A trial to learn how well AZD0120 works and about its safety in adults with transplant eligible newly diagnosed multiple myeloma.
Key facts
- Where
- Berlin, Dresden, Essen, Hamburg, Leipzig, Munich és Oldenburg, NémetországSee the 7 sites
- Phase
- 3. fázis
Where in Németország
- Charite Universitaetsmedizin Berlin KöRBerlin, NémetországToborzás még nem indult
- Technische Universitaet DresdenDresden, NémetországToborzás még nem indult
- Universitaetsklinikum Essen (AoR)Essen, NémetországToborzás még nem indult
- University Medical Center Hamburg-EppendorfHamburg, NémetországToborzás még nem indult
- Universitaet LeipzigLeipzig, NémetországToborzás még nem indult
- Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)Munich, NémetországToborzás még nem indult
- Klinikum Oldenburg AorOldenburg, NémetországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca AB
- Trial code
- EU 2026-525367-40-00
- Record updated
- 2026. október 12.
- Original description
Primary Objective 1: To demonstrate the superiority of single administration of AZD0120 compared with ASCT as consolidation followed by lenalidomide maintenance by assessment of PFS in participants with TE NDMM.Read full original descriptionShow less
A Phase III, Open-label, Multicentre, Randomised Study Comparing Consolidation Treatment with AZD0120, an Autologous Dual Targeting Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against BCMA and CD19, versus Autologous Stem Cell Transplant (ASCT) in Participants with Newly Diagnosed Multiple Myeloma who are Transplant Eligible (TE NDMM) (DURGA-6)
Primary Objective 1: To demonstrate the superiority of single administration of AZD0120 compared with ASCT as consolidation followed by lenalidomide maintenance by assessment of PFS in participants with TE NDMM.
Primary Objective 2: To demonstrate the superiority of single administration of AZD0120 compared with ASCT as consolidation followed by lenalidomide maintenance by assessment of MRD negative CR rate at 9 months in participants with TE NDMM.
Inclusion: Participant must be at least 18 years, at the time of signing the ICF; ECOG performance status score of 0 or 1; Participant must be eligible for treatment with high-dose melphalan (200 mg/m²) followed by ASCT; Participant must have adequate organ and bone marrow function (as detailed in CSP Table 9); Participant must have documented measurable disease at diagnosis, as defined by any of the following: (a) Serum M-protein level ≥ 1.0 g/dL (b) Urine M-protein level ≥ 200 mg/24 hour (c) Serum Ig FLC ≥ 10 mg/dL (100 mg/L) and abnormal serum Ig kappa lambda FLC ratio; Participant must have documented diagnosis of NDMM, per IMWG diagnostic criteria, and must have completed 4 to 6 cycles of approved induction therapy (anti-CD38+VRd, DVTd, DRd or VRd) prior to randomisation; Participant must have at least SD or better per IMWG 2016 after completion of induction, and prior to randomisation.
Exclusion: Participant has a known active, or prior history of central nervous system involvement or exhibits clinical signs of meningeal involvement of MM; Participant has significant neurological or psychiatriccondition within 6 months before signing ICF; Prior treatment with CAR-T and/or CAR-natural killer cell therapies directed at any target for any indications and any therapy that is targeted to BCMA and CD19; Participant received any prior T-cell engager therapy directed at any target; Participant has primary amyloidosis, active plasma cell leukaemia at time of screening, Waldenstrom macroglobulinemia or POEMS syndrome; Participant has any other significant medical condition which, in the opinion of the investigator, places the participant at an unacceptable risk for treatment-related complications, could interfere with the successful or safe delivery of therapy, or could interfere with evaluation of study intervention or interpretation of participant safety or study results; Participants who required the introduction of an additional agent due to inadequate response.