Phase 3 Randomized Study of Teclistamab and Talquetamab (Tec-Tal) Versus Daratumumab and Lenalidomide (DR) in Minimal Residual Disease (MRD) Positive Patients With Newly Diagnosed Multiple Myeloma After Autologous Hematopoietic Stem Cell Transplantation (TiTan)

Condition studied

Multiple myeloma

Investigational medicinal product(s)

Eligibility

Primary endpoint

MRD-CR negativity (10^-5) with complete response at Month 12

Endpoint detail

Progression-free survival (PFS), Complete response (CR) or better, PFS2 (progression‑free survival to second disease progression or death), Overall survival (OS), Incidence and severity of AEs, Incidences of SAEs, MRD negativity (10^-5), Sustained MRD negativity (10^-5) for at least 12 months, • Time to worsening of symptoms • Mean change from baseline in the EORTC QLQ-C30 global health status and functional scale scores (including MY-20)