Phase 2 trial evaluates teclistamab-daratumumab's efficacy and safety in previously untreated AL amyloidosis, indicating potential for improved hematologic responses.
Key Points
To assess the efficacy and safety of teclistamab-daratumumab combination therapy in newly diagnosed AL amyloidosis patients.
Open-label multicenter phase 2 clinical trial
Enrolled patients with previously untreated Mayo 2004 stage I-IIIa AL amyloidosis
Administered six cycles of subcutaneous teclistamab and daratumumab-hyaluronidase
Primary endpoint: hematologic complete response rate at 6 months with target of 80%
Secondary endpoints: minimal residual negativity and safety outcomes including cytokine release syndrome
Evaluated overall survival and organ responses in heart, liver, and kidneys