Fig. 1: GENESIS trial enrollment. | Nature Medicine

Fig. 1: GENESIS trial enrollment.

From: Motixafortide and G-CSF to mobilize hematopoietic stem cells for autologous transplantation in multiple myeloma: a randomized phase 3 trial

Fig. 1

a, 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. b, Patients were enrolled across 18 centers and five countries, with the majority treated in the United States. c, Enrollment numbers are presented by individual study center, grouped by geographic region (United States and Europe) and mobilization regimen (motixafortide + G-CSF or placebo + G-CSF), with the proportion of patients at each site meeting the primary endpoint (collection of ≥6 × 106 CD34+ cells kg–1 within two apheresis days) shown in red and the proportion not meeting the primary endpoint shown in black.

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