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Clinical Trials in the UK / NCT07764978
Recruiting Phase 3

Study of AZD0120 in Newly Diagnosed Multiple Myeloma Ineligible for ASCT

NCT07764978 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2026-06-26
Last updated
2026-08-14

Condition(s) studied

Newly Diagnosed Multiple Myeloma

Investigational drug(s) / intervention(s)

AZD0120DaratumumabDexamethasoneIsatuximabLenalidomideBortezomibCyclophosphamideFludarabine

AZD0120: AZD0120, is a BCMA/CD19 dual CAR T-cell product, which is administered intravenously.

Daratumumab: Induction, optional bridging and continuous therapy.

Dexamethasone: Induction, optional bridging and continuous therapy.

Isatuximab: Induction, optional bridging and continuous therapy.

Lenalidomide: Induction, optional bridging and continuous therapy.

Bortezomib: Induction therapy.

Cyclophosphamide: Lymphodepletion

Fludarabine: Lymphodepletion

Study summary

This is a randomised, multicentre, controlled, open-label, Phase III global study comparing the efficacy and safety of standard induction regimens (IsaVRd and DRd) followed by AZD0120 versus standard induction regimens followed by continuous therapy (IsaRd and DRd) in participants with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplant (ASCT) as initial therapy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
INCLUSION CRITERIA: 1. Participants must be 18 years or older, at the time of signing the ICF. 2. Participant must have documented diagnosis of MM according to the IMWG diagnostic criteria. 3. 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) and abnormal 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. 5. Participant is a candidate to receive at least one of the regimens (IsaVRd or DRd) as determined by the Investigator. 6. ECOG performance status Grade of 0 to 2. 7. Participant must have adequate organ and bone marrow function. EXCLUSION CRITERIA: 1. Participant has active or prior CNS or meningeal involvement of MM. 2. Participant has primary amyloidosis, active plasma cell leukemia (≥5% circulating plasma cells), Waldenström macroglobulinemia, or POEMS syndrome. 3. Participant has significant neurological or psychiatric condition posing risk or impairing evaluation. 4. Participant has any other significant medical condition that increases unacceptable risk, interferes with therapy delivery, or confounds evaluation. 5. 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. 6. Participant has a history of haematologic malignancies, other than MM, regardless of remission status. 7. Participant is positive for any of the following: 1. HIV: Known to be seropositive for HIV (including any history of HIV). 2. Chronic or active hepatitis B. 3. Active hepatitis C: Hepatitis C infection. 4. Additional local requirements for the testing for infectious diseases and exclusions of applicable participants should be followed per local regulations. 8. Participant has clinically significant cardiovascular disease. 9. Participant has COPD with an FEV1 \< 50% of predicted normal. 10. 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.

Primary outcome measure(s)

Trial sites (124)

FacilityCityRegionStatus
Research Site Gilbert Arizona Not Yet Recruiting
Research Site Phoenix Arizona Not Yet Recruiting
Research Site Tucson Arizona Not Yet Recruiting
Research Site Orange California Not Yet Recruiting
Research Site Santa Monica California Not Yet Recruiting
Research Site Aurora Colorado Not Yet Recruiting
Research Site Denver Colorado Not Yet Recruiting
Research Site New Haven Connecticut Not Yet Recruiting
Research Site Coral Gables Florida Not Yet Recruiting
Research Site Tampa Florida Not Yet Recruiting
Research Site Atlanta Georgia Not Yet Recruiting
Research Site Chicago Illinois Not Yet Recruiting
Research Site Iowa City Iowa Not Yet Recruiting
Research Site Wichita Kansas Not Yet Recruiting
Research Site Louisville Kentucky Not Yet Recruiting
Research Site Baton Rouge Louisiana Not Yet Recruiting
Research Site Baltimore Maryland Not Yet Recruiting
Research Site Detroit Michigan Not Yet Recruiting
Research Site St Louis Missouri Not Yet Recruiting
Research Site East Brunswick New Jersey Not Yet Recruiting
Research Site Albany New York Not Yet Recruiting
Research Site New Hyde Park New York Not Yet Recruiting
Research Site New York New York Not Yet Recruiting
Research Site New York New York Not Yet Recruiting
Research Site New York New York Not Yet Recruiting
Research Site The Bronx New York Not Yet Recruiting
Research Site Chapel Hill North Carolina Not Yet Recruiting
Research Site Charlotte North Carolina Not Yet Recruiting
Research Site Durham North Carolina Not Yet Recruiting
Research Site Winston-Salem North Carolina Not Yet Recruiting
Research Site Winston-Salem North Carolina Not Yet Recruiting
Research Site Cincinnati Ohio Not Yet Recruiting
Research Site Cleveland Ohio Not Yet Recruiting
Research Site Columbus Ohio Not Yet Recruiting
Research Site Montgomery Ohio Not Yet Recruiting
Research Site Portland Oregon Not Yet Recruiting
Research Site Nashville Tennessee Not Yet Recruiting
Research Site Nashville Tennessee Not Yet Recruiting
Research Site Dallas Texas Not Yet Recruiting
Research Site Houston Texas Not Yet Recruiting

+ 84 more sites — see the full list on the official registry below.

On this site

📄 Darzalex (daratumumab) drug profile → 📄 Revlimid (lenalidomide) drug profile →

More AstraZeneca trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07764978 on ClinicalTrials.gov ↗ ← All trials in the UK