NCT07764978 · AstraZeneca
Study of AZD0120 in Newly Diagnosed Multiple Myeloma Ineligible for ASCT
(DURGA-5)
What this study is about
This is a randomised, multicentre, controlled, where both patients and doctors know the treatment given, Phase III global study comparing the effectiveness 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.
View original scientific description
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.
Interventions
BIOLOGICAL
AZD0120
AZD0120, is a BCMA/CD19 dual CAR T-cell product, which is administered intravenously.
BIOLOGICAL
Daratumumab
Induction, optional bridging and continuous therapy.
DRUG
Dexamethasone
Induction, optional bridging and continuous therapy.
BIOLOGICAL
Isatuximab
Induction, optional bridging and continuous therapy.
DRUG
Lenalidomide
Induction, optional bridging and continuous therapy.
DRUG
Bortezomib
Induction therapy.
DRUG
Cyclophosphamide
Lymphodepletion
DRUG
Fludarabine
Lymphodepletion
Primary outcome measures
PFS in NDMM who are ineligible to receive ASCT is measured to demonstrate the superiority of IsaVRd or DRd induction followed by AZD0120 compared to IsaVRd or DRd induction followed by continuous DRd or IsaRd.
Time frame: Up to 9 years.
PFS: defined as time from randomisation until progression according to IMWG 2016 criteria as assessed by BICR, or death due to any cause, whichever occurs first.
MRD negative CR rate at 9M in NDMM who are ineligible to receive ASCT is measured to demonstrate the superiority of IsaVRd or DRd induction followed by AZD0120 compared to IsaVRd or DRd induction followed by continuous DRd or IsaRd
Time frame: Up to 9 years.
MRD negative CR rate at 9 months: defined as the proportion of participants with MRD negative status (at threshold of 10-5) and have a response of CR or sCR (according to the IMWG 2016 criteria) as assessed by BICR at 9 months (± 3 months) from randomisation before initiation of subsequent anti-myeloma therapy.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Participants must be 18 years or older, at the time of signing the ICF.
- Participant must have documented diagnosis of MM according 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) and abnormal serum immunoglobulin kappa lambda FLC ratio.
- 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 criteria
- Participant has active or prior CNS or meningeal involvement of MM.
- Participant has primary amyloidosis, active plasma cell leukemia (≥5% circulating plasma cells), Waldenström macroglobulinemia, or POEMS syndrome.
- Participant has significant neurological or psychiatric condition posing risk or impairing evaluation.
- Participant has any other significant medical condition that increases unacceptable risk, interferes with therapy delivery, or confounds evaluation.
- 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 a history of haematologic malignancies, other than MM, regardless of remission status.
- Participant is positive for any of the following:
- HIV: Known to be seropositive for HIV (including any history of HIV).
- Chronic or active hepatitis B.
- Active hepatitis C: Hepatitis C infection.
- 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.
- Participant has COPD with an FEV1 \< 50% of predicted normal.
- 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.
Where
- Gilbert, Arizona
- Phoenix, Arizona
- Tucson, Arizona
- Orange, California
- Santa Monica, California
- Aurora, Colorado
- Denver, Colorado
- New Haven, Connecticut
- Coral Gables, Florida
- Tampa, Florida
- Atlanta, Georgia
- Chicago, Illinois
And 28 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 14, 2026 · Source of record for eligibility and locations