NCT07764978 Study of AZD0120 in Newly Diagnosed Multiple Myeloma Ineligible for ASCT
| NCT ID | NCT07764978 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | AstraZeneca |
| Condition | Newly Diagnosed Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 750 participants |
| Start Date | 2026-06-26 |
| Primary Completion | 2029-01-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 750 participants in total. It began in 2026-06-26 with a primary completion date of 2029-01-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Jen Brudno, MD
STUDY DIRECTOR
AstraZeneca
Frequently Asked Questions
Who can join the NCT07764978 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Newly Diagnosed Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07764978 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 750 participants.
Is NCT07764978 currently recruiting?
Yes, NCT07764978 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT07764978 trial being conducted?
This trial is being conducted at Gilbert, United States, Phoenix, United States, Tucson, United States, Orange, United States and 11 additional locations.
Who is sponsoring the NCT07764978 clinical trial?
NCT07764978 is sponsored by AstraZeneca. The principal investigator is Jen Brudno, MD at AstraZeneca. The trial plans to enroll 750 participants.