Cardiovascular disease and amyloidosis in phase III multiple myeloma trials: a systematic review of eligibility, screening and event reporting.
Oliver Henriques Peck, Aimee McCoubrey, John A Snowden et al.
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In 30 seconds
This systematic review evaluated phase III randomized controlled trials of multiple myeloma therapies, focusing on eligibility criteria related to cardiovascular disease (CVD) and amyloidosis. Among 41 trials with 20,144 participants, 30 excluded amyloidosis, and none actively screened for it. The study highlights significant gaps in reporting cardiovascular characteristics and adverse events, which may impact trial interpretations.
Key findings
- 30 trials excluded amyloidosis, often using non-specific definitions.
- 98% of trials included at least one cardiovascular exclusion criterion.
- Baseline cardiovascular characteristics were reported in only one trial.
- Cardiovascular adverse events were inconsistently defined and not centrally adjudicated.
Why it matters
Understanding the reporting and screening practices for cardiovascular conditions in multiple myeloma trials is crucial for interpreting safety and efficacy outcomes. Inadequate assessment may lead to misinformed clinical decisions and affect patient care.