A Study Comparing AZD0120, a Dual-targeted CAR-T Against B-cell Maturation Antigen (BCMA) and CD19, Versus Standard Regimens in Participants With Relapsed Refractory Multiple Myeloma (DURGA-4)
18 Years and older, Male and Female
D8311C00001 (primary)
NCI-2026-01719
AZD0120
Summary
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.
Eligibility
- Age = 18 years
- Documented diagnosis of multiple myeloma according to the IMWG diagnostic criteria
- Documented evidence of measurable disease:
- Serum M-protein level = 1 g/dL
- Urine M-protein level = 200 mg/24h
- Serum immunoglobulin free light chain = 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa lambda free light chain ratio
- 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
- 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
- Eligible to receive at least one of the standard regimens (DKd, PVd, DPd, or Kd) as determined by the Investigator.
- ECOG performance status score of 0 to 1
- Adequate hematology and chemistry laboratory values:
- Haemoglobin = 8.0 g/dL
- Absolute neutrophil count = 1 × 10^9/L (1000 per mm3)
- Platelet count = 75 × 10^9/L (75000 per mm3) in participants with < 50% of bone marrow nucleated cells are plasma cells or = 50 × 10^9/L (50000 per mm3) in participants with = 50% of bone marrow nucleated cells are plasma cells
- Absolute lymphocyte count = 300/µL (0.3 × 109/L)
- 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/minute
Treatment Sites in Georgia
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