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Study comparing daratumumab, lenalidomide and dexamethasone followed by linvoseltamab versus continued initial treatment in newly diagnosed multiple myeloma patients

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 clinical trial focuses on treating patients with newly diagnosed Multiple Myeloma who are not eligible for transplant. The study compares two treatment approaches. The first approach uses a combination of Daratumumab, Lenalidomide, and Dexamethasone followed by Linvoseltamab. The second approach continues with Daratumumab, Lenalidomide, and Dexamethasone throughout the treatment period.

Multiple Myeloma is a type of blood cancer that affects plasma cells, which are special white blood cells that help fight infections. The study aims to determine which treatment combination is more effective at eliminating cancer cells to a level that cannot be detected by very sensitive testing methods.

The medications used in this study are given in different ways. Lenalidomide is taken by mouth in capsule form, while Daratumumab and Linvoseltamab are given through an infusion into a vein. Dexamethasone can be given either as tablets by mouth or as an injection. The treatment continues for several weeks, and patients will need regular visits to the hospital for monitoring and receiving their medications.

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

    Initial treatment phase

    You will receive a combination of three medications: daratumumab (given by injection), lenalidomide (taken as capsules by mouth), and dexamethasone (taken as tablets by mouth)

    This initial treatment will be provided to all study participants

  2. Step 2

    Treatment assignment

    You will be randomly assigned to one of two treatment groups

    The assignment process is done by computer and cannot be chosen by you or your doctor

  3. Step 3

    Continuation phase

    Depending on your assigned group, you will either:

    Continue with the same three-drug combination (daratumumab, lenalidomide, and dexamethasone)

    Or switch to linvoseltamab (given by infusion into a vein)

  4. Step 4

    Hospital stay requirement

    If assigned to the linvoseltamab group, you will need to stay in or near the hospital (within 30 minutes) after receiving the first dose

  5. Step 5

    Monitoring and testing

    Regular blood tests will be performed to monitor your health

    Bone marrow samples will be collected at various points during the study

    Your disease status will be regularly evaluated through various tests

  6. Step 6

    Study duration

    The study is planned to run from September 2025 to October 2035

    Your participation duration will depend on how your condition responds to treatment

Who can join the trial?

10 criteria

  • You must have a confirmed diagnosis of Multiple Myeloma with symptoms
  • You must be 18 years or older
  • You must be able to provide written informed consent to participate
  • You must be able to understand and complete study questionnaires
  • You must not be eligible for high-dose chemotherapy and stem cell transplant due to: - Advanced age, or - Significant health conditions that could affect treatment tolerance
  • You must have measurable disease levels through at least one of these tests: - Specific protein levels in blood of 1 g/dL or higher - Specific protein levels in 24-hour urine collection of 200 mg or higher - Certain blood protein chain levels of 10 mg/dL or higher
  • Your physical performance status must be rated as 0, 1, or 2 (able to perform most daily activities)
  • Your blood tests must show: - Adequate white blood cell counts - Hemoglobin levels of 7.5 g/dL or higher - Adequate platelet counts - Kidney function of 30 mL/min or better - Acceptable liver function tests - Controlled calcium levels
  • You must be willing to: - Attend clinic visits - Undergo bone marrow tests - Stay near the hospital (within 30 minutes) if assigned to the experimental treatment group
  • You must agree to follow pregnancy prevention guidelines if taking study medications

Who cannot join the trial?

15 criteria

  • Prior treatment for multiple myeloma (except for emergency use of local radiation therapy or a short course of corticosteroids)
  • Age under 18 years
  • Pregnant or breastfeeding women
  • History of other cancers within 3 years before starting the study (except for adequately treated non-melanoma skin cancer or carcinoma in situ)
  • Severe heart conditions including heart failure (reduced heart's ability to pump blood) or uncontrolled angina (chest pain)
  • Severe kidney problems requiring dialysis
  • Active, uncontrolled infections
  • Known HIV infection (human immunodeficiency virus)
  • Active hepatitis B or C infection (liver infections)
  • Major surgery within 4 weeks before starting the study
  • Participation in other clinical trials within 4 weeks before this study
  • Mental conditions that could interfere with following study procedures
  • Known allergies to any of the study medications
  • Inability to take oral medications
  • Life expectancy less than 6 months
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Investigated drugs

  • Daratumumab

    is a medication used to treat multiple myeloma. It works by targeting a specific protein on cancer cells, helping the immune system identify and destroy these cells.

  • Lenalidomide

    is a medication that helps fight multiple myeloma by strengthening the immune system and preventing the growth of cancer cells. It also works by blocking the blood supply to cancer cells.

  • Dexamethasone

    is a steroid medication that helps reduce inflammation and suppress the immune system. In multiple myeloma treatment, it is often used in combination with other medications to enhance their effectiveness.

  • Linvoseltamab

    is an investigational medication being studied for the treatment of multiple myeloma. It is being tested as an alternative treatment option to compare its effectiveness with the standard treatment combination.

What is already known about the treatment

  • Daratumumab

    An injectable monoclonal antibody medication that targets the CD38 protein found on multiple myeloma cells, making them more visible to the immune system for destruction. This medication is widely used in the treatment of multiple myeloma and is administered intravenously in a clinical setting, often in combination with other anti-cancer medications. It works by helping the body's immune system identify and attack cancer cells while also having direct anti-tumor effects.

  • Lenalidomide

    An oral immunomodulatory drug taken as a capsule that helps fight multiple myeloma by enhancing the immune system's ability to destroy cancer cells and prevent their growth. This medication is commonly used in combination therapy for multiple myeloma and works by affecting the body's immune system and blocking the growth of abnormal cells. It belongs to a class of drugs known as immunomodulators and is typically taken daily according to a prescribed schedule.

  • Dexamethasone

    An oral or injectable corticosteroid medication that helps reduce inflammation and suppress immune system activity in multiple myeloma treatment. It is commonly used in combination with other cancer medications to enhance their effectiveness and manage symptoms, working by decreasing the body's immune response and reducing inflammation. This medication is typically administered on a specific schedule as part of a combination therapy regimen.

  • Linvoseltamab

    A novel bispecific antibody medication administered intravenously that targets both BCMA (B-cell maturation antigen) and CD3 proteins to treat multiple myeloma. This investigational therapy works by bringing T-cells into close contact with myeloma cells, enabling the immune system to more effectively target and destroy cancer cells. It represents a newer approach to multiple myeloma treatment and is currently being studied in clinical trials as a potential alternative to existing therapies.

Investigated diseases

Multiple Myeloma – A type of blood cancer that develops in plasma cells, which are white blood cells that help fight infections. In this condition, abnormal plasma cells multiply uncontrollably in the bone marrow, forming tumors in multiple bones throughout the body. These cancerous cells interfere with the production of normal blood cells and can cause bone damage, leading to weakened bones. The disease also causes the overproduction of a single type of antibody, which can damage the kidneys and other organs. Multiple myeloma typically develops gradually and can affect various parts of the body, particularly the bones of the spine, skull, pelvis, rib cage, and hips.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519827-16-00Protocol codeEMN39Estimated enrolment930 patientsSponsorEmn Trial Office S.r.l. Impresa Sociale

sourced from the EU Clinical Trials Register and site verification

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