A trial to learn how well AZD0120 works and about its safety in adults with newly diagnosed multiple myeloma
Key facts
- Where
- Berlin, Cologne, Dresden, Essen, Freiburg im Breisgau, Hamburg, Leipzig, Magdeburg, Mainz, Munich, Nuremberg és Wuerzburg, NémetországSee the 12 sites
- Phase
- 3. fázis
Where in Németország
- Charite Universitaetsmedizin Berlin KöRBerlin, NémetországToborzás még nem indult
- Universitaetsklinikum Koeln AöRCologne, NémetországToborzás még nem indult
- Technische Universitaet DresdenDresden, NémetországToborzás még nem indult
- Universitaetsklinikum Essen (AoR)Essen, NémetországToborzás még nem indult
- Medical Center- University of FreiburgFreiburg im Breisgau, NémetországToborzás még nem indult
- University Medical Center Hamburg-EppendorfHamburg, NémetországToborzás még nem indult
- Universitaet LeipzigLeipzig, NémetországToborzás még nem indult
- Universitaetsklinikum Magdeburg AöRMagdeburg, NémetországToborzás még nem indult
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöRMainz, NémetországToborzás még nem indult
- Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)Munich, NémetországToborzás még nem indult
- Klinikum NuernbergNuremberg, NémetországToborzás még nem indult
- Universitaetsklinikum Wuerzburg AöRWuerzburg, 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 2025-524014-29-00
- Record updated
- 2026. szeptember 8.
- Original description
Primary Objective 1:To demonstrate the superiority of IsaVRd or DRd induction followed by a single administration of AZD0120 compared to IsaVRd or DRd induction followed by continuous DRd or IsaRd by assessment of PFS in participants with NDMM who ineligible to receive ASCT as initial therapy.Read full original descriptionShow less
A Phase III Open-Label, Randomised, Multicentre Study of Consolidation with a Single Administration of AZD0120, a Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CAR T) Therapy Directed Against BCMA and CD19, Compared with Continuous Standard Therapy in Participants with NDMM Who Are Ineligible to Receive ASCT as Initial Therapy (DURGA-5).
Primary Objective 1:To demonstrate the superiority of IsaVRd or DRd induction followed by a single administration of AZD0120 compared to IsaVRd or DRd induction followed by continuous DRd or IsaRd by assessment of PFS in participants with NDMM who ineligible to receive ASCT as initial therapy.
Primary Objective 2: To demonstrate the superiority of IsaVRd or DRd induction followed by a single administration of AZD0120 compared to IsaVRd or DRd induction followed by continuous DRd or IsaRd by assessment of MRD negative CR rate at 9 months in participants with NDMM who are ineligible to receive ASCT as initial therapy."
Inclusion: Participants must be 18 years or older, at the time ofsigning the ICF; Participant must have documented diagnosis of MMaccording to the IMWG diagnostic criteria; Participant must have one or more of the following measurable disease criteria: (a) Serum M-protein level ≥1.0 g/dL, (b) Urine M-protein level ≥ 200 mg/24 h, (c)Serum immunoglobulin FLC ≥ 10 mg/dL (100 mg/L) andabnormal serum immunoglobulin kappa lambda FLC ratio; 4.Participant must be deemed ineligible for ASCT while also having adequate organ function for CAR-T cell treatment; Participant is a candidate to receive at least one of the regimens (IsaVRd or DRd) as determined by the Investigator; ECOG performance status Grade of 0 to 2; Participant must have adequate organ and bone marrow function.
Exclusion: Participant has active or prior CNS or meningealinvolvement of MM; Participant has a history of a prior non-haematologic malignancy unless the participant has been disease-free with no evidence of recurrence for ≥ 2 years; Participant has primary amyloidosis, active plasma cellleukemia (≥5% circulating plasma cells), Waldenströmmacroglobulinemia, or POEMS syndrome; Participant has a history of haematologic malignancies, other than MM, regardless of remission status; Participant is positive for any of the following: a. HIV: Known to be seropositive for HIV (including any history of HIV). b. Chronic or active hepatitis B c. Active hepatitis C: Hepatitis C infection d. Additional local requirements for the testing for infectious diseases and exclusions of applicable participants should be followed per local regulations; Participant has clinically significant cardiovascular disease; Additional exclusion for participants who are planned to receive IsaVRd as induction: Participant has peripheral neuropathy Grade 4, Grade 3, Grade 2, or Grade 1 with pain; Participant has significant neurological or psychiatriccondition posing risk or impairing evaluation; Participant has any other significant medical conditionthat increases unacceptable risk, interferes with therapydelivery, or confounds evaluation; Participant has COPD with an FEV1 < 50% of predicted normal.