Pomalidomide, bortezomib, and dexamethasone at first relapse in lenalidomide-pretreated myeloma : A subanalysis of OPTIMISMM by clinical characteristics
Richardson, Paul G.. (Department of Medical Oncology. Harvard Medical School)
Schjesvold, Fredrik (University of Oslo)
Weisel, Katja (University Medical Center Hamburg-Eppendorf)
Moreau, Philippe (University Hospital Hôtel-Dieu)
Anderson, Larry D. (University of Texas Southwestern Medical Center)
White, Darrell (Dalhousie University and Queen Elizabeth II Health Sciences Centre)
Rodriguez-Otero, Paula (Clínica Universidad de Navarra)
Sonneveld, Pieter (Erasmus MC Cancer Institute)
Engelhardt, Monika (Universitätsklinikum Freiburg)
Jenner, Matthew (University Hospital Southampton NHS Foundation Trust (Regne Unit))
Corso, Alessandro (Hospital of Legnano)
Dürig, Jan (University Hospital Essen (Alemanya))
Pavic, Michel (Centre Hospitalier Universitaire De Sherbrooke)
Salomo, Morten (Copenhagen University Hospital)
Beksac, Meral (Ankara University)
Oriol, Albert (Institut Germans Trias i Pujol. Institut de Recerca contra la Leucèmia Josep Carreras)
Lindsay, Jindriska (East Kent Hospitals University NHS Foundation Trust)
Liberati, Anna Marina (University of Perugia)
Galli, Monica (Ospedale Papa Giovanni XXIII. U.O. di Ematologia)
Robak, Pawel (Medical University of Lodz)
Larocca, Alessandra (A.O.U. Citta della Salute e della Scienza di Torino)
Yagci, Munci (Gazi University Medical Faculty)
Vural, Filiz (Ege University)
Kanate, Abraham (West Virginia University)
Jiang, Ruiyun (Bristol Myers Squibb)
Grote, Lara (Bristol Myers Squibb)
Peluso, Teresa (Celgene International Sàrl. a Bristol-Myers Squibb Company)
Dimopoulos, Meletios (National and Kapodistrian University of Athens)

Date:	2022
Abstract:	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.
Note:	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.
Rights:	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.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Aged ; Chromosome aberrations ; Multiple myeloma ; Pomalidomide ; Renal insufficiency
Published in:	European Journal of Haematology, Vol. 108 Núm. 1 (january 2022) , p. 73-83, ISSN 1600-0609

DOI: 10.1111/ejh.13706
PMID: 34496096

11 p, 396.3 KB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP) > Josep Carreras Leukaemia Research Institute
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