Early intervention with daratumumab may reduce the risk of disease progression and mortality in people with high-risk SMM. The evidence on the risk of adverse events with daratumumab is very uncertain. For immunomodulatory agents, the available evidence is of very low certainty, partly due to conflicting results, so we are unable to draw conclusions about their effects. There is insufficient evidence to support the use of older agents like alkylating agents or cytokine inhibitors. The decision to initiate early treatment in high-risk SMM requires a careful, individualized risk-benefit assessment and shared decision-making.
This approach was associated with only three grade 1-2 infections, indicating a favorable safety profile. These preliminary results support the design of a prospective multicenter study to evaluate the feasibility of home-based BiTE administration, integrating point-of-care testing, a digital health platform, and 24/7 remote monitoring via a dedicated call center, within a comprehensive medico-economic framework.
P2, N=30, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Oct 2025 --> Oct 2026 | Trial primary completion date: Oct 2025 --> Oct 2026
6 months ago
Trial completion date • Trial primary completion date