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Cemsidomide and Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario De Salamanca Salamanca Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu Wroclaw Poland
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Hospital Universitario Hm Sanchinarro Madrid Spain
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Centre Henri Becquerel Rouen France
Pratia Hematologia Sp. z o.o. Katowice Poland
Hospital Universitario De Cabuenes Gijon Spain
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Hospital Clinic De Barcelona Barcelona Spain
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Hospital Universitario De Leon Leon Spain
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Centre Hospitalier De La Cote Basque Bayonne France
In Vivo Sp. z o.o. Bydgoszcz Poland
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Casa Sollievo Della Sofferenza San Giovanni Rotondo Italy
Centre Hospitalier Lyon Sud Pierre Benite France
Acfqyzi Seenwkqni Litqms Rybt 1 Rome Italy
Ieipisty Pyhgaddgztorsbt Ctylnk Cxjqfl Marseille France
Cmifyo Hcogufdhdbv Roafzgcr Utjvzmnatfnwo Du Thnba Tours France
Uxvsalkjomgbyf Cfxkdox Kwepjeoao Gdansk Poland
Ifamcjrg Chetry Dlzmnspnearhdsfqb L'hospitalet De Llobregat Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
15.06.2026
Italy Italy
Not yet recruiting
15.06.2026
Poland Poland
Not yet recruiting
15.06.2026
Spain Spain
Not yet recruiting
15.06.2026

Trial locations

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.

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 ID:
2025-524181-26-00
Protocol code:
CFT7455-2101
NCT ID:
NCT07284758
Trial Phase:
Therapeutic exploratory (Phase II)

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