Criteria for a derived real-world response algorithm based on IMWG criteria.
MYELOMA
CR, complete response; FLC, free light chain; h, hours; IMWG, International Myeloma Working Group; M, monoclonal; PR, partial response; sCR, stringent complete response; VGPR, very good partial response.To generalize the algorithm, we required at least two laboratory measurements per patient; one at baseline and one following treatment initiation. Baseline measurements were defined as laboratory measurements obtained no earlier than 60 days prior to and no later than 30 days after the therapy start date. Confirmed response required two consecutive laboratory measurements to meet the response criteria for the given level or for a deeper response level (e.g. VGPR confirmed a previously observed PR). The best confirmed response was used in the comparison with the IRC’s assessment.In all cases when multiple distinct tests or test types were required to meet a criterion, a maximum time difference of 20 days was allowed between consecutive tests. For example, urine M protein measured or reported on two consecutive days would contribute to a single response evaluation at the same time point, while urine M protein and serum M protein measured 30 days apart would not be combined to assign VGPR. The 20-day interval was empirically chosen to ensure that no assessment time points were lost, while making sure that tests belonging to different assessment time points were not combined. No minimum time difference between consecutive tests was applied.