2026 年 16 巻 4 号 p. 13-22
Background and Objectives: Teclistamab, a BCMA ⨉ CD3 bispecific antibody, was approved in Japan in 2025 for heavily pretreated relapsed/refractory multiple myeloma (RRMM). As its real-world implementation begins, practical guidance on safety management and optimal patient selection is urgently needed.
Methods: Based on the U.S. TecPIONEER study, TecPIONEER-Japan utilized a two-step qualitative design: in-depth interviews (IDIs) with five early-adopter hematologists, followed by a roundtable discussion (RTD) with three expert co-authors to validate findings and propose practical considerations.
Results: Clinicians emphasized evaluating both medical and social factors (e.g., family support for weekly visits). Experts suggested considering teclistamab early upon becoming triple-class exposed. While cytokine release syndrome (CRS) and ICANS were deemed manageable by leveraging existing institutional infrastructures, infection control emerged as a critical concern. The RTD supported proactive IgG replacement (threshold: 400 mg/dL) and advised routine monthly cytomegalovirus (CMV) PCR monitoring. For high-risk extramedullary disease (EMD), experts emphasized standardized whole-body imaging (PET-CT/MRI) and expressed high expectations for the teclistamab-talquetamab combination.
Conclusions: TecPIONEER-Japan provides early, practical guidance for adopting teclistamab. Optimizing safety through rigorous infection prophylaxis and early treatment positioning will be vital as its use expands in Japan’s evolving MM therapeutic landscape.
