Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study Comparing Lenalidomide, Bortezomib, Dexamethasone, Isatuximab, and Iberdomide for Newly Diagnosed Multiple Myeloma Patients Eligible for Stem Cell Transplant

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for newly diagnosed multiple myeloma, a type of cancer that affects plasma cells in the bone marrow. The study will explore different treatment combinations to see which is most effective. The treatments being tested include a combination of medications: Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone, as well as a new drug called Iberdomide (also known by its code name CC-220). These medications are used in various combinations to see how well they work in treating the disease.

The purpose of the study is to compare the effectiveness of these treatment combinations in patients who are candidates for a procedure called autologous stem cell transplant (ASCT). This procedure involves collecting a patient's own stem cells, treating them with high doses of chemotherapy, and then returning the stem cells to the patient to help rebuild their bone marrow. The study will look at how well the treatments work in reducing the number of cancer cells in the bone marrow after 18 cycles of treatment, which includes different phases such as induction, consolidation, and continuous treatment.

Participants in the study will receive one of the treatment combinations and may also receive a placebo as part of the study design. The study will last for a maximum of 24 months, during which time the effectiveness of the treatments will be monitored. The goal is to find out which combination of treatments is most effective in helping patients achieve a state where no cancer cells are detected in their bone marrow, known as being MRD-negative (minimal residual disease-negative). This information will help doctors understand which treatments might be best for patients with newly diagnosed multiple myeloma.

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

    Induction phase

    During the induction phase, you will receive treatment to reduce the number of cancer cells. This phase lasts for 4 to 6 cycles, depending on the treatment arm you are assigned to.

    If you are in Arm A or Arm C, you will undergo 4 cycles of treatment. If you are in Arm B, you will undergo 6 cycles.

    The medications used in this phase include lenalidomide (oral capsules), bortezomib (subcutaneous injection), and dexamethasone (oral tablets).

  2. Step 2

    Autologous stem cell transplant (ASCT)

    After the induction phase, you will undergo an autologous stem cell transplant (ASCT). This procedure involves collecting your own stem cells, which are then returned to your body after intensive treatment to help restore your bone marrow.

  3. Step 3

    Consolidation phase

    Following the ASCT, you will enter the consolidation phase, which consists of 2 cycles of treatment. This phase aims to further reduce the number of cancer cells.

    The same medications used in the induction phase will be administered during this phase.

  4. Step 4

    Continuous or extended treatment phase

    In Arm A and Arm C, you will receive continuous treatment for 12 cycles. In Arm B, you will receive extended treatment for 10 cycles.

    The medications used in this phase may include lenalidomide, isatuximab (subcutaneous injection), and iberdomide (oral capsules).

  5. Step 5

    Early rescue intervention (ERI)

    If necessary, you may receive an early rescue intervention (ERI) with iberdomide and isatuximab to help achieve better treatment outcomes.

    This intervention is only applied if the treatment response requires additional support before completing the 18 cycles and ASCT.

Who can join the trial?

11 criteria

  • The patient must be newly diagnosed with multiple myeloma and need to start treatment.
  • The patient must be willing and able to follow the study requirements, according to the investigator's opinion.
  • The patient must be able to understand the study procedures.
  • The patient must provide written informed consent before any study-related procedures.
  • The patient must be 65 years old or younger.
  • The patient must have a performance status of 2 or less on the Eastern Cooperative Oncology Group (ECOG) scale, which measures the patient's ability to perform daily activities.
  • The patient must have adequate organ function as defined in the study protocol.
  • The patient must have a measurable secretory disease, which means having certain levels of specific proteins in the blood or urine.
  • All previous treatment-related side effects must be at a mild level (Grade 1 or less) at the time of joining the study, except for hair loss.
  • Male patients must use contraception according to local regulations for clinical studies.
  • Female patients must use contraception according to local regulations for clinical studies.

Who cannot join the trial?

4 criteria

  • Patients who have not been diagnosed with newly-diagnosed multiple myeloma (NDMM) cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who belong to a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who do not meet other specific health criteria set by the study cannot participate.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Lenalidomide

    is a medication used in this trial to help treat multiple myeloma, a type of blood cancer. It works by slowing down or stopping the growth of cancer cells. It also helps the immune system to attack the cancer cells more effectively.

  • Bortezomib

    is another medication used in the trial for treating multiple myeloma. It helps to kill cancer cells by interfering with their ability to grow and divide. This medication is often used in combination with other drugs to improve its effectiveness.

  • Dexamethasone

    is a type of steroid used in the trial. It helps reduce inflammation and can also help kill cancer cells. In this study, it is used alongside other medications to enhance their cancer-fighting effects.

  • Isatuximab

    is a medication used in the trial that targets specific proteins on the surface of cancer cells. By binding to these proteins, it helps the immune system to recognize and destroy the cancer cells more effectively.

  • Iberdomide

    is a medication being tested in the trial as part of an early rescue intervention. It is designed to help the immune system work better in fighting cancer cells, potentially improving the outcomes for patients with multiple myeloma.

What is already known about the treatment

Isatuximab – Isatuximab is administered intravenously, meaning it is given through a vein, typically in a hospital or clinic setting. It is currently being studied in clinical trials for its effectiveness in treating newly-diagnosed multiple myeloma, a type of blood cancer. The medication works by targeting a specific protein on the surface of cancer cells, helping the immune system to identify and destroy these cells. Isatuximab is classified as a monoclonal antibody, which is a type of drug designed to interact with specific targets in the body.

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. The disease begins when abnormal plasma cells multiply uncontrollably, leading to the production of a large amount of abnormal proteins. As the disease progresses, it can cause damage to bones, kidneys, and the immune system. Patients may experience symptoms such as bone pain, frequent infections, and fatigue. Over time, the accumulation of abnormal cells can lead to anemia and increased risk of fractures. The progression of multiple myeloma can vary, with periods of stability followed by more aggressive phases.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517008-12-00Protocol codeGEM21menos65Estimated enrolment480 patientsSponsorFundacion PETHEMA

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.