Selinexor, daratumumab, bortezomib and dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma : results of the phase II, non-randomized, multicenter GEM-SELIBORDARA study
González-Calle, Verónica (Hospital Universitario de Salamanca)
Rodríguez-Otero, Paula (Clínica Universidad de Navarra)
Sureda, Anna (Hospital Universitari de Bellvitge)
de Arriba, Felipe (Hospital General Universitario Morales Meseguer (Múrcia))
Reinoso, Marta (Hospital Universitario Virgen del Rocío (Sevilla, Andalusia))
Ribas, Paz (Hospital Universitari Doctor Peset (València))
González-Rodríguez, Ana Pilar (Hospital Universitario Central de Asturias)
González, Yolanda (Institut Catalá D'Oncologia Girona)
Oriol, Albert (Institut Catalá d'Oncologia Badalona)
Martínez-López, Joaquín (Hospital 12 de Octubre (Madrid))
González, Marta Sonia (Complejo Hospitalario Universitario de Santiago de Compostela)
Hernández, Miguel T. (Hospital Universitario de Canarias (La Laguna))
Sirvent, Maialen (Hospital de Donostia (Sant Sebastià, País Basc))
Cedena, Teresa (Hospital 12 de Octubre (Madrid))
Puig, Noemí (Hospital Universitario de Salamanca)
Paiva, Bruno (Clínica Universidad de Navarra)
Bladé Creixenti, Juan (Hospital Clínic i Provincial de Barcelona)
Lahuerta, J. J. (Hospital 12 de Octubre (Madrid))
San-Miguel, Jesús F. (Clínica Universidad de Navarra)
Mateos, M. V. (Hospital Universitario de Salamanca)
Universitat Autònoma de Barcelona

Data:	2024
Resum:	The treatment landscape for multiple myeloma has significantly evolved in the last decade. Notwithstanding, a large proportion of patients continue to relapse and novel combinations continue to be needed. In this phase II study, selinex- or, a first-in-class inhibitor of exportin-1 was evaluated in combination with standard daratumumab-bortezomib-dexamethasone (DVd), for the treatment of relapsed and refractory multiple myeloma (RRMM). The aim of the trial was to assess the efficacy and safety of the combination of selinexor with DVd (S-DVd). A total of 57 patients were enrolled in the two parts of the study. Part 1 enrolled a heavily pretreated population with at least three prior lines (PL) of therapy and part 2 enrolled an early relapse population with at least one PL of therapy. The primary endpoint was complete response (CR) rate in part 2 and overall response rate (ORR) in part 1. In the latter, 24 patients were treated with a median of three PL. Overall response rate (ORR) was 50% with two CR. Median progression-free survival (PFS) was 7 months. In part 2, 33 patients were enrolled, with a median of one PL. ORR was 82% and CR or better was 33%. Median PFS was 24 months. In lenalidomide-refractory patients, a median PFS of 22. 1 months was observed. Thrombocytopenia was the most common hematological adverse event (69%; grade 3-4: 34%) and nausea, the most frequent non-hematological adverse event (38%; grade 3-4: 6%). Sixty-two percent of the patients required dose modifications. In summary, although the primary endpoint of the study was not met, the combination of S-DVd showed encouraging clinical efficacy with a generally manageable safety profile representing a potential option for the treatment of RRMM patients.
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Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Adult ; Aged ; Aged, 80 and over ; Antibodies, Monoclonal ; Antineoplastic Combined Chemotherapy Protocols ; Bortezomib ; Dexamethasone ; Drug Resistance, Neoplasm ; Female ; Humans ; Hydrazines ; Male ; Middle Aged ; Multiple Myeloma ; Recurrence ; Treatment Outcome ; Triazoles
Publicat a:	Haematologica, Vol. 109 Núm. 7 (july 2024) , p. 2219-2228, ISSN 1592-8721

DOI: 10.3324/haematol.2023.284089
PMID: 38356463

10 p, 4.5 MB

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