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A Phase III Study of AZD0120 versus melphalan hydrochloride with lenalidomide maintenance in transplant‑eligible adults with newly diagnosed 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

The study focuses on adults who have been newly diagnosed with Multiple Myeloma, a cancer that starts in the plasma cells of the bone marrow. The experimental treatment being tested is a single intravenous infusion of AZD0120, which is a type of CAR‑T therapy – a laboratory‑made version of the patient’s own immune cells that are engineered to recognize and destroy cancer cells that carry the BCMA and CD19 markers. The comparison treatment is the standard approach of an Autologous Stem Cell Transplant followed by ongoing oral medication with lenalidomide to help keep the disease under control.

The purpose of the trial is to determine whether the single infusion of AZD0120 can keep the disease from returning and lead to deeper remission than the standard transplant‑based approach. Participants are randomly assigned to receive either the AZD0120 infusion or the transplant plus lenalidomide. After the assigned therapy, they will have regular clinic visits, blood tests, and imaging over many months to monitor for any signs of the cancer returning or progressing.

Key terms are explained in simple language: “CAR‑T” therapy uses the patient’s own immune cells that are re‑programmed in a lab to target the cancer; an “Autologous Stem Cell Transplant” involves collecting the patient’s own blood‑forming cells, giving high‑dose treatment to kill cancer cells, and then returning the collected cells to restore normal blood production; “lenalidomide” is a pill taken after the transplant to help prevent the cancer from coming back; and “MRD‑negative” means that very sensitive tests cannot find any remaining cancer cells, indicating a very deep response. Safety checks, including monitoring for side effects, vital signs, and lab results, are performed throughout the study.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomisation and assignment

    After you join the study you are randomly assigned to one of two treatment groups.

    The assignment determines whether you will receive the study drug azd0120 or the standard approach called autologous stem cell transplant (asct).

  2. Step 2

    Receive study treatment

    If you are assigned to the azd0120 arm you receive a single intravenous infusion of azd0120. the infusion is given once and the exact dose is set by the study protocol.

    If you are assigned to the asct arm you undergo a single autologous stem cell transplant. this includes an intravenous dose of melphalan hydrochloride as conditioning chemotherapy followed by infusion of your own stem cells.

  3. Step 3

    Start lenalidomide maintenance (asct arm only)

    After completing the transplant you begin oral lenalidomide maintenance therapy.

    Lenalidomide is taken by mouth; the dose, frequency and length of treatment are prescribed by the study team and continue for an extended period as part of the maintenance phase.

  4. Step 4

    Regular follow‑up visits

    You attend scheduled clinic visits for safety checks, blood tests and other examinations.

    These visits allow the study team to monitor side effects and assess how the disease is responding to treatment.

  5. Step 5

    Mr d assessment at nine months

    Around nine months after randomisation (plus or minus three months) a special test called mr d is performed to see if the disease is undetectable at a very low level.

    The result contributes to determining whether a complete response has been achieved.

  6. Step 6

    Ongoing monitoring until study end

    Throughout the study you continue to be monitored for disease progression, overall survival and any long‑term side effects.

    Monitoring continues until the study ends or you discontinue participation, whichever occurs first.

Who can join the trial?

7 criteria

  • Must be at least 18 years old when signing the consent form.
  • Must have an ECOG performance status score of 0 or 1, which means you are fully active (0) or able to do light work (1) without major limitation.
  • Must be able to receive a high dose of the chemotherapy drug melphalan (200 mg per square meter of body surface) followed by an autologous stem cell transplant (ASCT), a procedure that uses your own blood‑forming cells.
  • Must have sufficient organ and bone‑marrow function, meaning your heart, liver, kidneys, and blood‑forming system are healthy enough for the treatment.
  • Must have a measurable amount of disease at diagnosis, shown by any one of the following: a blood (serum) M‑protein level of 1.0 g/dL or higher; a urine M‑protein level of 200 mg in a 24‑hour collection; or a blood (serum) free light chain (FLC) level of 10 mg/dL (100 mg/L) with an abnormal kappa/lambda ratio. (M‑protein is a protein made by myeloma cells that can be measured in blood or urine; free light chains are small parts of antibodies that can also indicate disease activity.)
  • Must have a confirmed diagnosis of newly diagnosed multiple myeloma (NDMM) according to International Myeloma Working Group (IMWG) criteria, and must have completed 4 to 6 cycles of approved initial treatment (called induction therapy) such as anti‑CD38 + VRd, DVTd, DRd, or VRd before randomisation.
  • Must have shown at least stable disease (SD) or better after induction therapy, as defined by the IMWG 2016 response criteria (meaning the disease has not gotten worse).

Who cannot join the trial?

7 criteria

  • Having an active or past involvement of the disease in the central nervous system (the brain and spinal cord) or showing signs that it is affecting the protective covering of the brain (meningeal involvement).
  • Having any of the following conditions: primary amyloidosis (a buildup of abnormal protein in organs), active plasma cell leukemia (cancer cells in the blood), Waldenstrom macroglobulinemia (a rare blood cancer), or POEMS syndrome (a group of symptoms including nerve damage, organ enlargement, and other problems).
  • Having a serious brain, nerve, or mental‑health condition that started or worsened within the last 6 months.
  • Having any other major medical problem that the doctor believes makes the treatment too risky, could interfere with giving the therapy safely, or could make it difficult to understand the study results.
  • Needing an extra medication because the disease did not respond well enough to the planned treatment.
  • Having previously received CAR‑T cell or CAR‑natural killer cell therapies (lab‑engineered immune cells) aimed at any target, or any therapy that specifically targets the proteins BCMA or CD19 on cancer cells.
  • Having previously received any T‑cell engager therapy (a treatment that connects T‑cells to cancer cells) aimed at any target.
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Investigated drugs

  • AZD0120

    is an experimental therapy that uses the patient’s own immune cells, called CAR‑T cells, which are engineered in the lab to recognize and attack myeloma cells that have the BCMA and CD19 markers. The modified cells are given as a single intravenous infusion and are intended to replace the usual transplant step, helping to keep the disease from returning.

  • Lenalidomide

    is an oral medication taken after the main treatment (whether the CAR‑T infusion or a stem cell transplant). It works by influencing the immune system and the environment around myeloma cells, helping to prevent the cancer from growing back and to maintain a longer period without disease.

  • Melphalan Hydrochloride

    is a chemotherapy drug given through an IV line. In this study it is used as part of the standard high‑dose chemotherapy that prepares a patient for a stem cell transplant, helping to kill myeloma cells before the stem cells are returned.

  • Autologous Stem Cell Transplant (ASCT)

    is a procedure where a patient’s own blood‑forming stem cells are collected, then the patient receives high‑dose chemotherapy (such as melphalan) to destroy cancer cells. After the chemotherapy, the stored stem cells are infused back into the patient to restore normal blood cell production. This transplant is the standard consolidation method the trial is comparing against the new CAR‑T therapy.

What is already known about the treatment

  • AZD0120

    It is given as an intravenous infusion of a solution containing the patient’s own T‑cells that have been engineered to target the BCMA and CD19 proteins on myeloma cells; the product is still experimental and is being evaluated in clinical trials for newly diagnosed multiple myeloma; it is intended to be used as a single consolidation treatment after initial therapy; the engineered T‑cells recognize and kill cancer cells that display BCMA or CD19, and the therapy belongs to the class of cellular immunotherapies known as CAR‑T cell products.

  • Lenalidomide

    It is taken as an oral tablet; it is an approved medication that is widely used for multiple myeloma and other blood cancers; it is given as a maintenance therapy to help keep the disease under control after initial treatment; it works by adjusting the immune system and slowing the growth of cancer cells, and it is classified as an immunomodulatory drug.

  • Melphalan Hydrochloride

    It is administered by intravenous injection as a solution; it is a long‑standing chemotherapy drug that has been used for many years to treat multiple myeloma and other cancers; it is given as a high‑dose conditioning regimen before stem cell transplant; it works by attaching to DNA and stopping cancer cells from dividing, and it belongs to the class of alkylating agents.

Investigated diseases

Newly Diagnosed Multiple Myeloma - Multiple myeloma is a cancer that starts in plasma cells, which are a type of white blood cell made in the bone marrow. Abnormal plasma cells grow and multiply, producing large amounts of a single type of protein. As the number of cancerous cells increases, they can replace normal blood‑forming cells, leading to low blood counts and bone damage. The disease often spreads within the marrow, causing lesions in the bones and affecting kidney function. Over time the condition can move from an early, less active stage to a more extensive stage with greater involvement of organs and tissues.
Trial detailsLast updated 8 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-525367-40-00Protocol codeDURGA-6Estimated enrolment543 patientsSponsorAstraZeneca AB

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