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29 results on '"Lazaroiu, Mihaela"'

1. ROP-ET: a prospective phase III trial investigating the efficacy and safety of ropeginterferon alfa-2b in essential thrombocythemia patients with limited treatment options

Author

Kiladjian, Jean-Jacques, Marin, Francisca Ferrer, Al-Ali, Haifa Kathrin, Alvarez-Larrán, Alberto, Beggiato, Eloise, Bieniaszewska, Maria, Breccia, Massimo, Buxhofer-Ausch, Veronika, Cerna, Olga, Crisan, Ana-Manuela, Danaila, Catalin Doru, De Stefano, Valerio, Döhner, Konstanze, Empson, Victoria, Gora-Tybor, Joanna, Griesshammer, Martin, Grosicki, Sebastian, Guglielmelli, Paola, García-Gutierrez, Valentin, Heidel, Florian H., Illés, Arpád, Tomuleasa, Ciprian, James, Chloe, Koschmieder, Steffen, Krauth, Maria-Theresa, Krejcy, Kurt, Lazaroiu, Mihaela-Cornelia, Mayer, Jiri, Nagy, Zsolt György, Nicolini, Franck-Emmanuel, Palandri, Francesca, Pappa, Vassiliki, Reiter, Andreas Johannes, Sacha, Tomasz, Schlager, Stefanie, Schmidt, Stefan, Terpos, Evangelos, Unger, Martin, Wölfler, Albert, Cirici, Blanca Xicoy, and Klade, Christoph

Published
2024
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2. Momelotinib versus danazol in symptomatic patients with anaemia and myelofibrosis (MOMENTUM): results from an international, double-blind, randomised, controlled, phase 3 study

Author

Abulafia, Adi Shacham, Al-Ali, Haifa Kathrin, Andreasson, Bjorn, Angona, Anna, Ayala, Rosa, Bang, Soo-Mee, Bank, Bruce, Barraco, Fiorenza, Beggiato, Eloise, Benghiat, Fleur Samantha, Bonifacio, MassimiliaNo, Bories, Claire, Borsaru, Gabriela, Brabrand, Mette, Braester, Andrei, Broliden, Andes, Buxhofer-Ausch, Veronika, Cambier, Nathalie, Caramella, Marianna, Carpentier, Benjamin, Cascavilla, Nicola, Castellano, Maria Giraldo, Chang, Hung, Chen, Chih-Cheng, Cheong, June-Won, Choi, Yunsuk, Choi, Philip, Corsetti, Maria Teresa, Cuadrado, Isabel Montero, Cunningham, Julia, Damaj, Gandhi Laurent, De Stefano, Valerio, Delage, Robert, Delgado, Regina Garcĺa, Diaz, Jose Miguel Torregrosa, Dombi, Péter, Dubruille, Viviane, Egyed, Miklós, El Fassi, Daniel, Elinder-Camburn, Anna, Elli, Elena Maria, Ellis, Martin, Fava, Carmen, Fazal, Salman, Fleischman, Angela, Foltz, Lynda, Fox, Laura, Gabrail, Nashat, Garcĺa-Gutiérrez, Jose Valentĺn, Gerds, Aaron, Girault, Stephane, Gisslinger, Heinz, Gluvacov, Alexandru, Goh, Yeow Tee, Göthert, Joachim, Granacher, Nikki, Grosicki, Sebastian, Gupta, Vikas, Hadjiev (Hadzhiev), Evgeni (Evgueniy), Hafraoui, Kaoutar, Hamed, Aryan, Harrison, Claire, Hasselbalch, Hans, Hauser, Hanns, Heaney, Mark, Hebart, Holger, Hernandez Rivas, Jesus Maria, Higuero Saavedra, Victor, Hillis, Christopher, Hou, Hsin-An, How, Jonathan, Huang, Daniel, Hus, Marek, Illés, Arpad, Isidori, Alessandro, Iurlo, Alessandra, Ivanov, Vadim, Johansson, Peter, Jung, Chul Won, Kiladjian, Jean-Jacques, Kirgner, Ilya, Koren-Michowitz, Maya, Koschmieder, Steffen, Kosztolanyi, Szabolcs Ors, Kreiniz, Natalia, Kuykendall, Andrew, Lambert, Jonathan, Laribi, Kamel, Lascaux, Axelle, Lavie, Noa, Lavie, David, Lazaroiu, Mihaela, Leahy, Michael, Lech-Maranda, Ewa, Lee, Sung-Eun, Lee, Won Sik, Legrand, Ollivier, Lemoli, Roberto, Liang, James, Lim, Sung-Nam, Loschi, Michael, Lucchesi, Alessandro, Macarie, Ioan, Marolleau, Jean-Pierre, Martelli, Maurizio, Mayer, Jiri, McCloskey, James, McDermott, Christopher, McLornan, Donal, McMahon, Brandon, Mehta, Priyanka, Mesa, Ruben, Mikala, Gábor, Milojkovic, Dragana, Mineur, Philippe, Mishchenko, Elena, Moon, Joon Ho, Nagy, Zsolt, Narayanan, Srinivasan, O'Connell, Casey, Ocroteala, Luminita, Oh, Stephen, Ojeda-Uribe, Mario, Ong, Kiat Hoe, Otegbeye, Folashade, Palmer, Jeanne, Pane, Fabrizio, Passamonti, Francesco, Patriarca, Andrea, Perkins, Andrew, Pietrantuono, Giuseppe, Plander, Mark, Platzbecker, Uwe, Prasad, Ritam, Prejzner, Witold, Rachow, Tobias, Radinoff, Atanas, Rejtő, László, Rinaldi, Ciro, Robak, Tadeusz, Rodriguez, Maria Angeles Fernandez, Ronson, Aaron, Ross, David, Sacha, Tomasz, Sadjadian, Parvis, Salar, Antonio, Santillana, Guillermo Sanz, Scheid, Christof, Schmidt, Aline, Severinsen, Marianne Tang, Stoeva, Vera, Szwedyk, Paweł, Tiribelli, Mario, Trautmann-Grill, Karolin, Trottier, Amy, Tzvetkov, Nikolay, van Droogenbroeck, Janusz, Vannucchi, Alessandro, Verstovsek, Srdan, Vianelli, Nicola, von Bubnoff, Nikolas, Wolf, Dominik, Woszczyk, Dariusz, Woźny, Tomasz, Wróbel, Tomasz, Xicoy, Blanca, Yeh, Su-Peng, Yoon, Sung-Soo, Gerds, Aaron T, Vannucchi, Alessandro M, Kuykendall, Andrew T, Lazaroiu, Mihaela C, Egyed, Miklos, Fox, Maria Laura, Harrison, Claire N, Klencke, Barbara J, Ro, Sunhee, Donahue, Rafe, and Kawashima, Jun

Published
2023
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3. Momelotinib versus danazol in symptomatic patients with anaemia and myelofibrosis previously treated with a JAK inhibitor (MOMENTUM): an updated analysis of an international, double-blind, randomised phase 3 study

Author

Gerds, Aaron T, Verstovsek, Srdan, Vannucchi, Alessandro M, Al-Ali, Haifa Kathrin, Lavie, David, Kuykendall, Andrew T, Grosicki, Sebastian, Iurlo, Alessandra, Goh, Yeow Tee, Lazaroiu, Mihaela C, Egyed, Miklos, Fox, Maria Laura, McLornan, Donal, Perkins, Andrew, Yoon, Sung-Soo, Gupta, Vikas, Kiladjian, Jean-Jacques, Granacher, Nikki, Lee, Sung-Eun, Ocroteala, Luminita, Passamonti, Francesco, Harrison, Claire N, Oh, Stephen, Klencke, Barbara J, Yu, Jing, Donahue, Rafe, Kawashima, Jun, and Mesa, Ruben

Published
2023
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4. Addition of elotuzumab to lenalidomide and dexamethasone for patients with newly diagnosed, transplantation ineligible multiple myeloma (ELOQUENT-1): an open-label, multicentre, randomised, phase 3 trial

Author

Dimopoulos, Meletios A, Richardson, Paul G, Bahlis, Nizar J, Grosicki, Sebastian, Cavo, Michele, Beksaç, Meral, Legieć, Wojciech, Liberati, Anna M, Goldschmidt, Hartmut, Belch, Andrew, Magen, Hila, Larocca, Alessandra, Laubach, Jacob P, Petrucci, Maria T, Reece, Donna, White, Darrell, Mateos, María-Victoria, Špička, Ivan, Lazaroiu, Mihaela, Berdeja, Jesús, Kaufman, Jonathan L, Jou, Ying-Ming, Ganetsky, Alex, Popa McKiver, Mihaela, Lonial, Sagar, Weisel, Katja, Sandhu, Irwindeep, Podhorecka, Monika, Palumbo, Antonio, Shacham-Abulafia, Adi, Vaxman, Iuliana, Shpilberg, Ofer, Besemer, Britta, Martelli, Maurizio, Foà, Roberto, De Fabritiis, Paolo, Caravita di Toritto, Tommaso, Gheorghita, Emanuil, Oriol, Albert, Rowlings, Philip, Emanuele, Angelucci, Carella, Angelo M, Offidani, Massimo, Bladé, Joan, Casado, Luis F, Oakervee, Heather, Panelli, Victoria, Meza, Luis, Kühr, Thomas, Granell, Miguel, Benson, Don, Nair, Rajesh, Holden, Viran, Reeves, James, Jr., Eek, Richard W, Walker, Patricia A, Catalano, John, Rosta, András, Lech-Marańda, Ewa, Samaras, Christy, Reiman, Anthony, Weaver, Robert, Acs, Peter, Grigg, Andrew, De Prijck, Bernard, Louzada, Martha, Minuk, Leonard, Sebag, Michael, Klausmann, Martine, Welslau, Manfred, Hellmann, Andrzej, Danaila, Catalin, Becker, Pamela, Bensinger, William, Porterfield, Bruce, Modiano, Manuel, Schultz, Stephen M, Manges, Robert, Lee, Huey-Shin Cindy, Gray, James X, Wright, Matthew P, Vekemans, Marie-Christine, Hamed, Aryan, Gasztonyi, Zoltán, Mikala, Gábor, Masszi, Tamás, Gamberi, Barbara, Kuliczkowski, Kazimierz, Usnarska-Zubkiewicz, Lidia, Bengoechea, Enrique, Gutiérrez, María AE, García, Miguel TH, San-Miguel, Jesús, Driessen, Christoph, Behl, Rajesh, Brenner, Warren, Gray, Carl, Hansen, Vincent, Moezi, Mehdi, Cortes, Hector V, Yen, Charles, Gressot, Laurent, Horvath, Noemi, D'Rozario, James M, Latimer, Maya, Kyrtsonis, Maria-Christine, Chubar, Evgeni, Mittelman, Moshe, Baldini, Luca, Tosi, Patrizia, Vacca, Angelo, Jędrzejczak, Wiesław W, Robak, Tadeusz, Lahuerta, Juan J, Carney, Jennifer, Chen, Franklin, Hirsch, Robert, Ruiz, Marco, Alencar, Alvaro, Jagasia, Madan, Kasbari, Samer, Kuriakose, Philip, Mahmood, Aftab, Chaudhry, Madhu, Cohen, Gary, Noga, Stephen, Roa, Sch, Jakubowiak, Andrzej, Rosenbaum, Cara, Delforge, Michel, Delrieu, Vanessa, Doyen, Chantal, Dries, Deeren, Demuynck, Hilde, Schots, Rik, Maisnar, Vladimir, Blau, Igor W, Dürk, Heinz A, Kerkhoff, Andrea, Kropff, Martin, Munder, Markus, Röllig, Christoph, Scheid, Christof, Symeonidis, Argiris S, Illés, Árpád, Coyne, Mark, O'Gorman, Peter, Hayden, Patrick, O'Dwyer, Michael, Ben-Yehuda, Dina, Braester, Andrei, Nemets, Anatoly, Lugassy, Gilles, Cohen, Yossi, Rahimi-Levene, Naomi, Bosi, Alberto, Pezzatti, Sara, Rossini, Fausto, Pogliani, Enrico M, Pinto, Antonello, Komarnicki, Mieczysław, Borsaru, Gabriela, Stoia, Razvan, Afanasyev, Boris, Goñi, María A, Carboneras, Ana V, Ali, Sarah, Rubenstein, S. Eric, Caputto, Salvador, Cosgriff, Thomas, Fanning, Suzanne, Khojasteh, Ali, Liman, Andrew, Malcolm, Albert, Vrindavanam, Nandagopal, Patel, Ravindranath, Belani, Rajesh, Shieh, Marie, Stockerl-Goldstein, Keith, Strnad, Charles, Stuart, Robert, Chhabra, Saurabh, Costa, Luciano, Jhangiani, Haresh, Augustson, Bradley, Filshie, Robin, Johnston, Amanda, Hertzberg, Mark S, Mineur, Philippe, Fox, Susan, Kotb, Rami, Dao, Vi, LeBlanc, Richard, Gregora, Evzen, Brioli, Annamaria, Mügge, Lars-Olof, Hänel, Mathias, Langer, Christian, Kapsali, Eleni, Briasoulis, Evangelos, Kyriakou, Despoina, Hardan, Izhar, Horowitz, Netanel A, Clotilde, Cangialosi, Fabbiano, Francesco, Castagnari, Barbara, Ciceri, Fabio, Musuraca, Gerardo, Deptała, Andrzej, Kłoczko, Janusz, Balea, Marius, Vladareanu, Ana-Maria, Rossiev, Victor, Alegre, Adrián, Encinas, Cristina, Gayoso, Jorge, Pabst, Thomas, Rabin, Neil, Arledge, Sherri, Cabanillas, Fernando, Catlett, Joseph, Chidiac, Tarek, Clarkson, David, Dhodapkar, Madhav, Geils, George, Jr., Khan, Cyrus MA, Sahovic, Entezam, Khasawneh, Mohamad, Sehgal, Rajesh, Ballester, Oscar, Levy, Moshe, Fay, Joseph, Liem, Kiem, Lunning, Matthew, Vose, Julie, Faber, Edward, Jr., MacFarlane, Donald, Hohl, Raymond, Mahmood, Tariq, Bhaskar, Birbal, Mims, Martha, Oliff, Ira, Paner, Agne, Maciejewski, John, Padmanabhan, Arvinda, Richard, Robert, Sanyal, Amit, Schiller, Gary, Staszewski, Harry, Stevens, Don, Vaughn, Christopher, and Windsor, Kevin

Published
2022
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5. Melflufen or pomalidomide plus dexamethasone for patients with multiple myeloma refractory to lenalidomide (OCEAN): a randomised, head-to-head, open-label, phase 3 study

Author

Schjesvold, Fredrik, Delimpasi, Sosana, Robak, Pawel, Coriu, Daniel, Nikolayeva, Anna, Tomczak, Waldemar, Pour, Ludek, Spicka, Ivan, Dimopoulos, Meletios-Athanasios, Masszi, Tamas, Doronin, Vadim, Minarik, Jiri, Salogub, Galina, Alekseeva, Yulia, Maisnar, Vladimir, Mikala, Gabor, Rosinol, Laura, Konstantinova, Tatiana, Lazzaro, Antonio, Liberati, Anna Marina, Symeonidis, Anargyros, Gatt, Moshe, Illes, Arpad, Abdulhaq, Haifaa, Dungarwalla, Moez, Grosicki, Sebastian, Hajek, Roman, Leleu, Xavier, Myasnikov, Alexander, Richardson, Paul G., Avivi, Irit, Deeren, Dries, Gironella, Mercedes, Hernandez-Garcia, Miguel Teodoro, Martinez Lopez, Joaquin, Newinger-Porte, Muriel, Ribas, Paz, Samoilova, Olga, Voog, Eric, Arnao-Herraiz, Mario, Carrillo-Cruz, Estrella, Corradini, Paolo, Dodlapati, Jyothi, Granell Gorrochategui, Miquel, Huang, Shang-Yi, Jenner, Matthew, Karlin, Lionel, Kim, Jin Seok, Kopacz, Agnieszka, Medvedeva, Nadezhda, Min, Chang-Ki, Mina, Roberto, Palk, Katrin, Shin, Ho-Jin, Sohn, Sang Kyun, Sonneveld, Pieter, Tache, Jason, Anagnostopoulos, Achilles, Arguiñano, Jose-Maria, Cavo, Michele, Filicko, Joanne, Garnes, Margaret, Halka, Janusz, Herzog-Tzarfati, Kathrin, Ipatova, Natalia, Kim, Kihyun, Krauth, Maria-Theresa, Kryuchkova, Irina, Lazaroiu, Mihaela Cornelia, Luppi, Mario, Proydakov, Andrei, Rambaldi, Alessandro, Rudzianskiene, Milda, Yeh, Su-Peng, Alcalá-Peña, Maria Magdalena, Alegre Amor, Adrian, Alizadeh, Hussain, Bendandi, Maurizio, Brearton, Gillian, Brown, Randall, Cavet, Jim, Dally, Najib, Egyed, Miklos, Hernández-Rivas, José Ángel, Kaare, Ain, Karsenti, Jean-Michel, Kloczko, Janusz, Kreisle, William, Lee, Je-Jung, Legiec, Wojciech, Machherndl-Spandl, Sigrid, Manda, Sudhir, Mateos, Maria-Victoria, Moiseev, Ivan, Moreb, Jan, Nagy, Zsolt, Nair, Santosh, Oriol-Rocafiguera, Albert, Osswald, Michael, Otero-Rodriguez, Paula, Peceliunas, Valdas, Plesner, Torben, Rey, Philippe, Rossi, Giuseppe, Stevens, Don, Suriu, Celia, Tarella, Corrado, Verlinden, Anke, Zannetti, Alain, Schjesvold, Fredrik H, Pour, Luděk, Špička, Ivan, Mikala, Gábor, Rosiñol, Laura, Symeonidis, Argiris, Moody, Victoria, Thuresson, Marcus, Byrne, Catriona, Harmenberg, Johan, Bakker, Nicolaas A, Hájek, Roman, and Richardson, Paul G

Published
2022
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6. Copanlisib plus rituximab versus placebo plus rituximab in patients with relapsed indolent non-Hodgkin lymphoma (CHRONOS-3): a double-blind, randomised, placebo-controlled, phase 3 trial

Author

Matasar, Matthew J, Capra, Marcelo, Özcan, Muhit, Lv, Fangfang, Li, Wei, Yañez, Eduardo, Sapunarova, Katya, Lin, Tongyu, Jin, Jie, Jurczak, Wojciech, Hamed, Aryan, Wang, Ming-Chung, Baker, Ross, Bondarenko, Igor, Zhang, Qingyuan, Feng, Jifeng, Geissler, Klaus, Lazaroiu, Mihaela, Saydam, Guray, Szomor, Árpád, Bouabdallah, Krimo, Galiulin, Rinat, Uchida, Toshiki, Soler, Lidia Mongay, Cao, Anjun, Hiemeyer, Florian, Mehra, Aruna, Childs, Barrett H, Shi, Yuankai, and Zinzani, Pier Luigi

Published
2021
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7. Ropeginterferon alfa-2b versus standard therapy for polycythaemia vera (PROUD-PV and CONTINUATION-PV): a randomised, non-inferiority, phase 3 trial and its extension study

Author

Bauer, Franz, Berbec, Nicoleta, Besses Raebel, Carlos, Borbenyi, Zita, Bumbea, Horia, Buxhofer-Ausch, Veronika, Calbecka, Malgorzata, Cayssials-Caylus, Emilie, Cazzola, Mario, Cerna, Olga, Cucuianu, Andrei, Dima, Delia Monica, Forjan, Ernst, Gheorghita, Emanuil, Greil, Richard, Hatalova, Antonia, Hrubisko, Mikulas, Jakucs, Janos, Kaplan, Polina, Klymenko, Sergiy, Koschmieder, Steffen, Lazaroiu, Mihaela, Lysa, Tamila, Masliak, Zvenyslava, Masszi, Tamas, Mihaylov, Georgi, Myasnikov, Alexander, Platzbecker, Uwe, Puyade, Mathieu, Rey, Jerome, Roy, Lydia, Schwarz, Jiri, Skotnicki, Aleksander, Sokolova, Irina, Soroka-Wojtaszko, Maria, Starzak-Gwozdz, Jolanta, Stoeva, Vera, Torregrosa-Diaz, Jose Miguel, Vallova, Anna, Volodicheva, Elena, Warzocha, Krzysztof, Willenbacher, Ella, Wolf, Dominik, Gisslinger, Heinz, Klade, Christoph, Georgiev, Pencho, Krochmalczyk, Dorota, Gercheva-Kyuchukova, Liana, Egyed, Miklos, Rossiev, Viktor, Dulicek, Petr, Illes, Arpad, Pylypenko, Halyna, Sivcheva, Lylia, Mayer, Jiri, Yablokova, Vera, Krejcy, Kurt, Grohmann-Izay, Barbara, Hasselbalch, Hans C, Kralovics, Robert, and Kiladjian, Jean-Jacques

Published
2020
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8. MPN-483 Thrombocytopenic Myelofibrosis (MF) Patients Previously Treated With a JAK Inhibitor in a Phase 3 Randomized Study of Momelotinib (MMB) versus Danazol (DAN) [MOMENTUM]

Author

Gerds, Aaron, Verstovsek, Srdan, Vannucchi, Alessandro, Al-Ali, Haifa Kathrin, Lavie, David, Kuykendall, Andrew, Grosicki, Sebastian, Iurlo, Alessandra, Goh, Yeow Tee, Lazaroiu, Mihaela, Egyed, Miklos, Fox, Maria Laura, McLornan, Donal, Perkins, Andrew, Yoon, Sung-Soo, Gupta, Vikas, Kiladjian, Jean-Jacques, Donahue, Rafe, Kawashima, Jun, and Mesa, Ruben

Published
2022
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9. MPN-478 MOMENTUM: Phase 3 Randomized Study of Momelotinib (MMB) versus Danazol (DAN) in Symptomatic and Anemic Myelofibrosis (MF) Patients Previously Treated With a JAK Inhibitor

Author

Mesa, Ruben, Gerds, Aaron, Vannucchi, Alessandro, Al-Ali, Haifa Kathrin, Lavie, David, Kuykendall, Andrew, Grosicki, Sebastian, Iurlo, Alessandra, Goh, Yeow Tee, Lazaroiu, Mihaela, Egyed, Miklos, Fox, Maria Laura, McLornan, Donal, Perkins, Andrew, Yoon, Sung-Soo, Gupta, Vikas, Kiladjian, Jean-Jacques, Donahue, Rafe, Kawashima, Jun, and Verstovsek, Srdan

Published
2022
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10. Momelotinib versus danazol in symptomatic patients with anaemia and myelofibrosis (MOMENTUM): results from an international, double-blind, randomised, controlled, phase 3 study

Author

Verstovsek, Srdan, primary, Gerds, Aaron T, additional, Vannucchi, Alessandro M, additional, Al-Ali, Haifa Kathrin, additional, Lavie, David, additional, Kuykendall, Andrew T, additional, Grosicki, Sebastian, additional, Iurlo, Alessandra, additional, Goh, Yeow Tee, additional, Lazaroiu, Mihaela C, additional, Egyed, Miklos, additional, Fox, Maria Laura, additional, McLornan, Donal, additional, Perkins, Andrew, additional, Yoon, Sung-Soo, additional, Gupta, Vikas, additional, Kiladjian, Jean-Jacques, additional, Granacher, Nikki, additional, Lee, Sung-Eun, additional, Ocroteala, Luminita, additional, Passamonti, Francesco, additional, Harrison, Claire N, additional, Klencke, Barbara J, additional, Ro, Sunhee, additional, Donahue, Rafe, additional, Kawashima, Jun, additional, Mesa, Ruben, additional, Abulafia, Adi Shacham, additional, Andreasson, Bjorn, additional, Angona, Anna, additional, Ayala, Rosa, additional, Bang, Soo-Mee, additional, Bank, Bruce, additional, Barraco, Fiorenza, additional, Beggiato, Eloise, additional, Benghiat, Fleur Samantha, additional, Bonifacio, MassimiliaNo, additional, Bories, Claire, additional, Borsaru, Gabriela, additional, Brabrand, Mette, additional, Braester, Andrei, additional, Broliden, Andes, additional, Buxhofer-Ausch, Veronika, additional, Cambier, Nathalie, additional, Caramella, Marianna, additional, Carpentier, Benjamin, additional, Cascavilla, Nicola, additional, Castellano, Maria Giraldo, additional, Chang, Hung, additional, Chen, Chih-Cheng, additional, Cheong, June-Won, additional, Choi, Yunsuk, additional, Choi, Philip, additional, Corsetti, Maria Teresa, additional, Cuadrado, Isabel Montero, additional, Cunningham, Julia, additional, Damaj, Gandhi Laurent, additional, De Stefano, Valerio, additional, Delage, Robert, additional, Delgado, Regina Garcĺa, additional, Diaz, Jose Miguel Torregrosa, additional, Dombi, Péter, additional, Dubruille, Viviane, additional, Egyed, Miklós, additional, El Fassi, Daniel, additional, Elinder-Camburn, Anna, additional, Elli, Elena Maria, additional, Ellis, Martin, additional, Fava, Carmen, additional, Fazal, Salman, additional, Fleischman, Angela, additional, Foltz, Lynda, additional, Fox, Laura, additional, Gabrail, Nashat, additional, Garcĺa-Gutiérrez, Jose Valentĺn, additional, Gerds, Aaron, additional, Girault, Stephane, additional, Gisslinger, Heinz, additional, Gluvacov, Alexandru, additional, Göthert, Joachim, additional, Hadjiev (Hadzhiev), Evgeni (Evgueniy), additional, Hafraoui, Kaoutar, additional, Hamed, Aryan, additional, Harrison, Claire, additional, Hasselbalch, Hans, additional, Hauser, Hanns, additional, Heaney, Mark, additional, Hebart, Holger, additional, Hernandez Rivas, Jesus Maria, additional, Higuero Saavedra, Victor, additional, Hillis, Christopher, additional, Hou, Hsin-An, additional, How, Jonathan, additional, Huang, Daniel, additional, Hus, Marek, additional, Illés, Arpad, additional, Isidori, Alessandro, additional, Ivanov, Vadim, additional, Johansson, Peter, additional, Jung, Chul Won, additional, Kirgner, Ilya, additional, Koren-Michowitz, Maya, additional, Koschmieder, Steffen, additional, Kosztolanyi, Szabolcs Ors, additional, Kreiniz, Natalia, additional, Kuykendall, Andrew, additional, Lambert, Jonathan, additional, Laribi, Kamel, additional, Lascaux, Axelle, additional, Lavie, Noa, additional, Lazaroiu, Mihaela, additional, Leahy, Michael, additional, Lech-Maranda, Ewa, additional, Lee, Won Sik, additional, Legrand, Ollivier, additional, Lemoli, Roberto, additional, Liang, James, additional, Lim, Sung-Nam, additional, Loschi, Michael, additional, Lucchesi, Alessandro, additional, Macarie, Ioan, additional, Marolleau, Jean-Pierre, additional, Martelli, Maurizio, additional, Mayer, Jiri, additional, McCloskey, James, additional, McDermott, Christopher, additional, McMahon, Brandon, additional, Mehta, Priyanka, additional, Mikala, Gábor, additional, Milojkovic, Dragana, additional, Mineur, Philippe, additional, Mishchenko, Elena, additional, Moon, Joon Ho, additional, Nagy, Zsolt, additional, Narayanan, Srinivasan, additional, O'Connell, Casey, additional, Oh, Stephen, additional, Ojeda-Uribe, Mario, additional, Ong, Kiat Hoe, additional, Otegbeye, Folashade, additional, Palmer, Jeanne, additional, Pane, Fabrizio, additional, Patriarca, Andrea, additional, Pietrantuono, Giuseppe, additional, Plander, Mark, additional, Platzbecker, Uwe, additional, Prasad, Ritam, additional, Prejzner, Witold, additional, Rachow, Tobias, additional, Radinoff, Atanas, additional, Rejtő, László, additional, Rinaldi, Ciro, additional, Robak, Tadeusz, additional, Rodriguez, Maria Angeles Fernandez, additional, Ronson, Aaron, additional, Ross, David, additional, Sacha, Tomasz, additional, Sadjadian, Parvis, additional, Salar, Antonio, additional, Santillana, Guillermo Sanz, additional, Scheid, Christof, additional, Schmidt, Aline, additional, Severinsen, Marianne Tang, additional, Stoeva, Vera, additional, Szwedyk, Paweł, additional, Tiribelli, Mario, additional, Trautmann-Grill, Karolin, additional, Trottier, Amy, additional, Tzvetkov, Nikolay, additional, van Droogenbroeck, Janusz, additional, Vannucchi, Alessandro, additional, Verstovsek, Srdan, additional, Vianelli, Nicola, additional, von Bubnoff, Nikolas, additional, Wolf, Dominik, additional, Woszczyk, Dariusz, additional, Woźny, Tomasz, additional, Wróbel, Tomasz, additional, Xicoy, Blanca, additional, and Yeh, Su-Peng, additional

Published
2023
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11. Updated Results from the Momentum Phase 3 Study of Momelotinib (MMB) Versus Danazol (DAN) in Symptomatic and Anemic Myelofibrosis (MF) Patients Previously Treated with a JAK Inhibitor

Author

Gerds, Aaron T., primary, Mesa, Ruben, additional, Vannucchi, Alessandro M, additional, Al-Ali, Haifa Kathrin, additional, Lavie, David, additional, Kuykendall, Andrew, additional, Grosicki, Sebastian, additional, Iurlo, Alessandra, additional, Goh, Yeow Tee, additional, Lazaroiu, Mihaela, additional, Egyed, Miklos, additional, Fox, Maria Laura, additional, McLornan, Donal P., additional, Perkins, Andrew Charles, additional, Yoon, Sung-Soo, additional, Gupta, Vikas, additional, Kiladjian, Jean-Jacques, additional, Donahue, Rafe, additional, Kawashima, Jun, additional, and Verstovsek, Srdan, additional

Published
2022
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12. Poster: MPN-478 MOMENTUM: Phase 3 Randomized Study of Momelotinib (MMB) versus Danazol (DAN) in Symptomatic and Anemic Myelofibrosis (MF) Patients Previously Treated With a JAK Inhibitor

Author

Mesa, Ruben, primary, Gerds, Aaron, additional, Vannucchi, Alessandro, additional, Al-Ali, Haifa Kathrin, additional, Lavie, David, additional, Kuykendall, Andrew, additional, Grosicki, Sebastian, additional, Iurlo, Alessandra, additional, Goh, Yeow Tee, additional, Lazaroiu, Mihaela, additional, Egyed, Miklos, additional, Fox, Maria Laura, additional, McLornan, Donal, additional, Perkins, Andrew, additional, Yoon, Sung-Soo, additional, Gupta, Vikas, additional, Kiladjian, Jean-Jacques, additional, Donahue, Rafe, additional, Kawashima, Jun, additional, and Verstovsek, Srdan, additional

Published
2022
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13. Poster: MPN-483 Thrombocytopenic Myelofibrosis (MF) Patients Previously Treated With a JAK Inhibitor in a Phase 3 Randomized Study of Momelotinib (MMB) versus Danazol (DAN) [MOMENTUM]

Author

Gerds, Aaron, primary, Verstovsek, Srdan, additional, Vannucchi, Alessandro, additional, Al-Ali, Haifa Kathrin, additional, Lavie, David, additional, Kuykendall, Andrew, additional, Grosicki, Sebastian, additional, Iurlo, Alessandra, additional, Goh, Yeow Tee, additional, Lazaroiu, Mihaela, additional, Egyed, Miklos, additional, Fox, Maria Laura, additional, McLornan, Donal, additional, Perkins, Andrew, additional, Yoon, Sung-Soo, additional, Gupta, Vikas, additional, Kiladjian, Jean-Jacques, additional, Donahue, Rafe, additional, Kawashima, Jun, additional, and Mesa, Ruben, additional

Published
2022
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14. Thrombocytopenic myelofibrosis (MF) patients previously treated with a JAK inhibitor in a phase 3 randomized study of momelotinib (MMB) versus danazol (DAN) [MOMENTUM].

Author

Gerds, Aaron Thomas, primary, Verstovsek, Srdan, additional, Vannucchi, Alessandro, additional, Al-Ali, Haifa Kathrin, additional, Lavie, David, additional, Kuykendall, Andrew T., additional, Grosicki, Sebastian, additional, Iurlo, Alessandra, additional, Goh, Yeow Tee, additional, Lazaroiu, Mihaela Cornelia, additional, Egyed, Miklos, additional, Fox, Maria Laura, additional, McLornan, Donal P., additional, Perkins, Andrew, additional, Yoon, Sung-Soo, additional, Gupta, Vikas, additional, Kiladjian, Jean-Jacques, additional, Donahue, Rafe, additional, Kawashima, Jun, additional, and Mesa, Ruben A., additional

Published
2022
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15. MOMENTUM: Phase 3 randomized study of momelotinib (MMB) versus danazol (DAN) in symptomatic and anemic myelofibrosis (MF) patients previously treated with a JAK inhibitor.

Author

Mesa, Ruben A., primary, Gerds, Aaron Thomas, additional, Vannucchi, Alessandro, additional, Al-Ali, Haifa Kathrin, additional, Lavie, David, additional, Kuykendall, Andrew T., additional, Grosicki, Sebastian, additional, Iurlo, Alessandra, additional, Goh, Yeow Tee, additional, Lazaroiu, Mihaela Cornelia, additional, Egyed, Miklos, additional, Fox, Maria Laura, additional, McLornan, Donal P., additional, Perkins, Andrew, additional, Yoon, Sung-Soo, additional, Gupta, Vikas, additional, Kiladjian, Jean-Jacques, additional, Donahue, Rafe, additional, Kawashima, Jun, additional, and Verstovsek, Srdan, additional

Published
2022
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16. Rozrolimupab, a mixture of 25 recombinant human monoclonal RhD antibodies, in the treatment of primary immune thrombocytopenia

Author

Robak, Tadeusz, Windyga, Jerzy, Trelinski, Jacek, von Depka Prondzinski, Mario, Giagounidis, Aristoteles, Doyen, Chantal, Janssens, Ann, Álvarez-Román, María Teresa, Jarque, Isidro, Loscertales, Javier, Rus, Gloria Pérez, Hellmann, Andrzej, Jêdrzejczak, Wiesław Wiktor, Kuliczkowski, Kazimierz, Golubovic, Lana M., Celeketic, Dusica, Cucuianu, Andrei, Gheorghita, Emanuil, Lazaroiu, Mihaela, Shpilberg, Ofer, Attias, Dina, Karyagina, Elena, Svetlana, Kalinina, Vilchevska, Kateryna, Cooper, Nichola, Talks, Kate, Prabhu, Mukhyaprana, Sripada, Prasad, Bharadwaj, T.P.R., Næsted, Henrik, Skartved, Niels J.Ø., Frandsen, Torben P., Flensburg, Mimi F., Andersen, Peter S., and Petersen, Jørgen

Published
2012
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17. Poster: MPN-106: Improved Transfusion Independence Rates for Momelotinib vs Ruxolitinib in Anemic JAKi-Naïve Myelofibrosis Patients are Independent of Baseline Platelet or Transfusion Status

Author

Kiladjian, Jean-Jacques, primary, Platzbecker, Uwe, additional, Mayer, Jiří, additional, Illés, Árpád, additional, Prejzner, Witold, additional, Woźny, Tomasz, additional, Tzvetkov, Nikolay, additional, Vannucchi, Alessandro M, additional, Kirgner, Ilya, additional, Nagy, Zsolt, additional, Grosicki, Sebastian, additional, Derolf, Åsa, additional, Lazaroiu, Mihaela Cornelia, additional, Yoon, Sung-Soo, additional, Goh, Yeow Tee, additional, von Bubnoff, Nikolas, additional, Mesa, Ruben, additional, Klencke, Barbara J, additional, Donahue, Rafe, additional, and Verstovsek, Srdan, additional

Published
2021
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18. MPN-106: Improved Transfusion Independence Rates for Momelotinib vs Ruxolitinib in Anemic JAKi-Naïve Myelofibrosis Patients are Independent of Baseline Platelet or Transfusion Status

Author

Kiladjian, Jean-Jacques, primary, Platzbecker, Uwe, additional, Mayer, Jiří, additional, Illés, Árpád, additional, Prejzner, Witold, additional, Woźny, Tomasz, additional, Tzvetkov, Nikolay, additional, Vannucchi, Alessandro M, additional, Kirgner, Ilya, additional, Nagy, Zsolt, additional, Grosicki, Sebastian, additional, Derolf, Åsa, additional, Lazaroiu, Mihaela Cornelia, additional, Yoon, Sung-Soo, additional, Goh, Yeow Tee, additional, von Bubnoff, Nikolas, additional, Mesa, Ruben, additional, Klencke, Barbara J, additional, Donahue, Rafe, additional, and Verstovsek, Srdan, additional

Published
2021
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19. Abstract CT001: CHRONOS-3: Randomized Phase III study of copanlisib plus rituximab vs rituximab/placebo in relapsed indolent non-Hodgkin lymphoma (iNHL)

Author

Matasar, Matthew J., primary, Capra, Marcelo, additional, Özcan, Muhit, additional, Lv, Fangfang, additional, Li, Wei, additional, Yañez, Eduardo, additional, Sapunarova, Katya, additional, Lin, Tongyu, additional, Jin, Jie, additional, Jurczak, Wojciech, additional, Hamed, Aryan, additional, Wang, Ming-Chung, additional, Baker, Ross, additional, Bondarenko, Igor, additional, Zhang, Qingyuan, additional, Feng, Jifeng, additional, Geissler, Klaus, additional, Lazaroiu, Mihaela, additional, Saydam, Guray, additional, Szomor, Árpád, additional, Bouabdallah, Krimo, additional, Galiulin, Rinat, additional, Uchida, Toshiki, additional, Soler, Lidia Mongay, additional, Cao, Anjun, additional, Hiemeyer, Florian, additional, Mehra, Aruna, additional, Childs, Barrett H., additional, Shi, Yuankai, additional, and Zinzani, Pier Luigi, additional

Published
2021
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20. MOMENTUM: momelotinib vs danazol in patients with myelofibrosis previously treated with JAKi who are symptomatic and anemic

Author

Verstovsek, Srdan, Chen, Chih-Cheng, Egyed, Miklos, Ellis, Martin, Fox, Laura, Goh, Yeow T., Gupta, Vikas, Harrison, Claire, Kiladjian, Jean-Jacques, Lazaroiu, Mihaela C., Mead, Adam, McLornan, Donal, McMullin, Mary F., Oh, Stephen T., Perkins, Andrew, Platzbecker, Uwe, Scheid, Christof, Vannucchi, Alessandro, Yoon, Sung-Soo, Kowalski, Mark M., Mesa, Ruben A., Verstovsek, Srdan, Chen, Chih-Cheng, Egyed, Miklos, Ellis, Martin, Fox, Laura, Goh, Yeow T., Gupta, Vikas, Harrison, Claire, Kiladjian, Jean-Jacques, Lazaroiu, Mihaela C., Mead, Adam, McLornan, Donal, McMullin, Mary F., Oh, Stephen T., Perkins, Andrew, Platzbecker, Uwe, Scheid, Christof, Vannucchi, Alessandro, Yoon, Sung-Soo, Kowalski, Mark M., and Mesa, Ruben A.

Abstract

Hallmark features of myelofibrosis (MF) are cytopenias, constitutional symptoms and splenomegaly. Anemia and transfusion dependency are among the most important negative prognostic factors and are exacerbated by many JAK inhibitors (JAKi). Momelotinib (MMB) has been investigated in over 820 patients with MF and possesses a pharmacological and clinical profile differentiated from other JAKi by inhibition of JAK1, JAK2 and ACVR1. MMB is designed to address the complex drivers of iron-restricted anemia and chronic inflammation in MF and should improve constitutional symptoms and splenomegaly while maintaining or improving hemoglobin in JAKi-naive and previously JAKi-treated patients. The MOMENTUM Phase III study is designed to confirm and extend observations of safety and clinical activity of MMB. Lay abstract:The most important features of myelofibrosis (MF) are low blood cell counts and symptoms including tiredness, night sweats and itching, along with increased size of the spleen, which may cause a feeling of fullness and pain. Low red blood cell counts (anemia) may mean regular blood transfusions are needed and this is one of the signs MF is getting worse. Drugs called JAK inhibitors (JAKi) are available to treat MF, but can have a side effect of making blood cell counts lower. Momelotinib (MMB) is a different type of JAKi to the ones currently available, and is an experimental drug for MF. MMB is designed to treat symptoms and spleen like other JAKi, but also to improve blood cell counts. MMB has already been given to more than 820 patients with MF in other clinical studies. Some of the patients in these studies had been treated with different JAKi before, and others got MMB as their first JAKi treatment. The MOMENTUM Phase III study is designed to collect more information on the safety and effectiveness of MMB in MF.

Published
2021

21. Improved transfusion independence rates for momelotinib versus ruxolitinib in anemic JAKi naïve myelofibrosis patients independent of baseline platelet or transfusion status.

Author

Kiladjian, Jean-Jacques, primary, Platzbecker, Uwe, additional, Mayer, Jiří, additional, Illés, Árpád, additional, Prejzner, Witold, additional, Woźny, Tomasz, additional, Tzvetkov, Nikolay, additional, Vannucchi, Alessandro M., additional, Kirgner, Ilya, additional, Nagy, Zsolt, additional, Grosicki, Sebastian, additional, Derolf, Åsa, additional, Lazaroiu, Mihaela Cornelia, additional, Yoon, Sung-Soo, additional, Goh, Yeow Tee, additional, von Bubnoff, Nikolas, additional, Verstovsek, Srdan, additional, Klencke, Barbara J., additional, Donahue, Rafe, additional, and Mesa, Ruben A., additional

Published
2021
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22. MOMENTUM: momelotinib vs danazol in patients with myelofibrosis previously treated with JAKi who are symptomatic and anemic

Author

Verstovsek, Srdan, primary, Chen, Chih-Cheng, additional, Egyed, Miklós, additional, Ellis, Martin, additional, Fox, Laura, additional, Goh, Yeow T, additional, Gupta, Vikas, additional, Harrison, Claire, additional, Kiladjian, Jean-Jacques, additional, Lazaroiu, Mihaela C, additional, Mead, Adam, additional, McLornan, Donal, additional, McMullin, Mary F, additional, Oh, Stephen T, additional, Perkins, Andrew, additional, Platzbecker, Uwe, additional, Scheid, Christof, additional, Vannucchi, Alessandro, additional, Yoon, Sung-Soo, additional, Kowalski, Mark M, additional, and Mesa, Ruben A, additional

Published
2021
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23. Momelotinib's Spleen, Symptom and Anemia Efficacy Is Maintained in Intermediate/High Risk Myelofibrosis Patients with Thrombocytopenia

Author

Kiladjian, Jean Jacques, primary, Platzbecker, Uwe, additional, Mayer, Jiri, additional, Illés, Árpád, additional, Prejzner, Witold, additional, Wozny, Tomasz, additional, Tzvetkov, Nikolay, additional, Vannucchi, Alessandro M., additional, Kirgner, Ilya, additional, Nagy, Zsolt, additional, Grosicki, Sebastian, additional, Rangert Derolf, Åsa, additional, Lazaroiu, Mihaela, additional, Yoon, Sung-Soo, additional, Goh, Yeow Tee, additional, Von Bubnoff, Nikolas, additional, Verstovsek, Srdan, additional, Klencke, Barbara Jane, additional, Donahue, Rafe, additional, and Mesa, Ruben, additional

Published
2020
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24. Long-Term Outcomes and Health-Related Quality of Life (HRQoL) By Response Status for Bortezomib, Melphalan, and Prednisone (VMP) ± Daratumumab (DARA) in Alcyone

Author

Rodriguez-Otero, Paula, primary, Boccadoro, Mario, additional, Hajek, Roman, additional, Fujisaki, Tomoaki, additional, Lee, Jae Hoon, additional, Martinez-Lopez, Joaquin, additional, Lucio, Paulo, additional, Nagy, Zsolt, additional, Usenko, Ganna, additional, Liberati, Anna Marina, additional, Lazaroiu, Mihaela, additional, Woszczyk, Dariusz, additional, Takamatsu, Hiroyuki, additional, Romejko-Jarosinska, Joanna, additional, Knop, Stefan Tobias, additional, Pavlovsky, Astrid, additional, Forsyth, Cecily, additional, Ishikawa, Takayuki, additional, Gries, Katharine S., additional, Pei, Huiling, additional, Kudva, Anupa, additional, Ukropec, Jon, additional, Wroblewski, Susan, additional, Carson, Robin, additional, and Dimopoulos, Meletios A, additional

Published
2020
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25. Ropeginterferon alfa-2b versus standard therapy for polycythaemia vera (PROUD-PV and CONTINUATION-PV): a randomised, non-inferiority, phase 3 trial and its extension study

Author

Gisslinger, Heinz, primary, Klade, Christoph, additional, Georgiev, Pencho, additional, Krochmalczyk, Dorota, additional, Gercheva-Kyuchukova, Liana, additional, Egyed, Miklos, additional, Rossiev, Viktor, additional, Dulicek, Petr, additional, Illes, Arpad, additional, Pylypenko, Halyna, additional, Sivcheva, Lylia, additional, Mayer, Jiri, additional, Yablokova, Vera, additional, Krejcy, Kurt, additional, Grohmann-Izay, Barbara, additional, Hasselbalch, Hans C, additional, Kralovics, Robert, additional, Kiladjian, Jean-Jacques, additional, Bauer, Franz, additional, Berbec, Nicoleta, additional, Besses Raebel, Carlos, additional, Borbenyi, Zita, additional, Bumbea, Horia, additional, Buxhofer-Ausch, Veronika, additional, Calbecka, Malgorzata, additional, Cayssials-Caylus, Emilie, additional, Cazzola, Mario, additional, Cerna, Olga, additional, Cucuianu, Andrei, additional, Dima, Delia Monica, additional, Forjan, Ernst, additional, Gheorghita, Emanuil, additional, Greil, Richard, additional, Hatalova, Antonia, additional, Hrubisko, Mikulas, additional, Jakucs, Janos, additional, Kaplan, Polina, additional, Klymenko, Sergiy, additional, Koschmieder, Steffen, additional, Lazaroiu, Mihaela, additional, Lysa, Tamila, additional, Masliak, Zvenyslava, additional, Masszi, Tamas, additional, Mihaylov, Georgi, additional, Myasnikov, Alexander, additional, Platzbecker, Uwe, additional, Puyade, Mathieu, additional, Rey, Jerome, additional, Roy, Lydia, additional, Schwarz, Jiri, additional, Skotnicki, Aleksander, additional, Sokolova, Irina, additional, Soroka-Wojtaszko, Maria, additional, Starzak-Gwozdz, Jolanta, additional, Stoeva, Vera, additional, Torregrosa-Diaz, Jose Miguel, additional, Vallova, Anna, additional, Volodicheva, Elena, additional, Warzocha, Krzysztof, additional, Willenbacher, Ella, additional, and Wolf, Dominik, additional

Published
2020
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26. Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomised, phase 3 trial

Author

Horwitz, Steven, primary, O'Connor, Owen A, additional, Pro, Barbara, additional, Illidge, Tim, additional, Fanale, Michelle, additional, Advani, Ranjana, additional, Bartlett, Nancy L, additional, Christensen, Jacob Haaber, additional, Morschhauser, Franck, additional, Domingo-Domenech, Eva, additional, Rossi, Giuseppe, additional, Kim, Won Seog, additional, Feldman, Tatyana, additional, Lennard, Anne, additional, Belada, David, additional, Illés, Árpád, additional, Tobinai, Kensei, additional, Tsukasaki, Kunihiro, additional, Yeh, Su-Peng, additional, Shustov, Andrei, additional, Hüttmann, Andreas, additional, Savage, Kerry J, additional, Yuen, Sam, additional, Iyer, Swaminathan, additional, Zinzani, Pier Luigi, additional, Hua, Zhaowei, additional, Little, Meredith, additional, Rao, Shangbang, additional, Woolery, Joseph, additional, Manley, Thomas, additional, Trümper, Lorenz, additional, Aboulafia, David, additional, Alpdogan, Onder, additional, Ando, Kiyoshi, additional, Arcaini, Luca, additional, Baldini, Luca, additional, Bellam, Naresh, additional, Bartlett, Nancy, additional, Yehuda, Dina Ben, additional, Benedetti, Fabio, additional, Borchman, Peter, additional, Bordessoule, Dominique, additional, Brice, Pauline, additional, Briones, Javier, additional, Caballero, Dolores, additional, Carella, Angelo Michele, additional, Chang, Hung, additional, Cheong, June Weon, additional, Cho, Seok-Goo, additional, Choi, Ilseung, additional, Choquet, Sylvain, additional, Colita, Andrei, additional, Congui, Angela Giovanna, additional, D'amore, Francesco, additional, Dang, Nam, additional, Davison, Kelly, additional, de Guibert, Sophie, additional, Brown, Peter de Nully, additional, Delwail, Vincent, additional, Demeter, Judit, additional, di Raimondo, Francesco, additional, Do, Young Rok, additional, Domingo, Eva, additional, Douvas, Michael, additional, Dreyling, Martin, additional, Ernst, Thomas, additional, Fay, Keith, additional, Ferrero, Silvia Fernandez, additional, Flinn, Ian Winchester, additional, Forero-Torres, Andres, additional, Fox, Christopher, additional, Friedberg, Jonathan, additional, Fukuhara, Noriko, additional, Garcia-Marco, Jose, additional, Cruz, Jorge Gayoso, additional, Codina, Jose Gomez, additional, Gressin, Remy, additional, Grigg, Andrew, additional, Gurion, Ronit, additional, Haioun, Corinne, additional, Hajek, Roman, additional, Hanel, Mathias, additional, Hatake, Kiyohiko, additional, Hensen, Robert, additional, Horowitz, Netanel, additional, Horwitz, Steven, additional, Huttmann, Andreas, additional, Illes, Arpad, additional, Ishizawa, Kenichi, additional, Islas-Ohlmayer, Miguel, additional, Jacobsen, Eric, additional, Janakiram, Murali, additional, Jurczak, Wojciech, additional, Kaminski, Mark, additional, Kato, Koji, additional, Kirgner, Ilya, additional, Kuo, Ching-Yuan, additional, Lazaroiu, Mihaela Cornelia, additional, Du, Katell Le, additional, Lee, Jong-Seok, additional, LeGouill, Steven, additional, LaRosee, Paul, additional, Levi, Itai, additional, Link, Brian, additional, Maisonneuve, Herve, additional, Maruyama, Dai, additional, Mayer, Jiri, additional, McCarty, John, additional, McKay, Pam, additional, Minami, Yosuke, additional, Mocikova, Heidi, additional, Morra, Enrica, additional, Munoz, Javier, additional, Nagai, Hirokazu, additional, O'Connor, Owen, additional, Opat, Stephen, additional, Pettengell, Ruth, additional, Pezzutto, Antonio, additional, Pfreundschuh, Michael, additional, Pluta, Andrzej, additional, Porcu, PierLuigi, additional, Quach, Hang, additional, Rambaldi, Alessandro, additional, Renwick, William, additional, Reyes, Ruben, additional, Izquierdo, Antonia Rodriguez, additional, Ruan, Jia, additional, Rusconi, Chiara, additional, Salles, Gilles, additional, Santoro, Armando, additional, Sarriera, Jose, additional, Savage, Kerry, additional, Shibayama, Hirohiko, additional, Suh, Cheolwon, additional, Sureda, Anna, additional, Tanimoto, Mitsune, additional, Taniwaki, Masafumi, additional, Tilly, Herve, additional, Trneny, Marek, additional, Trumper, Lorenz, additional, Tsukamoto, Norifumi, additional, Vitolo, Umberto, additional, Walewski, Jan, additional, Weidmann, Eckhart, additional, Wilhelm, Martin, additional, Witzens-Harig, Mathias, additional, Yacoub, Abdulraheem, additional, Yamamoto, Kazuhito, additional, Yoon, Sung-Soo, additional, Yun, Hwan Jung, additional, and Zain, Jasmine, additional

Published
2019
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27. Thrombocytopenic Myelofibrosis (MF) Patients Previously Treated with a JAK Inhibitor in a Phase 3 Randomized Study of Momelotinib (MMB) versus Danazol (DAN) (MOMENTUM).

Author

Gerds, Aaron, Verstovsek, Srdan, Vannucchi, Alessandro, Al-Ali, Haifa Kathrin, Lavie, David, Kuykendall, Andrew, Grosicki, Sebastian, Iurlo, Alessandra, Goh, Yeow Tee, Lazaroiu, Mihaela, Egyed, Miklos, Fox, Maria Laura, McLornan, Donal, Perkins, Andrew, Sung-Soo Yoon, Gupta, Vikas, Kiladjian, Jean-Jacques, Donahue, Rafe, Kawashima, Jun, and Mesa, Ruben

Subjects
DRUG efficacy, MYELOFIBROSIS, HETEROCYCLIC compounds, JANUS kinases, TREATMENT effectiveness, PLATELET count, NEUROTRANSMITTER uptake inhibitors, DRUG side effects
Abstract

Background: MMB, an oral JAK1/2 and ACVR1/ALK2 inhibitor, was evaluated (vs DAN) in a pivotal phase 3 study of MF patients previously treated with a JAK inhibitor (JAKi). This subgroup analysis evaluated MOMENTUM patients with baseline platelet counts ≤150 x 109/L. Methods: Eligibility: Primary or post-ET/PV MF; DIPSS high risk, Int-2, or Int-1; total symptom score (TSS) ≥10; hemoglobin <10 g/dL; prior JAKi ≥90 days, or ≥28 days if red blood cell transfusions ≥4 units in 8 weeks or grade 3/4 thrombocytopenia, anemia, or hematoma; palpable spleen ≥5 cm; platelets ≥25 x 109/L. JAKi taper/washout ≥21 days. Randomization 2:1 to MMB 200 mg or DAN 600 mg qd (+ placebo) for 24 weeks. Primary end point: TSS response (≥50% reduction from baseline) rate at week 24. Secondary end points at week 24: transfusion independence (TI) rate, splenic response rate (SRR; ≥25% volume reduction from majorbaseline), TSS change from baseline, SRR (≥35% reduction), and rate of zero transfusions since baseline. Results: Mean baseline TSS: 29 MMB, 26 DAN, hemoglobin: 8.1 g/dL MMB, 7.8 g/dL DAN; and platelets: 74 x 109/L MMB, 73 x 109/L DAN. Efficacy results are consistent with the intention-to-treat analysis set for MMB versus DAN, respectively: TSS response rate (29.6% vs 11.6%), TI rate (32.1% vs 18.6%), SRR ≥25% (39.5% vs 7.0%), TSS change (-10.7 vs -3.8), SRR ≥35% (22.2% vs 4.7%), and rate of zero transfusions (30.9% vs 11.6%). Most common grade ≥3 treatment-emergent adverse events (TEAEs) were thrombocytopenia (MMB, 31%; DAN, 16%) and anemia (MMB, 7%; DAN, 14%); grade ≥3 bleeding events: 9% MMB, 5% DAN. TEAEs leading to study drug discontinuation: 15% MMB, 19% DAN. A trend toward improved overall survival up to week 24 was seen with MMB versus DAN [hazard ratio (95% CI) = 0.490 (0.195-1.235)]. Analyses of patients with baseline platelets <100 x 109/L (n = 100) and baseline platelets <50 x 109/L (n = 31) show similar efficacy, safety, and survival profiles for MMB versus DAN. Conclusions: In symptomatic, anemic, and thrombocytopenic MF patients, MMB was superior to DAN for symptom responses, transfusion requirements, and spleen responses with comparable safety and favorable survival. MMB may address a critical unmet need in thrombocytopenic MF patients. [ABSTRACT FROM AUTHOR]

Published
2022

28. MOMENTUM: Phase 3 Randomized Study of Momelotinib (MMB) versus Danazol (DAN) in Symptomatic and Anemic Myelofibrosis (MF) Patients Previously Treated with a JAK Inhibitor.

Author

Mesa, Ruben, Gerds, Aaron, Vannucchi, Alessandro, Al-Ali, Haifa Kathrin, Lavie, David, Kuykendall, Andrew, Grosicki, Sebastian, Iurlo, Alessandra, Yeow Tee Goh, Lazaroiu, Mihaela, Egyed, Miklos, Fox, Maria Laura, McLornan, Donal, Perkins, Andrew, Sung-Soo Yoon, Gupta, Vikas, Kiladjian, Jean-Jacques, Donahue, Rafe, Kawashima, Jun, and Verstovsek, Srdan

Subjects
THERAPEUTIC use of antineoplastic agents, DRUG efficacy, MYELOFIBROSIS, JANUS kinases, TREATMENT effectiveness, ANEMIA, NEUROTRANSMITTER uptake inhibitors, DANAZOL
Abstract

Background: MF is a rare bone marrow cancer characterized by fibrosis, abnormal blood cell production, and dysregulated JAK/STAT signaling.1,2 Clinical manifestations include anemia, constitutional symptoms, and splenomegaly, which can negatively impact patient quality of life.3-5 Although approved JAK inhibitors (JAKi) may improve symptoms and splenomegaly, none actively treat anemia and some may exacerbate it; the efficacy of other agents currently used to manage anemia in MF (eg, DAN) is short-lived.6-8 MF-associated anemia is driven by chronic inflammation and due in part to resultant hyperactive ACVR1 signaling and elevated hepcidin levels.6 MMB is unique among JAKi in that it inhibits not only JAK1 and JAK2 to drive symptom and spleen improvements but also ACVR1 to drive anemia benefits, including increased serum iron and hemoglobin levels.9 In the SIMPLIFY trials, MMB was associated with improvements in symptoms, splenomegaly, and transfusion burden in both JAKi-naive and JAKi-experienced patients with MF.10,11 The pivotal phase 3 MOMENTUM study of MF patients previously treated with a JAKi tested MMB versus DAN on key symptom, anemia, and splenic end points. Methods: Eligibility: Primary or post-ET/PV MF; DIPSS Background: MF is a rare bone marrow cancer characterized by fibrosis, abnormal blood cell production, and dysregulated JAK/STAT signaling.1,2 Clinical manifestations include anemia, constitutional symptoms, and splenomegaly, which can negatively impact patient quality of life.3-5 Although approved JAK inhibitors (JAKi) may improve symptoms and splenomegaly, none actively treat anemia and some may exacerbate it; the efficacy of other agents currently used to manage anemia in MF (eg, DAN) is short-lived.6-8 MF-associated anemia is driven by chronic inflammation and due in part to resultant hyperactive ACVR1 signaling and elevated hepcidin levels.6 MMB is unique among JAKi in that it inhibits not only JAK1 and JAK2 to drive symptom and spleen improvements but also ACVR1 to drive anemia benefits, including increased serum iron and hemoglobin levels.9 In the SIMPLIFY trials, MMB was associated with improvements in symptoms, splenomegaly, and transfusion burden in both JAKi-naive and JAKi-experienced patients with MF.10,11 The pivotal phase 3 MOMENTUM study of MF patients previously treated with a JAKi tested MMB versus DAN on key symptom, anemia, and splenic end points. Methods: Eligibility: Primary or post-ET/PV MF; DIPSS response (24.6% vs 9.2%), TI (30.8% vs 20.0%), SRR25 (40.0% vs 6.2%), TSS change (-9.36 vs -3.13), SRR35 (23.1% vs 3.1%), and zero transfusions (35.4% vs 16.9%). Most common grade ≥3 treatment-emergent adverse events (TEAEs) in RT were thrombocytopenia (MMB, 22%; DAN, 12%) and anemia (MMB, 8%; DAN, 11%). TEAEs led to study drug discontinuation in 18% of MMB and 23% of DAN patients in RT. A trend toward improved survival up to week 24 was seen with MMB versus DAN (hazard ratio, 0.506; P = .0719). Conclusions: In symptomatic and anemic MF patients, MMB was superior to DAN for symptom responses, transfusion requirements, and spleen responses with comparable safety and favorable survival. MMB may improve MF patient care and quality of life by addressing a critical unmet need, particularly in patients with anemia. [ABSTRACT FROM AUTHOR]

Published
2022

29. Abstract 3847: The anti-hepcidin Spiegelmer® Lexaptepid Pegol (NOX-H94) as treatment of anemia of chronic disease in patients with multiple myeloma, low grade lymphoma, and CLL: A phase II pilot study

Author

Georgiev, Pencho, primary, Lazaroiu, Mihaela, additional, Ocroteala, Luminita, additional, Grudeva-Popova, Janet, additional, Gheorghita, Emanuil, additional, Vasilica, Mariana, additional, Popescu, Sanda M, additional, Cucuianu, Andrei, additional, Summo, Luciana, additional, Schwoebel, Frank, additional, Riecke, Kai, additional, and Ludwig, Heinz, additional

Published
2014
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