A Phase II, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma
Categories (click each to see list of all clinical trials associated with that category): FPBCC CTO Studies, Myeloma/Plasma Cell Dyscrasia (ONC)
Current Status: Open
Phase: II
Principal Investigator: Holstein, Sarah
Contact Information:
Kellee Halliburton
khalliburton@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT07284758?term=NCT07284758&rank=1#participation-criteria
Summary
Primary
- To determine antitumor activity of cemsidomide in combination with 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 insubjects with r/r MM
- To evaluate the PK of cemsidomide in subjects with r/r MM
Exploratory
- To evaluate antitumor activity of cemsidomide in combination with dexamethasone in subjects with r/r MM
- To explore the relationship between PD biomarkers and clinical outcomes
- To assess exposure-response relationships between cemsidomide and relevant markers of safety and efficacy
- To assess quality of life (QoL) in subjects with r/r MM treated with cemsidomide in combination with dexamethasone