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Recruiting Phase 3 NCT07391657

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)

Phase 3 – large-scale trial before approval
Conditions: Relapsed Refractory Multiple Myeloma

Sponsor: AstraZeneca

trial.available_in: БГ
Overview
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.
Who can participate
Inclusion Criteria: * Age ≥ 18 years * Documented diagnosis of multiple myeloma according to the IMWG diagnostic criteria * Documented evidence of measurable disease: 1. Serum M-protein level ≥ 1 g/dL 2. Urine M-protein level ≥ 200 mg/24h 3. 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: 1. Haemoglobin ≥ 8.0 g/dL 2. Absolute neutrophil count ≥ 1 × 10\^9/L (1000 per mm3) 3. 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 4. Absolute lymphocyte count ≥ 300/µL (0.3 × 109/L) 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/minute Exclusion Criteria: * Known active, or prior history of CNS involvement or exhibits clinical signs of meningeal involvement of MM. * Primary amyloidosis, active plasma cell leukaemia, Waldenstrom macroglobulinemia or Polyneuropathy Organomegaly Endocrinopathy M-protein and Skin (POEMS) syndrome. * Participants with primary refractory MM (failed to generate at least a minimal response to any prior therapy) * Significant neurological or psychiatric condition * Significant medical condition that places the participant at an unacceptable risk for treatment-related complications * Previously received any prior BCMA-targeted treatment * Previously received CAR-T or CAR-NK therapy directed at any target * Previously received T-cell engager therapy directed at any target * Previously received allogeneic stem cell transplantation at any time during prior therapy or received autologous stem cell transplantation within 12 weeks of randomization
Locations 14
Australia (1)
Research Site
Camperdown
NOT_YET_RECRUITING
Brazil (1)
Research Site
Salvador
NOT_YET_RECRUITING
Canada (1)
Research Site
Calgary , Alberta
NOT_YET_RECRUITING
France (1)
Research Site
Lille
NOT_YET_RECRUITING
Germany (1)
Research Site
Berlin
NOT_YET_RECRUITING
Italy (1)
Research Site
Bologna
NOT_YET_RECRUITING
Japan (1)
Research Site
Bunkyō City
NOT_YET_RECRUITING
Norway (1)
Research Site
Oslo
NOT_YET_RECRUITING
Poland (1)
Research Site
Gdansk
NOT_YET_RECRUITING
South Korea (1)
Research Site
Seoul
NOT_YET_RECRUITING
Spain (1)
Research Site
Barcelona
NOT_YET_RECRUITING
Taiwan (1)
Research Site
Taipei
NOT_YET_RECRUITING
United Kingdom (1)
Research Site
Birmingham
NOT_YET_RECRUITING
United States (1)
Research Site
Gilbert , Arizona
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
23.02.2026
Completion date
29.07.2030
Registry ID
NCT07391657
Source
anzctr
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