| Title: |
Ide-cel or Standard Regimens in Relapsed and Refractory Multiple Myeloma |
| Authors: |
Rodriguez-Otero P.; Ailawadhi S.; Arnulf B.; Patel K.; Cavo M.; Nooka A. K.; Manier S.; Callander N.; Costa L. J.; Vij R.; Bahlis N. J.; Moreau P.; Solomon S. R.; Delforge M.; Berdeja J.; Truppel-Hartmann A.; Yang Z.; Favre-Kontula L.; Wu F.; Piasecki J.; Cook M.; Giralt S. |
| Contributors: |
Rodriguez-Otero P.; Ailawadhi S.; Arnulf B.; Patel K.; Cavo M.; Nooka A.K.; Manier S.; Callander N.; Costa L.J.; Vij R.; Bahlis N.J.; Moreau P.; Solomon S.R.; Delforge M.; Berdeja J.; Truppel-Hartmann A.; Yang Z.; Favre-Kontula L.; Wu F.; Piasecki J.; Cook M.; Giralt S. |
| Publication Year: |
2023 |
| Collection: |
IRIS Università degli Studi di Bologna (CRIS - Current Research Information System) |
| Subject Terms: |
Hematology/Oncology; Leukemia/Lymphoma; Treatments in Oncology |
| Description: |
Background Survival is poor among patients with triple-class-exposed relapsed and refractory multiple myeloma. Idecabtagene vicleucel (ide-cel), a B-cell maturation antigen-directed chimeric antigen receptor (CAR) T-cell therapy, previously led to deep, durable responses in patients with heavily pretreated relapsed and refractory multiple myeloma. Methods In this international, open-label, phase 3 trial involving adults with relapsed and refractory multiple myeloma who had received two to four regimens previously (including immunomodulatory agents, proteasome inhibitors, and daratumumab) and who had disease refractory to the last regimen, we randomly assigned patients in a 2:1 ratio to receive either ide-cel (dose range, 150×106 to 450×106 CAR-positive T cells) or one of five standard regimens. The primary end point was progression-free survival. Key secondary end points were overall response (partial response or better) and overall survival. Safety was assessed. Results A total of 386 patients underwent randomization: 254 to ide-cel and 132 to a standard regimen. A total of 66% of the patients had triple-class-refractory disease, and 95% had daratumumab-refractory disease. At a median follow-up of 18.6 months, the median progression-free survival was 13.3 months in the ide-cel group, as compared with 4.4 months in the standard-regimen group (hazard ratio for disease progression or death, 0.49; 95% confidence interval, 0.38 to 0.65; P |
| Document Type: |
article in journal/newspaper |
| File Description: |
STAMPA |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/36762851; info:eu-repo/semantics/altIdentifier/wos/WOS:000940954700001; volume:388; issue:11; firstpage:1002; lastpage:1014; numberofpages:13; journal:THE NEW ENGLAND JOURNAL OF MEDICINE; https://hdl.handle.net/11585/959168 |
| DOI: |
10.1056/NEJMoa2213614 |
| Availability: |
https://hdl.handle.net/11585/959168; https://doi.org/10.1056/NEJMoa2213614; https://www.nejm.org/doi/pdf/10.1056/NEJMoa2213614 |
| Rights: |
info:eu-repo/semantics/openAccess |
| Accession Number: |
edsbas.76A3781D |
| Database: |
BASE |