Mohamad Mohty1, Evangelos Terpos2, Maria-Victoria Mateos3, Michele Cavo4, Sandra Lejniece5, Meral Beksac6, Mohamed Amine Bekadja7, Wojciech Legiec8, Meletios Dimopoulos2, Svetlana Stankovic9, Maria Soledad Durán10, Valerio De Stefano11, Alessandro Corso12, Yulia Kochkareva13, Edward Laane14, Christian Berthou15, Hans Salwender16, Zvenyslava Masliak17, Valdas Pečeliūnas18, Wolfgang Willenbacher19, João Silva20, Vernon Louw21, Damir Nemet22, Zita Borbényi23, Uri Abadi24, Robert Schou Pedersen25, Peter Černelč26, Anna Potamianou27, Catherine Couturier28, Caroline Feys29, Florence Thoret-Bauchet28, Mario Boccadoro30. 1. Hematology and Cellular Therapy Department, Saint-Antoine Hospital, Pierre & Marie Curie University, Paris, France. Electronic address: mohamad.mohty@inserm.fr. 2. Hematology and Medical Oncology, Department of Clinical Therapeutics, National and Kapodistrian University of Athens, School of Medicine, Alexandra General Hospital, Athens, Greece. 3. Servicio de Hematologia, Hospital Universitario de Salamanca, Centro de Investigación del Cáncer, Instituto de Biología Molecular y Cellular del Cáncer (Universitario de Salamanca-Consejo Superior de Investigaciones Científicas), Salamanca, Spain. 4. Seràgnoli Institute of Hematology, University of Bologna, Bologna, Italy. 5. Department of Doctoral Studies, Riga Stradiņš University, Riga, Latvia. 6. Department of Hematology, Ankara University, Ankara, Turkey. 7. Hematology and Cell Therapy, Etablissement Hospitalier Universitaire, Oran, Algeria. 8. Department Hemato-Oncology and Bone Marrow Transplantation, Medical University of Lublin, Lublin, Poland. 9. University Clinic of Hematology, Medical Faculty, Skopje, Macedonia. 10. Hematologia, Complejo Hospitalario de Jaén, Jaén, Spain. 11. Institute of Hematology, Catholic University, Rome, Italy. 12. Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Policlinico San Matteo, University of Pavia, Pavia, Italy. 13. State Budget Healthcare Institution of Moscow, City Outpatient Clinic, 68 of Healthcare Department of Moscow, Branch 3, Moscow, Russia. 14. North Estonia Medical Centre Foundation, Tallinn, Estonia. 15. Université de Bretagne Occidentale, Brest, France. 16. Multiples Myelom, Asklepios Klinik Altona, Hamburg, Germany. 17. Institute of Blood Pathology and Transfusion Medicine, Lviv, Ukraine. 18. Hematology, Oncology, and Transfusion Medicine Center, Vilnius University Hospital, Santariskiu Klinikos, Vilnius, Lithuania. 19. Universitätsklinik Innsbruck Innere Medizin V, and Oncotyrol - Center for Personalized Cancer Medicine, Innsbruck, Austria. 20. Department of Medical Oncology and Hematology, University Health Network, Toronto, ON, Canada. 21. Department of Internal Medicine, University of the Free State, Bloemfontein, South Africa. 22. Internal Medicine, Clinical Hospital Centre Zagreb, Zagreb, Croatia. 23. Szegedi Tudomanyegyetem, II. Belgyógyászati Klinika, Szeged, Hungary. 24. Hematology, Meir Medical Center, Kfar Saba, Israel. 25. Regionshospitalet i Holstebro, Medicinsk Afdeling, Holstebro, Denmark. 26. Division of Internal Medicine, University Medical Centre Ljubljana, Ljubljana, Slovenia. 27. Janssen-Cilag, Neuss, Germany. 28. Janssen-Cilag, Issy-les-Moulineaux, France. 29. Janssen Research and Development, Beerse, Belgium. 30. Myeloma Unit, Division of Hematology, Città della Salute e della Scienza, University of Torino, Turin, Italy.
Abstract
BACKGROUND: The present prospective, multinational, noninterventional study aimed to document and describe real-world treatment regimens and disease progression in multiple myeloma (MM) patients. PATIENTS AND METHODS: Adult patients initiating any new MM therapy from October 2010 to October 2012 were eligible. A multistage patient/site recruitment model was applied to minimize the selection bias; enrollment was stratified by country, region, and practice type. The patient medical and disease features, treatment history, and remission status were recorded at baseline, and prospective data on treatment, efficacy, and safety were collected electronically every 3 months. RESULTS: A total of 2358 patients were enrolled. Of these patients, 775 and 1583 did and did not undergo stem cell transplantation (SCT) at any time during treatment, respectively. Of the patients in the SCT and non-SCT groups, 49%, 21%, 14%, and 15% and 57%, 20%, 12% and 10% were enrolled at treatment line 1, 2, 3, and ≥ 4, respectively. In the SCT and non-SCT groups, 45% and 54% of the patients had received bortezomib-based therapy without thalidomide/lenalidomide, 12% and 18% had received thalidomide/lenalidomide-based therapy without bortezomib, and 30% and 4% had received bortezomib plus thalidomide/lenalidomide-based therapy as frontline treatment, respectively. The corresponding proportions of SCT and non-SCT patients in lines 2, 3, and ≥ 4 were 45% and 37%, 30% and 37%, and 12% and 3%, 33% and 27%, 35% and 32%, and 8% and 2%, and 27% and 27%, 27% and 23%, and 6% and 4%, respectively. In the SCT and non-SCT patients, the overall response rate was 86% to 97% and 64% to 85% in line 1, 74% to 78% and 59% to 68% in line 2, 55% to 83% and 48% to 60% in line 3, and 49% to 65% and 36% and 45% in line 4, respectively, for regimens that included bortezomib and/or thalidomide/lenalidomide. CONCLUSION: The results of our prospective study have revealed great diversity in the treatment regimens used to manage MM in real-life practice. This diversity was linked to factors such as novel agent accessibility and evolving treatment recommendations. Our results provide insight into associated clinical benefits.
BACKGROUND: The present prospective, multinational, noninterventional study aimed to document and describe real-world treatment regimens and disease progression in multiple myeloma (MM) patients. PATIENTS AND METHODS: Adult patients initiating any new MM therapy from October 2010 to October 2012 were eligible. A multistage patient/site recruitment model was applied to minimize the selection bias; enrollment was stratified by country, region, and practice type. The patient medical and disease features, treatment history, and remission status were recorded at baseline, and prospective data on treatment, efficacy, and safety were collected electronically every 3 months. RESULTS: A total of 2358 patients were enrolled. Of these patients, 775 and 1583 did and did not undergo stem cell transplantation (SCT) at any time during treatment, respectively. Of the patients in the SCT and non-SCT groups, 49%, 21%, 14%, and 15% and 57%, 20%, 12% and 10% were enrolled at treatment line 1, 2, 3, and ≥ 4, respectively. In the SCT and non-SCT groups, 45% and 54% of the patients had received bortezomib-based therapy without thalidomide/lenalidomide, 12% and 18% had received thalidomide/lenalidomide-based therapy without bortezomib, and 30% and 4% had received bortezomib plus thalidomide/lenalidomide-based therapy as frontline treatment, respectively. The corresponding proportions of SCT and non-SCT patients in lines 2, 3, and ≥ 4 were 45% and 37%, 30% and 37%, and 12% and 3%, 33% and 27%, 35% and 32%, and 8% and 2%, and 27% and 27%, 27% and 23%, and 6% and 4%, respectively. In the SCT and non-SCT patients, the overall response rate was 86% to 97% and 64% to 85% in line 1, 74% to 78% and 59% to 68% in line 2, 55% to 83% and 48% to 60% in line 3, and 49% to 65% and 36% and 45% in line 4, respectively, for regimens that included bortezomib and/or thalidomide/lenalidomide. CONCLUSION: The results of our prospective study have revealed great diversity in the treatment regimens used to manage MM in real-life practice. This diversity was linked to factors such as novel agent accessibility and evolving treatment recommendations. Our results provide insight into associated clinical benefits.
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