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Study Comparing Elranatamab and Lenalidomide with Daratumumab and Lenalidomide for Maintenance Therapy 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 is focused on studying a disease called multiple myeloma, which is a type of cancer that affects the blood cells in the bone marrow. The study is testing two different treatment combinations to see which is more effective as a maintenance therapy after a patient has undergone a transplant. The first combination includes the medications elranatamab and lenalidomide, while the second combination includes daratumumab and lenalidomide. Elranatamab is given as an injection under the skin, while lenalidomide is taken as a capsule by mouth. Daratumumab is also given as an injection under the skin.

The purpose of the study is to compare the effectiveness of these two treatment combinations in helping patients maintain their health after a transplant. Participants in the study will receive one of the two treatment combinations and will be monitored over a period of time to see how well the treatments work. The study will look at various outcomes, such as how long patients remain free of disease progression and their overall survival rates.

Throughout the study, participants will have regular check-ups and assessments to monitor their health and the effects of the treatment. The study aims to provide valuable information on which treatment combination might offer better support for patients with newly diagnosed multiple myeloma after they have received a transplant. This research could help improve future treatment options for people with this condition.

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

    Joining the study

    Upon joining the study, you will be randomly assigned to one of two groups. This means you will either receive a combination of elranatamab and lenalidomide or a combination of daratumumab and lenalidomide as part of your treatment.

  2. Step 2

    Treatment administration

    If you are in the elranatamab and lenalidomide group, you will receive elranatamab through an injection under the skin (subcutaneous use) and lenalidomide orally (by mouth).

    If you are in the daratumumab and lenalidomide group, you will receive daratumumab through an injection under the skin (subcutaneous use) and lenalidomide orally (by mouth).

  3. Step 3

    Treatment schedule

    The treatment will be administered in cycles. Each cycle lasts for a specific period, and you will receive the medications according to the schedule provided by the study team.

    The study aims to compare the effectiveness of the two treatment combinations over a period of 12 cycles, with assessments at various points to monitor your response to the treatment.

  4. Step 4

    Monitoring and assessments

    Throughout the study, regular assessments will be conducted to monitor your health and the effectiveness of the treatment. This includes blood tests and other evaluations as required by the study protocol.

    The primary goal is to determine the rate of minimal residual disease (MRD) negativity, which indicates the absence of detectable cancer cells after treatment.

  5. Step 5

    End of treatment

    After completing 12 cycles of treatment, further assessments will be conducted to evaluate the long-term effects and benefits of the treatment.

    You will continue to be monitored for any changes in your condition, and additional follow-up may be required as part of the study's objectives.

Who can join the trial?

16 criteria

  • Participants must be male or female and 18 years of age or older.
  • Men must agree not to father a child and use a latex condom during the study and for 6 months after the last dose of the study drug, even if they have had a successful vasectomy, if their partner can become pregnant.
  • Participants must provide voluntary written informed consent before any study-related procedures that are not part of normal medical care. They can withdraw consent at any time without affecting future medical care.
  • Participants must have documented multiple myeloma according to specific criteria and have received 4 to 6 cycles of a specific therapy that includes a proteasome inhibitor, IMID (a type of drug), and anti CD38 monoclonal antibody (a type of protein used in treatment).
  • Participants must have received only one line of therapy and achieved at least a partial response according to specific criteria.
  • Participants must have received high-dose melphalan (a chemotherapy drug) and ASCT (a type of stem cell transplant) within 12 months of starting initial therapy and be within 6 months of the last ASCT at the time of the first treatment dose.
  • Participants must have had NGS analysis (a type of genetic testing) performed at the time of multiple myeloma diagnosis or have adequate stored bone marrow material for this analysis.
  • Participants must have a Karnofsky performance status score of 50% or higher, which is a way to measure their ability to perform daily activities.
  • Participants must have certain clinical laboratory values during the screening phase, including:
    • Hemoglobin greater than 8.0 g/dL without a recent red blood cell transfusion.
    • Platelets 75 x 109/L or higher without recent transfusion support.
    • Absolute neutrophil count 1.0 x 109/L or higher without recent growth factor support.
    • AST and ALT levels 2.5 times the upper limit of normal or lower.
    • Creatinine clearance 30 mL/min or higher, which measures kidney function.
    • Total bilirubin 1.5 times the upper limit of normal or lower, except in certain conditions.
    • Serum calcium corrected for albumin 14 mg/dL or lower.
    • Women of childbearing potential must have a negative pregnancy test before starting the study and agree to use two methods of birth control or remain abstinent from heterosexual intercourse, starting at least 4 weeks before treatment and continuing for at least 6 months after the last dose of the study drug. They must also agree to report any pregnancy during the study.

Who cannot join the trial?

6 criteria

  • Patients who have not had a stem cell transplant cannot participate. A stem cell transplant is a procedure where healthy blood-forming cells are given to replace damaged or diseased bone marrow.
  • Patients who have not been diagnosed with multiple myeloma cannot participate. Multiple myeloma is a type of cancer that affects plasma cells in the bone marrow.
  • Patients who are under 18 years old cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have any other serious medical conditions that might interfere with the study cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
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Investigated drugs

  • Elranatamab

    is a medication being studied for its potential to help patients with newly-diagnosed myeloma. It is used in combination with another medication to see if it can improve the outcomes for patients who have undergone a transplant. Elranatamab works by targeting specific cells in the body that are involved in the disease, aiming to reduce their activity and help control the condition.

  • Lenalidomide

    is a medication that is often used in the treatment of myeloma. It helps the immune system fight cancer cells and can also stop the growth of new blood vessels that tumors need to grow. In this study, lenalidomide is used alongside other medications to see if it can improve the effectiveness of the treatment after a transplant.

  • Daratumumab

    is another medication used in the treatment of myeloma. It is an antibody that targets a specific protein on the surface of myeloma cells, helping the immune system to identify and destroy these cancer cells. In this trial, daratumumab is combined with lenalidomide to evaluate its effectiveness as a maintenance therapy after a transplant.

What is already known about the treatment

  • Elranatamab

    Elranatamab is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating multiple myeloma, a type of blood cancer. It is not yet widely used in standard medical practice, as it is still under investigation. The medication works by targeting specific proteins on cancer cells, helping the immune system to recognize and destroy these cells. Elranatamab is classified as a monoclonal antibody, which is a type of drug designed to interact with specific targets in the body.

  • Lenalidomide

    Lenalidomide is taken orally in the form of a capsule and is an established medication used in the treatment of multiple myeloma. It is well-documented in medical literature and is commonly used in combination with other drugs. Lenalidomide works by affecting the immune system and directly attacking cancer cells, slowing their growth and spread. It is classified as an immunomodulatory drug, which means it modifies the immune response to help fight cancer.

  • Daratumumab

    Daratumumab is administered through an intravenous infusion and is a well-known treatment for multiple myeloma. It is widely recognized in medical literature and is often used in combination with other therapies. Daratumumab works by binding to a specific protein on the surface of cancer cells, marking them for destruction by the immune system. It is classified as a monoclonal antibody, which targets specific proteins to help the body fight cancer.

Investigated diseases

Multiple Myeloma – Multiple myeloma 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 disease, abnormal plasma cells multiply uncontrollably, leading to the production of a large amount of abnormal proteins. These proteins can cause damage to bones and other organs, such as the kidneys. As the disease progresses, it can lead to bone pain, fractures, and anemia due to the overcrowding of healthy blood cells. Patients may also experience increased susceptibility to infections. Over time, the accumulation of abnormal cells and proteins can disrupt normal bodily functions.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517325-43-00Protocol codeRC23_0603Estimated enrolment176 patientsSponsorCentre Hospitalier Universitaire De Nantes

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