Tests cemsidomide with dexamethasone for relapsed or refractory multiple myeloma
Tests cemsidomide with dexamethasone in adults with returning or resistant multiple myeloma.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Key facts
- Where
- Meldola, Naples, Pavia, Rimini, Rome, and San Giovanni Rotondo, ItalySee the 6 sites
- Phase
- Phase 2
Where in Italy
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.lMeldola, ItalyTaking people
- Azienda Ospedaliera Universitaria Federico II Di NapoliNaples, ItalyTaking people
- Fondazione IRCCS Policlinico San MatteoPavia, ItalyTaking people
- Azienda Unita Sanitaria Locale Della RomagnaRimini, ItalyTaking people
- Azienda Sanitaria Locale Roma 1Rome, ItalyTaking people
- Casa Sollievo della SofferenzaSan Giovanni Rotondo, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- C4 Therapeutics, Inc.
- Trial code
- NCT07284758EU 2025-524181-26-00
- Record updated
- 30 October 2026
- Original description
This is a Phase 2, open-label, single-arm, multicenter study to assess the antimyeloma activity and further characterize the safety, tolerability, PK, and PD of cemsidomide in combination with dexamethasone in participants with relapsed/refractory multiple myeloma (r/r MM).Read full original descriptionShow less
A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma
This is a Phase 2, open-label, single-arm, multicenter study to assess the antimyeloma activity and further characterize the safety, tolerability, PK, and PD of cemsidomide in combination with dexamethasone in participants with relapsed/refractory multiple myeloma (r/r MM).
Inclusion: Be willing and able to provide signed informed consent for the study; Age ≥ 18 years at the time of signed consent; Subjects must have a documented diagnosis of MM and measurable disease at enrollment; 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; Subjects need to have adequate organ function; Toxicities from prior anticancer therapies must have resolved to baseline severity or CTCAE ≤ Grade 1; 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; 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; Male subjects must refrain from donating sperm during the Treatment Period and for 30 days after discontinuation; Subjects must refrain from donating blood during study treatment and for 30 days after discontinuation.
Exclusion: Previously treated with cemsidomide; Thromboembolic event within 3 months prior to enrollment; Subjects with any of the following:; Systemic light chain amyloidosis; Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin changes (POEMS) Syndrome; Myelodysplastic syndrome (MDS); Clinically significant impaired cardiac function or cardiac disease; Known malignancy other than study indication that has progressed or required treatment within the past 3 years; Uncontrolled active bacterial, fungal, or viral infection; Presence of myeloma in the central nervous system (CNS); Inability or difficulty swallowing tablets; NOTE: Other inclusion/exclusion criteria may apply, per protocol.