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Study Comparing Linvoseltamab to Elotuzumab, Pomalidomide, and Dexamethasone 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 clinical trial is focused on studying a condition called Relapsed/Refractory Multiple Myeloma, which is a type of blood cancer that has returned or is not responding to treatment. The study aims to compare the effectiveness of a new treatment called Linvoseltamab (also known by its code name REGN5458) with a combination of three existing medications: Elotuzumab, Pomalidomide, and Dexamethasone. Linvoseltamab is a type of medication known as a bispecific antibody, which is designed to target specific proteins on cancer cells to help the immune system attack them.

Participants in the study will be randomly assigned to receive either Linvoseltamab or the combination of Elotuzumab, Pomalidomide, and Dexamethasone. The study will observe how long participants live without their disease getting worse, which is known as progression-free survival. The trial will also monitor other health outcomes, such as overall survival and the response of the disease to the treatment. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments being studied.

The study will take place over a period of time, with regular check-ups and assessments to monitor the participants' health and the effectiveness of the treatments. The goal is to gather information that could lead to better treatment options for people with Relapsed/Refractory Multiple Myeloma. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and well-being.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

    Eligibility criteria include being 18 years or older, having a specific performance status, and having received certain prior treatments for multiple myeloma.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two treatment groups: one receiving linvoseltamab and the other receiving a combination of elotuzumab, pomalidomide, and dexamethasone.

  3. Step 3

    Treatment administration

    For those in the linvoseltamab group, the medication is administered as an infusion. The frequency and duration of administration are determined by the study protocol.

    Participants in the combination group receive elotuzumab via infusion, pomalidomide orally in capsule form, and dexamethasone as an oral tablet or injection. Dosages and schedules are specified in the study protocol.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the response to treatment and any side effects. This includes physical exams, blood tests, and other necessary evaluations.

    Participants are required to attend scheduled follow-up visits to ensure ongoing assessment of their health and treatment efficacy.

  5. Step 5

    Completion of study participation

    Upon completion of the treatment phase, a final assessment is conducted to evaluate the overall response to the treatment.

    Participants may be asked to provide feedback on their experience and any changes in their quality of life.

Who can join the trial?

7 criteria

  • Must be **18 years or older** (or the legal adult age in your country) at the time of the screening visit.
  • Must have an **ECOG performance status** of 0 or 1. This is a scale that measures how well you can perform daily activities. If your status is 2 due to local symptoms of myeloma, like pain, you might still be eligible after discussion with the Medical Monitor.
  • Must have **Multiple Myeloma (MM)** and have received at least 1 and no more than 4 previous treatments for MM, including specific drugs like lenalidomide and a proteasome inhibitor. You must have shown disease progression after the last treatment. If you have only had 1 previous treatment, you must be **lenalidomide refractory**, meaning the disease did not respond to lenalidomide or worsened within 60 days of the last dose. In the EU and UK, you must have had 2 to 4 previous treatments, including a CD38 antibody.
  • Must have **measurable disease** for response assessment, which means the disease can be measured to see how it responds to treatment.
  • Must have **adequate function** of blood, liver, kidneys, and heart, and enough healthy bone marrow.
  • Must have a **life expectancy** of at least 6 months.
  • Other specific criteria defined in the study protocol may apply.

Who cannot join the trial?

4 criteria

  • Patients who have not been diagnosed with Relapsed Refractory Multiple Myeloma cannot participate. This is a type of cancer that affects the blood and bone marrow and has returned after treatment or is not responding to treatment.
  • Patients who have not been previously treated with CD38 antibodies cannot participate. CD38 antibodies are a type of medication used to treat certain blood cancers.
  • Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study and includes adults.
  • Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.
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Investigated drugs

  • Linvoseltamab

    This is a bispecific antibody designed to target two specific proteins, BCMA and CD3. It is used in this study to treat patients with relapsed or refractory multiple myeloma. The medication works by engaging the immune system to attack and destroy cancer cells.

  • Elotuzumab

    This is a monoclonal antibody that targets a protein called SLAMF7 on the surface of myeloma cells. It helps the immune system recognize and kill these cancer cells. In this study, it is used in combination with other medications to treat multiple myeloma.

  • Pomalidomide

    This medication is an immunomodulatory drug that helps the immune system fight cancer. It works by affecting the growth of cancer cells and enhancing the body's immune response against them. It is used in combination with other drugs in this trial for treating multiple myeloma.

  • Dexamethasone

    This is a corticosteroid medication that helps reduce inflammation and suppresses the immune system. In the context of this study, it is used to help manage symptoms and enhance the effectiveness of other cancer treatments in patients with multiple myeloma.

What is already known about the treatment

Linvoseltamab – Linvoseltamab is administered as an intravenous infusion, allowing direct delivery into the bloodstream. It is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory multiple myeloma. This medication works by targeting specific proteins on cancer cells, known as BCMA and CD3, to help the immune system recognize and destroy these cells. Linvoseltamab is classified as a bispecific antibody, which means it can bind to two different targets simultaneously, enhancing its therapeutic potential.

Investigated diseases

Relapsed Refractory Multiple Myeloma – This is a type of blood cancer that affects plasma cells, which are a kind of white blood cell found in the bone marrow. In this condition, the cancer returns after treatment or does not respond to treatment. It typically progresses by causing damage to bones, kidneys, and the immune system. Patients may experience symptoms such as bone pain, fatigue, and frequent infections. The disease is characterized by the uncontrolled growth of abnormal plasma cells, leading to a decrease in the production of normal blood cells. Over time, this can result in complications like anemia, bone fractures, and kidney problems.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501396-62-00Protocol codeR5458-ONC-2245Estimated enrolment380 patientsSponsorRegeneron Pharmaceuticals Inc.

sourced from the EU Clinical Trials Register and site verification

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