[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641005":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":47,"centralContacts":48,"locations":54,"responsibleParty":73,"collaborators":47,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":47,"eligibilityCriteria":81,"healthyVolunteers":77,"sex":82,"minAge":83,"maxAge":47,"enrollmentInfo":84,"targetDuration":47,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":47,"overallStatus":93,"whyStopped":47,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Innovent Biologics (Suzhou) Co. Ltd.","INDUSTRY",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"the investigator's choice regimen (DPd or PVd)","ACTIVE_COMPARATOR","participants will receive DPd or PVd until death, disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent to participate in the study, or other reasons for discontinuation of study treatment, whichever occurs first.",[13,14,15],"Drug: Pomalidomide Capsules","Drug: Bortezomib for Injection","Drug: Daratumumab Injection (Subcutaneous Injection)",{"label":17,"type":18,"description":19,"interventionNames":20},"IBI3003","EXPERIMENTAL","participants will receive IBI3003 until death, disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent to participate in the study, or other reasons for discontinuation of study treatment, whichever occurs first.",[21],"Drug: IBI3003",[23,30,36,42],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Pomalidomide Capsules","1. The DPd treatment regimen, one cycle every 28 days: Pomalidomide 4mg\u002Fd orally, on days 1-21;\n2. The PVd treatment regimen, one cycle every 21 days: Pomalidomide 4 mg\u002Fd orally, on days 1-14 of each treatment cycle;",[9],[29],"P",{"type":24,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Bortezomib for Injection","The PVd treatment regimen, with one cycle every 21 days: Bortezomib on days 1, 4, 8, and 11 of cycles 1-8, and on days 1 and 8 from cycle 9 onwards.",[9],[35],"V",{"type":24,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Daratumumab Injection (Subcutaneous Injection)","The DPd treatment regimen, one cycle every 28 days: on days 1, 8, 15, and 22 of cycles 1 and 2; on days 1 and 15 from cycles 3-6; and on day 1 from cycle 7 onwards.",[9],[41],"D",{"type":24,"name":17,"description":43,"armGroupLabels":44,"otherNames":45},"According to body weight",[17],[46],"trispecific antibody",null,[49],{"name":50,"role":51,"phone":52,"phoneExt":47,"email":53},"Haiyan Zhu","CONTACT","0512-69566088","haiyan.zhu@innoventbio.com",[55],{"facility":56,"status":47,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"ZhongShan Hospital FuDan University","Shanghai","Shanghai Municipality","132101","China","CN",{"type":63,"coordinates":64},"Point",[65,66],121.45806,31.22222,{"lat":66,"lon":65},[69],{"name":70,"role":51,"phone":71,"phoneExt":47,"email":72},"Peng Liu","021-3115199","liu.peng@zs-hospital.sh.cn",{"type":74,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR","100641005","phase-3-a-study-in-participants-with-relapsed-or-refractory-multiple-myeloma-for-ibi3003-100641005",false,"NCT07623798","A Study in Participants With Relapsed or Refractory Multiple Myeloma for IBI3003","A Phase 3 Randomized Study Comparing IBI3003 Versus Treatment Per Investigator's Choice in Participants With Relapsed or Refractory Multiple Myeloma","Inclusion Criteria：\n\n1. Age ≥18 years.\n2. Documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria.\n3. At least one of the following measurable disease indicators:\n\n   * Serum M-protein ≥ 5 g\u002FL（For IgA and IgD subtypes, it is recommended to use quantitative immunoglobulin measurements instead of M protein）\n   * Urine M-protein ≥200 mg\u002F24h\n   * Serum free light chain (FLC) test: affected FLC level ≥100 mg\u002FL and abnormal serum FLC ratio (\\\u003C0.26 or \\>1.65)\n4. Life expectancy ≥3 months.\n5. Fertile females and sexually active fertile males must agree to use highly effective contraception (failure rate \\\u003C1% per year) during the study and for 90 days after the last dose of the investigational drug. For participants in the clinical trial, contraceptive measures must comply with local regulations regarding the use of contraceptive methods. Females and males must agree not to donate eggs (ova, oocytes) or sperm during the study and for 90 days after the last dose of the investigational drug.\n6. Willing and able to comply with the prohibitions and restrictions specified in this protocol.\n\nExclusion Criteria：\n\n1. Previous treatment with any BCMA-targeted therapy and any GPRC5D-targeted therapy. Patients who have received either BCMA-targeted or GPRC5D-targeted therapy are allowed to participate in the study.\n2. Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.\n3. Spinal cord compression that leads to limited self-care ability occurs within six months prior to informed consent or is expected to occur in the near future.\n4. Have history of primary immunodeficiency.\n5. Have history of organ transplantation.\n6. Have received allogeneic hematopoietic stem cell transplantation within 6 months before the first administration of the study drug, or have received autologous stem cell transplantation within 3 months before the first administration of the study drug.","ALL","18 Years",{"count":85,"type":86},255,"ESTIMATED","INTERVENTIONAL",[89],"PHASE3","The purpose of this study is to evaluate how well IBI3003 works when compared with the investigator's choice regimen (DPd or PVd)",[92],"Relapsed or Refractory Multiple Myeloma","NOT_YET_RECRUITING","2026-05-28",{"date":96,"type":97},"2026-06-03","ACTUAL",{"date":99,"type":86},"2026-06-05",{"date":101,"type":86},"2029-12-31",{"name":5,"class":6},1]