TY - JOUR
T1 - A Noninterventional, Observational, European Post-Authorization Safety Study of Patients With Relapsed/Refractory Multiple Myeloma Treated With Lenalidomide
AU - Gamberi, Barbara
AU - Berthou, Christian
AU - Hernandez, Miguel
AU - Semenzato, Gianpietro
AU - Tholouli, Eleni
AU - Hájek, Roman
AU - Caers, Jo
AU - Dimopoulos, Meletios
AU - Minnema, Monique C
AU - Andreasson, Bjorn
AU - Parreira, Joana
AU - Crotty, Gerard
AU - Remes, Kari
AU - Kueenburg, Elisabeth
AU - Rosettani, Barbara
AU - Di Micco, Antonia
AU - Peters, Sarah
AU - Bacon, Pamela
AU - Blau, Igor Wolfgang
N1 - Funding Information:
JC reports consultancy fees from Janssen, Celgene, a Bristol-Myers Squibb Company, Amgen, and Takeda and research support from Celgene, a Bristol-Myers Squibb Company. GS reports consultancy fees from AbbVie and Janssen and research funding from Roche and Novartis. ET reports honoraria from Celgene, a Bristol-Myers Squibb Company. RH reports consultancy fees, honoraria, and research funding from Amgen and Takeda; consultancy fees and research funding from Celgene, a Bristol-Myers Squibb Company; consultancy fees from Takeda and Janssen; and honoraria from Janssen, Takeda, and Bristol-Myers Squibb. MD reports consultancy fees and honoraria from Amgen, Genesis, Celgene, a Bristol-Myers Squibb Company, Janssen, and Novartis. MM reports consultancy fees from Janssen-Cilag, Celgene, a Bristol-Myers Squibb Company, Bristol-Myers Squibb, and Amgen. JP reports employment with Roche and honoraria from Celgene, a Bristol-Myers Squibb Company, and Amgen. GC reports honoraria from Bristol-Myers Squibb, Takeda, Novartis, Janssen, and Roche. KR reports consultancy fees from Amgen, Celgene, a Bristol-Myers Squibb Company, Janssen-Cilag, and Takeda and research funding from Amgen and Novartis. EK reports consultancy fees from Celgene, a Bristol-Myers Squibb Company. BR and PB report employment with Celgene International S?rl, a Bristol-Myers Squibb Company, and equity ownership of Bristol-Myers Squibb. ADM reports employment with Celgene Corporation. SP reports consultancy fees from Celgene, a Bristol-Myers Squibb Company. The remaining authors have stated that they have no conflicts of interest.This study was funded by Celgene, a Bristol-Myers Squibb Company. All authors reviewed and approved this manuscript. The authors are fully responsible for all content and editorial decisions for this manuscript. The authors thank Shawn Vahabzadeh, PharmD, for medical writing assistance, which was sponsored by Bristol-Myers Squibb.
Funding Information:
This study was funded by Celgene , a Bristol-Myers Squibb Company . All authors reviewed and approved this manuscript. The authors are fully responsible for all content and editorial decisions for this manuscript. The authors thank Shawn Vahabzadeh, PharmD, for medical writing assistance, which was sponsored by Bristol-Myers Squibb .
Publisher Copyright:
© 2020 The Authors
PY - 2020/10
Y1 - 2020/10
N2 - 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.
AB - 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.
KW - Adverse events of special interest
KW - Immunomodulatory
KW - Incidence rate
KW - Prospective
KW - Real-world
UR - http://www.scopus.com/inward/record.url?scp=85087009078&partnerID=8YFLogxK
U2 - 10.1016/j.clml.2020.05.006
DO - 10.1016/j.clml.2020.05.006
M3 - Article
C2 - 32605897
SN - 2152-2650
VL - 20
SP - e629-e644
JO - Clinical Lymphoma, Myeloma and Leukemia
JF - Clinical Lymphoma, Myeloma and Leukemia
IS - 10
ER -