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Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma (DURGA-4)","A Phase III Open-label, Randomised, Multicentre Study Comparing AZD0120, a Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CART) Therapy Directed Against BCMA and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma.","DURGA-4","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Documented diagnosis of multiple myeloma according to the IMWG diagnostic criteria\n* Documented evidence of measurable disease:\n\n  1. Serum M-protein level ≥ 1 g\u002FdL\n  2. Urine M-protein level ≥ 200 mg\u002F24h\n  3. Serum immunoglobulin free light chain ≥ 10 mg\u002FdL (100 mg\u002FL) and abnormal serum immunoglobulin kappa lambda free light chain ratio\n* Documented evidence of PD by IMWG 2016 criteria based on investigator's determination during or after the most recent line of therapy. Participants with only 1 prior line of therapy must have progressed within 47 months of a stem cell transplant, or if not transplanted, then within 42 months of starting initial therapy\n* Received 1 to 3 lines of prior therapy including an IMiD and either a PI or a CD38 antibody. Participant must have undergone at least 2 complete cycles of treatment for each line of therapy, unless PD was the best response to the line of therapy\n* Eligible to receive at least one of the standard regimens (DKd, PVd, DPd, or Kd) as determined by the Investigator.\n* ECOG performance status score of 0 to 1\n* Adequate hematology and chemistry laboratory values:\n\n  1. Haemoglobin ≥ 8.0 g\u002FdL\n  2. Absolute neutrophil count ≥ 1 × 10\\^9\u002FL (1000 per mm3)\n  3. Platelet count ≥ 75 × 10\\^9\u002FL (75000 per mm3) in participants with \\\u003C 50% of bone marrow nucleated cells are plasma cells or ≥ 50 × 10\\^9\u002FL (50000 per mm3) in participants with ≥ 50% of bone marrow nucleated cells are plasma cells\n  4. Absolute lymphocyte count ≥ 300\u002FµL (0.3 × 109\u002FL)\n  5. Total bilirubin ≤ 1.5 × ULN in the absence of Gilbert's syndrome or ≤ 3 × ULN if the participant has Gilbert's syndrome. AST and ALT≤ 3.0 × ULN. CrCl by Cockcroft and Gault method ≥ 30 mL\u002Fminute\n\nExclusion Criteria:\n\n* Known active, or prior history of CNS involvement or exhibits clinical signs of meningeal involvement of MM.\n* Primary amyloidosis, active plasma cell leukaemia, Waldenstrom macroglobulinemia or Polyneuropathy Organomegaly Endocrinopathy M-protein and Skin (POEMS) syndrome.\n* Participants with primary refractory MM (failed to generate at least a minimal response to any prior therapy)\n* Significant neurological or psychiatric condition\n* Significant medical condition that places the participant at an unacceptable risk for treatment-related complications\n* Previously received any prior BCMA-targeted treatment\n* Previously received CAR-T or CAR-NK therapy directed at any target\n* Previously received T-cell engager therapy directed at any target\n* Previously received allogeneic stem cell transplantation at any time during prior therapy or received autologous stem cell transplantation within 12 weeks of randomization","ALL","18 Years",{"count":1178,"type":1179},508,"ESTIMATED","INTERVENTIONAL",[1182],"PHASE3","This is a randomised, multicentre, controlled, open-label, Phase III global study comparing the efficacy and safety of AZD0120 versus standard regimens (DKd \\[daratumumab, carfilzomib, and dexamethasone\\], DPd \\[daratumumab, pomalidomide, and dexamethasone\\], PVd \\[pomalidomide, bortezomib and dexamethasone\\], or Kd \\[carfilzomib and dexamethasone\\]) in participants with RRMM.",[1185],"Relapsed Refractory Multiple Myeloma",[1187,1188,1189],"BCMA","CAR-T","CD19","2026-06-29",{"date":1192,"type":1193},"2026-06-30","ACTUAL",{"date":1195,"type":1193},"2026-02-23",{"date":1197,"type":1179},"2030-07-29",{"name":5,"class":6},138]