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Recruiting Phase 2

A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

NCT07284758 · tracked via the Priya Life Science France tracker
Phase
Phase 2
Started
2026-02-18
Last updated
2026-10-30

Condition(s) studied

Multiple MyelomaRelapsed/Refractory Multiple Myeloma

Investigational drug(s) / intervention(s)

Cemsidomide →Dexamethasone →

Cemsidomide: dosed orally (PO) once a day (QD) 14 days on/14 days off for each 28-day cycle

Dexamethasone: dosed PO once a week (QW) on Days 1, 8, 15, and 22 for each 28-day cycle

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 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 during the Treatment Period and for 30 days after discontinuation. 10. Subjects must refrain from donating blood during study treatment and for 30 days after discontinuation. Exclusion Criteria: 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. Uncontrolled active bacterial, fungal, or viral infection. 8. Inability or difficulty swallowing tablets. NOTE: Other inclusion/exclusion criteria may apply, per protocol.

Primary outcome measure(s)

  • Overall response rate (ORR) per International Myeloma Working Group (IMWG) Response Criteria by an Independent Review Committee (IRC) — up to approximately 43 months

Trial sites (60)

FacilityCityRegionStatus
Clearview Cancer Institute Huntsville Alabama Recruiting
Mayo Clinic - Arizona Phoenix Arizona Recruiting
HonorHealth Scottsdale Arizona Recruiting
City of Hope Duarte California Recruiting
Berenson Cancer Center West Hollywood California Recruiting
Mayo Clinic - Florida Jacksonville Florida Recruiting
Winship Cancer Institute, Emory University Atlanta Georgia Recruiting
Indiana University Health Indianapolis Indiana Recruiting
University of Iowa Iowa City Iowa Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts Not Yet Recruiting
Dana Farber Cancer Institute Boston Massachusetts Not Yet Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
University of Michigan Ann Arbor Michigan Recruiting
Karmanos Cancer Institute Detroit Michigan Recruiting
START Midwest Grand Rapids Michigan Recruiting
Mayo Clinic - Minnesota Rochester Minnesota Recruiting
Washington University/Siteman Cancer Center St Louis Missouri Recruiting
University of Nebraska Medical Center Omaha Nebraska Recruiting
The Tisch Cancer Institute/Mount Sinai New York New York Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
UNC Hospitals Adult Oncology Clinics Chapel Hill North Carolina Recruiting
Tennessee Oncology Nashville Tennessee Recruiting
START San Antonio San Antonio Texas Recruiting
University of Wisconsin - Carbone Cancer Center Madison Wisconsin Recruiting
MCW-Clinical Cancer Center at Froedtert Hospital Campus Milwaukee Wisconsin Recruiting
Centre Hospitalier de la Côte Basque Bayonne France Recruiting
Hospices Civils de Lyon (HCL) - Centre Hospitalier Lyon-Sud Lyon France Not Yet Recruiting
Institut Paoli-Calmettes (IPC) Marseille France Not Yet Recruiting
Centre Henri-Becquerel Rouen France Not Yet Recruiting
Centre Hospitalier Universitaire (CHU) de Toulouse-Institut Universitaire du Cancer de Toulouse-Oncopole (IUCT-Oncopole) Toulouse France Not Yet Recruiting
Centre Hospitalier Regional et Universitaire de Tours (CHRU Tours) Hospital Bretonneau Tours France Not Yet Recruiting
Institut Gustave Roussy Villejuif France Not Yet Recruiting
Servizio Sanitario Regionale Emilia-Romagna-Istituto Scientifico Romagnolo per lo Studio dei Tumori "Dino Amadori" Srl Meldola Italy Not Yet Recruiting
Azienda Ospedaliera Universitaria (AOU) "Federico II" Naples Italy Not Yet Recruiting
Universita degli Studi di Pavia-Fondazione IRCCS Policlinico San Matteo Pavia Italy Not Yet Recruiting
Servizio Sanitario Regionale Emilia-Romagna - Ematologia Ospedale Infermi di Rimini Rimini Italy Not Yet Recruiting
Azienda Sanitaria Locale (ASL) Roma 1 - Ospedale Santo Spirito Roma Italy Not Yet Recruiting
Ospedale Casa Sollievo della Sofferenza San Giovanni Rotondo Italy Recruiting
IN-VIVO Sp.z.o.o Bydgoszcz Poland Not Yet Recruiting
Uniwersyteckie Centrum Kliniczne w Gdańsku Gdansk Poland Not Yet Recruiting

+ 20 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07284758 on ClinicalTrials.gov ↗ ← All trials in France