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001-es BibID:	BIBFORM113622
035-os BibID:	(scopus)85153100489 (wos)000989808500004
Első szerző:	Crees, Zachary D.
Cím:	Motixafortide and G-CSF to mobilize hematopoietic stem cells for autologous transplantation in multiple myeloma : a randomized phase 3 trial / Crees Zachary D., Rettig Michael P., Jayasinghe Reyka G., Stockerl-Goldstein Keith, Larson Sarah M., Arpad Illes, Milone Giulio A., Martino Massimo, Stiff Patrick, Sborov Douglas, Pereira Denise, Micallef Ivana, Moreno-Jiménez Gemma, Mikala Gabor, Coronel Maria Liz Paciello, Holtick Udo, Hiemenz John, Qazilbash Muzaffar H., Hardy Nancy, Latif Tahir, García-Cadenas Irene, Vainstein-Haras Abi, Sorani Ella, Gliko-Kabir Irit, Goldstein Inbal, Ickowicz Debby, Shemesh-Darvish Liron, Kadosh Shaul, Gao Feng, Schroeder Mark A., Vij Ravi, DiPersio John F.
Dátum:	2023
ISSN:	1078-8956
Megjegyzések:	Autologous hematopoietic stem cell transplantation (ASCT) improves survival in multiple myeloma (MM). However, many individuals are unable to collect optimal CD34+ hematopoietic stem and progenitor cell (HSPC) numbers with granulocyte colony-stimulating factor (G-CSF) mobilization. Motixafortide is a novel cyclic-peptide CXCR4 inhibitor with extended in vivo activity. The GENESIS trial was a prospective, phase?3, double-blind, placebo-controlled, multicenter study with the objective of assessing the superiority of motixafortide?+?G-CSF over placebo +?G-CSF to mobilize HSPCs for ASCT in MM. The primary endpoint was the proportion of patients collecting ?6???106 CD34+ cells?kg?1 within two apheresis procedures; the secondary endpoint was to achieve this goal in one apheresis. A total of 122?adult patients with MM undergoing ASCT were enrolled at 18?sites across five countries and randomized (2:1) to motixafortide?+ G-CSF or placebo?+?G-CSF for HSPC mobilization. Motixafortide?+?G-CSF enabled 92.5% to successfully meet the primary endpoint versus 26.2% with placebo?+?G-CSF (odds ratio (OR) 53.3, 95% confidence interval (CI) 14.12?201.33, P?<?0.0001). Motixafortide?+ G-CSF also enabled 88.8% to meet the secondary endpoint versus 9.5% with placebo?+?G-CSF (OR 118.0, 95% CI 25.36 549.35, P?<?0.0001). Motixafortide?+?G-CSF was safe and well tolerated, with the most common treatment-emergent adverse events observed being transient, grade?1/2 injection site reactions (pain, 50%; erythema, 27.5%; pruritis, 21.3%). In conclusion, motixafortide?+?G-CSF mobilized significantly greater CD34+ HSPC numbers within two apheresis procedures versus placebo?+?G-CSF while preferentially mobilizing increased numbers of immunophenotypically and transcriptionally primitive HSPCs. Trial Registration: ClinicalTrials.gov, NCT03246529
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban folyóiratcikk
Megjelenés:	Nature Medicine. - 29 : 4 (2023), p. 869-879. -
További szerzők:	Rettig, Michael P. Jayasinghe, Reyka G. Stockerl-Goldstein, Keith Larson, Sarah M. Illés Árpád (1959-) (belgyógyász, haematológus, onkológus) Milone, Giulio A. Martino, Massimo Stiff, Patrick Sborov, Douglas Pereira, Denise Micallef, Ivana Moreno-Jiménez, Gemma Mikala Gábor Coronel, Maria Liz Paciello Holtick, Udo Hiemenz, John Qazilbash, Muzaffar H. Hardy, Nancy Latif, Tahir García-Cadenas, Irene Vainstein-Haras, Abi Sorani, Ella Gliko-Kabir, Irit Goldstein, Inbal Ickowicz, Debby Shemesh-Darvish, Liron Kadosh, Shaul Gao, Feng Schroeder, Mark A. Vij, Ravi DiPersio, John F.
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