Efficacy and safety of single-agent belantamab mafodotin versus pomalidomide plus low-dose dexamethasone in patients with relapsed or refractory multiple myeloma (DREAMM-3): a phase 3, open-label, randomised study

Authors: Dimopoulos, Meletios Athanasios ^*, Hungria, Vania T M, Radinoff, Atanas, Delimpasi, Sosana, Mikala, Gabor, Masszi, Tamas, Li, Jian, Capra, Marcelo, Maiolino, Angelo, Pappa, Vasiliki, Chraniuk, Dominik, Osipov, Iurii, Leleu, Xavier, Low, Michael, Matsumoto, Morio, Sule, Neal, Li, Mary, McKeown, Astrid, He, Wei, Bright, Shelley, Currie, Brooke, Perera, Sue, Boyle, Julia, Roy-Ghanta, Sumita, Opalinska, Joanna, Weisel, Katja

Source: In The Lancet Haematology October 2023 10(10):e801-e812

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

Authors: 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, Kawashima, Jun

Source: In The Lancet 28 January 2023 401(10373):269-280

Once-per-week selinexor, bortezomib, and dexamethasone versus twice-per-week bortezomib and dexamethasone in patients with multiple myeloma (BOSTON): a randomised, open-label, phase 3 trial

Authors: Grosicki, Sebastian ^*, Simonova, Maryana, Spicka, Ivan, Pour, Ludek, Kriachok, Iryrna, Gavriatopoulou, Maria, Pylypenko, Halyna, Auner, Holger W, Leleu, Xavier, Doronin, Vadim, Usenko, Ganna, Bahlis, Nizar J, Hajek, Roman, Benjamin, Reuben, Dolai, Tuphan K, Sinha, Dinesh K, Venner, Christopher P, Garg, Mamta, Gironella, Mercedes, Jurczyszyn, Artur, Robak, Pawel, Galli, Monica, Wallington-Beddoe, Craig, Radinoff, Atanas, Salogub, Galina, Stevens, Don A, Basu, Supratik, Liberati, Anna M, Quach, Hang, Goranova-Marinova, Vesselina S, Bila, Jelena, Katodritou, Eirini, Oliynyk, Hanna, Korenkova, Sybiryna, Kumar, Jeevan, Jagannath, Sundar, Moreau, Phillipe, Levy, Moshe, White, Darrell, Gatt, Moshe E, Facon, Thierry, Mateos, Maria V, Cavo, Michele, Reece, Donna, Anderson, Larry D, Jr, Saint-Martin, Jean-Richard, Jeha, Jacqueline, Joshi, Anita A, Chai, Yi, Li, Lingling, Peddagali, Vishnuvardhan, Arazy, Melina, Shah, Jatin, Shacham, Sharon, Kauffman, Michael G, Dimopoulos, Meletios A, Richardson, Paul G, Delimpasi, Sosana

Source: In The Lancet 14-20 November 2020 396(10262):1563-1573

Transform-1: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, International Phase 3 Study of Navitoclax in Combination with Ruxolitinib Versus Ruxolitinib Plus Placebo in Patients with Untreated Myelofibrosis

Authors: Pemmaraju, Naveen, Mead, Adam J, Somervaille, Tim CP, McCloskey, James K, Palandri, Francesca, Koschmieder, Steffen, Lavie, David, Leber, Brian, Yeh, Su-Peng, Gómez-Casares, Maria Teresa, Ammatuna, Emanuele, Shin, Ho-Jin, Kirito, Keita, Jourdan, Eric, Devos, Timothy, Chuah, Hun S, Radinoff, Atanas, Bogdanovic, Andrija, Moskal, Rastislav, Jiang, Qi, Chopra, Avijeet S, Papadopoulos, Elektra, Potluri, Jalaja, Passamonti, Francesco

Source: In Blood 2 November 2023 142 Supplement 1:620-620

Impact of Long-Term Treatment with Belantamab Mafodotin on Safety and Efficacy Outcomes in Patients with Relapsed/Refractory Multiple Myeloma in DREAMM-3

Authors: Hungria, Vania T.M, Weisel, Katja, Radinoff, Atanas, Delimpasi, Sosana, Mikala, Gabor, Masszi, Tamas, Li, Jian, Capra, Marcelo, Maiolino, Angelo, Pappa, Vasiliki, Chraniuk, Dominik, Osipov, Iurii, Leleu, Xavier, Low, Michael, Matsumoto, Morio, Li, Mary, Sule, Neal, Polinkovsky, Margaret, Davis, Randy, Bright, Shelley, McKeown, Astrid, Opalinska, Joanna, Dimopoulos, Meletios Athanasios

Source: In Blood 2 November 2023 142 Supplement 1:3357-3357

MM-509 A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Single-Agent Belantamab Mafodotin (Belamaf) Compared With Pomalidomide Plus Low-Dose Dexamethasone (Pd) in Patients With Relapsed or Refractory Multiple Myeloma (RRMM) (DREAMM-3)

Authors: Weisel, Katja, Hungria, Vania T.M., Radinoff, Atanas, Delimpasi, Sosana, Gabor, Mikala, Masszi, Tamas, Li, Jian, Capra, Marcelo, Matsumoto, Morio, Sule, Neal, Li, Mary, McKeown, Astrid, He, Wei, Bright, Shelley, Currie, Brooke, Boyle, Julia, Opalinska, Joanna, Dimopoulos, Meletios Athanasios

Source: In Clinical Lymphoma, Myeloma and Leukemia September 2023 23 Supplement 1:S504-S505

POSTER: MM-509 A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Single-Agent Belantamab Mafodotin (Belamaf) Compared With Pomalidomide Plus Low-Dose Dexamethasone (Pd) in Patients With Relapsed or Refractory Multiple Myeloma (RRMM) (DREAMM3)

Authors: Weisel, Katja, Hungria, Vania T.M., Radinoff, Atanas, Delimpasi, Sosana, Gabor, Mikala, Masszi, Tamas, Li, Jian, Capra, Marcelo, Matsumoto, Morio, Sule, Neal, Li, Mary, McKeown, Astrid, He, Wei, Bright, Shelley, Currie, Brooke, Boyle, Julia, Opalinska, Joanna, Dimopoulos, Meletios Athanasios

Source: In Clinical Lymphoma, Myeloma and Leukemia September 2023 23 Supplement 1:S223-S223

S210: AN OPEN‐LABEL, GLOBAL, PHASE (PH) 1B/2 STUDY ADDING NAVTEMADLIN (NVTM) TO RUXOLITINIB (RUX) IN PATIENTS (PTS) WITH PRIMARY OR SECONDARY MYELOFIBROSIS (MF) WHO HAVE A SUBOPTIMAL RESPONSE TO RUX.

Authors: Mascarenhas, John, Jain, Tania, Otoukesh, Salman, Gerds, Aaron T., Lucchesi, Alessandro, Romina Sosa, Iberia, Laribi, Kamel, Mishchenko, Elena, Radinoff, Atanas, Benevolo, Giulia, Vannucchi, Alessandro M., Boyer, Francoise, Quittet, Philippe, Radsak, Markus, Machet, Antoine, Bose, Prithviraj, Huang, Zhuying, Qamoos, Hope, Mcgreivy, Jesse, Rothbaum, Wayne P.

Source: HemaSphere; 2023 Supplement 3, Vol. 7, p1-3, 3p

Case of Non-Langerhans Cell Histiocytosis in a Person Living with HIV - Clinical and Therapeutic Challenge.

Authors: Yancheva, Nina, Strashimirov, Dimitar, Dardanov, Dragomir, Kamenov, Bojidar, Radinoff, Atanas

Source: Journal of the International Association of Providers of AIDS Care; 6/30/2022, p1-4, 4p

Clinical Outcomes in Patients (Pts) with Dose Reduction of Selinexor in Combination with Bortezomib, and Dexamethasone (XVd) in Previously Treated Multiple Myeloma from the Boston Study

Authors: Jagannath, Sundar, Facon, Thierry, Badros, Ashraf Z., Levy, Moshe, Moreau, Philippe, Delimpasi, Sosana, Simonova, Maryana, Spicka, Ivan, Kriachok, Iryna, Gavriatopoulou, Maria, Pylypenko, Halyna, Auner, Holger W, Leleu, Xavier, Doronin, Vadim, Usenko, Ganna, Hajek, Roman, Benjamin, Reuben, Dolai, Tuphan Kanti, Sinha, Dinesh Kumar, Venner, Chris P., Garg, Mamta, Gironella Mesa, Mercedes, Jurczyszyn, Artur, Robak, Tadeusz, Galli, Monica, Wallington-Beddoe, Craig Thomas, Radinoff, Atanas, Salogub, Galina, Stevens, Don, Basu, Supratik, Liberati, Anna Marina, Quach, Hang, Goranova Marinova, Veselina S, Bila, Jelena Sreten, Katodritou, Eirini, DeCastro, Andrew, Chai, Yi, Van Domelen, Dane R., Mishal, Moran, Bentur, Ohad S., Shah, Jatin, Shacham, Sharon, Kauffman, Michael G., Grosicki, Sebastian, Richardson, Paul G.

Source: In Blood 23 November 2021 138 Supplement 1:3793-3793

MDS-344: Pevonedistat Plus Azacitidine vs Azacitidine Alone in Higher-Risk Myelodysplastic Syndromes (MDS): Efficacy and Safety Results from Study P-2001 (NCT02610777)

Authors: Watts, Justin, Sekeres, Mikkael, Radinoff, Atanas, Arnan, Montserrat, Cerrano, Marco, Lopez, Patricia Font, Zeidner, Joshua, Campelo, Maria Diez, Graux, Carlos, Liesveld, Jane, Selleslag, Dominik, Tzvetkov, Nikolai, Fram, Robert, Zhao, Dan, Friedlander, Sharon, Galinsky, Kevin, Faller, Douglas, Adès, Lionel

Source: In Clinical Lymphoma, Myeloma and Leukemia September 2021 21 Supplement 1:S347-S348

Poster: MDS-344: Pevonedistat Plus Azacitidine vs Azacitidine Alone in Higher-Risk Myelodysplastic Syndromes (MDS): Efficacy and Safety Results from Study P-2001 (NCT02610777)

Authors: Watts, Justin, Sekeres, Mikkael, Radinoff, Atanas, Arnan, Montserrat, Cerrano, Marco, Lopez, Patricia Font, Zeidner, Joshua, Campelo, Maria Diez, Graux, Carlos, Liesveld, Jane, Selleslag, Dominik, Tzvetkov, Nikolai, Fram, Robert, Zhao, Dan, Friedlander, Sharon, Galinsky, Kevin, Faller, Douglas, Adès, Lionel

Source: In Clinical Lymphoma, Myeloma and Leukemia September 2021 21 Supplement 1:S227-S227

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An Open Label, Phase 2 Study to Assess the Efficacy and Safety of Tenalisib (RP6530), a PI3K δ/γ and SIK3 Inhibitor, in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)

Authors: Grosicki, Sebastian, Iosava, Genadi ^*, Zodelava, Mamia ^*, Tzvetkov, Nikolay ^*, Robak, Tadeusz, Radinoff, Atanas ^*, Routhu, Kasi Viswanath ^*, Barde, Prajak ^*, Nair, Ajit Mohanchandran ^*

Source: In Blood 5 November 2020 136 Supplement 1:25-25

MDS-336: Phase 2 Study of Pevonedistat + Azacitidine versus Azacitidine in Patients with Higher-Risk Myelodysplastic Syndromes (MDS)/Chronic Myelomonocytic Leukemia (CMML) or Low-Blast Acute Myelogenous Leukemia (LB-AML) (NCT02610777): Subset Analysis in Higher-Risk MDS

Authors: Watts, Justin, Adès, Lionel, Radinoff, Atanas, Sangerman, Montserrat Arnan, Cerrano, Marco, Lopez, Patricia Font, Zeidner, Joshua, Campelo, Maria Diez, Graux, Carlos, Liesveld, Jane, Selleslag, Dominik, Tzvetkov, Nikolay, Fram, Robert J., Zhao, Dan, Bell, Jill, Friedlander, Sharon, Faller, Douglas V., Sekeres, Mikkael A.

Source: In Clinical Lymphoma, Myeloma and Leukemia September 2020 20 Supplement 1:S323-S324

S199: A PHASE 3, OPEN‐LABEL, RANDOMIZED STUDY EVALUATING THE EFFICACY AND SAFETY OF SINGLE AGENT BELANTAMAB MAFODOTIN VS POMALIDOMIDE PLUS DEXAMETHASONE IN RELAPSED/REFRACTORY MULTIPLE MYELOMA (DREAMM‐3)

Authors: Dimopoulos, Meletios A., Hungria, Vania, Radinoff, Atanas, Delimpasi, Sosana, Mikala, Gabor, Masszi, Tamas, LI, Jian, Capra, Marcelo Eduardo, Matsumoto, Morio, Sule, Neal, LI, Mary, Mckeown, Astrid, He, Wei, Bright, Shelley, Currie, Brooke, Boyle, Julia, Opalinska, Joanna, Weisel, Katja

Source: HemaSphere; 2023 Supplement 3, Vol. 7, p1-2, 2p

A phase III randomized, multicentre, double blind, active controlled trial to compare the efficacy and safety of two different anagrelide formulations in patients with essential thrombocythaemia – the TEAM‐ET 2·0 trial.

Authors: Gisslinger, Heinz, Buxhofer‐Ausch, Veronika, Hodisch, Juri, Radinoff, Atanas, Karyagina, Elena, Kyrcz‐Krzemień, Slawomira, Abdulkadyrov, Kudrat, Gerbutavicius, Rolandas, Melikyan, Anait, Burgstaller, Sonja, Hus, Marek, Kłoczko, Janusz, Yablokova, Vera, Tzvetkov, Nikolay, Całbecka, Malgorzata, Shneyder, Tatyana, Warzocha, Krzysztof, Jurgutis, Mindaugas, Kaplanov, Kamil, Jilma, Bernd

Source: British Journal of Haematology; May2019, Vol. 185 Issue 4, p691-700, 10p, 1 Diagram, 3 Charts, 2 Graphs

Subject Terms: PLATELET count, THERAPEUTICS, BLIND people, CONFIDENCE intervals, SAFETY

Six-year safety and efficacy results from the CHRONOS-1 study of the PI3K inhibitor copanlisib in patients with relapsed or refractory follicular lymphoma.

Authors: Dreyling, Martin H.¹ (AUTHOR), Santoro, Armando² (AUTHOR), Leppä, Sirpa³ (AUTHOR), Demeter, Judit⁴ (AUTHOR), Follows, George⁵ (AUTHOR), Lenz, Georg⁶ (AUTHOR), Kim, Won Seog⁷ (AUTHOR), Mollica, Luigina⁸ (AUTHOR), Nagler, Arnon⁹ (AUTHOR), Diong, Colin Phipps¹⁰ (AUTHOR), Provencio, Mariano¹¹ (AUTHOR), Magagnoli, Massimo¹² (AUTHOR), Radinoff, Atanas¹³ (AUTHOR), Munoz, Javier¹⁴ (AUTHOR), Cao, Anjun¹⁵ (AUTHOR), Hiemeyer, Florian¹⁶ (AUTHOR), Odongo, Fatuma¹⁷ (AUTHOR), Garcia-Vargas, Jose E.¹⁵ (AUTHOR), Childs, Barrett H.¹⁵ (AUTHOR), Zinzani, Pier Luigi¹⁸ (AUTHOR)

Source: Journal of Clinical Oncology. 2023 Supplement 16, Vol. 41, p7555-7555. 1p.

A phase 3, open-label, randomized study to evaluate the efficacy and safety of single-agent belantamab mafodotin (belamaf) compared to pomalidomide plus low-dose dexamethasone (Pd) in patients (pts) with relapsed/refractory multiple myeloma (RRMM): DREAMM-3

Authors: Weisel, Katja¹ (AUTHOR), Hungria, Vania TM² (AUTHOR), Radinoff, Atanas³ (AUTHOR), Delimpasi, Sosana⁴ (AUTHOR), Mikala, Gabor⁵ (AUTHOR), Masszi, Tamas⁶ (AUTHOR), Li, Jian⁷ (AUTHOR), Capra, Marcelo⁸ (AUTHOR), Matsumoto, Morio⁹ (AUTHOR), Sule, Neal¹⁰ (AUTHOR), Li, Mary¹⁰ (AUTHOR), McKeown, Astrid¹¹ (AUTHOR), He, Wei¹² (AUTHOR), Bright, Shelley¹⁰ (AUTHOR), Currie, Brooke¹³ (AUTHOR), Boyle, Julia¹⁴ (AUTHOR), Opalinska, Joanna¹⁰ (AUTHOR), Dimopoulos, Meletios A.¹⁵ (AUTHOR)

Source: Journal of Clinical Oncology. 2023 Supplement 16, Vol. 41, p8007-8007. 1p.

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