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Study Comparing Selinexor, Pomalidomide, and Dexamethasone with Elotuzumab, Pomalidomide, and Dexamethasone for 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 known as Relapsed or Refractory Multiple Myeloma (RRMM), which is a type of blood cancer that has returned or is not responding to treatment. The study aims to compare two different treatment combinations to see which is more effective. One combination includes the medications Selinexor, Pomalidomide, and Dexamethasone (referred to as SPd), while the other includes Elotuzumab, Pomalidomide, and Dexamethasone (referred to as EloPd). These medications are used to help control the growth of cancer cells and manage the disease.

The purpose of the study is to determine which combination of treatments is more effective in managing RRMM. Participants in the study will receive one of the two treatment combinations. The study will monitor the participants over a period to see how the disease responds to the treatments. The medications will be administered in different forms, such as tablets, capsules, or injections, depending on the specific drug. The study will also look at the safety and tolerability of these treatments, which means checking for any side effects or health changes that occur during the study.

Throughout the study, participants will have regular check-ups and tests to monitor their health and the progress of the disease. The study will help researchers understand which treatment combination works better for patients with RRMM and could lead to improved treatment options in the future. The study is expected to continue until 2028, providing valuable information on the effectiveness and safety of these treatment combinations for RRMM.

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 visit and randomization

    Upon joining the study, you will attend an initial visit where you will be randomly assigned to one of two treatment groups. This process is called randomization and ensures that each participant has an equal chance of receiving either treatment.

  2. Step 2

    Treatment group assignment

    You will be assigned to either the SPd group, which includes selinexor, pomalidomide, and dexamethasone, or the EloPd group, which includes elotuzumab, pomalidomide, and dexamethasone.

  3. Step 3

    Medication administration

    If you are in the SPd group, you will take selinexor orally, pomalidomide orally, and dexamethasone orally. The specific dosages and frequency will be provided by the study team.

    If you are in the EloPd group, you will receive elotuzumab through an intravenous infusion, and take pomalidomide and dexamethasone orally. The specific dosages and frequency will be provided by the study team.

  4. Step 4

    Regular follow-up visits

    You will attend regular follow-up visits to monitor your health and response to the treatment. These visits will include physical examinations, blood tests, and other necessary assessments.

  5. Step 5

    Quality of life assessments

    Throughout the study, you will be asked to complete questionnaires about your quality of life. These assessments help understand the impact of the treatment on your daily activities and overall well-being.

  6. Step 6

    End of treatment

    At the end of the treatment period, you will have a final visit to assess your health and discuss the next steps. This may include transitioning to other treatments or follow-up care as needed.

Who can join the trial?

16 criteria

  • Must have Relapsed or Refractory Multiple Myeloma (RRMM) with measurable disease.
  • Must be at least 18 years old.
  • Must have signed a written informed consent form.
  • Must have received at least 1 and no more than 4 prior treatments for multiple myeloma.
  • Must have had prior therapy that includes at least 2 consecutive cycles of lenalidomide and a proteasome inhibitor.
  • Must have had prior therapy with an anti-CD38 monoclonal antibody as part of the last treatment before joining the study.
  • Must have an ECOG performance status of 2 or less. (This is a scale used to assess how a patient's disease is progressing and how the disease affects their daily living abilities.)
  • Must have adequate liver function within 28 days before starting the study.
  • Must have adequate kidney function within 28 days before starting the study.
  • Must have adequate blood cell counts within 7 days before starting the study.
  • Female patients of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 90 days after the last dose.
  • Male patients must agree to use effective contraception during the study and for 90 days after the last dose and must not donate sperm during this time.
  • Patients with hepatitis B can participate if they have been treated for more than 8 weeks and have a low viral load.
  • Patients with a history of hepatitis C can participate if they have been successfully treated and have a low viral load.
  • Patients with a history of HIV can participate if they have a certain level of immune cells, no recent serious infections, and are on stable antiretroviral therapy.
  • Must be able and willing to take aspirin or other blood thinners as needed.

Who cannot join the trial?

4 criteria

  • Patients who have not been diagnosed with Relapsed or Refractory Multiple Myeloma (RRMM) cannot participate. This is a type of blood cancer that has returned after treatment or did not respond to treatment.
  • Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study and may vary.
  • Patients who are not part of the specified clinical trial group cannot participate. This group is defined by the study and includes specific characteristics or conditions.
  • Patients who are not able to provide informed consent or are considered part of a vulnerable population may not be eligible. A vulnerable population includes individuals who may have limited ability to make informed decisions about their participation.
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Investigated drugs

  • Selinexor

    is a medication used in this trial to treat multiple myeloma, a type of blood cancer. It works by blocking a protein in cancer cells that helps them grow and survive. By stopping this protein, selinexor can help slow down or stop the growth of cancer cells.

  • Pomalidomide

    is another medication used in the trial for treating multiple myeloma. It helps the immune system fight cancer by boosting the body's natural defenses. Pomalidomide also works to stop cancer cells from growing and spreading.

  • Dexamethasone

    is a type of steroid used in this trial. It helps reduce inflammation and can also kill cancer cells or make them more sensitive to other cancer treatments. In this trial, dexamethasone is used alongside other medications to enhance their effectiveness against multiple myeloma.

  • Elotuzumab

    is a medication used in the trial that targets a specific protein found on the surface of multiple myeloma cells. By attaching to this protein, elotuzumab helps the immune system recognize and attack the cancer cells, which can help control the disease.

What is already known about the treatment

  • Selinexor

    Selinexor is administered orally in the form of tablets and is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory multiple myeloma (RRMM). It is part of a combination therapy with pomalidomide and dexamethasone. Selinexor works by blocking a protein that helps cancer cells grow and survive, making it harder for the cancer to spread. It is classified as a selective inhibitor of nuclear export, which means it interferes with the transport of certain molecules within cells.

  • Pomalidomide

    Pomalidomide is taken orally as a capsule and is used in combination with other medications to treat relapsed or refractory multiple myeloma (RRMM). It is an established treatment in medical practice and works by enhancing the immune system's ability to fight cancer and by directly attacking cancer cells. Pomalidomide is classified as an immunomodulatory agent, which means it modifies the immune response to help control the disease.

  • Dexamethasone

    Dexamethasone is administered orally in tablet form and is used in combination with other drugs to treat relapsed or refractory multiple myeloma (RRMM). It is a well-known medication in the medical field and helps reduce inflammation and suppress the immune system to aid in cancer treatment. Dexamethasone is classified as a corticosteroid, which means it mimics the effects of hormones your body produces naturally in the adrenal glands.

  • Elotuzumab

    Elotuzumab is given as an intravenous infusion and is used in combination with other medications to treat relapsed or refractory multiple myeloma (RRMM). It is recognized in medical literature and works by targeting a specific protein on the surface of cancer cells, helping the immune system to identify and destroy them. Elotuzumab is classified as a monoclonal antibody, which means it is a type of protein made in the lab that can bind to substances in the body, including cancer cells.

Investigated diseases

Relapsed or Refractory Multiple Myeloma – Multiple Myeloma is a type of blood cancer that affects plasma cells, which are a type of white blood cell found in the bone marrow. In relapsed or refractory cases, the disease has returned after treatment or does not respond to therapy. The disease progresses as abnormal plasma cells multiply, leading to bone damage, kidney problems, and weakened immune function. Patients may experience symptoms such as bone pain, fatigue, and frequent infections. Over time, the accumulation of these abnormal cells can cause anemia and other blood-related issues. The progression of the disease can vary, with periods of stability followed by worsening symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518304-53-00Protocol codeENM29Estimated enrolment156 patientsSponsorEuropean Myeloma Network B.V.

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