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Study of elranatamab and lenalidomide combination versus standard chemotherapy and transplant in newly diagnosed multiple myeloma patients

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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 Multiple Myeloma, a type of blood cancer affecting plasma cells in the bone marrow. The study evaluates a treatment combination using elranatamab with lenalidomide and compares it to standard treatments. The medications used in the study include bortezomib, dexamethasone, daratumumab, and human normal immunoglobulin.

The purpose of this research is to determine if using elranatamab and lenalidomide together is more effective than current standard treatments for newly diagnosed multiple myeloma patients. The study is divided into two main phases: a consolidation phase, which follows initial treatment, and a maintenance phase, which aims to prevent the disease from returning.

During the study, patients will receive different combinations of medications through various methods, including oral capsules, tablets, and injections under the skin. Some medications will be given through an infusion into a vein. The treatment schedule will vary depending on which study group the patient is assigned to, and the total treatment period may last several months to years.

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

    Initial treatment phase

    Treatment begins with a combination of medications to target multiple myeloma

    You will receive lenalidomide capsules taken by mouth

    A bortezomib injection will be administered under the skin

    Dexamethasone tablets will be taken orally

    You will also receive normal immunoglobulin through an intravenous infusion

  2. Step 2

    Consolidation phase

    This phase includes two possible treatment paths:

    Path 1: Combination of elranatamab and lenalidomide

    Path 2: Standard chemotherapy followed by stem cell transplant

    The treatment path will be determined randomly

    Elranatamab is administered as an injection under the skin

    Lenalidomide is taken as oral capsules

  3. Step 3

    Maintenance phase

    This phase also includes two possible treatment paths:

    Path 1: Treatment with elranatamab injections under the skin

    Path 2: Standard care treatment

    The treatment path will be determined randomly

    Regular assessments will monitor your response to treatment

    Blood tests and medical examinations will be conducted throughout this phase

  4. Step 4

    Follow-up period

    Regular monitoring will continue to track your health status

    Assessment of treatment effectiveness will be performed

    Your overall health and quality of life will be evaluated

    The study will continue until March 2036

Who can join the trial?

8 criteria

  • Age between 18 and 70 years old, both men and women can participate
  • Must have newly diagnosed multiple myeloma that qualifies for high-dose chemotherapy and stem cell transplantation
  • Must have at least 10% abnormal plasma cells in bone marrow OR have a confirmed tumor made up of plasma cells
  • Must have at least one of these signs: - High calcium levels in blood - Reduced kidney function - Low red blood cell count (anemia) - Bone damage visible on scans - High levels of abnormal proteins in blood or urine
  • Must have a performance status of 2 or better (able to perform most daily activities)
  • Must meet specific blood test requirements: - Adequate red blood cell levels - Adequate white blood cell counts - Normal liver function - Kidney function at least 40% of normal - Acceptable calcium levels - Adequate platelet counts
  • Must be willing and able to provide written informed consent
  • Women who can become pregnant must have a negative pregnancy test during screening and before starting treatment

Who cannot join the trial?

13 criteria

  • History of cancer other than Multiple Myeloma within the past 5 years, except for adequately treated skin cancers
  • Pregnant or breastfeeding women
  • Known active or chronic hepatitis B or C infection (inflammation of the liver caused by viruses)
  • Active, uncontrolled infections requiring treatment
  • Major surgery within 14 days before starting the study treatment
  • Serious heart conditions, including:
    • Heart attack within the past 6 months
    • Unstable heart rhythm problems
    • Heart failure with symptoms
    • Severe kidney problems requiring dialysis
    • History of severe allergic reactions to similar treatments
    • Participation in other clinical trials within 30 days before starting this study
    • Mental conditions that could interfere with following study procedures
    • Any medical condition that the study doctor believes would make participation unsafe
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Investigated drugs

  • Elranatamab

    is a medication being studied for treating newly diagnosed multiple myeloma. It belongs to a class of drugs that help the immune system fight cancer cells. It is being tested as part of a combination therapy during the consolidation phase of treatment and as a maintenance therapy.

  • Lenalidomide

    is a medication commonly used to treat multiple myeloma. It works by helping to strengthen the immune system and can slow or stop the growth of cancer cells. In this trial, it is being studied in combination with elranatamab during the consolidation phase of treatment.

  • Autologous Stem Cell Transplant

    is a standard treatment procedure for multiple myeloma where the patient's own healthy blood-forming stem cells are collected and later reinfused after receiving high-dose chemotherapy. This trial is evaluating whether the combination of elranatamab and lenalidomide could potentially replace this procedure.

What is already known about the treatment

  • Elranatamab

    A novel bispecific antibody administered through subcutaneous injection, designed for treating Multiple Myeloma. This medication works by simultaneously binding to BCMA (B-cell maturation antigen) on myeloma cells and CD3 on T-cells, activating the immune system to target cancer cells. Currently being evaluated in Phase 3 clinical trials, it represents a promising immunotherapy approach that may potentially replace traditional chemotherapy in consolidation treatment.

  • Lenalidomide

    An oral immunomodulatory drug used in the treatment of Multiple Myeloma, typically taken as a capsule once daily. It works by enhancing the immune system's ability to fight cancer cells while also directly inhibiting the growth of myeloma cells. This medication is well-established in medical practice and is often used in combination therapy, showing significant effectiveness in both newly diagnosed and relapsed/refractory multiple myeloma cases.

Investigated diseases

Multiple Myeloma – A type of blood cancer that develops in plasma cells, which are white blood cells that produce antibodies. The condition occurs when abnormal plasma cells multiply rapidly in the bone marrow, crowding out healthy blood cells and producing faulty antibodies called M proteins. These abnormal cells can cause several issues throughout the body, particularly in the bones, which can become weak and prone to problems. Over time, the disease can affect multiple body systems, including the bones, blood, kidneys, and immune system. The disease typically develops gradually, and some people may not experience symptoms in early stages.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516418-39-00Protocol codeIFM2025-01Estimated enrolment872 patientsSponsorIntergroupe Francophone Du Myelome

sourced from the EU Clinical Trials Register and site verification

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