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A study of cemsidomide and dexamethasone in subjects with relapsed or refractory multiple myeloma (r/r MM)
EU CTIS ID: 2025-524181-26-00
What this study is testing
To determine antitumor activity of cemsidomide in combination with dexamethasone in subjects with r/r MM.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Be willing and able to provide signed informed consent for the study.
- 2. Male subjects must agree to use a condom when having intercourse with a person of childbearing potential during the Treatment Period and for at least 30 days after the last dose of study treatment.
- 3. Subjects must have a documented diagnosis of MM and measurable disease at enrollment.
- 4. Received at least 3 prior anti-myeloma regimens (for a minimum of 2 or more consecutive cycles) that must have included an immunomodulatory drug (i.e., IKZF 1/3 degrader), a proteasome inhibitor, an anti-CD38 antibody, and a T-cell engager (TCE) or chimeric antigen receptor T-cell (CAR-T) therapy, unless not available per local standard of care.
- 5. Subjects need to have adequate organ function.
- 6. Toxicities from prior anticancer therapies must have resolved to ≤ Grade 1.
You likely can't join if
- 1. Presence of myeloma in the central nervous system (CNS).
- 2. Subjects with any of the following: • Systemic light chain amyloidosis • Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin changes (POEMS) Syndrome • Myelodysplastic syndrome (MDS).
- 3. Previously treated with cemsidomide.
- 4. Clinically significant impaired cardiac function or cardiac disease.
- 5. Thromboembolic event within 3 months prior to enrollment.
- 6. Known malignancy other than study indication that has progressed or required treatment within the past 3 years.
See the full eligibility criteria
- 1. Be willing and able to provide signed informed consent for the study.
- 2. Male subjects must agree to use a condom when having intercourse with a person of childbearing potential during the Treatment Period and for at least 30 days after the last dose of study treatment.
- 3. Subjects must have a documented diagnosis of MM and measurable disease at enrollment.
- 4. Received at least 3 prior anti-myeloma regimens (for a minimum of 2 or more consecutive cycles) that must have included an immunomodulatory drug (i.e., IKZF 1/3 degrader), a proteasome inhibitor, an anti-CD38 antibody, and a T-cell engager (TCE) or chimeric antigen receptor T-cell (CAR-T) therapy, unless not available per local standard of care.
- 5. Subjects need to have adequate organ function.
- 6. Toxicities from prior anticancer therapies must have resolved to ≤ Grade 1.
- 7. Female subjects may not be pregnant or intend to become pregnant, may not breastfeed or intend to breastfeed, or donate ova during their participation in this study until 30 days after the last dose of study treatment.
- 8. Male subjects must refrain from donating sperm during the Treatment Period and for 30 days after discontinuation.
- 9. Subjects must refrain from donating blood during study treatment and for 30 days after discontinuation.
- 1. Presence of myeloma in the central nervous system (CNS).
- 2. Subjects with any of the following: • Systemic light chain amyloidosis • Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin changes (POEMS) Syndrome • Myelodysplastic syndrome (MDS).
- 3. Previously treated with cemsidomide.
- 4. Clinically significant impaired cardiac function or cardiac disease.
- 5. Thromboembolic event within 3 months prior to enrollment.
- 6. Known malignancy other than study indication that has progressed or required treatment within the past 3 years.
- 7. Any active uncontrolled bacterial, fungal or viral infection.
- 8. Inability or difficulty swallowing tablets.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.