dc.contributor.author |
Spicka, Ivan |
dc.contributor.author |
Moreau, Philippe |
dc.contributor.author |
Martin, Thomas G. |
dc.contributor.author |
Facon, Thierry |
dc.contributor.author |
Martínez, Gracia |
dc.contributor.author |
Oriol, Albert |
dc.contributor.author |
Koh, Youngil |
dc.contributor.author |
Lim, Andrew |
dc.contributor.author |
Mikala, Gabor |
dc.contributor.author |
Rosiñol, Laura |
dc.contributor.author |
Yağci, Münci |
dc.contributor.author |
Cavo, Michele |
dc.contributor.author |
Risse, Marie-Laure |
dc.contributor.author |
Asset, Gaëlle |
dc.contributor.author |
Macé, Sandrine |
dc.contributor.author |
Van de Velde, Helgi |
dc.contributor.author |
Yong, Kwee |
dc.contributor.author |
Universitat Autònoma de Barcelona |
dc.date |
2022 |
dc.identifier |
https://ddd.uab.cat/record/270517 |
dc.identifier |
urn:10.1111/ejh.13835 |
dc.identifier |
urn:oai:ddd.uab.cat:270517 |
dc.identifier |
urn:scopus_id:85136102163 |
dc.identifier |
urn:articleid:16000609v109n5p504 |
dc.identifier |
urn:pmid:35871357 |
dc.identifier |
urn:pmc-uid:9804737 |
dc.identifier |
urn:pmcid:PMC9804737 |
dc.identifier |
urn:oai:pubmedcentral.nih.gov:9804737 |
dc.format |
application/pdf |
dc.language |
eng |
dc.publisher |
|
dc.relation |
European Journal of Haematology ; Vol. 109 Núm. 5 (november 2022), p. 504-512 |
dc.rights |
open access |
dc.rights |
Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original. |
dc.rights |
https://creativecommons.org/licenses/by/4.0/ |
dc.title |
Isatuximab plus carfilzomib and dexamethasone in relapsed multiple myeloma patients with high-risk cytogenetics : IKEMA subgroup analysis |
dc.type |
Article |
dc.description.abstract |
Introduction: The presence of high-risk chromosomal abnormalities [t(4;14), del(17p), and t(14;16)] has been linked with inferior outcomes in patients with multiple myeloma (MM). A prespecified interim analysis of the Phase 3 IKEMA study (NCT03275285) demonstrated that isatuximab (Isa) + carfilzomib (K) and dexamethasone (d; Isa-Kd) significantly improved progression-free survival (PFS) versus Kd in patients with relapsed MM. This prespecified subgroup analysis of IKEMA examined efficacy and safety in patients with high-risk cytogenetics. Methods: High-risk cytogenetics was assessed by central laboratory and patients were classified as high risk if abnormalities were present in ≥1 of the following: del(17p): 50% cutoff; t(4;14), and/or t(14;16): 30% cutoff. Results: Of the randomized patients, 23.5% (Isa-Kd) and 25.2% (Kd) had ≥1 high-risk chromosomal abnormality. A PFS benefit was seen in favor of Isa-Kd for patients with standard-risk (HR 0.440; 95% CI 0.266-0.728) and high-risk cytogenetics (HR 0.724; 95% CI 0.361-1.451). Grade ≥3 treatment-emergent adverse events (TEAEs) were more common with Isa-Kd (85.7%) versus Kd (63.3%) in patients with high-risk cytogenetics; however, the incidence of serious TEAEs (64.3% vs. 66.7%) was similar. Conclusions: Isa-Kd is a new treatment option for the difficult-to-treat subgroup of patients with relapsed MM and high-risk cytogenetics |