AZD0120 versus standard regimens in patients with relapsed or refractory multiple myeloma

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What is this study about?

This study is in relapsed or refractory multiple myeloma, a type of cancer that starts in plasma cells, which are a kind of white blood cell. Relapsed means the disease has come back after treatment, and refractory means it has not responded well to treatment. The study is testing AZD0120, a CAR-T therapy made from a person’s own immune cells and designed to attack two targets on myeloma cells, called BCMA and CD19. The purpose of the study is to compare AZD0120 with standard treatment and to learn how well it works and how safe it is.

People in the study are assigned by chance to receive either AZD0120 or one of the standard treatment plans used for this disease. The standard plans may include combinations such as daratumumab, carfilzomib, bortezomib, pomalidomide, and dexamethasone. AZD0120 is given through a vein, while the other treatments may be given by infusion, injection, or as capsules or tablets taken by mouth. The study then follows participants over time to see how the disease changes, how long the treatment effects last, and how safe the treatments are, with regular checks of general health and blood tests.

Who Can Join the Study?

Be 18 years of age or older when signing the consent form, which is the document saying the person agrees to take part in the study.
Have a documented diagnosis of multiple myeloma according to the IMWG criteria, meaning the diagnosis must match the official rules used by myeloma specialists.
Have measurable disease, meaning the myeloma can be tracked with at least one of these tests: serum M-protein of at least 1.0 g/dL, urine M-protein of at least 200 mg in 24 hours, or serum free light chains of at least 10 mg/dL (100 mg/L) with an abnormal kappa/lambda ratio, which is a blood test showing an unusual balance of these proteins.
Have progressive disease confirmed by the investigator, meaning the cancer has gotten worse, based on the IMWG 2016 criteria during or after the most recent treatment.
If the person has had only 1 prior treatment line, the disease must have returned or worsened within 47 months after a stem cell transplant, or within 42 months after starting the first treatment if no transplant was done.
Have received 1 to 3 previous lines of therapy, meaning 1 to 3 earlier treatment plans, including an IMiD such as an immunomodulatory drug, and either a PI such as a proteasome inhibitor, or an anti-CD38 antibody, which are types of myeloma medicines.
Have completed at least 2 full treatment cycles for each previous line of therapy, unless the best response to that treatment was that the disease got worse.
Be considered able to receive at least one of the standard treatment options used in the study, which are DKd, PVd, DPd, or Kd. These are combinations of myeloma medicines.
Have an ECOG performance status of 0 to 1, meaning the person is fully active or only slightly limited in daily activities.
Have adequate organ and bone marrow function, meaning the major organs and the bone marrow are working well enough for study treatment.

Who Cannot Join the Study?

People with active or past involvement of the central nervous system or the lining around the brain and spinal cord by multiple myeloma cannot join. The central nervous system includes the brain and spinal cord, and the meninges are the protective layers around them.
People with primary amyloidosis cannot join. This means a condition where abnormal proteins build up in organs and tissues.
People with active plasma cell leukemia cannot join. This means there are at least 5% circulating plasma cells in the blood, which are a type of blood cell related to myeloma.
People with Waldenström macroglobulinemia cannot join.
People with POEMS syndrome cannot join.
People with primary refractory multiple myeloma cannot join. This means the disease did not show even a minimal response to any previous treatment.
People with a serious neurological or psychiatric condition that could make the study unsafe or make it hard to judge the treatment effect cannot join. This includes severe brain injury, dementia, Parkinson’s disease, stroke, bleeding inside the skull, or a seizure within the past 6 months. A neurological condition affects the brain, nerves, or spinal cord. A psychiatric condition affects mental health.
People with any other serious medical problem that would make the study too risky, interfere with treatment, or make the results hard to interpret cannot join.
People with a serious active or uncontrolled infection cannot join. This means an infection that is not under control.
People who need supplemental oxygen cannot join. This means they need extra oxygen to breathe.
People with an active autoimmune disease, or a history of autoimmune disease within the past 2 years, cannot join. An autoimmune disease is a condition where the immune system attacks the body’s own tissues.
People with a clinically significant gastrointestinal disease cannot join if it could affect the study. Gastrointestinal means the stomach and intestines. This includes inflammatory bowel disease that needed treatment within the past 5 years.
People who have already received any BCMA-targeted treatment cannot join. BCMA is a protein found on myeloma cells that some treatments are designed to target.
People who have already received CAR-T therapy or CAR-NK therapy cannot join. These are treatments that use modified immune cells to attack cancer cells.
People who have already received T-cell engager therapy cannot join. This is a treatment that helps T cells, a type of immune cell, attach to and attack cancer cells.
People who have had an allogeneic stem cell transplant at any time cannot join. This is a transplant using stem cells from another person.
People who had an autologous stem cell transplant within 12 weeks before randomization cannot join. An autologous stem cell transplant uses the person’s own stem cells, and randomization is the step where treatment is assigned by chance.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
Oslo Universitetssykehus HF	Oslo	Norway
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
IRCCS Humanitas Research Hospital	Rozzano	Italy
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Hospital Universitario De Salamanca	Salamanca	Spain
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland
Centre Hospitalier Universitaire De Lille	Lille	France
Universitaet Leipzig	Leipzig	Germany
Oncopole Claudius Regaud	Toulouse	France
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Klinikum Nuernberg	Nürnberg	Germany
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Hospital Universitario 12 De Octubre	Madrid	Spain
Instytut Hematologii I Transfuzjologii	Warsaw	Poland
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli	Lublin	Poland
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Ospedale San Raffaele S.r.l.	Milan	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Centre Hospitalier Universitaire De Nantes	Nantes	France
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
Centre Hospitalier Lyon Sud	Pierre Benite	France
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Udomoiyubs Mgnspis Calkxe Hplvuwwuodgikjoil	Hamburg	Germany
Ueislifkrjuvphjrfwwdw Ekzfd Asj	Essen	Germany
Hhnpuism Useurdzbpqhgz Mubhuiu Dl Vwqmekffli	Santander	Spain
Anxqlmiskc Pyuwqwef Hrsnqllx Dm Ppxdn	Paris	France
Awigcif Oisfrxtymhc Ugxvuaixnaoyp Cfwpqpsxouqs Dsewq Sxqvim E Dnxax Semjcdv Dk Twckrf	Turin	Italy
Nizsagdw Irfftdmz Otzbgrygn Iyg Mqiof Sxdfyhrrkxiyaplivlbshdrdqhbh Imbswwhh Bhkigzte	Cracow	Poland
Ubdlllvshmfxdmlowvnxc Whnrlzfxw Ahu	Wuerzburg	Germany
Azufaoh Uhbgv Sdepvugsl Lmaooh De Bizocvf	Bologna	Italy
Usvqrpkkdqdomy Cltolwx Klynjybzj	Gdansk	Poland
Hkfyduzo Vrfv ddtrfqur	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	08.06.2026
Germany	Not yet recruiting	08.06.2026
Italy	Not yet recruiting	08.06.2026
Norway	Not yet recruiting	08.06.2026
Poland	Not yet recruiting	08.06.2026
Spain	Not yet recruiting	08.06.2026

Trial locations

Investigated drugs:

AZD0120 is the study treatment being tested in this trial. It is a CAR-T cell therapy made from the participant’s own T cells, which are collected, changed in a lab to help them recognize myeloma cells, and then given back through a vein. It is designed to attack two targets on myeloma cells, called BCMA and CD19, with the goal of helping the immune system find and destroy the cancer cells.

Bortezomib is a standard myeloma medicine given into a vein. It is used in one of the comparison treatment plans to help slow down or kill myeloma cells. In this trial, it is part of a combination treatment used instead of AZD0120 for some participants.

Daratumumab is a cancer medicine given into a vein. It works by attaching to a protein on myeloma cells and helping the body’s immune system attack them. In this study, it is one of the medicines used in standard treatment combinations being compared with AZD0120.

Dexamethasone is a steroid medicine taken by mouth. In multiple myeloma, it is often used with other anti-cancer medicines to help improve their effect and reduce inflammation. In this trial, it is part of the standard treatment options being compared with the study CAR-T therapy.

Carfilzomib is a myeloma medicine given into a vein. It helps stop myeloma cells from breaking down proteins they need to survive, which can lead to cancer cell death. In this study, it is used in one of the standard regimens instead of AZD0120.

Pomalidomide is a medicine taken by mouth that helps the immune system work against myeloma cells and can also slow cancer cell growth. It is part of one of the standard treatment combinations in this trial and is being compared with the new CAR-T therapy AZD0120.

Investigated diseases:

Relapsed or Refractory Multiple Myeloma – A cancer of plasma cells, which are a type of white blood cell found in the bone marrow. It relapses when it returns after a period of improvement and is refractory when it no longer responds well to prior treatment. The disease usually progresses by increasing the number of abnormal plasma cells in the bone marrow and spreading to other bones or organs. It can lead to worsening bone damage, anemia, kidney problems, and frequent infections as it advances.

Trial ID:

2025-523285-25-00

Protocol code:

D8311C00001

Trial Phase:

Therapeutic confirmatory (Phase III)

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AZD0120 versus standard regimens in patients with relapsed or refractory multiple myeloma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?