of treatment. Response options are presented as a 5-point Likert scale ranging from Strongly agree\u002Fvery satisfied\u002Fdefinitely yes to strongly disagree\u002Fvery dissatisfied\u002Fdefinitely no.","Cycle 3\u002FDay 15 and Cycle 6\u002FDay 15",{"measure":43,"description":44,"timeFrame":45},"Positivity titer of anti-drug antibodies (ADA) in a subset of approximately 30 participants","Blood samples will be collected for assessing the presence of ADA against isatuximab in plasma from approximately 30 participants. Plasma samples will be screened for antibodies binding to isatuximab and the titer of confirmed positive samples will be reported.","From Cycle 1 Day 1 to follow-up (90 days from last administration) i.e, approximately up to 15 months (1 cycle = 28 days)",{"measure":47,"description":16,"timeFrame":48},"Maximum observed concentration (Cmax) of isatuximab in a subset of approximately 30 participants","Multiple timepoints in Cycle 1 (1 cycle = 28 days)",{"measure":50,"description":16,"timeFrame":48},"Cumulative area under the curve over the first 4 weeks of isatuximab treatment (AUC4 weeks) in a subset of approximately 30 participants",{"allocation":52,"interventionModel":53,"interventionModelDescription":16,"primaryPurpose":54,"observationalModel":16,"timePerspective":16,"maskingInfo":55},"NA","SINGLE_GROUP","TREATMENT",{"masking":56,"maskingDescription":16,"whoMasked":16},"NONE","The duration of the study for a participant will include a period for screening of up to 28 days, a study treatment period of 12 months (except early discontinuation), the end-of-treatment (EOT) visit about 30 days after the last dose of study treatment, and a study follow-up period until death or the final study cut-off date. A cycle duration is 28 days. After study treatment discontinuation, participants will return to the study site 30 days after the last dose of study treatment for the EOT visit or before further anti-myeloma therapy initiation, whichever comes first.",[59],{"label":60,"type":61,"description":62,"interventionNames":63},"Isatuximab in combination with weekly carfilzomib and dexamethasone","EXPERIMENTAL","Participants will receive isatuximab via SC-OBDS administration in combination with weekly carfilzomib and dexamethasone. Isatuximab will be administered on days 1, 8, 15 and 22 for Cycle 1 and then on days 1, 15 for subsequent cycles. Carfilzomib will be administered intravenously (IV) at a starting dose on Day 1 of Cycle 1 and then escalated dose on Days 8 and 15 of Cycle 1, followed by Days 1, 8 and 15 of subsequent cycles. Dexamethasone will be given on Days 1, 8, 15, and 22 of Cycle 1 and then on Days 1, 8 and 15 of subsequent cycles. Dexamethasone will be administered IV on Cycle 1 Day 1, and IV or PO in the subsequent administrations. 1 cycle = 28 days.",[64,65,66,67,68,69,70],"Drug: Isatuximab SC-OBDS","Drug: Montelukast","Drug: Dexamethasone","Drug: Acetaminophen","Drug: Diphenhydramine","Drug: Methylprednisolone","Drug: Carfilzomib",[72,80,84,88,91,95,99],{"type":73,"name":74,"description":75,"armGroupLabels":76,"otherNames":77},"DRUG","Isatuximab SC-OBDS","Pharmaceutical form:Solution for SC-OBDS administration-Route of administration:SC-OBDS",[60],[78,79],"SAR650984","Sarclisa",{"type":73,"name":81,"description":82,"armGroupLabels":83,"otherNames":16},"Montelukast","Pharmaceutical form:As per local commercial product-Route of administration:Oral",[60],{"type":73,"name":85,"description":86,"armGroupLabels":87,"otherNames":16},"Dexamethasone","Pharmaceutical form:As per local commercial product-Route of administration:Oral or IV",[60],{"type":73,"name":89,"description":86,"armGroupLabels":90,"otherNames":16},"Acetaminophen",[60],{"type":73,"name":92,"description":93,"armGroupLabels":94,"otherNames":16},"Diphenhydramine","Pharmaceutical form:As per local commercial product-Route of administration:Oral (as premedication) or IV\u002Foral equivalent (for management of infusion reaction)",[60],{"type":73,"name":96,"description":97,"armGroupLabels":98,"otherNames":16},"Methylprednisolone","Pharmaceutical form:As per local commercial product-Route of administration:IV",[60],{"type":73,"name":100,"description":97,"armGroupLabels":101,"otherNames":16},"Carfilzomib",[60],[103],{"name":104,"role":105,"phone":106,"phoneExt":107,"email":108},"Trial Transparency email recommended (Toll free for US & Canada)","CONTACT","800-633-1610","option 6","Contact-US@sanofi.com",[110,124,134,143,153,163,173,182,191,200,209,218,227,236,246,256,266,275,285,294,304,314,323,333,343,352,358,368,377,386,396,402,411,421],{"facility":111,"status":112,"city":113,"state":114,"zip":115,"country":116,"countryCode":117,"cosmosGeoPoint":118,"geoPoint":123,"contacts":16},"Mayo Clinic in Arizona - Phoenix- Site Number : 8400058","RECRUITING","Phoenix","Arizona","85054","United States","US",{"type":119,"coordinates":120},"Point",[121,122],-112.07404,33.44838,{"lat":122,"lon":121},{"facility":125,"status":112,"city":126,"state":127,"zip":128,"country":116,"countryCode":117,"cosmosGeoPoint":129,"geoPoint":133,"contacts":16},"Los Angeles Hematology Oncology Medical Group- Site Number : 8400027","Los Angeles","California","90017",{"type":119,"coordinates":130},[131,132],-118.24368,34.05223,{"lat":132,"lon":131},{"facility":135,"status":112,"city":136,"state":127,"zip":137,"country":116,"countryCode":117,"cosmosGeoPoint":138,"geoPoint":142,"contacts":16},"Private Practice - Dr. James R. Berenson- Site Number : 8400044","West Hollywood","90069",{"type":119,"coordinates":139},[140,141],-118.36174,34.09001,{"lat":141,"lon":140},{"facility":144,"status":112,"city":145,"state":146,"zip":147,"country":116,"countryCode":117,"cosmosGeoPoint":148,"geoPoint":152,"contacts":16},"Smilow Cancer Center at Yale-New Haven- Site Number : 8400020","New Haven","Connecticut","06511",{"type":119,"coordinates":149},[150,151],-72.92816,41.30815,{"lat":151,"lon":150},{"facility":154,"status":112,"city":155,"state":156,"zip":157,"country":116,"countryCode":117,"cosmosGeoPoint":158,"geoPoint":162,"contacts":16},"Maryland Oncology Hematology- Site Number : 8400038","Washington D.C.","District of Columbia","20017",{"type":119,"coordinates":159},[160,161],-77.03637,38.89511,{"lat":161,"lon":160},{"facility":164,"status":112,"city":165,"state":166,"zip":167,"country":116,"countryCode":117,"cosmosGeoPoint":168,"geoPoint":172,"contacts":16},"Life Clinical Trials - Coral Springs- Site Number : 8400055","Coral Springs","Florida","33071",{"type":119,"coordinates":169},[170,171],-80.2706,26.27119,{"lat":171,"lon":170},{"facility":174,"status":112,"city":175,"state":166,"zip":176,"country":116,"countryCode":117,"cosmosGeoPoint":177,"geoPoint":181,"contacts":16},"Center for Rheumatology, Immunology and Arthritis- Site Number : 8400031","Fort Lauderdale","33309",{"type":119,"coordinates":178},[179,180],-80.14338,26.12231,{"lat":180,"lon":179},{"facility":183,"status":112,"city":184,"state":166,"zip":185,"country":116,"countryCode":117,"cosmosGeoPoint":186,"geoPoint":190,"contacts":16},"Mayo Clinic in Florida- Site Number : 8400002","Jacksonville","32224",{"type":119,"coordinates":187},[188,189],-81.65565,30.33218,{"lat":189,"lon":188},{"facility":192,"status":112,"city":193,"state":166,"zip":194,"country":116,"countryCode":117,"cosmosGeoPoint":195,"geoPoint":199,"contacts":16},"The Oncology Institute of Hope & Innovation - Lakeland- Site Number : 8400054","Lakeland","33812",{"type":119,"coordinates":196},[197,198],-81.9498,28.03947,{"lat":198,"lon":197},{"facility":201,"status":112,"city":202,"state":166,"zip":203,"country":116,"countryCode":117,"cosmosGeoPoint":204,"geoPoint":208,"contacts":16},"D&H Pompano Research Center- Site Number : 8400049","Margate","33063",{"type":119,"coordinates":205},[206,207],-80.20644,26.24453,{"lat":207,"lon":206},{"facility":210,"status":112,"city":211,"state":166,"zip":212,"country":116,"countryCode":117,"cosmosGeoPoint":213,"geoPoint":217,"contacts":16},"Millennium Oncology - Pembroke Pines- Site Number : 8400011","Pembroke Pines","33024",{"type":119,"coordinates":214},[215,216],-80.22394,26.00315,{"lat":216,"lon":215},{"facility":219,"status":112,"city":220,"state":166,"zip":221,"country":116,"countryCode":117,"cosmosGeoPoint":222,"geoPoint":226,"contacts":16},"BRCR Global- Site Number : 8400008","Plantation","33322",{"type":119,"coordinates":223},[224,225],-80.23184,26.13421,{"lat":225,"lon":224},{"facility":228,"status":112,"city":229,"state":166,"zip":230,"country":116,"countryCode":117,"cosmosGeoPoint":231,"geoPoint":235,"contacts":16},"Florida Cancer Specialists - North- Site Number : 8400030","St. Petersburg","33705",{"type":119,"coordinates":232},[233,234],-82.67927,27.77086,{"lat":234,"lon":233},{"facility":237,"status":112,"city":238,"state":239,"zip":240,"country":116,"countryCode":117,"cosmosGeoPoint":241,"geoPoint":245,"contacts":16},"Pontchartrain Cancer Center - Covington- Site Number : 8400046","Covington","Louisiana","70433",{"type":119,"coordinates":242},[243,244],-90.10042,30.47549,{"lat":244,"lon":243},{"facility":247,"status":112,"city":248,"state":249,"zip":250,"country":116,"countryCode":117,"cosmosGeoPoint":251,"geoPoint":255,"contacts":16},"Beth Israel Deaconess Medical Center - Boston- Site Number : 8400005","Boston","Massachusetts","02215",{"type":119,"coordinates":252},[253,254],-71.05977,42.35843,{"lat":254,"lon":253},{"facility":257,"status":112,"city":258,"state":259,"zip":260,"country":116,"countryCode":117,"cosmosGeoPoint":261,"geoPoint":265,"contacts":16},"Michigan Hematology & Oncology Consultants - Dearborn- Site Number : 8400036","Dearborn","Michigan","48126",{"type":119,"coordinates":262},[263,264],-83.17631,42.32226,{"lat":264,"lon":263},{"facility":267,"status":112,"city":268,"state":259,"zip":269,"country":116,"countryCode":117,"cosmosGeoPoint":270,"geoPoint":274,"contacts":16},"Hematology Oncology Consultants - Royal Oak- Site Number : 8400039","Royal Oak","48073",{"type":119,"coordinates":271},[272,273],-83.14465,42.48948,{"lat":273,"lon":272},{"facility":276,"status":112,"city":277,"state":278,"zip":279,"country":116,"countryCode":117,"cosmosGeoPoint":280,"geoPoint":284,"contacts":16},"Alliance for Multispeciality Research - Kansas City- Site Number : 8400056","Kansas City","Missouri","64114",{"type":119,"coordinates":281},[282,283],-94.57857,39.09973,{"lat":283,"lon":282},{"facility":286,"status":112,"city":287,"state":278,"zip":288,"country":116,"countryCode":117,"cosmosGeoPoint":289,"geoPoint":293,"contacts":16},"Washington University- Site Number : 8400007","St Louis","63110",{"type":119,"coordinates":290},[291,292],-90.19789,38.62727,{"lat":292,"lon":291},{"facility":295,"status":112,"city":296,"state":297,"zip":298,"country":116,"countryCode":117,"cosmosGeoPoint":299,"geoPoint":303,"contacts":16},"Hackensack Meridian Health - Hackensack University Medical Center- Site Number : 8400021","Hackensack","New Jersey","07601",{"type":119,"coordinates":300},[301,302],-74.04347,40.88593,{"lat":302,"lon":301},{"facility":305,"status":112,"city":306,"state":307,"zip":308,"country":116,"countryCode":117,"cosmosGeoPoint":309,"geoPoint":313,"contacts":16},"San Juan Oncology Associates- Site Number : 8400016","Farmington","New Mexico","87401",{"type":119,"coordinates":310},[311,312],-108.21869,36.72806,{"lat":312,"lon":311},{"facility":315,"status":112,"city":316,"state":316,"zip":317,"country":116,"countryCode":117,"cosmosGeoPoint":318,"geoPoint":322,"contacts":16},"Memorial Sloan Kettering Cancer Center - New York - York Avenue- Site Number : 8400003","New York","10065",{"type":119,"coordinates":319},[320,321],-74.00597,40.71427,{"lat":321,"lon":320},{"facility":324,"status":112,"city":325,"state":326,"zip":327,"country":116,"countryCode":117,"cosmosGeoPoint":328,"geoPoint":332,"contacts":16},"Duke University Medical Center- Site Number : 8400018","Durham","North Carolina","27710",{"type":119,"coordinates":329},[330,331],-78.89862,35.99403,{"lat":331,"lon":330},{"facility":334,"status":112,"city":335,"state":336,"zip":337,"country":116,"countryCode":117,"cosmosGeoPoint":338,"geoPoint":342,"contacts":16},"Gabrail Cancer Center- Site Number : 8400010","Canton","Ohio","44718",{"type":119,"coordinates":339},[340,341],-81.37845,40.79895,{"lat":341,"lon":340},{"facility":344,"status":112,"city":345,"state":336,"zip":346,"country":116,"countryCode":117,"cosmosGeoPoint":347,"geoPoint":351,"contacts":16},"University of Cincinnati Medical Center- Site Number : 8400043","Cincinnati","45219",{"type":119,"coordinates":348},[349,350],-84.51439,39.12711,{"lat":350,"lon":349},{"facility":353,"status":112,"city":345,"state":336,"zip":354,"country":116,"countryCode":117,"cosmosGeoPoint":355,"geoPoint":357,"contacts":16},"Oncology Hematology Care - Kenwood- Site Number : 8400014","45236",{"type":119,"coordinates":356},[349,350],{"lat":350,"lon":349},{"facility":359,"status":112,"city":360,"state":361,"zip":362,"country":116,"countryCode":117,"cosmosGeoPoint":363,"geoPoint":367,"contacts":16},"Roper Saint Francis Healthcare- Site Number : 8400013","Charleston","South Carolina","29401",{"type":119,"coordinates":364},[365,366],-79.93275,32.77632,{"lat":366,"lon":365},{"facility":369,"status":112,"city":370,"state":361,"zip":371,"country":116,"countryCode":117,"cosmosGeoPoint":372,"geoPoint":376,"contacts":16},"Prisma Health Cancer Institute - Greenville- Site Number : 8400019","Greenville","29615",{"type":119,"coordinates":373},[374,375],-82.39401,34.85262,{"lat":375,"lon":374},{"facility":378,"status":112,"city":379,"state":361,"zip":380,"country":116,"countryCode":117,"cosmosGeoPoint":381,"geoPoint":385,"contacts":16},"Gibbs Cancer Center & Research Institute - Spartanburg- Site Number : 8400001","Spartanburg","29303",{"type":119,"coordinates":382},[383,384],-81.93205,34.94957,{"lat":384,"lon":383},{"facility":387,"status":112,"city":388,"state":389,"zip":390,"country":116,"countryCode":117,"cosmosGeoPoint":391,"geoPoint":395,"contacts":16},"Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road- Site Number : 8400035","Knoxville","Tennessee","37909",{"type":119,"coordinates":392},[393,394],-83.92074,35.96064,{"lat":394,"lon":393},{"facility":397,"status":112,"city":388,"state":389,"zip":398,"country":116,"countryCode":117,"cosmosGeoPoint":399,"geoPoint":401,"contacts":16},"University of Tennessee Medical Center- Site Number : 8400006","37920",{"type":119,"coordinates":400},[393,394],{"lat":394,"lon":393},{"facility":403,"status":112,"city":404,"state":389,"zip":405,"country":116,"countryCode":117,"cosmosGeoPoint":406,"geoPoint":410,"contacts":16},"Tennessee Oncology Nashville- Site Number : 8400012","Nashville","37203",{"type":119,"coordinates":407},[408,409],-86.78444,36.16589,{"lat":409,"lon":408},{"facility":412,"status":112,"city":413,"state":414,"zip":415,"country":116,"countryCode":117,"cosmosGeoPoint":416,"geoPoint":420,"contacts":16},"Northern Virginia Oncology Group- Site Number : 8400045","Fairfax","Virginia","22031",{"type":119,"coordinates":417},[418,419],-77.30637,38.84622,{"lat":419,"lon":418},{"facility":422,"status":112,"city":423,"state":424,"zip":425,"country":116,"countryCode":117,"cosmosGeoPoint":426,"geoPoint":430,"contacts":16},"SSM Health Dean Medical Group - Wisconsin - Madison- Site Number : 8400009","Madison","Wisconsin","53715",{"type":119,"coordinates":427},[428,429],-89.40123,43.07305,{"lat":429,"lon":428},{"type":432,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100543492","phase-2-a-study-to-investigate-subcutaneous-isatuximab-in-combination-with-weekly-carfilzomib-and-dexamethasone-in-adult-participants-with-relapsed-andor-refractory-multiple-myeloma-100543492",false,"NCT06356571","A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and\u002For Refractory Multiple Myeloma","A Single-arm, Open-label, Phase 2 Study Evaluating Subcutaneous Administration of Isatuximab, Administered by an On Body Delivery System, in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and\u002For Refractory Multiple Myeloma (RRMM)","SubQSA","Inclusion Criteria:\n\n* Participants must have a documented diagnosis of MM.\n* Participants with measurable disease defined as at least one of the following:\n\n  * Serum M-protein ≥0.5 g\u002FdL measured using serum protein immunoelectrophoresis and\u002For\n  * Urine M-protein ≥200 mg\u002F24 hours measured using urine protein immunoelectrophoresis and\u002For\n  * Serum free light chain (FLC) assay: Involved FLC assay ≥10 mg\u002FdL (≥100 mg\u002FL) and an abnormal serum FLC ratio (\\\u003C0.26 or \\>1.65).\n* Participants with relapsed and\u002For refractory MM with at least 1 prior line of therapy and no more than 3 prior lines of therapy.\n* Contraceptive use by \\[men and women\\] should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\n  * Male participants agree to practice true abstinence or agree to use contraception while receiving study treatment, during dose interruptions and at least 5 months following study treatment discontinuation, even if has undergone a successful vasectomy.\n  * A female participant is eligible to participate if she is not pregnant, not breastfeeding, and either is not a female of childbearing potential (FCBP XE \" FCBP \" \\\\f Abbreviation \\\\t \"female of childbearing potential\" ) or agrees to practice complete abstinence or use contraception.\n* Capable of giving signed informed consent.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Primary refractory MM defined as participants who have never achieved at least a minimal response (MR) with any treatment during the disease course.\n* Participants with prior anti-CD38 treatment if: a) administered \\\u003C 6 months before first isatuximab administration or, b) intolerant to the anti-CD38 previously received.\n* Participants who are refractory to carfilzomib.\n* Known history of allergy to captisol (a cyclodextrin derivative used to solubilize carfilzomib), prior hypersensitivity to sucrose, histidine (as base and hydrochloride salt), polysorbate 80, or any of the components (active substance or excipient) of study treatment that are not amenable to premedication with steroids, or intolerance to arginine and Poloxamer 188 that would prohibit further treatment with these agents.\n* Participants with contraindication to dexamethasone and\u002For to carfilzomib.\n* Any anti-myeloma drug treatment within 14 days before the first isatuximab administration, including dexamethasone.\n* Prior allogenic HSC transplant with active graft versus host disease (GvHD XE \" GvHD \" \\\\f Abbreviation \\\\t \"graft versus host disease\" ) (GvHD any grade and\u002For being under immunosuppressive treatment within the last 2 months).\n* Any major procedure within 14 days before the first isatuximab administration: plasmapheresis, major surgery (kyphoplasty is not considered a major procedure), radiotherapy.\n* Vaccination with a live vaccine within 4 weeks before the first isatuximab administration. Seasonal flu vaccines that do not contain live virus are permitted.\n* Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.\n\nThe above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.","ALL","18 Years",{"count":444,"type":445},64,"ESTIMATED","INTERVENTIONAL",[448],"PHASE2","The primary purpose of this study is to assess the efficacy (overall response rate) of subcutaneous (SC) via on body delivery system (SC-OBDS) isatuximab in combination with weekly carfilzomib and dexamethasone (Kd) in adult participants with RRMM having received 1 to 3 prior lines of therapy.",[451],"Plasma Cell Myeloma Refractory",[453,454],"Anti CD38 monoclonal antibody","SARCLISA","2026-02-20",{"date":457,"type":458},"2026-02-23","ACTUAL",{"date":460,"type":458},"2025-03-17",{"date":462,"type":445},"2027-07-15",{"name":5,"class":6},34]