Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruitingRare disease

Study Comparing Subcutaneous and Intravenous Isatuximab with Pomalidomide and Dexamethasone for Adults with Relapsed or Refractory Multiple Myeloma

Fast replyRegistered drug
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 a type of cancer called multiple myeloma, which affects plasma cells in the bone marrow. The study is testing a combination of medications to see how well they work together. The medications being tested include isatuximab, pomalidomide, and dexamethasone. Isatuximab is given in two different ways: as a subcutaneous injection (under the skin) and as an intravenous infusion (into a vein). Pomalidomide and dexamethasone are taken orally in capsule and tablet forms, respectively.

The purpose of the study is to compare the effectiveness of the subcutaneous and intravenous methods of administering isatuximab when used with pomalidomide and dexamethasone. Participants in the study will receive one of these combinations and may also receive a placebo. The study will last for a period of up to 80 weeks, during which participants will be monitored regularly to assess their response to the treatment and any side effects they may experience.

Throughout the study, researchers will collect information on how well the treatment works, how the body processes the medications, and the overall health and satisfaction of the participants. This information will help determine if the subcutaneous method of administering isatuximab is as effective as the intravenous method, potentially offering a more convenient option for patients with multiple myeloma in the future.

The research process

The trial runs in 7 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, eligibility is confirmed based on specific criteria related to multiple myeloma, including previous treatments and measurable protein levels.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline health status and to collect necessary medical history.

  3. Step 3

    Treatment phase

    The treatment involves a combination of medications: pomalidomide, isatuximab, and dexamethasone.

    Pomalidomide is administered orally in capsule form, with available dosages of 1 mg, 2 mg, 3 mg, and 4 mg.

    Isatuximab is administered either intravenously or subcutaneously, depending on the study group assignment.

    Dexamethasone is taken orally in tablet form, with dosages of 4 mg and 8 mg.

  4. Step 4

    Medication schedule

    The specific dosage and frequency of each medication are determined by the study protocol and may vary based on individual response and tolerance.

  5. Step 5

    Monitoring and assessments

    Regular monitoring is conducted to assess the effectiveness of the treatment and to track any side effects.

    Assessments include blood tests, imaging studies, and questionnaires to evaluate health status and quality of life.

  6. Step 6

    Completion of treatment

    Upon completion of the treatment phase, a final assessment is conducted to evaluate the overall response to the therapy.

  7. Step 7

    Follow-up

    Follow-up visits are scheduled to monitor long-term health outcomes and to gather additional data on the treatment's effectiveness.

Who can join the trial?

7 criteria

  • Participants must have a type of cancer called multiple myeloma that has come back after treatment.
  • Participants should have received at least one previous treatment for multiple myeloma. This treatment must have included a medicine called lenalidomide and a type of medicine known as a proteasome inhibitor, either alone or together.
  • Participants need to have certain levels of a protein in their blood or urine. This includes:
    • Serum M-protein of at least 0.5 grams per deciliter (g/dL).
    • Urine M-protein of at least 200 milligrams in a 24-hour period.
    • A test called the serum free light chain (FLC) assay with specific results: involved FLC assay of at least 10 milligrams per deciliter (mg/dL) and an abnormal serum FLC ratio, which means less than 0.26 or more than 1.65.
    • Participants can be of any gender.
    • Participants must be adults, which means they are 18 years or older.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or take the study medications as required.
  • Patients who have a medical condition that could interfere with the study or make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies to the study medications or their ingredients.
  • Patients who have a history of certain serious medical conditions, such as heart disease or liver problems.
  • Patients who are taking medications that could interfere with the study drugs.
  • Patients who have an active infection that requires treatment.
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

  • Isatuximab

    This medication is used in the treatment of multiple myeloma, a type of blood cancer. It works by targeting and attaching to a specific protein on the surface of cancer cells, helping the immune system to identify and destroy these cells. In this trial, isatuximab is being tested in two forms of administration: subcutaneous (under the skin) and intravenous (into a vein).

  • Pomalidomide

    This is a medication that helps to slow down or stop the growth of cancer cells. It is used in combination with other drugs to treat multiple myeloma, especially in patients who have not responded to other treatments. Pomalidomide works by affecting the immune system and has anti-cancer properties.

  • Dexamethasone

    This is a type of steroid medication that is used to reduce inflammation and suppress the immune system. In the context of multiple myeloma, dexamethasone is used to help enhance the effects of other cancer treatments and manage symptoms associated with the disease.

What is already known about the treatment

Isatuximab – This medication is administered either subcutaneously or intravenously and is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory multiple myeloma, a type of cancer affecting plasma cells. It is an investigational drug in the medical literature, with ongoing research to compare its efficacy and pharmacokinetics in different forms of administration. Isatuximab works by targeting a specific protein on the surface of cancer cells, helping the immune system to identify and destroy these cells. It is classified as a monoclonal antibody, which is a type of targeted cancer therapy.

Investigated diseases

Plasma Cell Myeloma Recurrent – Plasma cell myeloma, also known as multiple myeloma, is a type of cancer that affects plasma cells, which are a type of white blood cell found in the bone marrow. In recurrent cases, the disease returns after a period of improvement or remission. It typically progresses by causing an overproduction of abnormal plasma cells, which can crowd out healthy blood cells and lead to bone damage, kidney problems, and weakened immune function. Symptoms may include bone pain, fatigue, frequent infections, and anemia. The disease can vary in its rate of progression, with some individuals experiencing slow development while others may have a more aggressive form.
Trial detailsLast updated 2 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2023-508869-32-00Protocol codeEFC15951Estimated enrolment606 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.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).