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1. Mass spectrometry–based assessment of M protein in peripheral blood during maintenance therapy in multiple myeloma

Author

Kubicki, Tadeusz, Dytfeld, Dominik, Barnidge, David, Sakrikar, Dhananjay, Przybyłowicz-Chalecka, Anna, Jamroziak, Krzysztof, Robak, Paweł, Czyż, Jarosław, Tyczyńska, Agata, Druzd-Sitek, Agnieszka, Giannopoulos, Krzysztof, Wróbel, Tomasz, Nowicki, Adam, Szczepaniak, Tomasz, Łojko-Dankowska, Anna, Matuszak, Magdalena, Gil, Lidia, Puła, Bartosz, Szukalski, Łukasz, Końska, Agnieszka, Zaucha, Jan Maciej, Walewski, Jan, Mikulski, Damian, Czabak, Olga, Robak, Tadeusz, Jiang, Ken, Cooperrider, Jennifer H., Jakubowiak, Andrzej J., and Derman, Benjamin A.

Published
2024
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3. 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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5. Ixazomib plus daratumumab and dexamethasone: Final analysis of a phase 2 study among patients with relapsed/refractory multiple myeloma.

Author

Delimpasi, Sosana, Dimopoulos, Meletios A., Straub, Jan, Symeonidis, Argiris, Pour, Luděk, Hájek, Roman, Touzeau, Cyrille, Bhanderi, Viralkumar K., Berdeja, Jesus G., Pavlíček, Petr, Matous, Jeffrey V., Robak, Pawel J., Suryanarayan, Kaveri, Miller, Alison, Villarreal, Miguel, Cherepanov, Dasha, Srimani, Jaydeep K., Yao, Huilan, Labotka, Richard, and Orlowski, Robert Z.

Published
2024
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6. 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

Author

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, and Delimpasi, Sosana

Published
2020
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7. Efficacy of daratumumab monotherapy in real-world heavily pretreated patients with relapsed or refractory multiple myeloma

Author

Salomon-Perzyński, Aleksander, Walter-Croneck, Adam, Usnarska-Zubkiewicz, Lidia, Dytfeld, Dominik, Zielińska, Patrycja, Wojciechowska, Małgorzata, Hołojda, Jadwiga, Robak, Paweł, Pasternak, Anna, Knopińska-Posłuszny, Wanda, Hawrylecka, Dorota, Wójtowicz, Marcin, Szeremet, Agnieszka, Osowiecki, Michał, Mordak-Domagała, Monika, Zaucha, Jan Maciej, Giannopoulos, Krzysztof, Warzocha, Krzysztof, and Jamroziak, Krzysztof

Published
2019
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8. Pomalidomide, bortezomib, and dexamethasone for patients with relapsed or refractory multiple myeloma previously treated with lenalidomide (OPTIMISMM): a randomised, open-label, phase 3 trial

Author

Abildgaard, Niels, Adler, Howard, Altuntas, Fevzi, Akay, Olga Meltem, Amin, Bipinkumar, Anagnostopoulos, Achilleas, Anderson, Larry, Anttila, Pekka, Araujo, Carla, Arce-Lara, Carlos, Aydin, Yildiz, Basu, Supratik, Battini, Ramakrishna, Beeker, Thaddeus, Benboubker, Lotfi, Ben-Yehuda, Dina, Bladé, Joan, Blau, Igor Wolfgang, Boccia, Ralph, Burke, Lillian, Byeff, Peter, Cascavilla, Nicola, Cavo, Michele, Chantry, Andrew, Charles, Yen, Chaudhry, Arvind, Corso, Alessandro, Coyne, Mark, De Arriba, Felipe, Delimpasi, Sosana, Desjardins, Pierre, Dhakal, Binod, Di Bartolomeo, Paolo, Di Raimondo, Francesco, Dürig, Jan, Engelhardt, Monika, Escoffre-Barbe, Martine, Esteves, Graca, Flogegard, Max, Gabrail, Nashat, Gamberi, Barbara, Garrison, Mitchell, Gay, Julie, Gisslinger, Heinz, Goldschmidt, Hartmut, Goncalves, Cristina, Gressot, Laurent, Grosicki, Sebastian, Hanna, Wahid, Hayden, Patrick, Henriques Bernardo, Maria Manuela, Hermann, Robert, Holden, Viran, Honkalehto, Kirsti, Huben, Marianne, Huffman, John, Hunter, Hannah, Hus, Marek, Jagasia, Madan, Jagganath, Sundar, Janakiram, Murali, Jaiyesimi, Ishmael, Jenner, Matthew, João, Cristina, Johnson, Peter, Jurcyszyn, Artur, Kalayoğlu Beşişik, Sevgi, Kambhampati, Suman, Kanate, Abraham, Karadoğan, Ihsan, Khojasteh, Ali, Kirkel, Dean, Komarnicki, Mieczyslaw, Krauth, Maria-Theresa, Kuriakose, Phillip, Larocca, Alessandra, Lauri, Birgitta, Leleu, Xavier, Lucio, Paulo, Luppi, Mario, Mangiacavalli, Silvia, Mariette, Clara, Matsue, Kosei, Mellqvist, Ulf-Henri, Mendeleeva, Larisa, Meshad, Michael, Miller, Carole, Mohrbacher, Ann, Moreau, Philippe, Morelli, Anna Maria, Müldür, Ercan, Naassan, Anthony, Nahi, Hareth, Nair, Rajesh, O'Dwyer, Mike, Öngören Aydin, Seniz, Openshaw, Thomas, O'Rourke, Timothy, Osswald, Michael, Overton, Lindsay, Pati, Asmin, Pavic, Michel, Pegourie, Brigitte, Pehlivan, Mustafa, Pierola, Ana Alfonso, Plesner, Torben, Pluta, Andrzej, Rabin, Neil, Ramasamy, Karthik, Rambaldi, Alessandro, Rodriguez, Paula, Röllig, Christoph, Rosenblatt, Jacalyn, Rosenbluth, Jonathan, Salomo, Morten, Samoylova, Olga, Sastre Moral, Jose, Sati, Hamdi, Selleri, Carmine, Shafeek, Salim, Shinagawa, Atsushi, Sleckman, Bethany, Smith, Clay, Sonmez, Mehmet, Stone, Chester, Streetly, Matthew, Suzuki, Kenshi, Taetle, Raymond, Tafuri, Agostino, Takezako, Naoki, Teke, Hava Üsküdar, Vapaatalo, Mirja, Vassilopoulos, George, Verma, Amit, Vidito, Sarah, Viterbo, Luisa, Vural, Filiz, Wang, Xiang Sean, Yağci, Munci, Yee, Andrew, Richardson, Paul G, Oriol, Albert, Beksac, Meral, Liberati, Anna Marina, Galli, Monica, Schjesvold, Fredrik, Lindsay, Jindriska, Weisel, Katja, White, Darrell, Facon, Thierry, San Miguel, Jesus, Sunami, Kazutaka, O'Gorman, Peter, Sonneveld, Pieter, Robak, Pawel, Semochkin, Sergey, Schey, Steve, Yu, Xin, Doerr, Thomas, Bensmaine, Amine, Biyukov, Tsvetan, Peluso, Teresa, Zaki, Mohamed, Anderson, Kenneth, and Dimopoulos, Meletios

Published
2019
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9. Results from the randomized phase 3 DREAMM-8 study of belantamab mafodotin plus pomalidomide and dexamethasone (BPd) vs pomalidomide plus bortezomib and dexamethasone (PVd) in relapsed/refractory multiple myeloma (RRMM).

Author

Trudel, Suzanne, Beksac, Meral, Pour, Luděk, Delimpasi, Sosana, Quach, Hang, Vorobyev, Vladimir I., Cavo, Michele, Suzuki, Kazuhito, Robak, Pawel, Morris, Kristin, Phillips-Jones, Amy, Zhou, Xiaoou Linnette, Fulci, Giulia, Sule, Neal, Kremer, Brandon, Opalinska, Joanna, Mateos, Maria-Victoria, and Dimopoulos, Meletios Athanasios

Published
2024
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16. MM-557 DREAMM-7 Update: Subgroup Analyses From a Phase 3 Trial of Belantamab Mafodotin (Belamaf) + Bortezomib and Dexamethasone (BVd) vs Daratumumab, Bortezomib, and Dexamethasone (DVd) in Relapsed/Refractory Multiple Myeloma (RRMM)

Author

Victoria, Maria, Robak, Pawel, Hus, Marek, Fu, ChengCheng, Zherebtsova, Vera, Ward, Christopher, Ho, P. Joy, de Almeida, Ana Carolina, Hajek, Roman, Kim, Kihyun, Dimopoulos, Meletios, Cerchione, Claudio, Pirooz, Nick, McKeown, Astrid, Kazeem, Benga, Baig, Hena, Eccersley, Lydia, Roy-Ghanta, Sumita, Opalinska, Joanna, and Hungria, Vania

Published
2024
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17. MM-542 Patient-Reported Outcomes From the DREAMM-7 Randomized Phase 3 Study Comparing Belantamab Mafodotin (Belamaf), Bortezomib, and Dexamethasone vs Daratumumab Bortezomib, and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma

Author

Hungria, Vania, Robak, Pawel, Hus, Marek, Fu, ChengCheng, Zherebtsova, Vera, Ward, Christopher, de Almeida, Ana Carolina, Ho, P. Joy, Hajek, Roman, Cerchione, Claudio, Pirooz, Nick, McKeown, Astrid, Baig, Hena, Eccersley, Lydia, Pompilus, Farrah, McNamara, Simon, Paul Lin, Chee, Roy-Ghanta, Sumita, Opalinska, Joanna, and Victoria, Maria

Published
2024
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18. DREAMM-7 Update: Subgroup Analyses From a Phase 3 Trial of Belantamab Mafodotin (Belamaf) + Bortezomib and Dexamethasone (BVd) vs Daratumumab, Bortezomib, and Dexamethasone (DVd) in Relapsed/Refractory Multiple Myeloma (RRMM)

Author

Mateos, Maria Victoria, Robak, Pawel, Hus, Marek, Fu, ChengCheng, Zherebtsova, Vera, Ward, Christopher, Joy Ho, P., Carolina de Almeida, Ana, Hajek, Roman, Kim, Kihyun, Dimopoulos, Meletios, Cerchione, Claudio, Pirooz, Nick, McKeown, Astrid, Kazeem, Benga, Baig, Hena, Eccersley, Lydia, Roy-Ghanta, Sumita, Opalinska, Joanna, and Hungria, Vania

Published
2024
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19. Patient-Reported Outcomes From the DREAMM-7 Randomized Phase 3 Study Comparing Belantamab Mafodotin (Belamaf), Bortezomib, and Dexamethasone vs Daratumumab, Bortezomib, and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma

Author

Hungria, Vania, Robak, Pawel, Hus, Marek, Fu, ChengCheng, Zherebtsova, Vera, Ward, Christopher, Carolina de Almeida, Ana, Joy Ho, P., Hajek, Roman, Cerchione, Claudio, Pirooz, Nick, McKeown, Astrid, Baig, Hena, Eccersley, Lydia, Pompilus, Farrah, McNamara, Simon, Paul Lin, Chee, Roy-Ghanta, Sumita, Opalinska, Joanna, and Victoria Mateos, Maria

Published
2024
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20. Efficacy and Safety of Oral Ixazomib (Ixa), Intravenous (IV) Daratumumab (Dara), and IV/Oral Dexamethasone (Dex; IDd) in Patients (Pts) with Relapsed/Refractory Multiple Myeloma (RRMM) and 1-3 Prior Therapies: Results of the Final Analysis of a Phase 2 Study

Author

Delimpasi, Sosana, Dimopoulos, Meletios A., Straub, Jan, Symeonidis, Argiris, Hájek, Roman, Touzeau, Cyrille, Bhanderi, Viralkumar K., Berdeja, Jesus, Pavlíček, Petr, Matous, Jeffrey V., Robak, Pawel J., Suryanarayan, Kaveri, Villareal, Miguel, Cherepanov, Dasha, Srimani, Jaydeep K., Yao, Huilan, Labotka, Richard, and Orlowski, Robert Z.

Published
2022
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21. Pomalidomide, bortezomib, and dexamethasone at first relapse in lenalidomide-pretreated myeloma: A subanalysis of OPTIMISMM by clinical characteristics

Author

Richardson, Paul G. Schjesvold, Fredrik Weisel, Katja and Moreau, Philippe Anderson, Jr., Larry D. White, Darrell and Rodriguez-Otero, Paula Sonneveld, Pieter Engelhardt, Monika and Jenner, Matthew Corso, Alessandro Duerig, Jan Pavic, Michel and Salomo, Morten Beksac, Meral Oriol, Albert Lindsay, Jindriska Liberati, Anna Marina Galli, Monica Robak, Pawel and Larocca, Alessandra Yagci, Munci Vural, Filiz Kanate, Abraham S. Jiang, Ruiyun Grote, Lara Peluso, Teresa and Dimopoulos, Meletios

Abstract

Objective We evaluated the efficacy and safety of pomalidomide, bortezomib, and dexamethasone (PVd) vs bortezomib and dexamethasone (Vd) by age, renal function, and high-risk cytogenetic abnormalities in lenalidomide-pretreated patients with multiple myeloma at first relapse. Methods OPTIMISMM was a phase 3, multicenter, open-label, randomized study (NCT01734928; N = 559). The primary endpoint was progression-free survival (PFS). Results Overall, 226 patients had received one prior line of therapy. PVd significantly prolonged PFS vs Vd in patients aged 65 years (median, 17.6 vs 9.9 months; P = .0369). Median PFS in patients with renal impairment (RI; creatinine clearance

Published
2022

22. 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 H. Dimopoulos, Meletios-Athanasios and Delimpasi, Sosana Robak, Pawel Coriu, Daniel Legiec, Wojciech Pour, Ludek Spicka, Ivan Masszi, Tamas Doronin, Vadim Minarik, Jiri Salogub, Galina Alekseeva, Yulia and Lazzaro, Antonio Maisnar, Vladimir Mikala, Gabor Rosinol, Laura Liberati, Anna Marina Symeonidis, Argiris Moody, Victoria Thuresson, Marcus Byrne, Catriona Harmenberg, Johan and Bakker, Nicolaas A. Hajek, Roman Mateos, Maria-Victoria and Richardson, Paul G. Sonneveld, Pieter OCEAN OP-103 Investigators

Abstract

Background Melphalan flufenamide (melflufen), an alkylating peptide-drug conjugate, plus dexamethasone showed clinical activity and manageable safety in the phase 2 HORIZON study. We aimed to determine whether melflufen plus dexamethasone would provide a progression-free survival benefit compared with pomalidomide plus dexamethasone in patients with previously treated multiple myeloma. Methods In this randomised, open-label, head-to-head, phase 3 study (OCEAN), adult patients (aged >= 18 years) were recruited from 108 university hospitals, specialist hospitals, and community-based centres in 21 countries across Europe, North America, and Asia. Eligible patients had an ECOG performance status of 0-2; must have had relapsed or refractory multiple myeloma, refractory to lenalidomide (within 18 months of randomisation) and to the last line of therapy; and have received two to four previous lines of therapy (including lenalidomide and a proteasome inhibitor). Patients were randomly assigned (1:1), stratified by age, number of previous lines of therapy, and International Staging System score, to either 28-day cycles of melflufen and dexamethasone (melflufen group) or pomalidomide and dexamethasone (pomalidomide group). All patients received dexamethasone 40 mg orally on days 1, 8, 15, and 22 of each cycle. In the melflufen group, patients received melflufen 40 mg intravenously over 30 min on day 1 of each cycle and in the pomalidomide group, patients received pomalidomide 4 mg orally daily on days 1 to 21 of each cycle. The primary endpoint was progression-free survival assessed by an independent review committee in the intention-to-treat (ITT) population. Safety was assessed in patients who received at least one dose of study medication. This study is registered with ClinicalTrials.gov, NCT03151811, and is ongoing. Findings Between June 12, 2017, and Sept 3, 2020, 246 patients were randomly assigned to the melflufen group (median age 68 years [IQR 60-72]; 107 [43%] were female) and 249 to the pomalidomide group (median age 68 years [IQR 61-72]; 109 [44%] were female). 474 patients received at least one dose of study drug (melflufen group n=228; pomalidomide group n=246; safety population). Data cutoff was Feb 3, 2021. Median progression-free survival was 6middot8 months (95% CI 5middot0-8middot5; 165 [67%] of 246 patients had an event) in the melflufen group and 4middot9 months (4middot2-5middot7; 190 [76%] of 249 patients had an event) in the pomalidomide group (hazard ratio [HR] 0middot79, [95% CI 0middot64-0middot98]; p=0middot032), at a median follow-up of 15middot5 months (IQR 9middot4-22middot8) in the melflufen group and 16middot3 months (10middot1-23middot2) in the pomalidomide group. Median overall survival was 19middot8 months (95% CI 15middot1-25middot6) at a median follow-up of 19middot8 months (IQR 12middot0-25middot0) in the melflufen group and 25middot0 months (95% CI 18middot1-31middot9) in the pomalidomide group at a median follow-up of 18middot6 months (IQR 11middot8-23middot7; HR 1middot10 [95% CI 0middot85-1middot44]; p=0middot47). The most common grade 3 or 4 treatment-emergent adverse events were thrombocytopenia (143 [63%] of 228 in the melflufen group vs 26 [11%] of 246 in the pomalidomide group), neutropenia (123 [54%] vs 102 [41%]), and anaemia (97 [43%] vs 44 [18%]). Serious treatment-emergent adverse events occurred in 95 (42%) patients in the melflufen group and 113 (46%) in the pomalidomide group, the most common of which were pneumonia (13 [6%] vs 21 [9%]), COVID-19 pneumonia (11 [5%] vs nine [4%]), and thrombocytopenia (nine [4%] vs three [1%]). 27 [12%] patients in the melflufen group and 32 [13%] in the pomalidomide group had fatal treatment-emergent adverse events. Fatal treatment-emergent adverse events were considered possibly treatment related in two patients in the melflufen group (one with acute myeloid leukaemia, one with pancytopenia and acute cardiac failure) and four patients in the pomalidomide group (two patients with pneumonia, one with myelodysplastic syndromes, one with COVID-19 pneumonia). Interpretation Melflufen plus dexamethasone showed superior progression-free survival than pomalidomide plus dexamethasone in patients with relapsed or refractory multiple myeloma. Funding Oncopeptides AB Copyright (c) 2022 Elsevier Ltd. All rights reserved.

Published
2022

24. Long-Term Outcomes from the Phase 3 OCEAN (OP-103) Study: Melflufen and Dexamethasone (Dex) Versus Pomalidomide (Pom) and Dex in Relapsed Refractory Multiple Myeloma (RRMM)

Author

Schjesvold, Fredrik, Dimopoulos, Meletios A., Delimpasi, Sosana, Robak, Pawel, Coriu, Daniel, Legiec, Wojciech Maciej, Pour, Ludek, Spicka, Ivan, Masszi, Tamas, Doronin, Vadim Anatolievich, Minarik, Jiri, Salogub, Galina, Alexeeva, Yulia, Lazzaro, Antonio, Maisnar, Vladimir, Mikala, Gabor, Norin, Stefan, Thuresson, Marcus, Bergan, Anna, Obermüller, Jakob, Hajek, Roman, Mateos, Maria-Victoria, Richardson, Paul G., and Sonneveld, Pieter

Published
2023
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25. Longitudinal Assessment of Minimal Residual Disease (MRD) in the ATLAS Randomized Phase 3 Trial of Post-Transplant Treatment with Carfilzomib, Lenalidomide, and Dexamethasone (KRd) Versus Lenalidomide (R) Alone in Patients with Newly Diagnosed Multiple Myeloma (NDMM)

Author

Kubicki, Tadeusz, Dytfeld, Dominik, Wrobel, Tomasz, Jamroziak, Krzysztof, Robak, Pawel, Czyz, Jaroslaw, Tyczynska, Agata, Druzd-Sitek, Agnieszka, Giannopoulos, Krzysztof, Nowicki, Adam, Szczepaniak, Tomasz, Lojko-Dankowska, Anna, Matuszak, Magdalena, Gil, Lidia, Pula, Bartosz Michal, Rybka, Justyna, Majcherek, Maciej, Usnarska-Zubkiewicz, Lidia, Szukalski, Lukasz, Konska, Agnieszka, Zaucha, Jan M., Walewski, Jan, Mikulski, Damian, Czabak, Olga, Robak, Tadeusz, Kruk-Kwapisz, Dorota, Lahoud, Oscar Boutros, Zonder, Jeffrey A., Griffith, Kent, Stefka, Andrew T, Jiang, Ken, Cooperrider, Jennifer H, Derman, Ben A, and Jakubowiak, Andrzej J

Published
2023
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26. Mass Spectrometry-Based Assessment of M-Protein in Peripheral Blood during Maintenance Therapy in Multiple Myeloma (MM) in the Phase III ATLAS Trial

Author

Kubicki, Tadeusz, Dytfeld, Dominik, Barnidge, David, Sakrikar, DJ, Lakos, Gabriella, Przybylowicz-Chalecka, Anna, Jamroziak, Krzysztof, Robak, Pawel, Czyz, Jaroslaw, Tyczynska, Agata, Druzd-Sitek, Agnieszka, Giannopoulos, Krzysztof, Wrobel, Tomasz, Nowicki, Adam, Szczepaniak, Tomasz, Lojko-Dankowska, Anna, Matuszak, Magdalena, Gil, Lidia, Pula, Bartosz Michal, Szukalski, Lukasz, Konska, Agnieszka, Zaucha, Jan M., Walewski, Jan, Mikulski, Damian, Czabak, Olga, Robak, Tadeusz, Jiang, Ken, Cooperrider, Jennifer H, Jakubowiak, Andrzej J, and Derman, Benjamin A

Published
2023
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27. Health-Related Quality of Life in Polish Patients with Multiple Myeloma Treated in the Phase 3 ATLAS Trial of Post-Transplant Maintenance with Carfilzomib, Lenalidomide, Dexamethasone or Lenalidomide Alone

Author

Kubicki, Tadeusz, Derman, Ben A, Jamroziak, Krzysztof, Robak, Pawel, Czyz, Jaroslaw, Tyczynska, Agata, Druzd-Sitek, Agnieszka, Giannopoulos, Krzysztof, Wrobel, Tomasz, Nowicki, Adam, Szczepaniak, Tomasz, Lojko-Dankowska, Anna, Matuszak, Magdalena, Gil, Lidia, Pula, Bartosz Michal, Szukalski, Lukasz, Konska, Agnieszka, Zaucha, Jan M., Walewski, Jan, Mikulski, Damian, Czabak, Olga, Robak, Tadeusz, Kruk-Kwapisz, Dorota, Jakubowiak, Andrzej J, and Dytfeld, Dominik

Published
2023
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28. P-397 Polyclonal immunoglobulin recovery in myeloma patients receiving maintenance after autologous hematopoietic stem cell transplantation with carfilzomib, lenalidomide and dexamethasone or lenalidomide

Author

Kubicki, Tadeusz, Dytfeld, Dominik, Wrobel, Tomasz, Jamroziak, Krzysztof, Robak, Pawel, Czyz, Jaroslaw, Tyczynska, Agata, Druzd-Sitek, Agnieszka, Giannopoulos, Krzysztof, Nowicki, Adam, Lojko-Dankowska, Anna, Matuszak, Magdalena, Gil, Lidia, Pula, Bartosz, Rybka, Justyna, Usnarska-Zubkiewicz, Lidia, Czabak, Olga, Stefka, Andrew, Jiang, Ken, Derman, Benjamin, and Jakubowiak, Andrzej

Published
2023
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32. Pomalidomide, bortezomib, and dexamethasone at first relapse in lenalidomide‐pretreated myeloma: A subanalysis of OPTIMISMM by clinical characteristics.

Author

Richardson, Paul G., Schjesvold, Fredrik, Weisel, Katja, Moreau, Philippe, Anderson, Larry D., White, Darrell, Rodriguez‐Otero, Paula, Sonneveld, Pieter, Engelhardt, Monika, Jenner, Matthew, Corso, Alessandro, Dürig, Jan, Pavic, Michel, Salomo, Morten, Beksac, Meral, Oriol, Albert, Lindsay, Jindriska, Liberati, Anna Marina, Galli, Monica, and Robak, Pawel

Subjects
MULTIPLE myeloma, BORTEZOMIB, PROGNOSIS, DEXAMETHASONE, PROGRESSION-free survival
Abstract

Objective: We evaluated the efficacy and safety of pomalidomide, bortezomib, and dexamethasone (PVd) vs bortezomib and dexamethasone (Vd) by age, renal function, and high‐risk cytogenetic abnormalities in lenalidomide‐pretreated patients with multiple myeloma at first relapse. Methods: OPTIMISMM was a phase 3, multicenter, open‐label, randomized study (NCT01734928; N = 559). The primary endpoint was progression‐free survival (PFS). Results: Overall, 226 patients had received one prior line of therapy. PVd significantly prolonged PFS vs Vd in patients aged ≤65 years (median, 22.0 vs 13.1 months; P =.0258) and >65 years (median, 17.6 vs 9.9 months; P =.0369). Median PFS in patients with renal impairment (RI; creatinine clearance <60 mL/min) was 15.1 months with PVd vs 9.5 months with Vd (hazard ratio [HR], 0.67 [95% CI, 0.34‐1.34]). In patients without RI, median PFS was 22.0 vs 13.1 months (HR, 0.45 [95% CI, 0.27‐0.76]). In patients with high‐risk cytogenetics, median PFS was 14.7 vs 9.9 months (HR, 0.39 [95% CI, 0.13‐1.17]). PVd significantly improved overall response rate vs Vd in all subgroups. The safety profile of PVd was consistent with previous reports. Conclusions: These findings confirmed the benefits of PVd at first relapse, including in patients with poor prognostic factors. [ABSTRACT FROM AUTHOR]

Published
2022
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33. OAB-010: Atlas: a phase 3 randomized trial of carfilzomib, lenalidomide, and dexamethasone versus lenalidomide alone after stem-cell transplant for multiple myeloma

Author

Jakubowiak, Andrzej, Wrobel, Tomasz, Jamroziak, Krzysztof, Kubicki, Tadeusz, Robak, Pawel, Czyz, Jarosław, Tyczynska, Agata, Druzd-Sitek, Agnieszka, Giannopoulos, Krzysztof, Nowicki, Adam, Lojko-Dankowska, Anna, Matuszak, Magdalena, Gil, Lidia, Pula, Bartosz, Rybka, Justyna, Usnarska-Zubkiewicz, Lidia, Czabak, Olga, Stefka, Andrew, Derman, Benjamin, and Dytfeld, Dominik

Published
2022
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37. P-210: Oral ixazomib (Ixa), IV daratumumab (Dara), and dexamethasone (dex; IDd) in relapsed/refractory multiple myeloma (RRMM) patients (pts) with 1–3 prior therapies: phase 2 study interim analysis (IA)

Author

Orlowski, Robert, Delimpasi, Sosana, Straub, Jan, Symeonidis, Argiris, Pour, Luděk, Hájek, Roman, Touzeau, Cyrille, Bhanderi, Viralkumar, Pavlíček, Petr, Robak, Pawel, Berdeja, Jesus G., Matous, Jeffrey V., Karlin, Lionel, Zweegman, Sonja, Grosicki, Sebastian, Pluta, Andrzej, Kambhampati, Suman, Suryanarayan, Kaveri, Twumasi-Ankrah, Philip, Dash, Ajeeta, Labotka, Richard, and Dimopoulos, Meletios-Athanasios

Published
2021
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38. Bone lesions in hairy cell leukemia: Diagnosis and treatment.

Author

Robak, Pawel, Jesionek‐Kupnicka, Dorota, Kupnicki, Piotr, Polliack, Aaron, and Robak, Tadeusz

Subjects
*BONES, *CANCER diagnosis, *FEMUR head, *FEMUR neck, *BONE marrow, *IDIOPATHIC femoral necrosis
Abstract

Skeletal involvement is a rare complication of hairy cell leukemia (HCL) with an incidence of approximately 3%. Bone lesions are commonly lytic, and the most common sites of involvement are the femoral head and neck. Skeletal involvement is typically associated with high tumor burden and bone marrow infiltration. However, isolated cases of skeletal disease without splenomegaly or bone marrow involvement are occasionally reported. This review focuses on skeletal lesions in HCL, particularly the pathogenesis, clinical symptoms, diagnostic methods, and treatment approach. A literature review of the MEDLINE database for articles in English concerning hairy cell leukemia, skeletal symptoms, bone involvement was conducted via PubMed. Publications from January 1970 to May 2020 were scrutinized. Additional relevant publications were obtained by reviewing the references from the chosen articles. [ABSTRACT FROM AUTHOR]

Published
2020
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39. OCEAN: a randomized Phase III study of melflufen + dexamethasone to treat relapsed refractory multiple myeloma.

Author

Schjesvold, Fredrik, Robak, Pawel, Pour, Ludek, Aschan, Johan, and Sonneveld, Pieter

Abstract

Melflufen is a novel peptide–drug conjugate that rapidly delivers a cytotoxic payload into tumor cells. It has emerged as a potential new multiple myeloma treatment, particularly for late-stage forms of the disease. Here we describe the rationale and design of OCEAN (NCT03151811), a randomized, head-to-head, superiority, open-label, global, Phase III study evaluating the efficacy and safety of melflufen + dexamethasone versus pomalidomide + dexamethasone. Eligible patients with relapsed refractory multiple myeloma have received 2–4 previous treatments and are refractory to both lenalidomide and their last treatment. Patients are excluded if they have previously received pomalidomide. The primary endpoint is progression-free survival, and key secondary endpoints include overall response rate, duration of response and overall survival. [ABSTRACT FROM AUTHOR]

Published
2020
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40. Early Mortality in Patients with Multiple Myeloma Treated with Novel Agents - Analysis from Polish Myeloma Study Group

Author

Charlinski, Grzegorz, Tyczyńska, Agata, Zaucha, Jan M, Czyz, Adriana, Czyż, Jarosław, Dytfeld, Dominik, Malecki, Bartosz, Gil, Lidia, Fornagiel, Szymon, Grosicki, Sebastian, Barchnicka, Agnieszka, Holojda, Jadwiga, Kolkowska, Agnieszka, Hus, Iwona, Helbig, Grzegorz, Kopinska, Anna, Masternak, Anna, Woszczyk, Dariusz, Markiewicz, Miroslaw, Piszcz, Jaroslaw, Kloczko, Janusz, Usnarska-Zubkiewicz, Lidia, Wrobel, Tomasz, Robak, Pawel J., Robak, Tadeusz, Waszczuk-Gajda, Anna, Basak, Grzegorz, and Jurczyszyn, Artur

Published
2020
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41. Safety and Preliminary Efficacy Results from a Phase Ib/II Study of Cobimetinib As a Single Agent and in Combination with Venetoclax with or without Atezolizumab in Patients with Relapsed/Refractory Multiple Myeloma

Author

Schjesvold, Fredrik, Ribrag, Vincent, Rodriguez-Otero, Paula, Robak, Pawel J., Hansson, Markus, Hajek, Roman, Amor, Adrián Alegre, Martinez-López, Joaquin, Onishi, Maika, Gallo, Jorge D., Raval, Aparna, Deshpande, Sameer, Malhi, Vikram, Hong, Wan-Jen, and Raab, Marc S.

Published
2020
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42. Mantle cell lymphoma: therapeutic options in transplant-ineligible patients.

Author

Robak, Tadeusz, Smolewski, Piotr, Robak, Pawel, and Dreyling, Martin

Subjects
MANTLE cell lymphoma, STEM cell transplantation
Abstract

Management of patients with newly diagnosed mantle cell lymphoma (MCL) depends on the age and fitness of the patient. For younger patients, the commonly accepted standard of care is a high-dose cytarabine-based induction chemotherapy followed by autologous stem cell transplantation (ASCT). In newly diagnosed patients with MCL ineligible for intensive therapy and ASCT, the standard-of-care has generally been R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone), followed by rituximab, maintenance. In recent years, bendamustine-based therapy has been increasingly adopted for older MCL patients and more recently, vincristine has been replaced by bortezomib in the R-CHOP combination as VR-CAP for previously untreated patients. Novel targeted agents now offer more promise than traditional chemotherapy or immunochemotherapy for both previously treated and untreated disease, and should also improve outcomes for older MCL patients. Here, we review standard therapies currently in use and novel agents that may soon be available for MCL patients and particularly for those unsuitable for ASCT. [ABSTRACT FROM AUTHOR]

Published
2019
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43. Results from the randomized phase III DREAMM-7 study of belantamab mafodotin (belamaf) + bortezomib, and dexamethasone (BVd) vs daratumumab, bortezomib, and dexamethasone (DVd) in relapsed/refractory multiple myeloma (RRMM).

Author

Mateos, Maria-Victoria, Robak, Pawel, Hus, Marek, Xia, Zhongjun, Zherebtsova, Vera, Ward, Christopher, Ho, P. Joy, Hajek, Roman, Kim, Kihyun, Dimopoulos, Meletios A., Cerchione, Claudio, Riccio, Antonio, McKeown, Astrid, Rogers, Rachel, Baig, Hena, Eccersley, Lydia, Roy-Ghanta, Sumita, Opalinska, Joanna, and Hungria, Vania

Published
2024
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44. The Prognostic Impact of t(14;16) in Multiple Myeloma: A Multicenter Retrospective Study of 213 Patients. Is It Time to Revise the Revised ISS?

Author

Jurczyszyn, Artur, Goldman-Mazur, Sarah, Castillo, Jorge J., Waszczuk-Gajda, Anna, Grząśko, Norbert, Radocha, Jakub, Bittrich, Max, Gozzetti, Alessandro, Usnarska-Zubkiewicz, Lidia, Hus, Iwona, Yee, Andrew J, Jayabalan, David S, Niesvizky, Ruben, Kelman, Julia, Coriu, Daniel, Rosinol Dachs, Laura, Szukalski, Łukasz, Dávila, Julio, Gonzalez De La Calle, Veronica, Jamroziak, Krzysztof, Avivi, Irit, Cohen, Yael C, Suska, Anna, Chappell, Aimee, Madduri, Deepu, Chhabra, Saurabh, Kleman, Ariel, Hari, Parameswaran, Robak, Paweł, Gentile, Massimo, Kozłowska, Izabela, Goldberg, Stuart L., and Vesole, David H

Published
2018
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45. Prognostic indicators in primary plasma cell leukaemia: a multicentre retrospective study of 117 patients.

Author

Jurczyszyn, Artur, Radocha, Jakub, Davila, Julio, Fiala, Mark A., Gozzetti, Alessandro, Grząśko, Norbert, Robak, Pawel, Hus, Iwona, Waszczuk-Gajda, Anna, Guzicka-Kazimierczak, Renata, Atilla, Erden, Mele, Giuseppe, Sawicki, Waldemar, Jayabalan, David S., Charliński, Grzegorz, Szabo, Agoston G., Hajek, Roman, Delforge, Michel, Kopacz, Agnieszka, and Fantl, Dorotea

Subjects
RETROSPECTIVE studies, PLASMA cell leukemia, STEM cell transplantation, MULTIVARIATE analysis, BLOOD platelets
Abstract

We report a multicentre retrospective study that analysed clinical characteristics and outcomes in 117 patients with primary plasma cell leukaemia (pPCL) treated at the participating institutions between January 2006 and December 2016. The median age at the time of pPCL diagnosis was 61 years. Ninety-eight patients were treated with novel agents, with an overall response rate of 78%. Fifty-five patients (64%) patients underwent upfront autologous stem cell transplantation (ASCT). The median followup time was 50 months (95% confidence interval [CI] 33; 76), with a median overall survival (OS) for the entire group of 23 months (95% CI 15; 34). The median OS time in patients who underwent upfront ASCT was 35 months (95% CI 24·3; 46) as compared to 13 months (95% CI 6&3183;3; 35·8) in patients who did not receive ASCT (P = 0&3183;001). Multivariate analyses identified age ≥60 years, platelet count ≤100 9 109/l and peripheral blood plasma cell count ≥20 9 109/l as independent predictors of worse survival. The median OS in patients with 0, 1 or 2–3 of these risk factors was 46, 27 and 12 months, respectively (P < 0·001). Our findings support the use of novel agents and ASCT as frontline treatment in patients with pPCL. The constructed prognostic score should be independently validated. [ABSTRACT FROM AUTHOR]

Published
2018
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46. Preemptive Daratumumab Therapy for Minimal Residual Disease Reappearance or Biochemical Relapse in Multiple Myeloma: Rationale and Design of the Polish Myeloma Consortium Predator Study

Author

Jamroziak, Krzysztof, Giannopoulos, Krzysztof, Wrobel, Tomasz, Nowicki, Adam, Pula, Bartosz, Grząśko, Norbert, Rybka, Justyna, Robak, Paweł J., Druzd-Sitek, Agnieszka, Walter-Croneck, Adam, Brzeźniakiewicz-Janus, Katarzyna, Czyż, Jarosław, Warzocha, Krzysztof, and Dytfeld, Dominik

Published
2017
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47. Subcutaneous Compared to Intravenous Administration of Rituximab Plus CHOP in Patients with Diffuse Large B-Cell Lymphoma — a Study By the Polish Lymphoma Research Group

Author

Paszkiewicz-Kozik, Ewa, Dlugosz-Danecka, Monika, Robak, Paweł J., Wojciechowska-Lampka, Elżbieta, Swierkowska-Czeneszew, Monika, Tajer, Joanna, Romejko-Jarosinska, Joanna, Domanska-Czyz, Katarzyna, Szymanski, Marcin, Morawska, Marta, Targonski, Lukasz, Osowiecki, Michal, Ostrowska, Beata, Dabrowska-Iwanicka, Anna Paulina, and Walewski, Jan

Published
2017
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49. BCR Signaling in Chronic Lymphocytic Leukemia and Related Inhibitors Currently in Clinical Studies.

Author

Robak, Tadeusz and Robak, Pawel

Abstract

Normal B lymphocytes receive signals from B-cell antigen receptor (BCR) that are triggered by binding of the BCR to an external antigen. Tonic signaling through the BCR provides growth and signals to chronic lymphocytic leukemia (CLL) cells, and plays an important role in the pathogenesis and progression of the disease. Antigen engagement of BCR is followed by intracellular recruitment and activation of BCR-associated kinases including spleen tyrosine kinase (Syk), Bruton's tyrosine kinase (Btk) and phosphatidylinositol 3-kinases (PI3K). Inhibition of signaling pathways downstream of the BCR induces disruption of chemokine-mediated CLL cell migration and cell killing. BCR signal transduction inhibitors represent a promising new strategy for targeted CLL treatment. A number of therapeutic agents have recently been developed with significant activity in CLL. The compounds that are currently investigated in patients with CLL include ibrutinib -inhibitor of Btk, fostamatinib-inhibitor of Syk and idelalisib (GS-1101) -a specific isoform of the PI3K (PI3K) inhibitor. The clinical activity of ibrutinib, GS-1101 and fostamatinib in patients with CLL is associated with marked lymphocytosis due to release of tumor cells from the lymph nodes into the peripheral blood. Further studies are ongoing with single agents and their combinations with other targeted and conventional therapies. This article will review the preclinical rationale of BCR signaling inhibitors in the treatment of CLL, and the clinical evidence supporting the use of these agents in CLL patients. [ABSTRACT FROM AUTHOR]

Published
2013
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50. The evaluation and optimal use of rituximab in lymphoid malignancies.

Author

Robak, Tadeusz, Robak, Pawel, and Smolewski, Piotr

Subjects
RITUXIMAB, B cell lymphoma, CHRONIC lymphocytic leukemia, CLINICAL trials, DRUG therapy, FLUDARABINE, PHARMACOKINETICS, IMMUNOGLOBULINS, TUMOR treatment
Abstract

Rituximab is an IgG1, chimeric monoclonal antibody (mAb) containing murine light- and heavy-chain variable-region sequences and human constant-region sequences. Rituximab targets the CD20 molecule expressed on normal and malignant B-lymphocytes. At present, rituximab is the most important mAb of clinical value in patients with B-cell lymphoid malignancies. Since approval in 1997, rituximab has become widely used in chronic lymphocytic leukemia (CLL), follicular lymphoma (FL), mantle cell lymphoma (MCL), and diffused large B-cell lymphoma (DLBCL) when combined with chemotherapy. Currently, rituximab is commonly combined with first-line chemotherapy for FL and should be offered as maintenance therapy to all appropriate patients with this disease. Randomized Phase III trials demonstrated the superiority of rituximab added to CHOP chemotherapy against CHOP chemotherapy alone in patients with DLBCL. Rituximab alone has limited activity in MCL but can be used in MCL in combination with chemotherapy, despite the benefits not being as impressive as when used against other lymphoma entities. In addition, for the less frequent B-cell lymphomas, small series show considerable activity for most of these entities. Fludarabine and rituximab combination therapies in CLL yielded promising results in several studies. Two large Phase III randomized trials demonstrated the superiority of chemoimmunotherapy with rituximab compared with chemotherapy alone in previously untreated and refractory/relapsed patients with CLL. Therefore, it can be concluded that rituximab, with only few exceptions, can generally be accepted as a standard component of anti B-cell non-Hodgkin-s lymphoma therapies. In this review, the pharmacology, mode of action, pharmacokinetics, and current place in the therapy of B-cell lymphoid malignancies of rituximab are presented. In addition, an overview of studies conducted to date and optimal use of this drug, including timing and doses, is presented [ABSTRACT FROM AUTHOR]

Published
2012
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