{"id":"arm-b-daratumumab-hyaluronidase","safety":{"commonSideEffects":[{"rate":null,"effect":"Infusion-related reactions"},{"rate":null,"effect":"Neutropenia"},{"rate":null,"effect":"Anemia"},{"rate":null,"effect":"Thrombocytopenia"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Upper respiratory tract infection"},{"rate":null,"effect":"Injection site reactions"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Daratumumab targets CD38, a surface antigen highly expressed on multiple myeloma cells, inducing cell death via antibody-dependent cellular cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), and complement-dependent cytotoxicity (CDC). The addition of recombinant human hyaluronidase allows for subcutaneous delivery instead of intravenous infusion, improving patient convenience and reducing infusion-related reactions while maintaining the same therapeutic efficacy.","oneSentence":"Daratumumab is a monoclonal antibody that binds to CD38 on multiple myeloma cells and triggers their destruction through multiple immune mechanisms, while hyaluronidase enables subcutaneous administration by breaking down hyaluronic acid in subcutaneous tissue.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:43:01.969Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Multiple myeloma (newly diagnosed and relapsed/refractory)"},{"name":"Light chain myeloma"}]},"trialDetails":[{"nctId":"NCT06948084","phase":"PHASE2","title":"Testing the Investigational Medication Combination of Daratumumab and Teclistamab Compared to the Usual Treatment (Daratumumab, Pomalidomide, Dexamethasone or Daratumumab, Carfilzomib, Dexamethasone) for Patients With High-risk Multiple Myeloma Refractory or in First Relapse","status":"NOT_YET_RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2026-04-29","conditions":"Recurrent Multiple Myeloma, Refractory Multiple Myeloma","enrollment":80},{"nctId":"NCT05020236","phase":"PHASE3","title":"A Study to Learn About the Study Medicine Elranatamab Alone and With Daratumumab in People With Multiple Myeloma Who Have Received Other Treatments","status":"RECRUITING","sponsor":"Pfizer","startDate":"2021-10-04","conditions":"Multiple Myeloma","enrollment":944},{"nctId":"NCT05907759","phase":"PHASE2","title":"Daratumumab for Relapsed/Refractory Primary Effusion Lymphoma, Plasmablastic Lymphoma, and Multicentric Castleman Disease","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2024-07-10","conditions":"Lymphoma, Primary Effusion","enrollment":28},{"nctId":"NCT03301220","phase":"PHASE3","title":"A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Janssen Research & Development, LLC","startDate":"2017-11-07","conditions":"Smoldering Multiple Myeloma","enrollment":390},{"nctId":"NCT04566328","phase":"PHASE3","title":"Testing the Use of Combination Therapy in Adult Patients With Newly Diagnosed Multiple Myeloma, the EQUATE Trial","status":"RECRUITING","sponsor":"ECOG-ACRIN Cancer Research Group","startDate":"2021-02-24","conditions":"Plasma Cell Myeloma, RISS Stage I Plasma Cell Myeloma, RISS Stage II Plasma Cell Myeloma","enrollment":1450},{"nctId":"NCT07285239","phase":"PHASE3","title":"Belantamab Mafodotin or Daratumumab With Bortezomib, Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma","status":"NOT_YET_RECRUITING","sponsor":"PrECOG, LLC.","startDate":"2026-05","conditions":"Multiple Myeloma","enrollment":500},{"nctId":"NCT07085728","phase":"PHASE2","title":"Testing the Investigational Agent Combination of Daratumumab, Bortezomib, and Dexamethasone Compared to the Usual Treatment of Cyclophosphamide, Bortezomib, and Dexamethasone in Newly Diagnosed Multiple Myeloma Patients With Kidney Failure","status":"NOT_YET_RECRUITING","sponsor":"Eastern Cooperative Oncology Group","startDate":"2025-08-11","conditions":"Myeloma Multiple","enrollment":74},{"nctId":"NCT04776018","phase":"PHASE1, PHASE2","title":"A Study Of TAK-981 Given With Monoclonal Antibodies (mAbs) In Adults With Relapsed or Refractory Multiple Myeloma (RRMM)","status":"TERMINATED","sponsor":"Takeda","startDate":"2021-04-20","conditions":"Relapsed and/or Refractory Multiple Myeloma (RRMM)","enrollment":27},{"nctId":"NCT05205252","phase":"PHASE1, PHASE2","title":"A Study of Tazemetostat in Combination With Various Treatments in Participants With Blood Cancer.","status":"WITHDRAWN","sponsor":"Epizyme, Inc.","startDate":"2021-12-22","conditions":"Relapsed Hematologic Malignancy, Refractory Hematologic Malignancy","enrollment":""}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["DARZALEX FASPRO™"],"phase":"phase_3","status":"active","brandName":"Arm B: Daratumumab Hyaluronidase","genericName":"Arm B: Daratumumab Hyaluronidase","companyName":"PrECOG, LLC.","companyId":"precog-llc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Daratumumab is a monoclonal antibody that binds to CD38 on multiple myeloma cells and triggers their destruction through multiple immune mechanisms, while hyaluronidase enables subcutaneous administration by breaking down hyaluronic acid in subcutaneous tissue. Used for Multiple myeloma (newly diagnosed and relapsed/refractory), Light chain myeloma.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}