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A Phase III study of AZD0120 with drug combination versus standard therapy in adults with newly diagnosed multiple myeloma not eligible for stem cell transplant

Fast replyRegistered drugNo placebo
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What is this trial about?

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

Newly diagnosed Multiple Myeloma is a blood cancer that starts in the bone‑marrow and can cause bone damage, fatigue, and infections. The trial evaluates a new therapy called AZD0120, which is a specially engineered cell treatment known as CAR T therapy, designed to recognize and attack cancer cells that carry the BCMA and CD19 markers. In the comparison arm, patients receive a combination of standard medicines that include bortezomib, lenalidomide, daratumumab, isatuximab and dexamethasone.

The purpose of the study is to determine whether a single infusion of the new cell therapy after an initial treatment period works better than staying on continuous standard therapy. All participants first receive an “induction” phase, which is an early round of treatment meant to quickly lower the amount of cancer. After this, one group receives the one‑time AZD0120 infusion, while the other group continues taking the standard medicines over time.

After the assigned treatment, participants are followed with regular doctor visits, blood tests, and imaging to check for signs of disease progression, which is measured as “progression‑free survival” (the time the cancer does not get worse). Additional checks look for a very deep response called “MRD negative complete response” (meaning tests cannot find any remaining cancer cells). Safety is also monitored through reports of side effects, vital signs, and laboratory results throughout the study period.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomisation

    After you join the study, you will be randomly assigned to one of two treatment groups. the assignment is made by a computer and you will not know which group you are placed in until treatment begins.

  2. Step 2

    Induction therapy (isaVRd or DRd)

    You will receive an initial combination of medicines to reduce the myeloma cells. the drugs used in this phase are:

    bortezomib: 1.3 mg per square meter of body‑surface area, given intravenously (through a vein).

    lenalidomide: 25 mg taken by mouth each day as directed by the study doctor.

    daratumumab: 1800 mg given intravenously.

    isatuximab: 10 mg per kilogram of body weight, given intravenously.

    dexamethasone: 40 mg taken by mouth each day as directed.

    The exact schedule (how many days each drug is given) follows the study protocol and will be explained by the study doctor.

  3. Step 3

    Assessment after induction

    Once the induction phase is completed, the study doctor will review your test results to decide whether you will continue with standard therapy or receive the single‑dose cell therapy.

  4. Step 4

    Single infusion of azd0120 (CAR‑T therapy)

    If you are assigned to the cell‑therapy arm, you will receive one intravenous infusion of azd0120. the dose is defined by the study protocol and is delivered as a solution for infusion. the infusion is given in a single session and no further doses of azd0120 are planned.

  5. Step 5

    Continuous standard therapy (DRd or IsaRd)

    If you are assigned to the standard‑therapy arm, you will continue to receive a combination of medicines on an ongoing basis. the drugs and their doses are:

    bortezomib: 1.3 mg/m² intravenously.

    lenalidomide: 25 mg orally.

    daratumumab: 1800 mg intravenously.

    isatuximab: 10 mg/kg intravenously.

    dexamethasone: 40 mg orally.

    These medicines are given repeatedly according to the schedule set by the study protocol until disease progression or the end of the study.

  6. Step 5

    Regular follow‑up visits

    Throughout the study you will attend scheduled clinic visits. at each visit you will:

    Have blood tests and other laboratory checks to monitor safety and how the disease is responding,

    Undergo imaging or other examinations as directed,

    Receive assessments of disease status, including measurements of progression‑free survival and minimal residual disease (mrD),

    Report any side effects or new symptoms to the study doctor.

  7. Step 6

    Final follow‑up and study completion

    The study continues until the planned end date, until disease progression, or until you discontinue for any reason. at the final visit you will have a comprehensive evaluation of your health status, disease response, and any long‑term safety information collected during the trial.

Who can join the trial?

7 criteria

  • Age 18 or older at the time you sign the consent form.
  • A confirmed diagnosis of multiple myeloma based on the International Myeloma Working Group (IMWG) criteria, which are the standard rules doctors use to identify this disease.
  • At least one measurable sign of disease, such as a blood test showing serum M‑protein (a protein made by myeloma cells) of 1.0 g/dL or higher, a urine test showing urine M‑protein of 200 mg in a 24‑hour collection or more, or a blood test showing serum free light chains (FLC) of 10 mg/dL (100 mg/L) together with an abnormal kappa/lambda ratio (a comparison of two types of light chains).
  • You must be considered ineligible for autologous stem cell transplant (ASCT) but have sufficient organ health to receive CAR‑T cell therapy (a treatment that uses your own immune cells that are engineered to fight cancer).
  • You must be a candidate to receive at least one of the study drug combinations, IsaVRd or DRd, as decided by your doctor.
  • Your overall health must be rated as ECOG performance status 0 to 2, meaning you are fully active (0) or able to care for yourself but not able to work (2).
  • You need adequate function of your organs and bone marrow (the tissue that makes blood cells) to safely take part in the trial.

Who cannot join the trial?

10 criteria

  • You have cancer that has involved the CNS (brain or spinal cord) or the protective covering of these areas (meningeal involvement), either now or in the past.
  • You have any of the following conditions: primary amyloidosis (abnormal protein buildup in organs), active plasma cell leukemia (a type of blood cancer with ≥5% cancer cells circulating in the blood), Waldenström macroglobulinemia (a rare blood disorder), or POEMS syndrome (a group of symptoms including nerve, skin, and bone problems).
  • You have a significant neurological (brain or nerve) or psychiatric (mental health) condition that could put you at risk or make it hard to evaluate the study results.
  • You have any other serious medical problem that would increase the risk of treatment, interfere with giving the medication, or make it difficult to understand the study outcomes.
  • You have a history of a non‑blood cancer (for example, breast, lung, or colon cancer) unless you have been completely free of that cancer with no signs of it returning for at least 2 years.
  • You have a history of any other blood cancers (such as leukemia or lymphoma) besides multiple myeloma, no matter whether they are currently in remission.
  • You test positive for any of the following infections: HIV (human immunodeficiency virus), chronic or active hepatitis B, or active hepatitis C. These infections can affect safety and study results.
  • You have serious heart or blood‑vessel disease (clinically significant cardiovascular disease) that could make treatment unsafe.
  • You have chronic obstructive pulmonary disease (COPD) and your lung function test (FEV1) is less than 50% of the normal value expected for your age and size.
  • If you are planned to receive the IsaVRd regimen, you have peripheral neuropathy (nerve damage causing tingling, numbness, or pain) at any severity level (Grade 1‑4) or even mild (Grade 1) neuropathy accompanied by pain.
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Investigated drugs

  • AZD0120

    is a special type of treatment called a CAR T‑cell therapy. In this approach, a patient’s own immune cells are taken out, changed in the lab to recognize two proteins (BCMA and CD19) that are found on myeloma cells, and then given back to the patient as a single infusion. The engineered cells are meant to find and destroy the cancer cells after the patient has completed initial induction therapy.

  • Bortezomib

    is a medicine given through a vein that blocks a process inside cancer cells called the proteasome. By stopping this process, the drug helps to kill myeloma cells. In the trial it is used as part of the standard treatment regimen that participants receive before the CAR T‑cell therapy.

  • Lenalidomide

    is a pill that works by modifying the immune system and directly slowing the growth of myeloma cells. It is taken regularly as part of the continuous standard therapy that is compared with the single CAR T‑cell infusion.

  • Daratumumab

    is an antibody given by infusion that attaches to a protein called CD38 on the surface of myeloma cells. This binding signals the immune system to attack the cancer cells. It is included in the standard treatment arm of the study.

  • Isatuximab

    is another antibody delivered intravenously that also targets the CD38 protein on myeloma cells. Like daratumumab, it helps the body’s immune system recognize and destroy the cancer. It is used in the standard therapy groups being compared in the trial.

  • Dexamethasone

    is an oral steroid that reduces inflammation and helps kill myeloma cells. It is taken together with other drugs in the standard therapy regimen and serves as a background treatment in both study arms.

What is already known about the treatment

  • Bortezomib

    Bortezomib is given by intravenous injection and is an approved drug for treating multiple myeloma. It works by blocking a cell‑cleaning system called the proteasome, causing cancer cells to die. This medication belongs to the class of proteasome inhibitors and is widely used in standard myeloma regimens.

  • AZD0120

    AZD0120 is administered as a single intravenous infusion of a solution for infusion and is currently an investigational therapy not yet approved for general use. It is a dual‑targeting autologous CAR‑T cell product that directs the patient’s own T cells to recognize and attack BCMA and CD19 proteins on myeloma cells. The treatment belongs to the class of CAR‑T cell therapies and is being studied as a one‑time consolidation approach in newly diagnosed multiple myeloma.

  • Lenalidomide

    Lenalidomide is taken as an oral tablet and is an approved medication for multiple myeloma. It enhances the body’s immune response and directly slows the growth of cancer cells. This drug is classified as an immunomodulatory agent and is commonly used in combination with other myeloma treatments.

  • Daratumumab

    Daratumumab is given by intravenous infusion and is an approved monoclonal antibody for multiple myeloma. It binds to the CD38 protein on myeloma cells, marking them for destruction by the immune system. The medication belongs to the class of anti‑CD38 monoclonal antibodies and is used in standard myeloma therapy.

  • Isatuximab

    Isatuximab is administered intravenously and is an approved monoclonal antibody used to treat multiple myeloma. It also targets the CD38 protein on cancer cells, leading to immune‑mediated cell death. This drug is classified as an anti‑CD38 monoclonal antibody and is part of modern myeloma treatment regimens.

  • Dexamethasone

    Dexamethasone is taken orally and is an approved corticosteroid commonly used in multiple myeloma therapy. It reduces inflammation and can help kill myeloma cells by weakening their survival signals. The medication belongs to the class of corticosteroids and is often combined with other anti‑myeloma drugs.

Investigated diseases

Newly Diagnosed Multiple Myeloma - Multiple myeloma is a cancer that begins in plasma cells, which are white blood cells that produce antibodies. In newly diagnosed patients, abnormal plasma cells proliferate within the bone marrow, gradually displacing normal blood‑forming cells. This expansion can weaken bones, causing pain or fractures, and can lower the production of healthy blood cells, leading to anemia and increased infection risk. As the disease advances, excess proteins released by the cancer cells may accumulate and affect the kidneys and other organs.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524014-29-00Protocol codeDURGA-5Estimated enrolment750 patientsSponsorAstraZeneca AB

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