Title
A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma

Description
A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma

Objective
Primary:
- To determine the antitumor activity of cemsidomide in combination dexamethasone in subjects with r/r MM

Secondary:
- To evaluate additional antitumor activity of cemsidomide in combination with dexamethasone in subjects with r/r MM
- To characterize the safety and tolerability of cemsidomide in subjects with r/r MM
- To evaluate the PK of cemsidomide in subjects with r/r MM

Treatment 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).

Key Eligibility 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.

Applicable Disease Sites
Multiple Myeloma

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital