Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

RecruitingRare disease

Study of isatuximab, pomalidomide and dexamethasone combination for patients with relapsed or refractory multiple myeloma

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 studies the effectiveness of combining isatuximab with other medications in treating relapsed or refractory multiple myeloma, a type of blood cancer that has returned or stopped responding to previous treatments. The study tests different combinations of isatuximab with pomalidomide and dexamethasone, along with other new medicines.

The treatment involves receiving isatuximab through an intravenous infusion (directly into a vein), while pomalidomide is taken as capsules by mouth and dexamethasone as tablets. The study is divided into two parts - the first part finds the right dose of the new medications when combined with isatuximab, and the second part tests how well these combinations work in treating the cancer.

The study will measure how many patients respond to treatment and how much their cancer improves. It will also track how long the treatment works, how long patients survive, and what side effects may occur. Researchers will monitor patients' quality of life during treatment using special questionnaires and collect blood samples to study how the medications work in the body.

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

    You will receive a combination of three medications:

    - Isatuximab through intravenous infusion

    - Pomalidomide capsules taken by mouth

    - Dexamethasone tablets taken by mouth

  2. Step 2

    Treatment cycles

    Your treatment will be organized in cycles

    During each cycle, you will receive:

    - Isatuximab through an intravenous line at the treatment center

    - Pomalidomide capsules (1-4 mg) to take at home daily as prescribed

    - Dexamethasone tablets (4-8 mg) to take at home as prescribed

  3. Step 3

    Regular assessments

    Throughout your treatment, your response will be monitored through:

    - Blood tests to measure disease markers

    - Assessment of your overall health status

    - Completion of quality of life questionnaires

    These assessments help determine how well the treatment is working

  4. Step 4

    Treatment duration

    The treatment will continue as long as it is providing benefit

    The study is planned to run until September 2028

    Your doctor will regularly evaluate your response to determine if you should continue treatment

Who can join the trial?

10 criteria

  • Must be at least 18 years old
  • Must have an ECOG performance status of 0-1 (ability to perform daily activities with minimal assistance)
  • Must have multiple myeloma that has returned or not responded to at least 2 previous treatments, including:
    • Proteasome inhibitors (PIs)
    • Immunomodulatory drugs (IMiDs)
    • Must have measurable disease, shown by at least one of these:
      • Blood protein level (serum M protein) of 0.5 g/dL or higher
      • Urine protein level (urine M protein) of 200 mg or more in 24 hours
      • Certain levels of free light chains in blood when other proteins are not measurable
      • Must use effective birth control methods if able to have children
      • For Substudy 01: Either:
        • Never received anti-CD38 therapy before, or
        • Had anti-CD38 therapy but completed it at least 12 months ago (must have received at least 2 treatment cycles)

Who cannot join the trial?

15 criteria

  • Age below 18 years old
  • History of severe allergic reactions to similar medications
  • Active or chronic infections like hepatitis B or hepatitis C
  • Significant heart problems including heart failure or recent heart attack (within last 6 months)
  • Severe kidney problems requiring dialysis
  • Severe liver disease
  • Pregnant or breastfeeding women
  • Active second cancer (other than the one being studied)
  • Major surgery within the last 4 weeks
  • Participation in other clinical trials within the last 30 days
  • Mental conditions that could interfere with following study procedures
  • Uncontrolled high blood pressure
  • Life-threatening bleeding within the last 3 months
  • Known HIV infection
  • History of stroke within the last 6 months
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.

RecruitingNot 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

Isatuximab is a medication used to treat multiple myeloma, a type of blood cancer. It works by targeting a specific protein on cancer cells, helping the immune system to identify and destroy these cells. Dexamethasone is a corticosteroid medication that helps reduce inflammation and suppress the immune system. In multiple myeloma treatment, it is often combined with other medications to enhance their effectiveness. Pomalidomide is a medication that helps fight multiple myeloma by working in several ways. It helps strengthen the immune system's response against cancer cells, prevents the growth of new blood vessels that feed tumors, and directly kills or stops the growth of cancer cells. These medications are being studied in various combinations to find the most effective treatment for patients with relapsed or refractory multiple myeloma, which means their cancer has either returned after previous treatment or did not respond well to earlier treatments.

What is already known about the treatment

  • Isatuximab

    A monoclonal antibody administered through intravenous infusion, used in the treatment of relapsed or refractory multiple myeloma. It works by targeting CD38, a protein found on the surface of myeloma cells, helping to destroy cancer cells through multiple mechanisms including direct tumor cell death and immune system activation. This medication belongs to the class of targeted immunotherapy drugs and is typically used in combination with other anti-myeloma medications such as pomalidomide and dexamethasone to enhance treatment effectiveness.

  • Dexamethasone

    A synthetic corticosteroid medication that can be taken orally or given by injection, commonly used in combination with other cancer treatments for multiple myeloma. It works by reducing inflammation and suppressing the immune system, which helps to control cancer growth and manage treatment-related symptoms. This medication belongs to the glucocorticoid class and is frequently used as part of combination therapy protocols in cancer treatment to enhance the effectiveness of other anti-cancer medications.

  • Pomalidomide

    An oral immunomodulatory drug used in the treatment of relapsed or refractory multiple myeloma, typically given in combination with other medications. It works by helping to strengthen the immune system's response against cancer cells while also interfering with blood vessel growth that supports tumor development. This medication belongs to the class of immunomodulatory drugs and is specifically designed to help patients whose multiple myeloma has returned or become resistant to other treatments.

Investigated diseases

Multiple Myeloma - A type of blood cancer that develops in plasma cells, which are white blood cells that normally produce antibodies to help fight infections. In this disease, cancerous plasma cells accumulate in the bone marrow, crowding out healthy blood cells and producing abnormal proteins. The condition often affects multiple bones in the body, leading to bone pain and weakness. Multiple myeloma can cause various complications including anemia, frequent infections, and kidney problems. The disease typically progresses through different stages, from early-stage (asymptomatic) to more advanced stages where symptoms become more apparent.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-514988-25-00Protocol codeACT16482-01Estimated enrolment17 patientsSponsorSanofi-Aventis Recherche & Developpement

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.