{"id":"arm-a-belantamab-mafodotin","safety":{"commonSideEffects":[{"rate":null,"effect":"Corneal microdepots/keratopathy"},{"rate":null,"effect":"Thrombocytopenia"},{"rate":null,"effect":"Anemia"},{"rate":null,"effect":"Fatigue"},{"rate":null,"effect":"Nausea"}]},"_chembl":{"chemblId":"CHEMBL4298209","moleculeType":"Antibody drug conjugate"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Belantamab mafodotin binds to B-cell maturation antigen (BCMA), a surface protein highly expressed on multiple myeloma cells. Upon binding, the drug is internalized and releases monomethyl auristatin F (MMAF), a microtubule-disrupting agent that induces apoptosis in myeloma cells. This targeted delivery mechanism allows concentration of cytotoxic activity at tumor cells while minimizing systemic toxicity.","oneSentence":"Belantamab mafodotin is an antibody-drug conjugate that targets BCMA on multiple myeloma cells and delivers a cytotoxic payload to kill them.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:02:23.262Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Relapsed or refractory multiple myeloma"}]},"trialDetails":[{"nctId":"NCT06232044","phase":"PHASE1, PHASE2","title":"Testing the Combination of Two Approved Drugs and One Experimental Drug in Patients With Relapsed or Refractory Multiple Myeloma","status":"RECRUITING","sponsor":"Alliance for Clinical Trials in Oncology","startDate":"2025-04-23","conditions":"Recurrent Multiple Myeloma, Refractory Multiple Myeloma","enrollment":88},{"nctId":"NCT06679101","phase":"PHASE3","title":"A Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Who Are Ineligible for Autologous Stem Cell Transplantation (TI-NDMM)","status":"RECRUITING","sponsor":"GlaxoSmithKline","startDate":"2024-12-16","conditions":"Multiple Myeloma, Newly Diagnosed Multiple Myeloma","enrollment":520},{"nctId":"NCT02343042","phase":"PHASE1, PHASE2","title":"Selinexor and Backbone Treatments of Multiple Myeloma Patients","status":"RECRUITING","sponsor":"Karyopharm Therapeutics Inc","startDate":"2015-10","conditions":"Multiple Myeloma","enrollment":300},{"nctId":"NCT05055063","phase":"PHASE1","title":"A Phase 1 With Extension Cohort, Single Arm, Single Center, Open Label Trial of Belantamab Mafodotin for the Treatment of High-Risk Smoldering Multiple Myeloma","status":"RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2022-05-18","conditions":"Myeloma","enrollment":30},{"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":"NCT05002816","phase":"PHASE1, PHASE2","title":"Novel Combination of Belantamab Mafodotin and Elotuzumab to Enhance Therapeutic Efficacy in Multiple Myeloma","status":"RECRUITING","sponsor":"Yale University","startDate":"2022-02-21","conditions":"Multiple Myeloma","enrollment":24},{"nctId":"NCT03525678","phase":"PHASE2","title":"A Study to Investigate the Efficacy and Safety of Two Doses of GSK2857916 in Participants With Multiple Myeloma Who Have Failed Prior Treatment With an Anti-CD38 Antibody","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2018-06-18","conditions":"Multiple Myeloma","enrollment":221},{"nctId":"NCT03828292","phase":"PHASE1","title":"An Open-label, Dose Escalation Study in Japanese Participants With Relapsed/Refractory Multiple Myeloma Who Have Failed Prior Anti Myeloma Treatments","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2019-03-14","conditions":"Multiple Myeloma","enrollment":15},{"nctId":"NCT05461209","phase":"PHASE3","title":"A Study of Comparing Talquetamab to Belantamab Mafodotin in Participants With Relapsed/Refractory Multiple Myeloma","status":"WITHDRAWN","sponsor":"Janssen Research & Development, LLC","startDate":"2022-10-20","conditions":"Relapsed/ Refractory Multiple Myeloma","enrollment":""},{"nctId":"NCT04643002","phase":"PHASE1, PHASE2","title":"Isatuximab in Combination With Novel Agents in RRMM - Master Protocol","status":"RECRUITING","sponsor":"Sanofi","startDate":"2021-01-25","conditions":"Plasma Cell Myeloma Refractory","enrollment":258},{"nctId":"NCT07019545","phase":"PHASE2","title":"A PHASE II TRIAL AIMING TO INVESTIGATE THE SAFETY AND CLINICAL ACTIVITY OF BELANTAMAB MAFODOTIN IN ADULT PATIENTS WITH PRIMARY IMMUNE THROMBOCYTOPENIA PREVIOUSLY TREATED WITH A THROMBOPOIETIN RECEPTOR AGONIST AND/OR RITUXIMAB AFTER CORTICOSTEROID FIRST-LINE THERAPY","status":"NOT_YET_RECRUITING","sponsor":"Hellenic Society of Hematology","startDate":"2025-06-20","conditions":"Primary Immune Thrombocytopenia (ITP)","enrollment":14},{"nctId":"NCT04892264","phase":"PHASE1","title":"Belantamab Mafodotin, Lenalidomide, and Daratumumab for the Treatment of Relapsed, Refractory, or Previously Untreated Multiple Myeloma","status":"TERMINATED","sponsor":"Mayo Clinic","startDate":"2021-06-03","conditions":"Plasma Cell Myeloma, Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma","enrollment":5},{"nctId":"NCT04896658","phase":"PHASE1, PHASE2","title":"Belantamab Mafodotin, Cyclophosphamide, and Dexamethasone in Relapsed/Refractory Multiple Myeloma","status":"TERMINATED","sponsor":"University of Maryland, Baltimore","startDate":"2021-12-03","conditions":"Relapsed/Refractory Multiple Myeloma","enrollment":10},{"nctId":"NCT03544281","phase":"PHASE1, PHASE2","title":"To Evaluate Safety, Tolerability, and Clinical Activity of the Antibody-drug Conjugate, GSK2857916 Administered in Combination With Lenalidomide Plus Dexamethasone (Arm A), or in Combination With Bortezomib Plus Dexamethasone (Arm B) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2018-09-20","conditions":"Multiple Myeloma","enrollment":153},{"nctId":"NCT04484623","phase":"PHASE3","title":"Belantamab Mafodotin Plus Pomalidomide and Dexamethasone (Pd) Versus Bortezomib Plus Pd in Relapsed/Refractory Multiple Myeloma","status":"ACTIVE_NOT_RECRUITING","sponsor":"GlaxoSmithKline","startDate":"2020-10-01","conditions":"Multiple Myeloma","enrollment":302},{"nctId":"NCT03732703","phase":"PHASE1, PHASE2","title":"Myeloma-Developing Regimens Using Genomics (MyDRUG)","status":"COMPLETED","sponsor":"Multiple Myeloma Research Consortium","startDate":"2019-04-01","conditions":"Relapsed Refractory Multiple Myeloma","enrollment":103},{"nctId":"NCT03715478","phase":"PHASE1, PHASE2","title":"Multi-Center Study of GSK2857916 in Combination With Pomalidomide and Dex","status":"ACTIVE_NOT_RECRUITING","sponsor":"Canadian Myeloma Research Group","startDate":"2018-11-26","conditions":"Relapsed and/or Refractory Multiple Myeloma","enrollment":120},{"nctId":"NCT04246047","phase":"PHASE3","title":"Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma","status":"ACTIVE_NOT_RECRUITING","sponsor":"GlaxoSmithKline","startDate":"2020-05-07","conditions":"Multiple Myeloma","enrollment":494},{"nctId":"NCT03848845","phase":"PHASE1, PHASE2","title":"Study Evaluating Safety, Tolerability and Clinical Activity of GSK2857916 in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Multiple Myeloma (RRMM)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2019-03-14","conditions":"Multiple Myeloma","enrollment":41},{"nctId":"NCT04808037","phase":"PHASE1, PHASE2","title":"Blmf, Lenalidomide and Dexamethasone in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma","status":"ACTIVE_NOT_RECRUITING","sponsor":"Hellenic Society of Hematology","startDate":"2021-02-22","conditions":"Multiple Myeloma","enrollment":66},{"nctId":"NCT05493618","phase":"PHASE1, PHASE2","title":"Pembrolizumab, Belantamab and Dexamethasone in Refractory Multiple Myeloma.","status":"WITHDRAWN","sponsor":"Hackensack Meridian Health","startDate":"2022-12","conditions":"Multiple Myeloma, Refractory","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":["GSK2857916","Blenrep","Belamaf"],"phase":"phase_3","status":"active","brandName":"Arm A: Belantamab Mafodotin","genericName":"Arm A: Belantamab Mafodotin","companyName":"PrECOG, LLC.","companyId":"precog-llc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Belantamab mafodotin is an antibody-drug conjugate that targets BCMA on multiple myeloma cells and delivers a cytotoxic payload to kill them. Used for Relapsed or refractory multiple myeloma.","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"EU","regulator":"EMA","status":"withdrawn","approval_date":"2020-08-25T00:00:00.000Z","mah":"GlaxoSmithKline Trading Services Limited","brand_name_local":"Blenrep","application_number":"EMEA/H/C/004935"},{"country_code":"EU","regulator":"EMA","status":"approved","approval_date":"2025-07-23T00:00:00.000Z","mah":"GlaxoSmithKline Trading Services Limited","brand_name_local":"Blenrep","application_number":"EMEA/H/C/006511"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2025-10-23T00:00:00.000Z","mah":"GLAXOSMITHKLINE LLC","brand_name_local":"BLENREP","application_number":"BLA761440"}],"regulatorySummaries":{"EU_EMA_approval_187866":{"country_code":"EU","agency":"EMA","entity_type":"approval","entity_id":"187866","summary_short":"EMA granted marketing authorisation for Belantamab Mafodotin (Blenrep) for treating relapsed or refractory multiple myeloma in adults.","summary_long":"On 23 July 2025, the European Medicines Agency (EMA) granted marketing authorisation for Belantamab Mafodotin, marketed as Blenrep, for the treatment of relapsed or refractory multiple myeloma in adults. This authorisation was granted to GlaxoSmithKline Trading Services Limited. Blenrep is indicated for use in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy, and in combination with pomalidomide and dexamethasone in patients who have received at least one prior therapy including lenalidomide.","key_points":["EMA granted marketing authorisation for Belantamab Mafodotin (Blenrep) on 23 July 2025.","Blenrep is indicated for treating relapsed or refractory multiple myeloma in adults.","Indications include combination with bortezomib and dexamethasone, and combination with pomalidomide and dexamethasone."],"citations":[{"source":"https://www.ema.europa.eu/en/medicines/human/EPAR/blenrep"}],"generated_at":"2026-05-18T08:38:03.688Z"}},"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}