Multiple myeloma treatment in real-world clinical practice: results of a prospective, multinational, noninterventional study

Mohty, Mohamad and Terpos, Evangelos and Mateos, Maria-Victoria and Cavo, Michele and Lejniece, Sandra and Beksac, Meral and Bekadja, Mohamed Amine and Legiec, Wojciech and Dimopoulos, Meletios and Stankovic, Svetlana and Durán, Maria Soledad and De Stefano, Valerio and Corso, Alessandro and Kochkareva, Yulia and Laane, Edward and Berthou, Christian and Salwender, Hans and Masliak, Zvenyslava and Pečeliūnas, Valdas and Willenbacher, Wolfgang and Silva, João and Louw, Vernon and Nemet, Damir and Borbényi, Zita and Abadi, Uri and Pedersen, Robert Schou and Černelč, Peter and Potamianou, Anna and Couturier, Catherine and Feys, Caroline and Thoret-Bauchet, Florence and Boccadoro, Mario and Bekadja, Mohamed and Hamladji, Rose-Marie and Ali, Hocine Ait and Hamdi, Selma and Touhami, Hadj and Mansour, Nourredine Sidi and Willenbacher, Wolfgang and Linkesch, Werner and Nemet, Damir and Pedersen, Robert Shou and Abildgaard, Niels and Laane, Edward and Hein, Marju and Mohty, Mohamad and Eveillard, Jean Richard and Yamani, Abderrazak el and Moreau, Philippe and Sanhes, Laurence and Lepeu, Gérard and Laribi, Kamel and Jourdan, Eric and Fitoussi, Olivier and Allangba, Olivier and Fleury, Joël and Escoffre, Martine and Benramdane, Riad and Cartron, Guillaume and Dine, Gérard and Legouffe, Eric and Harich, Hanns-Detlev and Illmer, Thomas and Dörfel, Steffen and Hannig, Carla Verena and Koenigsmann, Michael and Prange-Krex, Gabriele and Salwender, Hans and Tamm, Ingo and Zeller, Wolfgang and Maasberg, Michael and Schlag, Rudolf and Klausmann, Martine and Uhlig, Jens and Alkemper, Burkhard and Schütz, Stefan and Tessen, Hans-Werner and Mohr, Benno and Schmidt, Peter and Heinrich, Bernhard and Hebart, Holger and Seipelt, Gernot and Zoeller, Thomas and Heits, Frank and Müller-Naendrup, Clemens and Hansen, Richard and Repp, Roland and Von Weikersthal, Ludwig Fischer and Schmits, Rudolf and Heßling, Jörg and Krammer-Steiner, B. and Janzen, Viktor and Schauer, Michael and Grüner, Marcus W. and Kisro, Jens and Denzlinger, Claudio and Freier, Werner and Junghanss, Christian and Görner, Martin and Laichinger, Katharina and Ostermann, Helmut and Dürk, Heinz and Hess, Georg and Reich, Gernot and Terpos, Evangelos and Dimopoulos, Meletios and Matsouka, Panagiota and Pouli, Anastasia and Anagnostopoulos, Achilles and Masszi, Tamas and Borbényi, Zita and Ivanyi, Janos and Szomor, Arpad and Abadi, Uri and Nagler, Arnon and Magen, Hila and Avivi, Irit and Quitt, Miriam and Palumbo, Antonio and Boccadoro, Mario and De Stefano, Valerio and Za, Tommaso and Vallisa, Daniele and Foa, Roberto and Corso, Alessandro and Bosi, Alberto and Vacca, Angelo and Lanza, Francesco and Palazzo, Giulia and Avvisati, Giuseppe and Cavo, Michele and Ferrara, Felicetto and Consoli, Ugo and Cantonetti, Maria and Angelucci, Emanuele and Califano, Catello and Di Raimondo, Francesco and Guarini, Attilio and Musso, Maurizio and Pizzuti, Michele and Giuliani, Nicola and Ardizzoia, Antonio and Di Renzo, Nicola and Gaidano, Gianluca and Gozzetti, Alessandro and Pitini, Vincenzo and Farina, Gabriella and Centurioni, Riccardo and De Fabritiis, Paolo and Iuliano, Francesco and La Nasa, Giorgio and La Verde, Giacinto and Pane, Fabrizio and Recine, Umberto and La Targia, Maria and Mineo, Giuseppe and Cangialosi, Clotilde and Fagnani, Daniele and Federici, Augusto and Romano, Atelda and Specchia, Giorgina and Storti, Sergio and Bongarzoni, Velia and Bacigalupo, Andrea and Gobbi, Marco and Latte, Giancarlo and Mannina, Donato and Capalbo, Silvana and Lejniece, Sandra and Pečeliūnas, Valdas and Jurgutis, Mindaugas and Stankovic, Svetlana and Legiec, Wojciech and Woszczyk, Dariusz and Hołojda, Jadwiga and Gornik, Slawomir and Pluta, Andrzej and Morawiec-Szymonik, Elzbieta and Kyrcz-Krzemien, Slawomira and Homenda, Wojciech and Grosicki, Sebastian and Sulek, Kazimierz and Lange, Andrzej and Kloczko, Janusz and Starzak-Gwozdz, Jolanta and Hellmann, Andrzej and Komarnicki, Mieczyslaw and Kuliczkowski, Kazimierz and Viveiros, Carolina and Gonçalves, Cristina and Esefyeva, Natalia and Kochkareva, Julia and Kaplanov, Kamil and Volodicheva, Elena and Laricheva, Elena and Dergacheva, Valentina and Chukavina, Marina and Volchenko, Natalia and Nazarova, Irina and Anchukova, Ludmila and Ovanesova, Elena and Gritsenko, Taras and Salogub, Galina and Magomedova, Ludmila and Kuznetsova, Irina and Osyunikhina, Svetlana and Serdyuk, Olga and Karyagina, Elena and Ivanova, Valentina and Černelč, Slovenia Peter and Louw, Vernon and Coetzee, Corlia and Gunther, Karen and Moodley, Dhayanithi and Duran, Soledad and Gutiérrez, Asunción Echeveste and De Oteyza, Jaime Perez and Capote, Francisco Javier and Casanova, Maria and Sanchez, Jesus Martin and Rios-Herranz, Eduardo and Ibañez-Garcia, Jeronima and Herranz, Maria Jose and Hernandez, Belen and Sanchez, Sara Sanchez and Escalante, Fernando and Carnicero, Fernando and Lleonart, Joan Bargay and Gironella, Mercedes and Martínez, Rafael and De La Guia, Ana Lopez and Palomera, Luis and Iglesias, Rebeca and Ramos, Fernando Solano and De La Serna, Javier and Sanchez, Pedro Garcia and Vidal, Juan Besalduch and Mateos, Maria-Victoria and Morfa, Miguel Diaz and Beksac, Turkey – Meral and Vural, Filiz and Aydin, Yildiz and Unal, Ali and Goker, Hakan and Bilgir, Oktay and Guvenc, Birol and Turgut, Mehmet and Ozet, Gulsum Gulistan and Ali, Ridvan and Masliak, Zvenyslava and Kyselyova, Maryna and Glushko, Nataliia and Vybyrana, Renata and Skrypnyk, Igor and Tretyak, Natalya and Kharchevska, Tetiana and Dyagil, Iryna and Popovs'ka, Tetiana and Shimanskiy, Vadim and Lysa, Tamila and Oliynyk, Hanna and Vilchevskaya, Kateryna and Kryachok, Iryna and Popovych, Yuriy and Romanyuk, Natalia and Yushchenko, Natalia and Kaplan, Polina and Rekhtman, Grygoriy and Pylypenko, Halyna and Kozlov, Viktor and Mohty, Mohamad and Terpos, Evangelos and Mateos, Maria-Victoria and Palumbo, Antonio and Drach, Johannes and Boccadoro, Mario and Harousseau, Jean-Luc and Einsele, Hermann and Goldschmidt, Hartmut and Facon, Thierry and Michalet, Mauricette and Savchenko, Valery G. and De la Rubia, Javier and Cook, Gordon and Mellqvist, Ulf-Henrik and Ludwig, Heinz (2018) Multiple myeloma treatment in real-world clinical practice: results of a prospective, multinational, noninterventional study. Clinical Lymphoma Myeloma and Leukemia, 18 (10). e401-e419. ISSN 2152-2650

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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.

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