- A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma — Recruiting • Phase II • Cardiology / Cardiovascular • NCT07284758.
- What is being tested: Cemsidomide (a cereblon E3 ligase modulator) combined with dexamethasone in patients with relapsed/refractory multiple myeloma, evaluating its antimyeloma activity, safety, tolerability, and pharmacokinetic/pharmacodynamic properties.
- Patient eligibility overview: The trial targets patients with relapsed/refractory multiple myeloma—those whose disease has progressed despite or become unresponsive to prior treatment regimens.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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).
- : 1. Be willing and able to provide signed informed consent for the study. 2. Age ≥ 18 years at the time of signed consent. 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 baseline severity or CTCAE ≤ 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 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. 9. Male subjects must refrain from donating sperm…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.