A total of 162 patients signed informed consent (IC). Screen failures were due to patients not meeting study eligibility criteria; 124 patients began G-CSF mobilization, two elected to withdraw consent before randomization, leaving a total of 122 patients who were randomized (2:1) to either motixafortide + G-CSF or placebo + G-CSF and were included in the ITT analysis. In the motixafortide + G-CSF arm, one patient did not perform apheresis due to an adverse event unrelated to study drug. In the placebo + G-CSF arm, one patient elected not to undergo apheresis due to personal concerns regarding the COVID-19 pandemic. Both these patients were included as mobilization failures in the ITT analysis (that is, did not meet the primary endpoint) but were not remobilized on study. In total, 98.8% (79 of 80) of patients in the motixafortide + G-CSF arm and 97.6% (41 of 42) of patients in the placebo + G-CSF arm received all study-related mobilization injections and underwent apheresis on protocol without any events of treatment arm crossover.
