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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>randomisation</b> and assignment to a study treatment

    After joining the study, you are assigned by randomisation, which means the treatment is chosen by chance. You receive either azd0120 or one of the standard treatment regimens used in the study.

    The standard treatment regimens listed in the study are dkd, dpd, pvd, or kd. These names refer to combinations of medicines used to treat your condition.

  2. Step 2

    <b>azd0120</b> treatment

    If you are assigned to azd0120, you receive this medicine as a solution for infusion into a vein. The source data do not give a dose, frequency, or duration for azd0120.

    azd0120 is described as a car-t therapy, which means treatment made from your own immune cells that are changed in a laboratory to help target the cancer. It is directed against b-cma and cd19, which are proteins found on some myeloma cells.

  3. Step 3

    <b>standard treatment regimens</b>

    If you are assigned to standard treatment, you receive one of the following medicine combinations: dkd, dpd, pvd, or kd. The source data list the medicines used in these regimens, but they do not give the exact schedule, dose, or duration for the combinations.

    dkd includes daratumumab as darzalex 1800 mg solution for injection, carfilzomib as kyprolis 10 mg, 30 mg, or 60 mg powder for solution for infusion, and dexamethasone as dexamethason 1.5 mg, 4 mg, 8 mg, or 0.5 mg tablets. Daratumumab and carfilzomib are given into a vein. Dexamethasone is taken by mouth.

    dpd includes daratumumab as darzalex 1800 mg solution for injection, pomalidomide as pomalidomide zentiva 1 mg, 2 mg, 3 mg, or 4 mg hard capsules, and dexamethasone as dexamethason 1.5 mg, 4 mg, 8 mg, or 0.5 mg tablets. Pomalidomide and dexamethasone are taken by mouth. Daratumumab is given into a vein.

    pvd includes bortezomib as bortezomib hikma 3.5 mg solution for injection, pomalidomide as pomalidomide zentiva 1 mg, 2 mg, 3 mg, or 4 mg hard capsules, and dexamethasone as dexamethason 1.5 mg, 4 mg, 8 mg, or 0.5 mg tablets. Bortezomib is given into a vein. Pomalidomide and dexamethasone are taken by mouth.

    kd includes carfilzomib as kyprolis 10 mg, 30 mg, or 60 mg powder for solution for infusion, and dexamethasone as dexamethason 1.5 mg, 4 mg, 8 mg, or 0.5 mg tablets. Carfilzomib is given into a vein. Dexamethasone is taken by mouth.

  4. Step 4

    <b>follow-up assessment</b> during the study

    During the study, your condition is checked to see how the treatment is working. The main measure is progression-free survival, which means the time from randomisation until the disease gets worse or death occurs from any cause.

    Another main measure is whether you have no signs of myeloma that can still be found with a very sensitive test at 9 months after randomisation, with a window of plus or minus 3 months, before any new anti-myeloma treatment starts. This is called mrd negative cr, which means no measurable remaining disease and a complete response or very good complete response.

  5. Step 5

    <b>study end measures</b>

    The study also checks overall survival, which means the time from randomisation until death from any cause.

    Other measures include the rate of complete response or better, the rate of partial response or better, the length of time that a response lasts, the time to first response, the rate of sustained mrd negative cr, the time to the next line of treatment, and the time from the last dose of study treatment to the first dose of a later anti-myeloma treatment.

    Safety is also checked by looking at side effects, vital signs, and laboratory test results.

Who can join the trial?

10 criteria

  • 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 trial?

17 criteria

  • 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.
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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.

What is already known about the treatment

  • AZD0120

    AZD0120 is given by intravenous infusion, meaning it is delivered directly into a vein in a hospital setting. It is an investigational CAR-T cell therapy and is still being studied in medical research, so it is not yet an established standard treatment. It is designed for relapsed or hard-to-treat multiple myeloma and works by using modified immune cells to find and kill cancer cells through targets called BCMA and CD19; this type of treatment is classified as an antineoplastic immunotherapy and gene-based cell therapy.

  • Bortezomib

    Bortezomib is given by intravenous injection or infusion in a clinical setting. It is a well-known and widely used cancer medicine, especially in multiple myeloma and some other blood cancers. It blocks a cell system called the proteasome, which helps damaged proteins get broken down; when this system is blocked, cancer cells build up harmful proteins and die. It belongs to the class of proteasome inhibitors.

  • Daratumumab

    Daratumumab is given by intravenous injection and is administered under medical supervision. It is an established medicine in modern cancer care, especially for multiple myeloma, and is also well described in medical literature. It works by attaching to a protein called CD38 on myeloma cells, which helps the immune system recognize and destroy these cells; it is classified as a monoclonal antibody and anti-cancer immunotherapy.

  • Dexamethasone

    Dexamethasone is taken by mouth as a tablet. It is a long-used medicine in both everyday practice and medical literature, and it is often used in cancer treatment plans as a supportive and anti-cancer medicine. In multiple myeloma, it helps reduce inflammation and can directly slow the growth of cancer cells by affecting how genes turn on and off inside the cell; it belongs to the class of corticosteroids.

  • Carfilzomib

    Carfilzomib is given by intravenous infusion in a hospital or clinic. It is an established anti-cancer medicine used mainly in multiple myeloma, especially when the disease has returned or no longer responds well to other treatments. It works by blocking the proteasome, a protein-cleanup system inside cells, which leads to harmful protein build-up and cell death in cancer cells; it is classified as a proteasome inhibitor.

  • Pomalidomide

    Pomalidomide is taken by mouth as a hard capsule. It is a well-established medicine used mainly for relapsed or refractory multiple myeloma and is commonly discussed in medical literature. It helps the immune system work against cancer cells, reduces signals that support tumor growth, and can slow the blood supply that tumors need; it is classified as an immunomodulatory anti-cancer drug.

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523285-25-00Protocol codeD8311C00001Estimated enrolment508 patientsSponsorAstraZeneca AB

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