Review by Joseph Ross – 03/15/2021 – 3:50pm

Data Request Number: 2021-4638 Is the scientific purpose of the research proposal clearly described?: Yes Will request create or materially enhance generalizable scientific and/or medical knowledge to inform science and public health?: Yes Can the proposed research be reasonably addressed using the requested data?: Yes, or it’s highly likely Please use this space to provide any comments, feedback or concerns (optional):

Potentially valuable study to understand the impact of frailty on treatment outcomes for patients with multiple myeloma enrolled in NCT02252172. My only minor comment is that I expect the authors intended to propose that frailty, defined according to Facon et al using a composite score of age, ECOG performance status and Charlson comorbidity score, is their main independent/predictor variable. I expect they will conduct an interaction analysis to know if the effect of daratumumab in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone is any different, or an analysis stratified by frailty.

Recommendation for this data request: Approve