[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589289":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":61,"collaborators":26,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":26,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":26,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":26,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Celltrion","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CT-P44","EXPERIMENTAL","CT-P44 1800mg SC (subcutaneous)",[13],"Biological: CT-P44(Daratumumab)",{"label":15,"type":16,"description":17,"interventionNames":18},"Darzalex Faspro","ACTIVE_COMPARATOR","Darzalex Faspro 1800mg SC (subcutaneous)",[19],"Biological: Darzalex Faspro(Daratumumab)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","CT-P44(Daratumumab)","CT-P44 1800 mg will be administered as SC injection in combination with Rd until each patient's PD, unacceptable toxicity or Cycle 26, whichever occurs first.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Darzalex Faspro(Daratumumab)","Darzalex Faspro 1800 mg will be administered as SC injection in combination with Rd until each patient's PD, unacceptable toxicity or Cycle 13, whichever occurs first.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"JoonSoo Ha","CONTACT","+82 32 850 5727","joonsoo.ha@celltrion.com",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"NaRae Ryu","+82 32 850 5731","narae.ryu@celltrion.com",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Taipei Veterans General Hospital","RECRUITING","Taipei","Beitou District","11217","Taiwan","TW",{"type":51,"coordinates":52},"Point",[53,54],121.52639,25.05306,{"lat":54,"lon":53},[57],{"name":58,"role":34,"phone":59,"phoneExt":26,"email":60},"Chia-Jen Liu","+88622871212166600 000000000","cjliu5@vghtpe.gov.tw",{"type":62,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100589289","phase-3-a-study-to-compare-pharmacokinetics-efficacy-and-safety-of-subcutaneous-ct-p44-and-darzalex-faspro-in-combination-with-lenalidomide-and-dexamethasone-in-patients-with-refractory-or-relapsed-multiple-myeloma-100589289",false,"NCT06952478","A Study to Compare Pharmacokinetics, Efficacy and Safety of Subcutaneous CT-P44 and Darzalex Faspro in Combination With Lenalidomide and Dexamethasone in Patients With Refractory or Relapsed Multiple Myeloma","A Double-Blind, Randomized, Active-Controlled, Parallel-group, Phase 1\u002F3 Study to Compare Pharmacokinetics, Efficacy and Safety of Subcutaneous CT-P44 and Darzalex Faspro in Combination With Lenalidomide and Dexamethasone in Patients With Refractory or Relapsed Multiple Myeloma","\\[Main Inclusion Criteria\\]\n\n* Male or female with 18 years of age or older.\n* Patient must have documented multiple myeloma (MM) according to IMWG criteria\n* Patient must have a documented relapsed or refractory disease.\n* Patient must have achieved a response (PR or better based on investigator's determination of response by the IMWG criteria) to at least one prior regimen.\n* Patient must have a PD as defined by the IMWG criteria on or after their last line of therapy.\n\n\\[Main Exclusion Criteria\\]\n\n* Patient has received daratumumab or any other drug specifically targeting CD38 previously.\n* Patient's disease shows evidence of refractoriness or intolerance to lenalidomide.\n* Patient is known or suspected of not being able to comply with the study protocol (e.g., psychological disorder) or the patient has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (e.g., compromise their well-being) or that could prevent, limit, or confound the protocol-specified assessments.","ALL","18 Years",{"count":73,"type":74},486,"ESTIMATED","INTERVENTIONAL",[77],"PHASE3","This study is a phase 1\u002F3 study to Compare Pharmacokinetics, Efficacy and Safety of Subcutaneous CT-P44 and Darzalex Faspro in Combination with Lenalidomide and Dexamethasone in Patients with Refractory or Relapsed Multiple Myeloma",[80],"Refractory or Relapsed Multiple Myeloma","2025-08-12",{"date":83,"type":84},"2025-08-15","ACTUAL",{"date":81,"type":84},{"date":87,"type":74},"2029-06-25",{"name":5,"class":6},1]