A Phase 3 Randomized Study Comparing Teclistamab in Combination With Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab SC and Lenalidomide (Tal-DR) Versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Who Are Either Ineligible or Not Intended for Autologous Stem Cell Transplant as Initial Therapy
Categories (click each to see list of all clinical trials associated with that category): Myeloma/Plasma Cell Dyscrasia (ONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Wildes, Tanya
Contact Information:
Marnee Strege
+1 402-559-8155
marnee.strege@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT05552222?term=NCT05552222&rank=1#participation-criteria
Summary
Primary
To compare the efficacy of Tec-DR versus DRd and Tal-DR versus DRd
Secondary
To further compare the efficacy of Tec-DR versus DRd and Tal-DR versus DRd
To assess the safety and tolerability of teclistamab when administered in combination with DR and of talquetamab when administered in combination with DR
To characterize the PK of teclistamab and talquetamab
To assess the immunogenicity of teclistamab and talquetamab
To assess participant's symptoms, functioning, and HRQoL with Tec- DR versus DRd and Tal-DR versus DRd
Exploratory
To evaluate and explore pharmacodynamic biomarkers of antimyeloma and immune activity in participants treated with Tec-DR, Tal-DR, and DRd
To explore the relationship between PK, pharmacodynamic activity, AEs, and clinical response in participants treated with Tec-DR, Tal-DR, and DRd
To explore the relationship between MRD negativity with duration and depth of clinical response in participants treated with Tec-DR, Tal-DR, and DRd
To explore predictive biomarkers of response an