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A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Trial Status: active
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 Criteria
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 Criteria
Presence of myeloma in the central nervous system (CNS).
Subjects with any of the following:
Systemic light chain amyloidosis
Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy, and Skin changes (POEMS) Syndrome
Myelodysplastic syndrome (MDS).
Previously treated with cemsidomide.
Clinically significant impaired cardiac function or cardiac disease.
Thromboembolic event within 3 months prior to enrollment.
Known malignancy other than study indication that has progressed or required treatment within the past 3 years.
Uncontrolled active bacterial, fungal, or viral infection.
Inability or difficulty swallowing tablets. NOTE: Other inclusion/exclusion criteria may apply, per protocol.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07284758.
Locations matching your search criteria
United States
Arizona
Scottsdale
Mayo Clinic in Arizona
Status: Approved
Name Not Available
Florida
Jacksonville
Mayo Clinic in Florida
Status: Active
Name Not Available
Georgia
Atlanta
Emory University Hospital/Winship Cancer Institute
Status: Active
Name Not Available
Iowa
Iowa City
University of Iowa/Holden Comprehensive Cancer Center
Status: Active
Name Not Available
Michigan
Detroit
Wayne State University/Karmanos Cancer Institute
Status: Approved
Name Not Available
Minnesota
Rochester
Mayo Clinic in Rochester
Status: Active
Name Not Available
Missouri
Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Name Not Available
Nebraska
Omaha
University of Nebraska Medical Center
Status: Active
Name Not Available
North Carolina
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Approved
Name Not Available
Wisconsin
Madison
University of Wisconsin Carbone Cancer Center - University Hospital