(Department of Medical Oncology. Harvard Medical School)
Data: |
2022 |
Resum: |
Objective: We evaluated the efficacy and safety of pomalidomide, bortezomib, and dexamethasone (PVd) vs bortezomib and dexamethasone (Vd) by age, renal function, and high-risk cytogenetic abnormalities in lenalidomide-pretreated patients with multiple myeloma at first relapse. Methods: OPTIMISMM was a phase 3, multicenter, open-label, randomized study (NCT01734928; N = 559). The primary endpoint was progression-free survival (PFS). Results: Overall, 226 patients had received one prior line of therapy. PVd significantly prolonged PFS vs Vd in patients aged ≤65 years (median, 22. 0 vs 13. 1 months; P =. 0258) and >65 years (median, 17. 6 vs 9. 9 months; P =. 0369). Median PFS in patients with renal impairment (RI; creatinine clearance <60 mL/min) was 15. 1 months with PVd vs 9. 5 months with Vd (hazard ratio [HR], 0. 67 [95% CI, 0. 34-1. 34]). In patients without RI, median PFS was 22. 0 vs 13. 1 months (HR, 0. 45 [95% CI, 0. 27-0. 76]). In patients with high-risk cytogenetics, median PFS was 14. 7 vs 9. 9 months (HR, 0. 39 [95% CI, 0. 13-1. 17]). PVd significantly improved overall response rate vs Vd in all subgroups. The safety profile of PVd was consistent with previous reports. Conclusions: These findings confirmed the benefits of PVd at first relapse, including in patients with poor prognostic factors. |
Nota: |
This study was sponsored by Celgene, a Bristol-Myers Squibb Company. The authors would like to thank Eva Casal, PhD, of Bristol Myers Squibb, for clinical insights and contributions and Mihaela Marina, PhD, of MediTech Media, Ltd, for medical writing assistance in the preparation of this manuscript, which was sponsored by Bristol Myers Squibb. |
Drets: |
Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades. |
Llengua: |
Anglès |
Document: |
Article ; recerca ; Versió publicada |
Matèria: |
Aged ;
Chromosome aberrations ;
Multiple myeloma ;
Pomalidomide ;
Renal insufficiency |
Publicat a: |
European Journal of Haematology, Vol. 108 Núm. 1 (january 2022) , p. 73-83, ISSN 1600-0609 |