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Study of Isatuximab, Lenalidomide, and Dexamethasone for Patients with High-Risk Smoldering 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 high-risk smoldering multiple myeloma, which is a type of blood cancer that affects plasma cells in the bone marrow. The study is investigating the effectiveness of a treatment combination that includes isatuximab (also known by its code name SAR650984), lenalidomide, and dexamethasone. These medications are being tested to see if they can help delay the progression of the disease compared to using lenalidomide and dexamethasone alone.

The purpose of the study is to determine if adding isatuximab to the treatment can provide additional benefits for patients with high-risk smoldering multiple myeloma. Participants in the study will receive either the combination of isatuximab, lenalidomide, and dexamethasone or just lenalidomide and dexamethasone. The study will monitor the safety and effectiveness of these treatments over time.

Throughout the study, participants will be closely observed to assess how well the treatment works and to identify any side effects. The study aims to provide valuable information on whether the addition of isatuximab can improve outcomes for patients with this condition. The trial is expected to continue for several years to gather comprehensive data on the long-term effects of the treatment.

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

    Joining the study

    Upon joining the study, the participant will be informed about the trial's objectives and procedures. The participant must provide written consent to participate.

  2. Step 2

    Safety run-in phase

    The initial phase involves confirming the recommended dose of isatuximab when combined with lenalidomide and dexamethasone.

    Participants will receive isatuximab through intravenous infusion. The dosage and frequency will be determined based on safety assessments.

  3. Step 3

    Randomized phase 3

    Participants will be randomly assigned to receive either the combination of isatuximab, lenalidomide, and dexamethasone or lenalidomide and dexamethasone alone.

    The goal is to evaluate the clinical benefit of adding isatuximab in terms of prolonging the time before the disease progresses.

  4. Step 4

    Medication administration

    Isatuximab is administered intravenously. The specific schedule will be provided by the study team.

    Lenalidomide is taken orally in capsule form. The dosage may vary, including options like 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg capsules.

    Dexamethasone is available in tablet form and is also taken orally. The dosage will be specified by the study team.

  5. Step 5

    Monitoring and assessments

    Regular monitoring will occur to assess safety and effectiveness. This includes checking for any adverse effects and measuring the concentration of isatuximab in the blood.

    Participants will undergo various assessments to evaluate their response to the treatment and any changes in their condition.

  6. Step 6

    End of participation

    The study is estimated to conclude by May 30, 2034. Participants will be informed about the end of their involvement and any follow-up procedures.

Who can join the trial?

8 criteria

  • The participant must be at least 18 years old or older.
  • The participant should have been diagnosed with **high-risk smoldering multiple myeloma (SMM)** within the last 5 years. This is a condition where there are certain proteins in the blood or urine, or specific cells in the bone marrow, but without symptoms of myeloma.
  • The participant should have an **ECOG Performance Status** of 0, 1, or 2. This is a scale that measures how well a person can perform daily activities.
  • The participant must be able to provide written consent voluntarily.
  • The participant's **absolute neutrophil count (ANC)** should be at least 1000/µL. This is a measure of a type of white blood cell important for fighting infections.
  • The participant should have at least 50,000 platelets/µL. Platelets are cells that help with blood clotting.
  • The participant's **total bilirubin** should be 3 mg/dL or less, unless they have Gilbert syndrome, in which case the direct bilirubin should be 5 mg/dL or less. Bilirubin is a substance made by the liver.
  • The participant's **alanine aminotransferase (ALT)** and **aspartate aminotransferase (AST)** levels should be no more than 3 times the upper limit of normal. These are enzymes that help assess liver function.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer other than high-risk smoldering multiple myeloma cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not able to follow the study procedures or take the study medications as required cannot participate.
  • Patients who have certain medical conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have had another cancer within the last five years, except for certain skin cancers or in situ cancers, cannot participate.
  • Patients who have received certain treatments for their condition recently cannot participate.
  • Patients who have an active infection that requires treatment cannot participate.
  • Patients who have a history of severe allergic reactions to similar medications cannot participate.
  • Patients who have certain heart conditions that are not well controlled cannot participate.
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Investigated drugs

  • Isatuximab

    is a medication being studied for its potential to help treat high-risk smoldering multiple myeloma. It is used in combination with other medications to see if it can help delay the progression of the disease. Isatuximab works by targeting specific proteins on the surface of cancer cells, which may help the immune system to attack and destroy these cells.

  • Lenalidomide

    is a medication that is part of the treatment being tested in this study. It is used to help slow down or stop the growth of cancer cells. Lenalidomide can also help the immune system work better to fight cancer.

  • Dexamethasone

    is a type of steroid medication included in the treatment plan. It is used to reduce inflammation and help manage symptoms associated with multiple myeloma. Dexamethasone can also enhance the effects of other cancer treatments.

What is already known about the treatment

  • Isatuximab

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating high-risk smoldering multiple myeloma, a condition related to plasma cell myeloma. Isatuximab is an antibody that targets a specific protein on the surface of myeloma cells, helping the immune system to identify and destroy these cancerous cells. It is classified as a monoclonal antibody and is being evaluated for its ability to prolong progression-free survival when used in combination with other medications like lenalidomide and dexamethasone.

  • Lenalidomide

    This medication is taken orally and is widely used in the treatment of multiple myeloma and other blood disorders. It works by modulating the immune system and inhibiting the growth of cancer cells. Lenalidomide is classified as an immunomodulatory drug and is being studied in combination with isatuximab and dexamethasone to assess its effectiveness in delaying disease progression in high-risk smoldering multiple myeloma.

  • Dexamethasone

    This medication is administered orally or intravenously and is commonly used to reduce inflammation and suppress the immune system in various conditions, including multiple myeloma. It is a corticosteroid that helps to alleviate symptoms and enhance the effectiveness of other cancer treatments. In the context of the clinical trial, dexamethasone is being used alongside isatuximab and lenalidomide to evaluate its role in improving outcomes for patients with high-risk smoldering multiple myeloma.

Investigated diseases

Plasma Cell Myeloma – Plasma cell myeloma, also known as multiple myeloma, is a type of blood cancer that originates in the plasma cells, which are a type of white blood cell responsible for producing antibodies. In this disease, abnormal plasma cells multiply uncontrollably in the bone marrow, leading to the production of a large amount of abnormal proteins. This can result in damage to bones, kidneys, and the immune system. Patients may experience symptoms such as bone pain, fatigue, frequent infections, and anemia. Over time, the disease can cause significant bone damage and other complications. The progression of plasma cell myeloma can vary, with periods of stability followed by active disease phases.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507419-37-00Protocol codeEFC15992Estimated enrolment530 patientsSponsorSanofi-Aventis Recherche & Developpement

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