A Noninterventional, Observational, European Post-Authorization Safety Study of Patients With Relapsed/Refractory Multiple Myeloma Treated With Lenalidomide

Gamberi, B.; Berthou, C.; Hernandez, M.; Semenzato, G.; Tholouli, E.; Hájek, R.; Caers, Jo; Dimopoulos, M.; Minnema, M. C.; Andreasson, B.; Parreira, J.; Crotty, G.; Remes, K.; Kueenburg, E.; Rosettani, B.; Di Micco, A.; Peters, S.; Bacon, P.; Blau, I. W.

doi:10.1016/j.clml.2020.05.006

Article (Scientific journals)

A Noninterventional, Observational, European Post-Authorization Safety Study of Patients With Relapsed/Refractory Multiple Myeloma Treated With Lenalidomide

Gamberi, B.; Berthou, C.; Hernandez, M. et al.

2020 • In Clinical Lymphoma, Myeloma and Leukemia, 20, p. 629-e644

Peer reviewed

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https://hdl.handle.net/2268/249344

DOI
10.1016/j.clml.2020.05.006

PubMed
32605897

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Keywords :

Adverse events of special interest; Immunomodulatory; Incidence rate; Prospective; Real-world

Abstract :

[en] Introduction: Lenalidomide plus dexamethasone is effective and well tolerated in relapsed/refractory multiple myeloma (RRMM). In this observational, noninterventional European post-authorization safety study, the safety profile of lenalidomide plus dexamethasone was investigated and compared with that of other agents in the treatment of RRMM in a real-world setting. Patients and Methods: Patients had received ≥ 1 prior antimyeloma therapy; prior lenalidomide was excluded. Treatment was per investigator's routine practice. Adverse events were analyzed by incidence rates per 100 person-years to account for differences in observation length and treatment duration. Results: In total, 2150 patients initiated lenalidomide, and 1479 initiated any other antimyeloma therapy, predominately bortezomib (80.3%), which was primarily administered intravenously (74.3%). The incidence rate of neuropathy was lower with lenalidomide (10.5) than with bortezomib (78.9) or thalidomide (38.7). Lenalidomide also had a lower incidence rate of infections (68.7) versus bortezomib (95.9) and thalidomide (76.0). Conversely, the incidence rate of neutropenia was higher with lenalidomide (38.0) than with bortezomib (18.2) or thalidomide (25.7). The incidence rates of thrombocytopenia were 24.4, 40.4, and 14.4 with lenalidomide, bortezomib, and thalidomide, respectively. Conclusion: No new safety signals for lenalidomide were identified in this study, which is the largest prospective real-world European study of lenalidomide in patients with RRMM to date. These results confirm that the safety profile of lenalidomide plus dexamethasone in RRMM in a real-world setting is comparable to that reported in clinical trials. © 2020 The AuthorsGiven the key role of lenalidomide in the treatment of relapsed/refractory multiple myeloma, it is important to evaluate the safety of lenalidomide in real-world populations of patients who may not qualify for clinical trial participation. This noninterventional, European post-authorization safety study confirms that the real-world safety profile of lenalidomide is similar to what has been reported in clinical trials. © 2020 The Authors

Disciplines :

Hematology

Author, co-author :

Gamberi, B.; Department of Hematology, Azienda USL – IRCCS di Reggio Emilia, Reggio Emilia, Italy

Berthou, C.; Centre Hospitalier Régional Universitaire, Hôpital Auguste Morvan, Brest, France

Hernandez, M.; Hemotherapy Service, Hospital Universitario de Canarias, Tenerife, Spain

Semenzato, G.; Department of Medicine, Azienda Ospedale Università di Padova, Padova, Italy

Tholouli, E.; Department of Haematology, Manchester Royal Infirmary, Manchester, United Kingdom

Hájek, R.; Department of Clinic Subjects, University Hospital Ostrava and Faculty of Medicine Ostrava, Ostrava, Czech Republic

Caers, Jo ; Université de Liège - ULiège > Département des sciences cliniques > Département des sciences cliniques

Dimopoulos, M.; National and Kapodistrian University of Athens, School of Medicine, Athens, Greece

Minnema, M. C.; Department of Hematology, University Medical Center Utrecht, Utrecht, Netherlands

Andreasson, B.; Uddevalla Hospital, NU Hospital Group, Uddavella, Sweden

More authors (9 more)

Language :

English

Title :

A Noninterventional, Observational, European Post-Authorization Safety Study of Patients With Relapsed/Refractory Multiple Myeloma Treated With Lenalidomide

Publication date :

2020

Journal title :

Clinical Lymphoma, Myeloma and Leukemia

ISSN :

2152-2650

eISSN :

2152-2669

Publisher :

Elsevier Inc.

Volume :

Pages :

e629-e644

Peer reviewed :

Peer reviewed

Funders :

BMS - Bristol-Myers Squibb
Novartis
Takeda Pharmaceutical Company

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