Comparing AZD0120 with Daratumumab for newly diagnosed multiple myeloma
Official title: Study of AZD0120 in Newly Diagnosed Multiple Myeloma Ineligible for ASCT
Phase III Open-Label, Randomised Study of Consolidation With AZD0120 (Dual-Targeting BCMA/CD19 CAR-T) vs Continuous Standard Therapy in NDMM Patients Ineligible for ASCT as Initial Therapy (DURGA-5)
- Phase 3
- 2 groups
- Sites in Calgary, Vancouver and 4 more cities
- Recruiting
Interventions (8)
- Biological therapy
AZD0120
AZD0120, is a BCMA/CD19 dual CAR T-cell product, which is administered intravenously.
- Biological therapy
Daratumumab
Induction, optional bridging and continuous therapy.
- Medication
Dexamethasone
Induction, optional bridging and continuous therapy.
- Biological therapy
Isatuximab
Induction, optional bridging and continuous therapy.
- Medication
Lenalidomide
Induction, optional bridging and continuous therapy.
- Medication
Bortezomib
Induction therapy.
- Medication
Cyclophosphamide
Lymphodepletion
- Medication
Fludarabine
Lymphodepletion
Canadian Sites (6)
6 listed, none recruiting
- Not yet recruiting
Research Site
Calgary, Alberta
- Not yet recruiting
Research Site
Vancouver, British Columbia
- Not yet recruiting
Research Site
Halifax, Nova Scotia
- Not yet recruiting
Research Site
Ottawa, Ontario
- Not yet recruiting
Research Site
Montreal, Quebec
- Not yet recruiting
Research Site
Sherbrooke, Quebec
Eligibility Criteria
See who this study is looking for21 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +ECOG performance status Grade of 0 to 2.
- +Participants must be 18 years or older, at the time of signing the ICFInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
- +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 InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →.
- +Participant must have adequate organ and bone marrow function.
Exclusion
- −HIV: Known to be seropositive for HIV (including any history of HIV).
- −Chronic or active hepatitis B.
- −Active hepatitis C: Hepatitis C infection.
- −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:
- −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 exclusionExclusion criteriaThe things that would prevent someone from taking part.Read more → 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.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives one or more of: AZD0120, Daratumumab, Dexamethasone, Isatuximab, Lenalidomide, Bortezomib, Cyclophosphamide and Fludarabine.
Registry label: A: Arm A: Investigational Arm
Group B, the comparison group, receives one or more of: Daratumumab, Dexamethasone, Isatuximab, Lenalidomide and Bortezomib.
Registry label: B: Arm B: Control Arm
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 750 people.
The study is currently expected to finish around May 2034.
The main measurement is taken over: Up to 9 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study 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 — measured over Up to 9 years.
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 — measured over Up to 9 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07764978 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About AZD0120Biological
AZD0120, is a BCMA/CD19 dual CAR T-cell product, which is administered intravenously.
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About DaratumumabBiological
Induction, optional bridging and continuous therapy.
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About DexamethasoneDrug
Induction, optional bridging and continuous therapy.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About IsatuximabBiological
Induction, optional bridging and continuous therapy.
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About LenalidomideDrug
Induction, optional bridging and continuous therapy.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About BortezomibDrug
Induction therapy.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About CyclophosphamideDrug
Lymphodepletion
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About FludarabineDrug
Lymphodepletion
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to 9 years..
The study as a whole is currently expected to finish around 2034-05-12.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 750 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 13 locations, including: Calgary, Alberta, Canada; Vancouver, British Columbia, Canada; Halifax, Nova Scotia, Canada; Ottawa, Ontario, Canada; Montreal, Quebec, Canada; Sherbrooke, Quebec, Canada, and 7 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (10)
Research Site
Detroit, Michigan, United States
Research Site
Albany, New York, United States
Research Site
New Hyde Park, New York, United States
Research Site
New York, New York, United States
Research Site
New York, New York, United States
Research Site
New York, New York, United States
Research Site
The Bronx, New York, United States
Research Site
Puyallup, Washington, United States
Research Site
Seattle, Washington, United States
Research Site
Seattle, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.