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A study of etentamig and daratumumab compared to daratumumab, lenalidomide, and dexamethasone in adults with newly diagnosed multiple myeloma not eligible for transplant

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 being conducted to evaluate the effectiveness and safety of a new treatment for people with newly diagnosed Multiple Myeloma. Multiple Myeloma is a type of blood cancer that develops in the plasma cells, which are a type of white blood cell. This specific study focuses on individuals who are not eligible to receive a bone marrow transplant as part of their treatment.

Participants in the study will be assigned to receive different combinations of medications. One group will receive Etentamig, which is given as an intravenous infusion, alongside Daratumumab. The other group will receive a combination of Daratumumab, Lenalidomide, and Dexamethasone. Dexamethasone is a type of steroid used to reduce inflammation, and Lenalidomide is an oral medication often used to treat cancer.

The study is divided into two main parts. The first part aims to find the correct amount of Etentamig to use when combined with Daratumumab. The second part compares the effectiveness of the Etentamig and Daratumumab combination against the standard treatment of Daratumumab, Lenalidomide, and Dexamethasone. During the study, participants will be monitored to see how the treatments affect the disease and to track any side effects.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study entry

    Participation begins in a study designed for adults with newly diagnosed multiple myeloma, which is a type of blood cancer, who are not eligible for a stem cell transplant.

  2. Step 2

    Treatment assignment

    One of two treatment paths will be assigned.

  3. Step 3

    Treatment path 1: etentamig and daratumumab

    This path involves the administration of etentamig, which is given as a solution for infusion through a vein.

    This path also includes daratumumab, which is administered under the skin.

  4. Step 4

    Treatment path 2: comparator therapy

    This path involves a combination of three different medicines.

    lenalidomide is taken as an oral medication.

    dexamethasone is administered in two ways: through an injection into a vein and as an oral medication.

    daratumumab is also included and is administered under the skin.

Who can join the trial?

6 criteria

  • You must have a confirmed diagnosis of newly diagnosed multiple myeloma, which is a type of blood cancer that affects plasma cells in your bone marrow.
  • You must not be able to undergo high-dose chemotherapy or a stem cell transplant (a procedure where healthy blood-forming cells are put back into the body) because of health factors that might make these treatments too hard for your body to handle.
  • Your myeloma frailty index score, which is a tool used by doctors to measure how much a person's health is affected by their cancer, must be 1 or higher.
  • Your ECOG performance status, which is a scale used to measure how well you can perform everyday activities, must be 1 or lower, meaning you are mostly active and able to carry out light work.
  • Your cancer must be measurable through laboratory tests conducted within 28 days before joining the study.
  • To be considered measurable, you must have one of the following: a specific level of M-protein (an abnormal protein produced by cancer cells) in your blood, a specific level of M-protein in your urine, or an abnormal level of free light chains (small proteins produced by plasma cells) in your blood.

Who cannot join the trial?

7 criteria

  • You cannot participate if you have already received or are currently receiving systemic therapy (treatment that travels through your whole body, such as drugs) or SCT (stem cell transplant) for multiple myeloma or other conditions involving abnormal plasma cells (a type of white blood cell), unless you only took a short course of corticosteroids (a type of steroid medicine used to reduce swelling or inflammation).
  • You cannot participate if you have received anti-cancer therapy, such as chemotherapy (drugs used to kill cancer cells), radiotherapy (using radiation to treat cancer), biologics (medicines made from living organisms), immunotherapy (treatment that helps your immune system fight cancer), or cellular therapies (treatments using living cells), or if you took high doses of steroids (medicine to reduce inflammation), within 21 days before starting the study.
  • You cannot participate if you have had a major surgical procedure (a large operation) within 21 days before the first dose of the study treatment.
  • You cannot participate if you have used an investigational treatment (a medicine being tested in a study) within 30 days before starting the study.
  • You cannot participate if you are currently enrolled in another clinical study (a research test to see if a new treatment works).
  • You cannot participate if your multiple myeloma is known to be active in the central nervous system (the part of your body that includes your brain and spinal cord).
  • You cannot participate if you have a history in the last 6 months of serious diseases involving your renal (kidney) system, neurologic (brain or nerve) system, psychiatric (mental health) system, endocrine (hormone) system, metabolic (how your body uses energy) system, immunologic (immune system) system, pulmonary (lung) system, or hepatic (liver) system, if your doctor believes these conditions would make participating in the study unsafe or difficult.
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Investigated drugs

  • Etentamig

    is the experimental medication being studied in this trial. It is given as an infusion through a vein and is being tested alongside another medication to see how well it works in treating newly diagnosed multiple myeloma in patients who are not able to undergo a stem cell transplant.

  • Daratumumab

    is a medication used in this study both on its own and in combination with the experimental drug. It is administered as an injection under the skin to help target and fight the cancer cells.

  • Lenalidomide

    is a medication used in the comparison group of this study. It is taken by mouth and helps to treat multiple myeloma by affecting the immune system and the growth of cancer cells.

  • Dexamethasone

    is a type of steroid medication used in this study. It can be taken orally or given through an injection into a vein to help treat the cancer and reduce inflammation.

What is already known about the treatment

  • DARATUMUMAB

    This medication is an established treatment for multiple myeloma and is administered as an injection under the skin. It belongs to a class of drugs called monoclonal antibodies that work by attaching to a specific protein on the surface of cancer cells, marking them so the immune system can find and destroy them. By targeting these cells directly, it helps to reduce the overall amount of cancer in the body.

  • LENALIDOMIDE

    This is a well-known medication used to treat certain types of blood cancers, including multiple myeloma, and is taken orally as a pill. It belongs to a group of drugs called immunomodulatory agents that work by helping the immune system fight cancer while also interfering with the growth signals that cancer cells need to multiply. This dual action helps to slow down the progression of the disease.

  • DEXAMETHASONE

    This medication is a widely used steroid that can be taken by mouth or given through a vein to treat various conditions, including inflammation and certain cancers. It belongs to a class of drugs known as corticosteroids, which work by reducing swelling and calming an overactive immune system. In cancer treatment, it is often used to help reduce symptoms and can enhance the effectiveness of other therapies.

  • ETENTAMIG

    This is an investigational drug currently being studied in clinical trials for the treatment of multiple myeloma and is administered as an infusion through a vein. It belongs to a new class of medications that work by bringing immune cells into direct contact with cancer cells, acting like a bridge to help the body's own defenses attack the tumor. This experimental approach aims to provide a more targeted way to eliminate cancer cells.

Investigated diseases

Multiple Myeloma - This is a type of cancer that begins in the plasma cells, which are a type of white blood cell. These abnormal cells accumulate in the bone marrow and can crowd out healthy blood cells. As the disease progresses, the cancerous cells produce abnormal proteins that can interfere with normal body functions. This condition often leads to changes in the bone structure and can affect the kidneys. Over time, the uncontrolled growth of these cells continues to impact various bodily systems.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2025-520897-21-00Protocol codeM25-586Estimated enrolment60 patientsSponsorAbbVie Deutschland GmbH & Co. KG

sourced from the EU Clinical Trials Register and site verification

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