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Cemsidomide and Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma

Fast replyInvestigationalNo placebo
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What is this trial about?

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

This study is being done in relapsed/refractory multiple myeloma, a cancer of plasma cells, which are a type of blood cell found in the bone marrow. The treatment being studied is cemsidomide taken by mouth as a tablet together with dexamethasone, a steroid medicine that can help reduce cancer-related inflammation and may help the treatment work better. The purpose of the study is to see how well this medicine combination works against the cancer.

The study is a phase 2 trial, which means it is an early study of the treatment in people with this disease. All participants receive the same treatment, and the study team follows what happens over time. The treatment is given in repeated cycles, and the medicines are continued while they are helping and side effects remain manageable. Doctors also monitor for side effects and other health changes during the study.

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

    Start of the study

    You join a phase 2 study that is open-label, which means the study treatment is not hidden from you, and single-arm, which means there is only one treatment plan in the study.

    The study is for people with relapsed/refractory multiple myeloma, which is a type of blood cancer that has come back or has not responded well to treatment.

  2. Step 2

    Study treatment

    You take cemsidomide by mouth as a tablet. The dose is 100 micrograms each time it is taken.

    You also take dexamethasone with cemsidomide. The study information does not give the dose, how often it is taken, or how long it is taken.

    The treatment is given during the study period, but the exact duration of administration is not stated in the source information.

  3. Step 3

    Study assessments

    Your response to treatment is checked using overall response rate. This means the study looks at how many people have their cancer improve by the study criteria used for multiple myeloma.

    The study also checks how long any improvement lasts, how long it takes before a response is seen, whether a complete response occurs, how long the disease stays under control, and how long people live.

    Your blood levels of cemsidomide are measured during the study.

  4. Step 4

    Safety monitoring

    You are monitored for side effects, including serious side effects, side effects that lead to stopping treatment for a while, lowering the dose, or stopping treatment completely, and death.

    The study records the frequency and severity of these side effects during the trial.

  5. Step 5

    End of the study

    The study is planned to run from 2026-06-15 to 2030-03-31.

    Your participation in the trial ends when the study treatment and all required study checks are completed.

Who can join the trial?

10 criteria

  • Be willing and able to sign an informed consent form, which means agreeing to take part after the study has been explained.
  • Have a documented diagnosis of multiple myeloma and have measurable disease at the time of joining the study, meaning the cancer can be checked and measured by the study team.
  • Have already received at least 3 prior anti-myeloma treatment regimens (treatment plans), each for at least 2 straight cycles or more, unless one of the required treatments was not available as part of usual care where the patient lives.
  • The previous treatments must have included all of the following: an immunomodulatory drug (a medicine that helps change how the immune system works), a proteasome inhibitor (a medicine that blocks a cell waste-removal system), an anti-CD38 antibody (a targeted antibody medicine), and a T-cell engager or CAR-T therapy (treatments that help immune cells attack cancer).
  • Have adequate organ function, meaning the major organs are working well enough for study treatment.
  • Have side effects from previous cancer treatments that have improved to Grade 1 or lower, meaning only mild side effects remain.
  • If male and having sex with a person who could become pregnant, agree to use a condom during treatment and for at least 30 days after the last dose of study treatment.
  • If female, not be pregnant, not plan to become pregnant, not breastfeed, not plan to breastfeed, and not donate eggs during the study and for 30 days after the last dose of study treatment.
  • If male, agree not to donate sperm during the study treatment period and for 30 days after stopping study treatment.
  • Agree not to donate blood during study treatment and for 30 days after stopping study treatment.

Who cannot join the trial?

10 criteria

  • The person has myeloma in the central nervous system (CNS), which means the cancer has spread to the brain or spinal cord area.
  • The person has systemic light chain amyloidosis, a condition where abnormal proteins build up in organs and tissues.
  • The person has POEMS syndrome, a rare condition with nerve problems and other body changes.
  • The person has myelodysplastic syndrome (MDS), a disorder where the bone marrow does not make healthy blood cells normally.
  • The person has already been treated with cemsidomide.
  • The person has significant heart problems or poor heart function, meaning the heart is not working well enough or there is a serious heart disease.
  • The person had a blood clot or related blocked-blood-vessel event within the last 3 months before joining the study. A blood clot is a clump of blood that can block blood flow.
  • The person has another cancer that is not the study cancer and that has gotten worse or needed treatment within the past 3 years.
  • The person has an active infection that is not under control, including a bacterial, fungal, or viral infection. These are infections caused by bacteria, fungi, or viruses.
  • The person cannot swallow tablets, or has serious trouble swallowing them.
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Investigated drugs

  • Cemsidomide

    is the main study medicine in this trial. It is taken by mouth as a tablet and is being tested to see if it can help fight relapsed or hard-to-treat multiple myeloma by slowing down or killing cancer cells.

  • Dexamethasone

    is a steroid medicine given together with cemsidomide. In this trial, it is used to help the treatment work better against the myeloma and may also help reduce some symptoms caused by the disease.

What is already known about the treatment

Cemsidomide - Cemsidomide is an oral tablet taken by mouth, and in this trial it is being studied as a new cancer medicine for people with relapsed or hard-to-treat multiple myeloma. It is still an investigational drug in medical research, so its full place in routine care is not yet established. It is classified as an immunomodulatory anticancer agent, meaning it helps change how the immune system and cancer cells behave. At the molecular level, it binds to a protein called cereblon, which leads to the breakdown of specific proteins that cancer cells need to grow and survive, and this can also help the immune system attack the cancer more effectively.

Investigated diseases

Relapsed/Refractory Multiple Myeloma - Relapsed/refractory multiple myeloma is a form of multiple myeloma, a cancer of plasma cells in the bone marrow, that has come back after prior improvement or has stopped responding to previous treatment. It develops when abnormal plasma cells keep growing and collecting in the bone marrow, which can crowd out normal blood-forming cells and affect bones and other organs. The disease may worsen over time with increasing amounts of abnormal cells and more widespread bone marrow involvement.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524181-26-00Protocol codeCFT7455-2101Estimated enrolment98 patientsSponsorC4 Therapeutics Inc.

sourced from the EU Clinical Trials Register and site verification

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