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 (21)
Facility
City
Region
Status
Clearview Cancer Institute
Huntsville
Alabama
Recruiting
Mayo Clinic - Arizona
Phoenix
Arizona
Recruiting
HonorHealth
Scottsdale
Arizona
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
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
Imperial College Healthcare NHS Foundation Trust - Hammersmith Hospital
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.
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