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14. Differences among young adults, adults and elderly chronic myeloid leukemia patients

Author

Salvi, F., Pini, M., Leoni, P., Rupoli, S., Galieni, P., Bigazzi, C., Cantore, N., Palmieri, F., Albano, F., Russo Rossi, A., Rambaldi, A., Intermesoli, T., Palandri, F., Testoni, N., Luatti, S., Soverini, S., Iacobucci, I., Bochicchio, M.T., Apolinari, M., Fogli, M., Cervello, I., Capucci, A., Malagola, M., Malpignano, A., Girasoli, M., Angelucci, E., Usala, E., Storti, S., De Biasi, E., Tagariello, G., Sartori, R., Di Raimondo, F., Vigneri, P., Impera, S., Molica, S., Lanza, F., Viganò, C., Grasso, M., Rapezzi, D., Cavazzini, F., Bosi, A., Santini, V., Capalbo, S.F., Spinosa, G., Pierri, I., Bergamaschi, M., Carella, A.M., Bacigalupo, A., De Blasio, A., Ciccone, F., Di Renzo, N., Musolino, C., Russo, S., Cortelezzi, A., Morra, E., Pungolino, E.M., Luppi, M., Marasca, R., Pogliani, E.M., Gambacorti-Passerini, C., Luciano, L., Ferrara, F., Annunziata, M., Latte, G., Noli, D., Rege-Cambrin, G., Fava, C., Semenzato, G., Binotto, G., Fabbiano, F., Turri, D., Siragusa, S., Caracciolo, C., Musso, M., Porretto, F., Aversa, F., Crugnola, M., Cazzola, M., Orlandi, E., Falini, B., Falzetti, F., Visani, G., Isidori, A., Fioritoni, G., Di Lorenzo, R., Vallisa, D., Trabacchi, E., Petrini, M., Galimberti, S., Pizzuti, M., Zaccaria, A., Salvucci, M., Ronco, F., Ielo, D., Merli, F., Avanzini, P., Tosi, P., Merli, A., Musto, P., De Stefano, V., Sica, S., Latagliata, R., De Fabritiis, P., Trawiska, M., Majolino, I., Pacilli, L., Ronci, B., Cedrone, M., Petti, M.C., Pisani, F., Tafuri, A., Montefusco, E., Iuliano, F., Dore, F., Pardini, S., Bocchia, M., Defina, M., Liberati, A.M., Luzzi, D., Boccadoro, M., Ferrero, D., Vitolo, U., Gherlinzoni, F., Calistri, E., Fanin, R., Pizzolo, G., Meneghini, V., Rodighiero, F., D'Emilio, A., Castagnetti, F., Gugliotta, G., Baccarani, M., Breccia, M., Specchia, G., Levato, L., Abruzzese, E., Rossi, G., Iurlo, A., Martino, B., Pregno, P., Stagno, F., Cuneo, A., Bonifacio, M., Gobbi, M., Russo, D., Gozzini, A., Tiribelli, M., de Vivo, A., Alimena, G., Cavo, M., Martinelli, G., Pane, F., Saglio, G., and Rosti, G.

Published
2015
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15. Autologous transplant vs oral chemotherapy and lenalidomide in newly diagnosed young myeloma patients: a pooled analysis

Author

Gay, F, Oliva, S, Petrucci, M T, Montefusco, V, Conticello, C, Musto, P, Catalano, L, Evangelista, A, Spada, S, Campbell, P, Ria, R, Salvini, M, Offidani, M, Carella, A M, Omedé, P, Liberati, A M, Troia, R, Cafro, A M, Malfitano, A, Falcone, A P, Caravita, T, Patriarca, F, Nagler, A, Spencer, A, Hajek, R, Palumbo, A, and Boccadoro, M

Published
2017
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17. A phase 2 study of three low-dose intensity subcutaneous bortezomib regimens in elderly frail patients with untreated multiple myeloma

Author

Larocca, A, Bringhen, S, Petrucci, M T, Oliva, S, Falcone, A P, Caravita, T, Villani, O, Benevolo, G, Liberati, A M, Morabito, F, Montefusco, V, Passera, R, De Rosa, L, Omedé, P, Vincelli, I D, Spada, S, Carella, A M, Ponticelli, E, Derudas, D, Genuardi, M, Guglielmelli, T, Nozzoli, C, Aghemo, E, De Paoli, L, Conticello, C, Musolino, C, Offidani, M, Boccadoro, M, Sonneveld, P, and Palumbo, A

Published
2016
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22. Long-term results of the GIMEMA VEL-03-096 trial in MM patients receiving VTD consolidation after ASCT: MRD kinetics' impact on survival

Author

Ferrero, S, Ladetto, M, Drandi, D, Cavallo, F, Genuardi, E, Urbano, M, Caltagirone, S, Grasso, M, Rossini, F, Guglielmelli, T, Cangialosi, C, Liberati, A M, Callea, V, Carovita, T, Crippa, C, De Rosa, L, Pisani, F, Falcone, A P, Pregno, P, Oliva, S, Terragna, C, Musto, P, Passera, R, Boccadoro, M, and Palumbo, A

Published
2015
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25. Circulating miRNA markers show promise as new prognosticators for multiple myeloma

Author

Rocci, A, Hofmeister, C C, Geyer, S, Stiff, A, Gambella, M, Cascione, L, Guan, J, Benson, D M, Efebera, Y A, Talabere, T, Dirisala, V, Smith, E M, Omedè, P, Isaia, G, De Luca, L, Rossi, D, Gentili, S, Uccello, G, Consiglio, J, Ria, R, Benevolo, G, Bringhen, S, Callea, V, Weiss, B, Ferro, A, Magarotto, V, Alder, H, Byrd, J C, Boccadoro, M, Marcucci, G, Palumbo, A, and Pichiorri, F

Published
2014
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27. Lenalidomide and low-dose dexamethasone for newly diagnosed primary plasma cell leukemia

Author

Musto, P, Simeon, V, Martorelli, M C, Petrucci, M T, Cascavilla, N, Di Raimondo, F, Caravita, T, Morabito, F, Offidani, M, Olivieri, A, Benevolo, G, Mina, R, Guariglia, R, D'Arena, G, Mansueto, G, Filardi, N, Nobile, F, Levi, A, Falcone, A, Cavalli, M, Pietrantuono, G, Villani, O, Bringhen, S, Omedè, P, Lerose, R, Agnelli, L, Todoerti, K, Neri, A, Boccadoro, M, and Palumbo, A

Published
2014
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30. Differences among young adults, adults and elderly chronic myeloid leukemia patients

Author

Castagnetti, F., Gugliotta, G., Baccarani, M., Breccia, M., Specchia, G., Levato, L., Abruzzese, E., Rossi, G., Iurlo, A., Martino, B., Pregno, P., Stagno, F., Cuneo, A., Bonifacio, M., Gobbi, M., Russo, D., Gozzini, A., Tiribelli, M., de Vivo, A., Alimena, G., Cavo, M., Martinelli, G., Pane, F., Saglio, G., Rosti, G., Salvi, F., Pini, M., Leoni, P., Rupoli, S., Galieni, P., Bigazzi, C., Cantore, N., Palmieri, F., Albano, F., Russo Rossi, A., Rambaldi, A., Intermesoli, T., Palandri, F., Testoni, N., Luatti, S., Soverini, S., Iacobucci, I., Bochicchio, MT., Apolinari, M., Fogli, M., Cervello, I., Capucci, A., Malagola, M., Malpignano, A., Girasoli, M., Angelucci, E., Usala, E., Storti, S., De Biasi, E., Tagariello, G., Sartori, R., Di Raimondo, F., Vigneri, P., Impera, S., Molica, S., Lanza, F., Viganò, C., Grasso, M., Rapezzi, D., Cavazzini, F., Bosi, A., Santini, V., Capalbo, SF., Spinosa, G., Pierri, I., Bergamaschi, M., Carella, AM., Bacigalupo, A., De Blasio, A., Ciccone, F., Di Renzo, N., Musolino, C., Russo, S., Cortelezzi, A., Morra, E., Pungolino, EM., Luppi, M., Marasca, R., Pogliani, EM., Gambacorti-Passerini, C., Luciano, L., Ferrara, F., Annunziata, M., Latte, G., Noli, D., Rege-Cambrin, G., Fava, C., Semenzato, G., Binotto, G., Fabbiano, F., Turri, D., Siragusa, S., Caracciolo, C., Musso, M., Porretto, F., Aversa, F., Crugnola, M., Cazzola, M., Orlandi, E., Falini, B., Falzetti, F., Visani, G., Isidori, A., Fioritoni, G., Di Lorenzo, R., Vallisa, D., Trabacchi, E., Petrini, M., Galimberti, S., Pizzuti, M., Zaccaria, A., Salvucci, M., Ronco, F., Ielo, D., Merli, F., Avanzini, P., Tosi, P., Merli, A., Musto, P., De Stefano, V., Sica, S., Latagliata, R., De Fabritiis, P., Trawiska, M., Majolino, I., Pacilli, L., Ronci, B., Cedrone, M., Petti, MC., Pisani, F., Tafuri, A., Montefusco, E., Iuliano, F., Dore, F., Pardini, S., Bocchia, M., Defina, M., Liberati, AM., Luzzi, D., Boccadoro, M., Ferrero, D., Vitolo, U., Gherlinzoni, F., Calistri, E., Fanin, R., Pizzolo, G., Meneghini, V., Rodighiero, F., and DʼEmilio, A.

Published
2015
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32. Lenalidomide−prednisone induction followed by lenalidomide−melphalan−prednisone consolidation and lenalidomide−prednisone maintenance in newly diagnosed elderly unfit myeloma patients

Author

Falco, P, Cavallo, F, Larocca, A, Rossi, D, Guglielmelli, T, Rocci, A, Grasso, M, Siez, M L M, De Paoli, L, Oliva, S, Molica, S, Mina, R, Gay, F, Benevolo, G, Musto, P, Omedè, P, Freilone, R, Bringhen, S, Carella, A M, Gaidano, G, Boccadoro, M, and Palumbo, A

Published
2013
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33. Ixazomib-lenalidomide-dexamethasone in routine clinical practice: Effectiveness in relapsed/refractory multiple myeloma

Author

Hájek, R. Minarík, J. Straub, J. Pour, L. Jungova, A. Berdeja, J.G. Boccadoro, M. Brozova, L. Spencer, A. Van Rhee, F. Vela-Ojeda, J. Thompson, M.A. Abonour, R. Chari, A. Cook, G. Costello, C.L. Davies, F.E. Hungria, V.T.M. Lee, H.C. Leleu, X. Puig, N. Rifkin, R.M. Terpos, E. Usmani, S.Z. Weisel, K.C. Zonder, J.A. Barinová, M. Kuhn, M. Šilar, J. Cápková, L. Galvez, K. Lu, J. Elliott, J. Stull, D.M. Ren, K. Maisnar, V.

Abstract

Aim: To evaluate the effectiveness and safety of ixazomib-lenalidomide-dexamethasone (IRd) in relapsed/refractory multiple myeloma in routine clinical practice. Patients & methods: Patient-level data from the global, observational INSIGHT MM and the Czech Registry of Monoclonal Gammopathies were integrated and analyzed. Results: At data cut-off, 263 patients from 13 countries were included. Median time from diagnosis to start of IRd was 35.8 months; median duration of follow-up was 14.8 months. Overall response rate was 73%, median progression-free survival, 21.2 months and time-to-next therapy, 33.0 months. Ixazomib/lenalidomide dose reductions were required in 17%/36% of patients; 32%/30% of patients discontinued ixazomib/lenalidomide due to adverse events. Conclusion: The effectiveness and safety of IRd in routine clinical practice are comparable to those reported in TOURMALINE-MM1. Clinical trial registration: NCT02761187 (ClinicalTrials.gov)

Published
2021

34. Recommendations for vaccination in multiple myeloma: a consensus of the European Myeloma Network

Author

Ludwig, H. Boccadoro, M. Moreau, P. San-Miguel, J. Cavo, M. Pawlyn, C. Zweegman, S. Facon, T. Driessen, C. Hajek, R. Dimopoulos, M.A. Gay, F. Avet-Loiseau, H. Terpos, E. Zojer, N. Mohty, M. Mateos, M.-V. Einsele, H. Delforge, M. Caers, J. Weisel, K. Jackson, G. Garderet, L. Engelhardt, M. van de Donk, N. Leleu, X. Goldschmidt, H. Beksac, M. Nijhof, I. Abildgaard, N. Bringhen, S. Sonneveld, P.

Abstract

Vaccination is one of the most successful medical interventions that has saved the life of millions of people. Vaccination is particularly important in patients with multiple myeloma, who have an increased risk of infections due to the disease-inherent immune suppression, and because of the immune suppressive effects of therapy. Hence, all appropriate measures should be exploited, to elicit an effective immune response to common pathogens like influenza, pneumococci, varicella zoster virus, and to those bacteria and viruses (haemophilus influenzae, meningococci, and hepatitis) that frequently may pose a significant risk to patients with multiple myeloma. Patients after autologous, and specifically after allogeneic transplantation have severely reduced antibody titers, and therefore require a broader spectrum of vaccinations. Response to vaccination in myeloma often is less vigorous than in the general population, mandating either measurement of the postvaccination antibody titers and/or repeating the vaccination. Here, we compile the existing data on vaccination in multiple myeloma and provide recommendations for clinical practice. © 2020, The Author(s).

Published
2021

35. Treatment of relapsed and refractory multiple myeloma: recommendations from the International Myeloma Working Group

Author

Moreau, P. Kumar, S.K. San Miguel, J. Davies, F. Zamagni, E. Bahlis, N. Ludwig, H. Mikhael, J. Terpos, E. Schjesvold, F. Martin, T. Yong, K. Durie, B.G.M. Facon, T. Jurczyszyn, A. Sidana, S. Raje, N. van de Donk, N. Lonial, S. Cavo, M. Kristinsson, S.Y. Lentzsch, S. Hajek, R. Anderson, K.C. João, C. Einsele, H. Sonneveld, P. Engelhardt, M. Fonseca, R. Vangsted, A. Weisel, K. Baz, R. Hungria, V. Berdeja, J.G. Leal da Costa, F. Maiolino, A. Waage, A. Vesole, D.H. Ocio, E.M. Quach, H. Driessen, C. Bladé, J. Leleu, X. Riva, E. Bergsagel, P.L. Hou, J. Chng, W.J. Mellqvist, U.-H. Dytfeld, D. Harousseau, J.-L. Goldschmidt, H. Laubach, J. Munshi, N.C. Gay, F. Beksac, M. Costa, L.J. Kaiser, M. Hari, P. Boccadoro, M. Usmani, S.Z. Zweegman, S. Holstein, S. Sezer, O. Harrison, S. Nahi, H. Cook, G. Mateos, M.-V. Rajkumar, S.V. Dimopoulos, M.A. Richardson, P.G.

Abstract

This Policy Review presents the International Myeloma Working Group's clinical practice recommendations for the treatment of relapsed and refractory multiple myeloma. Based on the results of phase 2 and phase 3 trials, these recommendations are proposed for the treatment of patients with relapsed and refractory disease who have received one previous line of therapy, and for patients with relapsed and refractory multiple myeloma who have received two or more previous lines of therapy. These recommendations integrate the issue of drug access in both low-income and middle-income countries and in high-income countries to help guide real-world practice and thus improve patient outcomes. © 2021 Elsevier Ltd

Published
2021

36. Daratumumab plus pomalidomide and dexamethasone versus pomalidomide and dexamethasone alone in previously treated multiple myeloma (APOLLO): an open-label, randomised, phase 3 trial

Author

Dimopoulos, M.A. Terpos, E. Boccadoro, M. Delimpasi, S. Beksac, M. Katodritou, E. Moreau, P. Baldini, L. Symeonidis, A. Bila, J. Oriol, A. Mateos, M.-V. Einsele, H. Orfanidis, I. Ahmadi, T. Ukropec, J. Kampfenkel, T. Schecter, J.M. Qiu, Y. Amin, H. Vermeulen, J. Carson, R. Sonneveld, P. Alegre Amor, A. Belotti, A. Benboubker, L. Besemer, B. Besisik, S. Cavo, M. De La Rubia Comos, J. Dimopoulos, M.A. Doyen, C. Dytfeld, D. Engelhardt, M. Facon, T. Foà, R. Goldschmidt, H. Grosicki, S. Hajek, R. Hayri Ozsan, G. Hulin, C. Iversen, B. Karlin, L. Knop, S. Kyrtsonis, M.-C. Lahuerta, J.J. Leleu, X. Martinez Chamorro, C. Mateos Manteca, M.-V. Meuleman, N. Minnema, M. Offidani, M. Oriol Rocafiguera, A. Pehlivan, M. Pour, L. Roerdink, H.T.J. Rosinol Dacsh, L. Salwender, H. Symeonidis, A. Toftmann Hansen, C. Tuglular, T. Unal, A. Vlummens, P. Vural, F. Wu, K.L. Zweegman, S. APOLLO Trial Investigators

Abstract

Background: In a phase 1b study, intravenous daratumumab plus pomalidomide and dexamethasone induced a very good partial response or better rate of 42% and was well tolerated in patients with heavily pretreated multiple myeloma. We aimed to evaluate whether daratumumab plus pomalidomide and dexamethasone would improve progression-free survival versus pomalidomide and dexamethasone alone in patients with previously treated multiple myeloma. Methods: In this ongoing, open-label, randomised, phase 3 trial (APOLLO) done at 48 academic centres and hospitals across 12 European countries, eligible patients were aged 18 years or older, had relapsed or refractory multiple myeloma with measurable disease, had an Eastern Cooperative Oncology Group performance status of 0–2, had at least one previous line of therapy, including lenalidomide and a proteasome inhibitor, had a partial response or better to one or more previous lines of antimyeloma therapy, and were refractory to lenalidomide if only one previous line of therapy was received. Patients were randomly assigned (1:1) by an interactive web-response system in a random block size of two or four to receive pomalidomide and dexamethasone alone or daratumumab plus pomalidomide and dexamethasone. Randomisation was stratified by number of previous lines of therapy and International Staging System disease stage. All patients received oral pomalidomide (4 mg, once daily on days 1–21) and oral dexamethasone (40 mg once daily on days 1, 8, 15, and 22; 20 mg for those aged 75 years or older) at each 28-day cycle. The daratumumab plus pomalidomide and dexamethasone group received daratumumab (1800 mg subcutaneously or 16 mg/kg intravenously) weekly during cycles 1 and 2, every 2 weeks during cycles 3–6, and every 4 weeks thereafter until disease progression or unacceptable toxicity. The primary endpoint was progression-free survival in the intention-to-treat population. Safety was analysed in all patients who received at least one dose of study medication. This trial is registered with ClinicalTrials.gov, NCT03180736. Findings: Between June 22, 2017, and June 13, 2019, 304 patients (median age 67 years [IQR 60–72]; 161 [53%] men and 143 [47%] women) were randomly assigned to the daratumumab plus pomalidomide and dexamethasone group (n=151) or the pomalidomide and dexamethasone group (n=153). At a median follow-up of 16·9 months (IQR 14·4–20·6), the daratumumab plus pomalidomide and dexamethasone group showed improved progression-free survival compared with the pomalidomide and dexamethasone group (median 12·4 months [95% CI 8·3–19·3] vs 6·9 months [5·5–9·3]; hazard ratio 0·63 [95% CI 0·47–0·85], two-sided p=0·0018). The most common grade 3 or 4 adverse events were neutropenia (101 [68%] of 149 patients in the daratumumab plus pomalidomide and dexamethasone group vs 76 [51%] of 150 patients in the pomalidomide and dexamethasone group), anaemia (25 [17%] vs 32 [21%]), and thrombocytopenia (26 [17%] vs 27 [18%]). Serious adverse events occurred in 75 (50%) of 149 patients in the daratumumab plus pomalidomide and dexamethasone group versus 59 (39%) of 150 patients in the pomalidomide and dexamethasone group; pneumonia (23 [15%] vs 12 [8%] patients) and lower respiratory tract infection (18 [12%] vs 14 [9%]) were most common. Treatment-emergent deaths were reported in 11 (7%) patients in the daratumumab plus pomalidomide and dexamethasone group versus 11 (7%) patients in the pomalidomide and dexamethasone group. Interpretation: Among patients with relapsed or refractory multiple myeloma, daratumumab plus pomalidomide and dexamethasone reduced the risk of disease progression or death versus pomalidomide and dexamethasone alone and could be considered a new treatment option in this setting. Funding: European Myeloma Network and Janssen Research and Development. © 2021 Elsevier Ltd

Published
2021

41. Monoclonal gammopathy of undetermined significance (MGUS) and smoldering (asymptomatic) multiple myeloma: IMWG consensus perspectives risk factors for progression and guidelines for monitoring and management

Author

Kyle, R A, Durie, B G M, Rajkumar, S V, Landgren, O, Blade, J, Merlini, G, Kröger, N, Einsele, H, Vesole, D H, Dimopoulos, M, San Miguel, J, Avet-Loiseau, H, Hajek, R, Chen, W M, Anderson, K C, Ludwig, H, Sonneveld, P, Pavlovsky, S, Palumbo, A, Richardson, P G, Barlogie, B, Greipp, P, Vescio, R, Turesson, I, Westin, J, and Boccadoro, M

Published
2010
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46. International myeloma working group (IMWG) consensus statement and guidelines regarding the current status of stem cell collection and high-dose therapy for multiple myeloma and the role of plerixafor (AMD 3100)

Author

Giralt, S, Stadtmauer, E A, Harousseau, J L, Palumbo, A, Bensinger, W, Comenzo, R L, Kumar, S, Munshi, N C, Dispenzieri, A, Kyle, R, Merlini, G, San Miguel, J, Ludwig, H, Hajek, R, Jagannath, S, Blade, J, Lonial, S, Dimopoulos, M A, Einsele, H, Barlogie, B, Anderson, K C, Gertz, M, Attal, M, Tosi, P, Sonneveld, P, Boccadoro, M, Morgan, G, Sezer, O, Mateos, M V, Cavo, M, Joshua, D, Turesson, I, Chen, W, Shimizu, K, Powles, R, Richardson, P G, Niesvizky, R, Rajkumar, S V, and Durie, B G M

Published
2009
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47. International Myeloma Working Group guidelines for the management of multiple myeloma patients ineligible for standard high-dose chemotherapy with autologous stem cell transplantation

Author

Palumbo, A, Sezer, O, Kyle, R, Miguel, J S, Orlowski, R Z, Moreau, P, Niesvizky, R, Morgan, G, Comenzo, R, Sonneveld, P, Kumar, S, Hajek, R, Giralt, S, Bringhen, S, Anderson, K C, Richardson, P G, Cavo, M, Davies, F, Bladé, J, Einsele, H, Dimopoulos, M A, Spencer, A, Dispenzieri, A, Reiman, T, Shimizu, K, Lee, J H, Attal, M, Boccadoro, M, Mateos, M, Chen, W, Ludwig, H, Joshua, D, Chim, J, Hungria, V, Turesson, I, Durie, B G M, and Lonial, S

Published
2009
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48. CYCLOPHOSPHAMIDE-LENALIDOMIDE-DEXAMETHASONE VS ASCT, FOLLOWED BY MAINTENANCE WITH LENALIDOMIDE-PREDNISONE VS LENALIDOMIDE ALONE IN NEWLY DIAGNOSED MM PATIENTS: A PHASE 3 RANDOMIZED EMN TRIAL: PH-O132

Author

Palumbo, A., Gay, F., Spencer, A., Di Raimondo, F., Zdenek, A., Larocca, A., Falcone, Pia A., Catalano, L., Finsinger, P., Scudla, V., Aschero, S., Offidani, M., Liberati, Marina A., Carella, Michele A., Maisnar, V., Donato, F., Caravita, T., Corradini, P., Ria, R., Pulini, S., Stocchi, R., Conticello, C., Petrucci, Teresa M., Hajek, R., and Boccadoro, M.

Published
2014

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