AZD0120 CAR T-cell therapy in adults newly diagnosed with multiple myeloma
Tests a one-time AZD0120 CAR T treatment in adults with newly diagnosed multiple myeloma.
Key facts
- Who runs it
- AstraZeneca AB
- Where
- Aarhus N, DenmarkSee the siteAlso in 6 other countries, 41 sites
- Trial code
- Registry title
- A trial to learn how well AZD0120 works and about its safety in adults with newly diagnosed multiple myeloma
- Status
- Not yet recruiting
- Phase
- Phase 3
- People taking part
- 234 people, planned
- Started
- 27 May 2026
- Expected to end
- 31 Jan 2035
- Type of study
- Interventional
- Record updated
- 8 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed multiple myeloma who cannot have a stem cell transplant (ASCT) as first treatment. It tests a single dose of AZD0120 CAR T-cell therapy against continuous standard therapy.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Newly diagnosed multiple myeloma with measurable disease (serum M-protein 1.0 g/dL or more, urine M-protein 200 mg/24 h or more, or serum free light chain 10 mg/dL (100 mg/L) or more with an abnormal kappa/lambda ratio). Must be judged unable to have ASCT, but fit enough for CAR T-cell treatment. ECOG performance status 0 to 2.
- Earlier treatment
- The investigator must consider the person a candidate for IsaVRd or DRd induction.
Main reasons for not taking part
- Current or past multiple myeloma in the brain or meninges (CNS)
- Primary amyloidosis, active plasma cell leukemia, Waldenström macroglobulinemia or POEMS syndrome
- Known HIV, chronic or active hepatitis B, or active hepatitis C
- Earlier blood cancer other than myeloma, or earlier other cancer not disease-free for at least 2 years
- Clinically significant heart disease, or COPD with FEV1 below 50% of predicted
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Denmark
Also in 6 other countries, 41 sites
- Region MidtjyllandAarhus N, DenmarkNot yet recruiting
About the trial
What the trial wants to find out
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
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."
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?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- 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).
- Plain-language title
- AZD0120 CAR T-cell therapy in adults newly diagnosed with multiple myelomaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 8 September 2026