The addition of motixafortide to granulocyte colony-stimulating factor (G-CSF) mobilization increased CD34+ hematopoietic stem and progenitor cell (HSPC) numbers compared with G-CSF plus placebo. These findings were published in Nature Medicine.
Harvesting adequate numbers of CD34+ HSPCs is important for autologous hematopoietic stem cell transplantation (ASCT). As such, patients receive G-CSF for harvesting cells, however, up to 50% of patients with multiple myeloma (MM) are still unable to produce sufficient numbers.
The GENESIS (ClinicalTrials.gov Identifier: NCT03246529) study was a phase 3 study designed to evaluate the safety and efficacy of motixafortide in the mobilization of CD34+ HSPCs prior to ASCT harvesting. In this study, 122 patients with MM undergoing ASCT between 2018 and 2020 at 18 sites in 5 countries were randomly assigned in a 2:1 ratio to receive motixafortide (80 patients) or placebo (42 patients) plus G-CSF.
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Patients in the motixafortide and placebo groups were median ages 63.5 and 62.0 years, 68.8% and 57.1% were men, and 81.3% and 95.2% were White, respectively.
Among the motixafortide recipients, the proportion of patients who reached 6×106 CD34+ cells/kg was 88.8% on apheresis day 1, 92.5% on day 2, and 96.3% on day 3 compared with 9.5%, 26.2%, 36.5%, and 47.6% on days 1, 2, 3, and 4 for placebo recipients, respectively.
Compared with placebo plus G-CSF, motixafortide plus G-CSF associated with reaching sufficient CD34+ cells by day 2 (odds ratio [OR], 53.3; P <.0001) and day 1 (OR, 118.0; P <.0001) of apheresis.
The rates of treatment-emergent adverse events were 93.8% for motixafortide compared with 83.3% for placebo. The most common adverse events for the motixafortide group were low-grade local injection site reactions and systemic reactions.
“[T]he upfront use of a single injection of motixafortide added to G-CSF resulted in rapid, robust, and reliable mobilization of optimal numbers of CD34+ HSPCs in patients with MM undergoing ASCT,” the study authors concluded.
Disclosures: This research was supported by BioLineRx. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Crees ZD, Rettig MP, Jayasinghe RG, et al. Motixafortide and G-CSF to mobilize hematopoietic stem cells for autologous transplantation in multiple myeloma: a randomized phase 3 trial. Nat Med. 2023;29(4):869-879. doi:10.1038/s41591-023-02273-z
This article originally appeared on Oncology Nurse Advisor
