A Noninterventional,Observational, European Post-Authorization Safety Study of Patients With Relapsed/Refractory Multiple Myeloma Treated With Lenalidomide |
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| Institution: | 1. Department of Hematology, Azienda USL – IRCCS di Reggio Emilia, Reggio Emilia, Italy;2. Centre Hospitalier Régional Universitaire, Hôpital Auguste Morvan, Brest, France;3. Hemotherapy Service, Hospital Universitario de Canarias, Tenerife, Spain;4. Department of Medicine, Azienda Ospedale Università di Padova, Padova, Italy;5. Department of Haematology, Manchester Royal Infirmary, Manchester, United Kingdom;6. Department of Clinic Subjects, University Hospital Ostrava and Faculty of Medicine Ostrava, Ostrava, Czech Republic;7. Department of Hematology, Centre Hospitalier Universitaire de Liège, Liège, Belgium;8. National and Kapodistrian University of Athens, School of Medicine, Athens, Greece;9. Department of Hematology, University Medical Center Utrecht, Utrecht, the Netherlands;10. Uddevalla Hospital, NU Hospital Group, Uddavella, Sweden;11. Instituto de Histologia e Biologia do Desenvolvimento, Faculdade de Medicina, Universidade de Lisboa and Instiuto Português de Oncologia, Francisco Gentil, Lisboa, Portugal;12. Department of Haematology, Midland Regional Hospital, Tullamore, Ireland;13. Department of Internal Medicine, Turku University Hospital, Turku, Finland;14. Celgene International Sàrl, a Bristol-Myers Squibb Company, Boudry, Switzerland;15. Department of Internal Medicine III, Charité Campus Benjamin Franklin, Berlin, Germany;1. Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California;2. Harvard Radiation Oncology Program, Harvard Medical School, Boston, Massachusetts;3. Department of Reproductive Medicine, Division of Gynecologic Oncology, University of California San Diego, La Jolla, California;4. Department of Family and Preventive Medicine, Biostatistics and Bioinformatics, University of California San Diego Medical Center, San Diego, California;1. Molecular Biology Department, Oncology Center Mansoura University (OCMU), Mansoura University, Mansoura, Egypt;2. Biochemistry Division, Chemistry Department, Faculty of Science, Menoufeia University, Shebin El-Kom, Egypt;3. Clinical Pathology Department, Faculty of Medicine, Mansoura University, Mansoura, Egypt;4. Clinical Pathology Department, Oncology Center Mansoura University (OCMU), Faculty of Medicine, Mansoura University, Mansoura, Egypt;5. Chemistry Department, Faculty of Science, Menoufeia University, Shebin El-Kom, Egypt;6. Medical Oncology Department, Oncology Center Mansoura University (OCMU), Faculty of Medicine, Mansoura University, Mansoura, Egypt;1. Medical Oncology Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, United States;2. Lung and Upper Aerodigestive Cancer Research Group, Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, United States;1. Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC;2. Epidemiology Research Program, American Cancer Society, Atlanta, GA;3. Department of Otolaryngology/Head and Neck Surgery, School of Medicine, University of North Carolina, Chapel Hill, NC;4. Department of Pathology and Laboratory Medicine, School of Medicine, University of North Carolina, Chapel Hill, NC;5. Lineberger Comprehensive Cancer Center, School of Medicine, University of North Carolina, Chapel Hill, NC;1. Department of Oncology, Sydney Kimmel Cancer Center, Johns Hopkins Medical Institutes, Baltimore, MD;2. Department of Pathology, Drexel University College of Medicine, Philadelphia, PA;1. Department of Leukemia, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd, Houston, Texas, 77030, United States |
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| Abstract: | IntroductionLenalidomide 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 MethodsPatients 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.ResultsIn 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.ConclusionNo 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. |
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| Keywords: | Adverse events of special interest Immunomodulatory Incidence rate Prospective Real-world |
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