A multicenter prospective trial estimating the persistence of remission after stopping BCMA-CD3 bispecific antibody in multiple myeloma patients with major M-spike response by use MaldiTOF-based high sensitivity monitoring

Multiple myeloma

The primary endpoint is disease free survival (DFS) based on sustained MMR after 6 months and 3 years.

Efficacy: Survival: Overall Survival (OS) and Progression-Free Survival (PFS)., Efficacy: Relapse: a. Incidence of MMR loss at 6 months and 3 years. b. Incidence of clinical relapse (as per IMWG criteria) at 6 months and 3 years. c. Median time to MMR loss and to clinical relapse., Efficacy: Treatment Re-response: Proportion of patients achieving at new MMR upon re-initiation of therapy., Safety: Incidence and severity of adverse events, with special focus on infection rates (events per patient-year) during treatment versus after treatment discontinuation., Healthcare Utilization & Economics: Number of hospitalization days per patient-year before versus after treatment discontinuation., Healthcare Utilization & Economics: A health economic analysis assessing cost-effectiveness and resource utilization associated with treatment discontinuation., Patient-Reported Outcomes: Change from baseline in patient-reported Quality of Life (QoL) and symptom burden, measured using EQ-5D, assessed at serial time points throughout the study., Exploratory & Biomarker Analyses: Analysis of baseline factors (e.g., age, disease stage, cytogenetic risk, time since diagnosis, depth of initial response, refractoriness to prior lines of therapy) associated with: a. The risk of disease relapse (molecular and clinical). b. The durability of treatment-free remission.

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