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2. Isatuximab plus carfilzomib–dexamethasone versus carfilzomib–dexamethasone in patients with relapsed multiple myeloma (IKEMA): overall survival analysis of a phase 3, randomised, controlled trial

Author

Yong, Kwee, Martin, Thomas, Dimopoulos, Meletios-Athanasios, Mikhael, Joseph, Capra, Marcelo, Facon, Thierry, Hajek, Roman, Špička, Ivan, Baker, Ross, Kim, Kihyun, Martinez, Gracia, Min, Chang-Ki, Pour, Ludek, Leleu, Xavier, Oriol, Albert, Koh, Youngil, Suzuki, Kenshi, Casca, France, Macé, Sandrine, Risse, Marie-Laure, and Moreau, Philippe

Published
2024
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4. Correction: Isatuximab, carfilzomib, and dexamethasone in patients with relapsed multiple myeloma: updated results from IKEMA, a randomized Phase 3 study

Author

Martin, Thomas, Dimopoulos, Meletios-Athanasios, Mikhael, Joseph, Yong, Kwee, Capra, Marcelo, Facon, Thierry, Hajek, Roman, Špička, Ivan, Baker, Ross, Kim, Kihyun, Martinez, Gracia, Min, Chang-Ki, Pour, Ludek, Leleu, Xavier, Oriol, Albert, Koh, Youngil, Suzuki, Kenshi, Casca, France, Macé, Sandrine, Risse, Marie-Laure, and Moreau, Philippe

Published
2023
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5. Isatuximab, carfilzomib, and dexamethasone in patients with relapsed multiple myeloma: updated results from IKEMA, a randomized Phase 3 study

Author

Martin, Thomas, Dimopoulos, Meletios-Athanasios, Mikhael, Joseph, Yong, Kwee, Capra, Marcelo, Facon, Thierry, Hajek, Roman, Špička, Ivan, Baker, Ross, Kim, Kihyun, Martinez, Gracia, Min, Chang-Ki, Pour, Ludek, Leleu, Xavier, Oriol, Albert, Koh, Youngil, Suzuki, Kenshi, Casca, France, Macé, Sandrine, Risse, Marie-Laure, and Moreau, Philippe

Published
2023
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6. Selinexor, bortezomib, and dexamethasone versus bortezomib and dexamethasone in previously treated multiple myeloma: Outcomes by cytogenetic risk.

Author

Richard, Shambavi, Chari, Ajai, Delimpasi, Sosana, Simonova, Maryana, Spicka, Ivan, Pour, Ludek, Kriachok, Iryna, Dimopoulos, Meletios, Pylypenko, Halyna, Auner, Holger, Leleu, Xavier, Usenko, Ganna, Hajek, Roman, Benjamin, Reuben, Dolai, Tuphan, Sinha, Dinesh, Venner, Christopher, Garg, Mamta, Stevens, Don, Quach, Hang, Jagannath, Sundar, Moreau, Phillipe, Levy, Moshe, Badros, Ashraf, Anderson, Larry, Bahlis, Nizar, Facon, Thierry, Mateos, Maria, Cavo, Michele, Chang, Hua, Landesman, Yosef, Chai, Yi, Arazy, Melina, Shah, Jatin, Shacham, Sharon, Kauffman, Michael, Grosicki, Sebastian, and Richardson, Paul

Subjects
Adult, Aged, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Bortezomib, Cytogenetic Analysis, Dexamethasone, Female, Humans, Hydrazines, Male, Middle Aged, Multiple Myeloma, Progression-Free Survival, Treatment Outcome, Triazoles, Young Adult
Abstract

In the phase 3 BOSTON study, patients with multiple myeloma (MM) after 1-3 prior regimens were randomized to once-weekly selinexor (an oral inhibitor of exportin 1 [XPO1]) plus bortezomib-dexamethasone (XVd) or twice-weekly bortezomib-dexamethasone (Vd). Compared with Vd, XVd was associated with significant improvements in median progression-free survival (PFS), overall response rate (ORR), and lower rates of peripheral neuropathy, with trends in overall survival (OS) favoring XVd. In BOSTON, 141 (35.1%) patients had MM with high-risk (presence of del[17p], t[4;14], t[14;16], or ≥4 copies of amp1q21) cytogenetics (XVd, n = 70; Vd, n = 71), and 261 (64.9%) exhibited standard-risk cytogenetics (XVd, n = 125; Vd, n = 136). Among patients with high-risk MM, median PFS was 12.91 months for XVd and 8.61 months for Vd (HR, 0.73 [95% CI, (0.4673, 1.1406)], p = 0.082), and ORRs were 78.6% and 57.7%, respectively (OR 2.68; p = 0.004). In the standard-risk subgroup, median PFS was 16.62 months for XVd and 9.46 months for Vd (HR 0.61; p = 0.004), and ORRs were 75.2% and 64.7%, respectively (OR 1.65; p = 0.033). The safety profiles of XVd and Vd in both subgroups were consistent with the overall population. These data suggest that selinexor can confer benefits to patients with MM regardless of cytogenetic risk. ClinicalTrials.gov identifier: NCT03110562.

Published
2021

7. 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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10. Efficacy of ixazomib, lenalidomide, dexamethasone regimen in daratumumab‐exposed relapsed/refractory multiple myeloma patients: A retrospective analysis.

Author

Fric, Dominik, Stork, Martin, Boichuk, Ivanna, Sandecka, Viera, Adam, Zdenek, Krejci, Marta, Ondrouskova, Eva, Fidrichova, Anna, Radova, Lenka, Knechtova, Zdenka, Jarosova, Marie, and Pour, Ludek

Subjects
PROGRESSION-free survival, MULTIPLE myeloma, OVERALL survival, DARATUMUMAB, LENALIDOMIDE
Abstract

We performed retrospective analysis of relapsed/refractory multiple myeloma (RRMM) patients previously exposed to daratumumab treated with ixazomib, lenalidomide, dexamethasone (IRd) regimen in real clinical practice. Our aim was to evaluate efficacy of IRd in these patients and select a subset of patients that would benefit from this treatment the most. In total, we analyzed 43 daratumumab‐exposed RRMM patients treated in our center. Minimal response or better was achieved by 53.5% of patients from the cohort. Median progression free survival (PFS) was 4.56 months (95% CI: 2.56, 8.03) and median overall survival (OS) was 28.92 months (95% CI: 5.4, NR). Duration of response (DOR) was evaluable in 28 patients and reached a median of 21.3 months (95% CI: 6.85, NR). Next, we evaluated hazard ratios (HR) for OS and PFS. There was improved OS in patients that were not‐triple refractory or worse (HR = 0.39, 95%Cl (0.14; 1.10), p =.07) and in patients, that had less than three previous lines of treatment (LOT) (HR = 0.13, 95%Cl (0.03; 0.6) p =.003). Similar to OS, there was improved PFS in patients, that were not triple‐refractory or worse (HR = 0.52, 95%Cl (0.25; 1.10), p =.08). We concluded, that the best survival benefit for RRMM patients pretreated with daratumumab to IRd regimen was observed in patients that were not triple‐refractory and had less than three previous lines of treatment (LOT). The DOR in these patients was 21.3 months (95% CI: 6.85, NR). [ABSTRACT FROM AUTHOR]

Published
2024
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11. An open‐label, first‐in‐human, single agent, dose escalation study for the evaluation of safety and efficacy of SAR442085 in patients with relapsed or refractory multiple myeloma.

Author

Kapoor, Prashant, Nathwani, Nitya, Jelinek, Tomas, Pour, Ludek, Perrot, Aurore, Dimopoulos, Meletios‐Athanasios, Huang, Shang‐Yi, Spicka, Ivan, Chhabra, Saurabh, Lichtman, Eben, Mateos, Maria‐Victoria, Kanagavel, Dheepak, Zhao, Liang, Guillemin‐Paveau, Helene, Macé, Sandrine, van de Velde, Helgi, and Richardson, Paul G.

Subjects
MULTIPLE myeloma, CELL receptors, SURVIVAL rate, CD38 antigen, DARATUMUMAB
Abstract

Objectives: Cluster of differentiation 38 (CD38) is a key target on multiple myeloma (MM) cells. This multi‐centre, Phase 1, single‐agent study (NCT04000282) investigated SAR442085, a novel fragment crystallisable (Fc)‐modified anti‐CD38 monoclonal antibody (mAb), with enhanced affinity towards Fc‐gamma receptor on effector cells in patients with relapsed and/or refractory (RR) MM. Methods: This study comprised two parts: Part‐A (dose‐escalation involving anti‐CD38 mAb pre‐treated and naïve patients) and Part‐B (dose expansion). Primary endpoints were maximum tolerated dose and recommended Phase 2 dose (RP2D). Results: Thirty‐seven heavily pre‐treated patients were treated in Part A. Part‐B (dose‐expansion) was not studied. Seven dose‐limiting toxicities were reported at DL3, DL5, DL6, and DL7. RP2D was determined to be 5–7·5 mg/kg. Most common treatment‐emergent adverse events were infusion‐related reactions in 70·3% (26/37) patients. Grade ≥3 thrombocytopenia was reported in 48·6% (18/37). Overall response rate was 70% in anti‐CD38 mAb naïve and 4% in anti‐CD38 pre‐treated patients, with a median progression‐free survival of 7·62 (95%CI: 2·858; not calculable) months and 2·79 (95%CI: 1·150; 4·172) months and, respectively. Conclusions: The efficacy of SAR442085 was promising in anti‐CD38 mAb naïve patients but did not extend to the larger cohort of anti‐CD38 mAb pre‐treated patients. This observation, along with transient high‐grade thrombocytopenia, could potentially limit its clinical use. [ABSTRACT FROM AUTHOR]

Published
2024
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12. A phase 1b/2 study evaluating efficacy and safety of MP0250, a designed ankyrin repeat protein (DARPin) simultaneously targeting vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), in combination with bortezomib and dexamethasone, in patients with relapsed or refractory multiple myeloma

Author

Knop, Stefan, Szarejko, Monika, Grząśko, Norbert, Bringhen, Sara, Trautmann‐Grill, Karolin, Jurczyszyn, Artur, Vacca, Angelo, Khandanpour, Cyrus, Gamberi, Barbara, Pour, Ludek, Iversen, Katrine F., Stumpp, Michael T., Suter, Cosima, Dawson, Keith M., Zitt, Christof, Legenne, Philippe, Stavropoulou, Vaia, Fey, Martin F., Leupin, Nicolas, and Goldschmidt, Hartmut

Published
2024
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14. Limited efficacy of daratumumab in multiple myeloma with extramedullary disease

Author

Jelinek, Tomas, Sevcikova, Tereza, Zihala, David, Popkova, Tereza, Kapustova, Veronika, Broskevicova, Lucie, Capkova, Lenka, Rihova, Lucie, Bezdekova, Renata, Sevcikova, Sabina, Zidlik, Vladimir, Havel, Martin, Plonkova, Hana, Jungova, Alexandra, Minarik, Jiri, Stork, Martin, Pour, Ludek, Pavlicek, Petr, Spicka, Ivan, Maisnar, Vladimir, Radocha, Jakub, Simicek, Michal, and Hajek, Roman

Published
2022
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15. Daratumumab Plus Bortezomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone in Transplant-Ineligible Newly Diagnosed Multiple Myeloma: Frailty Subgroup Analysis of ALCYONE

Author

Mateos, Maria-Victoria, Dimopoulos, Meletios A., Cavo, Michele, Suzuki, Kenshi, Knop, Stefan, Doyen, Chantal, Lucio, Paulo, Nagy, Zsolt, Pour, Ludek, Grosicki, Sebastian, Crepaldi, Andre, Liberati, Anna Marina, Campbell, Philip, Yoon, Sung-Soo, Iosava, Genadi, Fujisaki, Tomoaki, Garg, Mamta, Iida, Shinsuke, Bladé, Joan, Ukropec, Jon, Pei, Huiling, Van Rampelbergh, Rian, Kudva, Anupa, Qi, Ming, and San-Miguel, Jesus

Published
2021
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17. Isatuximab, carfilzomib, and dexamethasone in relapsed multiple myeloma (IKEMA): a multicentre, open-label, randomised phase 3 trial

Author

Moreau, Philippe, Dimopoulos, Meletios-Athanasios, Mikhael, Joseph, Yong, Kwee, Capra, Marcelo, Facon, Thierry, Hajek, Roman, Spicka, Ivan, Baker, Ross, Kihyun, Kim, Martinez, Gracia, Chang-Ki, Min, Pour, Ludek, Leleu, Xavier, Oriol, Albert, Youngil, Koh, Suzuki, Kenshi, Martin, Tom, Quach, Hang, Lim, Andrew, Crowther, Helen, Sia, Hanlon, Hulin, Cyrille, Mohty, Mohamad, Mikala, Gabor, Nagy, Zsolt, Reinoso Segura, Marta, Rosinol, Laura, Yagci, Munci, Turgut, Mehmet, Garg, Mamta, Parmar, Gurdeep, Augustson, Brad, Castro, Nelson, Crusoe, Edvan, Pika, Tomas, Delimpasi, Sosana, Ishizawa, Kenichi, George, Anup, Konstantinova, Tatiana, De La Rubia, Javier, Sung-Hyun, Kim, Maiolino, Angelo, Reiman, Anthony, LeBlanc, Richard, Ito, Shigeki, Tanaka, Junji, Luchinin, Alexander, Kryuchkova, Irina, Martinez, Joaquin, Shustik, Jesse, Karlin, Lionel, Symeonidis, Anargyros, Egyed, Miklos, Petrini, Mario, Cavo, Michele, Uchiyama, Michihiro, Blacklock, Hilary, Arat, Mutlu, Griffin, James, Hunter, Hannah, Buck, Tonda, Anagnostopoulos, Achilles, Konstantopoulos, Konstantinos, Masszi, Tamas, Bringhen, Sara, Gamberi, Barbara, Kawano, Yawara, Jin Seok, Kim, Ozdogu, Hakan, Ozkalemkas, Fahir, Špička, Ivan, Kim, Kihyun, Min, Chang-Ki, Koh, Youngil, Risse, Marie-Laure, Asset, Gaelle, Macé, Sandrine, and Martin, Thomas

Published
2021
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18. Daratumumab plus pomalidomide and dexamethasone versus pomalidomide and dexamethasone alone in previously treated multiple myeloma (APOLLO): an open-label, randomised, phase 3 trial

Author

Alegre Amor, Adrian, Baldini, Luca, Beksac, Meral, Belotti, Angelo, Benboubker, Lotfi, Besemer, Britta, Besisik, Sevgi, Bila, Jelena, Boccadoro, Mario, Cavo, Michele, De La Rubia Comos, Javier, Delimpasi, Sosana, Dimopoulos, Meletios A., Doyen, Chantal, Dytfeld, Dominik, Engelhardt, Monika, Facon, Thierry, Foà, Roberto, Goldschmidt, Hartmut, Grosicki, Sebastian, Hajek, Roman, Hayri Ozsan, Guner, Hulin, Cyrille, Iversen, Brian, Karlin, Lionel, Katodritou, Eirini, Knop, Stefan, Kyrtsonis, Marie-Christine, Lahuerta, Juan Jose, Leleu, Xavier, Martinez Chamorro, Carmen, Mateos Manteca, María-Victoria, Meuleman, Nathalie, Minnema, Monique, Moreau, Philippe, Offidani, Massino, Oriol Rocafiguera, Albert, Pehlivan, Mustafa, Pour, Ludek, Roerdink, Henk Th.J., Rosinol Dacsh, Laura, Salwender, Hans, Sonneveld, Pieter, Symeonidis, Anargyros, Toftmann Hansen, Charlotte, Tuglular, Tulin, Unal, Ali, Vlummens, Philip, Vural, Filiz, Wu, Ka Lung, Zweegman, Sonja, Dimopoulos, Meletios A, Terpos, Evangelos, Symeonidis, Argiris, Oriol, Albert, Mateos, Maria-Victoria, Einsele, Hermann, Orfanidis, Ioannis, Ahmadi, Tahamtan, Ukropec, Jon, Kampfenkel, Tobias, Schecter, Jordan M, Qiu, Yanping, Amin, Himal, Vermeulen, Jessica, and Carson, Robin

Published
2021
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19. Isatuximab plus pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma according to prior lines of treatment and refractory status: ICARIA-MM subgroup analysis

Author

Bringhen, Sara, Pour, Ludek, Vorobyev, Vladimir, Vural, Filiz, Warzocha, Krzysztof, Benboubker, Lotfi, Koh, Youngil, Maisnar, Vladimir, Karlin, Lionel, Pavic, Michel, Campana, Frank, Le Guennec, Solenn, Menas, Fatima, van de Velde, Helgi, and Richardson, Paul G.

Published
2021
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20. Real‐World Evidence on Prognostic Value of MRD in Multiple Myeloma Using Flow Cytometry.

Author

Muronova, Ludmila, Soucek, Ondrej, Zihala, David, Sevcikova, Tereza, Popkova, Tereza, Plonkova, Hana, Venglar, Ondrej, Pour, Ludek, Stork, Martin, Rihova, Lucie, Bezdekova, Renata, Minarik, Jiri, Látal, Vojtech, Novak, Martin, Jungova, Alexandra, Dekojova, Tereza, Straub, Jan, Spacek, Martin, Rezacova, Vladimira, and Maisnar, Vladimir

Abstract

Minimal residual disease (MRD) is one of the most important prognostic factors in multiple myeloma (MM) and a valid surrogate for progression‐free survival (PFS) and overall survival (OS). Recently, MRD negativity was approved as an early clinical endpoint for accelerated drug approval in MM. Nevertheless, there is limited evidence of MRD utility in real‐world setting. In this retrospective multicenter study, we report outcomes of 331 newly diagnosed MM patients with MRD evaluation at Day+100 after autologous stem cell transplantation using flow cytometry with a median limit of detection of 0.001%. MRD negativity was reached in 47% of patients and was associated with significantly prolonged median PFS (49.2 months vs. 18.4 months; hazard ratios (HR) = 0.37; p < 0.001) and OS (not reached vs. 74.9 months; HR = 0.50; p = 0.007). Achieving MRD negativity was associated with PFS improvements regardless of age, International Staging System (ISS) stage, lactate dedydrogenase (LDH) level, or cytogenetic risk. Importantly, MRD positive patients benefited from lenalidomide maintenance versus no maintenance (18‐months PFS: 81% vs. 46%; HR = 0.24; p = 0.002) while in MRD negative patients such benefit was not observed (p = 0.747). The outcomes of our real‐world study recapitulate results from clinical trials including meta‐analyses and support the idea that MRD positive patients profit more from lenalidomide maintenance than MRD negative ones. [ABSTRACT FROM AUTHOR]

Published
2025
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21. Health-related quality of life in relapsed/refractory multiple myeloma treated with melflufen and dexamethasone:analyses from the phase III OCEAN study

Author

Schjesvold, Fredrik H., Ludwig, Heinz, Delimpasi, Sossana, Robak, Pawel, Coriu, Daniel, Tomczak, Waldemar, Pour, Ludek, Spicka, Ivan, Dimopoulos, Meletios Athanasios, Masszi, Tamas, Chernova, Natalia G., Sandberg, Anna, Thuresson, Marcus, Norin, Stefan, Bakker, Nicolaas A., Mateos, Maria Victoria, Richardson, Paul G., Sonneveld, Pieter, Schjesvold, Fredrik H., Ludwig, Heinz, Delimpasi, Sossana, Robak, Pawel, Coriu, Daniel, Tomczak, Waldemar, Pour, Ludek, Spicka, Ivan, Dimopoulos, Meletios Athanasios, Masszi, Tamas, Chernova, Natalia G., Sandberg, Anna, Thuresson, Marcus, Norin, Stefan, Bakker, Nicolaas A., Mateos, Maria Victoria, Richardson, Paul G., and Sonneveld, Pieter

Published
2024

22. 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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23. Autologous haematopoietic stem-cell transplantation versus bortezomib–melphalan–prednisone, with or without bortezomib–lenalidomide–dexamethasone consolidation therapy, and lenalidomide maintenance for newly diagnosed multiple myeloma (EMN02/HO95): a multicentre, randomised, open-label, phase 3 study

Author

Cavo, Michele, Gay, Francesca, Beksac, Meral, Pantani, Lucia, Petrucci, Maria Teresa, Dimopoulos, Meletios A, Dozza, Luca, van der Holt, Bronno, Zweegman, Sonja, Oliva, Stefania, van der Velden, Vincent H J, Zamagni, Elena, Palumbo, Giuseppe A, Patriarca, Francesca, Montefusco, Vittorio, Galli, Monica, Maisnar, Vladimir, Gamberi, Barbara, Hansson, Markus, Belotti, Angelo, Pour, Ludek, Ypma, Paula, Grasso, Mariella, Croockewit, Alexsandra, Ballanti, Stelvio, Offidani, Massimo, Vincelli, Iolanda D, Zambello, Renato, Liberati, Anna Marina, Andersen, Niels Frost, Broijl, Annemiek, Troia, Rossella, Pascarella, Anna, Benevolo, Giulia, Levin, Mark-David, Bos, Gerard, Ludwig, Heinz, Aquino, Sara, Morelli, Anna Maria, Wu, Ka Lung, Boersma, Rinske, Hajek, Roman, Durian, Marc, von dem Borne, Peter A, Caravita di Toritto, Tommaso, Zander, Thilo, Driessen, Christoph, Specchia, Giorgina, Waage, Anders, Gimsing, Peter, Mellqvist, Ulf-Henrik, van Marwijk Kooy, Marinus, Minnema, Monique, Mandigers, Caroline, Cafro, Anna Maria, Palmas, Angelo, Carvalho, Susanna, Spencer, Andrew, Boccadoro, Mario, and Sonneveld, Pieter

Published
2020
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24. Overall survival with daratumumab, bortezomib, melphalan, and prednisone in newly diagnosed multiple myeloma (ALCYONE): a randomised, open-label, phase 3 trial

Author

Mateos, Maria-Victoria, Cavo, Michele, Blade, Joan, Dimopoulos, Meletios A, Suzuki, Kenshi, Jakubowiak, Andrzej, Knop, Stefan, Doyen, Chantal, Lucio, Paulo, Nagy, Zsolt, Pour, Ludek, Cook, Mark, Grosicki, Sebastian, Crepaldi, Andre, Liberati, Anna Marina, Campbell, Philip, Shelekhova, Tatiana, Yoon, Sung-Soo, Iosava, Genadi, Fujisaki, Tomoaki, Garg, Mamta, Krevvata, Maria, Chen, Ying, Wang, Jianping, Kudva, Anupa, Ukropec, Jon, Wroblewski, Susan, Qi, Ming, Kobos, Rachel, and San-Miguel, Jesus

Published
2020
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25. Health-related quality of life in relapsed/refractory multiple myeloma treated with melflufen and dexamethasone: analyses from the phase III OCEAN study

Author

Schjesvold, Fredrik H., primary, Ludwig, Heinz, additional, Delimpasi, Sossana, additional, Robak, Pawel, additional, Coriu, Daniel, additional, Tomczak, Waldemar, additional, Pour, Ludek, additional, Spicka, Ivan, additional, Dimopoulos, Meletios-Athanasios, additional, Masszi, Tamas, additional, Chernova, Natalia G., additional, Sandberg, Anna, additional, Thuresson, Marcus, additional, Norin, Stefan, additional, Bakker, Nicolaas A., additional, Mateos, Maria-Victoria, additional, Richardson, Paul G., additional, and Sonneveld, Pieter, additional

Published
2024
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26. Transcriptional profiling of circulating tumor cells in multiple myeloma: a new model to understand disease dissemination

Author

Garcés, Juan-Jose, Simicek, Michal, Vicari, Marco, Brozova, Lucie, Burgos, Leire, Bezdekova, Renata, Alignani, Diego, Calasanz, Maria-Jose, Growkova, Katerina, Goicoechea, Ibai, Agirre, Xabier, Pour, Ludek, Prosper, Felipe, Rios, Rafael, Martinez-Lopez, Joaquin, Millacoy, Pamela, Palomera, Luis, Del Orbe, Rafael, Perez-Montaña, Albert, Garate, Sonia, Blanco, Laura, Lasa, Marta, Maiso, Patricia, Flores-Montero, Juan, Sanoja-Flores, Luzalba, Chyra, Zuzana, Vdovin, Alexander, Sevcikova, Tereza, Jelinek, Tomas, Botta, Cirino, El Omri, Halima, Keats, Jonathan, Orfao, Alberto, Hajek, Roman, San-Miguel, Jesus F., and Paiva, Bruno

Published
2020
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27. Health-related quality of life in patients with newly diagnosed multiple myeloma ineligible for stem cell transplantation: results from the randomized phase III ALCYONE trial

Author

Knop, Stefan, Mateos, Maria-Victoria, Dimopoulos, Meletios A., Suzuki, Kenshi, Jakubowiak, Andrzej, Doyen, Chantal, Lucio, Paulo, Nagy, Zsolt, Usenko, Ganna, Pour, Ludek, Cook, Mark, Grosicki, Sebastian, Crepaldi, Andre, Liberati, Anna Marina, Campbell, Philip, Shelekhova, Tatiana, Yoon, Sung-Soo, Losava, Genadi, Fujisaki, Tomoaki, Garg, Mamta, Wang, Jianping, Wroblewski, Susan, Kudva, Anupa, Gries, Katharine S., Fastenau, John, San-Miguel, Jesus, and Cavo, Michele

Published
2021
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28. Survival benefit of ixazomib, lenalidomide and dexamethasone (IRD) over lenalidomide and dexamethasone (Rd) in relapsed and refractory multiple myeloma patients in routine clinical practice

Author

Minarik, Jiri, Pika, Tomas, Radocha, Jakub, Jungova, Alexandra, Straub, Jan, Jelinek, Tomas, Pour, Ludek, Pavlicek, Petr, Mistrik, Martin, Brozova, Lucie, Krhovska, Petra, Machalkova, Katerina, Jindra, Pavel, Spicka, Ivan, Plonkova, Hana, Stork, Martin, Bacovsky, Jaroslav, Capkova, Lenka, Sykora, Michal, Kessler, Petr, Stejskal, Lukas, Heindorfer, Adriana, Ullrychova, Jana, Skacel, Tomas, Maisnar, Vladimir, and Hajek, Roman

Published
2021
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29. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study

Author

Attal, Michel, Richardson, Paul G., Rajkumar, Vincent, San-Miguel, Jesus, Beksac, Meral, Spicka, Ivan, Leleu, Xavier, Schjesvold, Fredrik, Moreau, Philippe, Dimopoulos, Meletios A., Huang, Jeffrey Shang-Yi, Minarik, Jiri, Cavo, Michele, Prince, H. Miles, Macé, Sandrine, Corzo, Kathryn P., Campana, Frank, Le-Guennec, Solenn, Dubin, Franck, Anderson, Kenneth C., Harrison, Simon, Janowski, Wojt, Kerridge, Ian, Spencer, Andrew, Delforge, Michel, Fostier, Karel, Vlummens, Philip, Wu, Ka Lung, Leblanc, Richard, Pavic, Michel, Sebag, Michael, Hajek, Roman, Maisnar, Vladimir, Pour, Ludek, Gregersen, Henrik, Benbouker, Lotfi, Caillot, Denis, Escoffre-Barbe, Martine, Facon, Thierry, Frenzel, Laurent, Hulin, Cyrille, Karlin, Lionel, Kolb, Brigitte, Pegourie, Brigitte, Perrot, Aurore, Tiab, Mourad, Vincent, Laure, Niederwieser, Dietger, Anagnostopoulos, Achilles, Delimpasi, Sosana, Kyrtsonis, Marie-Christine, Symeonidis, Anargyros, Illes, Arpad, Mikala, Gabor, Nagy, Zsolt, Bringen, Sara, Corradini, Paolo, Fabio, Ciceri, Lemoli, Roberto, Liberati, Anna, Nozzoli, Chiara, Zambello, Renato, Iida, Shinsuke, Ikeda, Takashi, Iyama, Satoshi, Matsumoto, Morio, Shimazaki, Chihiro, Sunami, Kazutaka, Suzuki, Kenshi, Uchiyama, Michihiro, Koh, Youngil, Kim, Kihyun, Lee, Jae Hoon, Min, Chang-Ki, Blacklock, Hillary, Goodman, Hugh, Neylon, Annette, Simpson, David, Grosicki, Sebastian, Jurczyszyn, Artur, Walter-Croneck, Adam, Warzocha, Krzysztof, Araujo, Luis, Moreira, Claudia, Doronin, Vadim, Mendeleeva, Larisa, Vorobyev, Vladimir, Vranovsky, Andrej, Alegre, Adrian, Gironella, Mercedes, Gonzalez Perez, Marta Sonia, Montes, Carmen, Ocio, Enrique, Rodriguez, Paula, Hardling, Mats, Lauri, Birgitta, Wang, Ming-Chung, Yeh, Su-Peng, Arat, Mutlu, Demirkan, Fatih, Gulbas, Zafer, Besisik, Sevgi Kalayoglu, Karadogan, Ihsan, Tuglular, Tulin, Unal, Ali, Vural, Filiz, Sive, Jonathan, Streetly, Matthew, Yong, Kwee, Tache, Jason, Richardson, Paul G, Rajkumar, S Vincent, Dimopoulos, Meletios A, Prince, H Miles, Corzo, Kathryn P, and Anderson, Kenneth C

Published
2019
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33. Oral ixazomib maintenance following autologous stem cell transplantation (TOURMALINE-MM3): a double-blind, randomised, placebo-controlled phase 3 trial

Author

Bar, Daniel, Basso, Alfredo, Fantl, Dorotea, He, Simon, Horvath, Neomi, Lee, Cindy, Rowlings, Phillip, Taylor, Kerry, Spencer, Andrew, Cochrane, Tara, Kwok, Fiona, Ramanathan, Sundreswran, Agis, Hermine, Zojer, Niklas, Kentos, Alain, Offner, Fritz, Van Droogenbroeck, Jan, Wu, Ka Lung, Maiolino, Angelo, Martinez, Gracia, Zanella, Karla, Capra, Marcelo, Araújo, Sérgio, Gregora, Evzen, Hajek, Roman, Maisnar, Vladimir, Pour, Ludek, Scudla, Vlastimil, Spicka, Ivan, Abildgaard, Niels, Andersen, Niels, Jensen, Bo Amdi, Helleberg, Carsten, Plesner, Torben, Salomo, Morten, Svirskaite, Asta, Delarue, Richard, Moreau, Philippe, Blau, Igor, Goldschmidt, Hartmut, Schieferdecker, Aneta, Teleanu, Veronica, Munder, Markus, Röllig, Christoph, Salwender, Han-Juergen, Fuhrmann, Stephan, Weisel, Katja, Duerig, Jan, Zeis, Matthias, Klein, Stefan, Reimer, Peter, Schmidt, Christian, Scheid, Christof, Mayer, Karin, Hoffmann, Martin, Sosada, Markus, Dimopoulos, Athanasios, Delimpasi, Sosana, Kyrtsonis, Mary-Christine, Anagnostopoulos, Achilleas, Nagy, Zsolt, Illés, Árpád, Egyed, Miklós, Borbényi, Zita, Mikala, Gabor, Dally, Najib, Horowitz, Netanel, Gutwein, Odit, Nemets, Anatoly, Vaxman, Iuliana, Shvetz, Olga, Trestman, Svetlana, Ruchlemer, Rosa, Nagler, Arnon, Tadmor, Tamar, Rouvio, Ory, Preis, Meir, Gay, Francesca, Cavo, Michele, De Rosa, Luca, Musto, Pellegrino, Cafro, Anna, Tosi, Patrizia, Offidani, Massimo, Corso, Alessandro, Rossi, Giuseppe, Liberati, Anna Marina, Bosi, Alberto, Suzuki, Kenshi, Iida, Shinsuke, Nakaseko, Chiaki, Ishikawa, Takayuki, Matsumoto, Morio, Nagai, Hirokazu, Sunami, Kazutaka, Chou, Takaaki, Akashi, Koichi, Takezako, Naoki, Hagiwara, Shotaro, Eom, Hyeon Seok, Jo, Deog-Yeon, Kim, Jin Seok, Lee, Jae Hoon, Min, Chang Ki, Yoon, Sung Soo, Yoon, Dok Hyun, Kim, Kihyun, Zweegman, Sonja, Levin, Mark-David, Vellenga, Edo, Minnema, Monique, Schjesvold, Fredrik, Waage, Anders, Haukås, Einar, Grosicki, Sebastian, Pluta, Andrzej, Robak, Tadeusz, Marques, Herlander, Bergantim, Rui, Campilho, Fernando, Chng, Wee Joo, Goh, Yeow Tee, McDonald, Andrew, Rapoport, Bernado, Álvarez Rivas, Miguel Angel, De Arriba de La Fuente, Felipe, González Montes, Yolanda, Martin Sanchez, Jesus, Mateos, Maria Victoria, Oriol Rocafiguera, Albert, Rosinol, Laura, San Miguel, Jesús, Pérez de Oteyza, Jaime, Encinas, Cristina, Alegre-Amor, Adrian, López-Guía, Ana, Axelsson, Per, Carlson, Kristina, Stromberg, Olga, Hansson, Markus, Hveding Blimark, Cecile, Mueller, Rouven, Chen, Chih-Cheng, Liu, Ta-Chih, Huang, Shang-Yi, Wang, Po-Nan, Na Nakorn, Thanyaphong, Prayongratana, Kannadit, Beksac, Meral, Unal, Ali, Goker, Hakan, Sonmez, Mehmet, Korenkova, Sybiryna, Chaidos, Aristeidis, Oakervee, Heather, Sati, Hamdi, Benjamin, Reuben, Wechalekar, Ashutosh, Garg, Mamta, Kaiser, Martin, Ramasamy, Karthik, Cook, Gordon, Chantry, Andrew, Jenner, Matthew, Buadi, Francis, Berryman, Robert, Janakiram, Murali, Dimopoulos, Meletios A, Weisel, Katja Christina, Pluta, Agnieszka, Chng, Wee-Joo, Mateos, Maria-Victoria, Morgan, Gareth, Suryanarayan, Kaveri, Teng, Zhaoyang, Skacel, Tomas, Palumbo, Antonio, Dash, Ajeeta B, Gupta, Neeraj, Labotka, Richard, and Rajkumar, S Vincent

Published
2019
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34. A phase 2 study of isatuximab monotherapy in patients with multiple myeloma who are refractory to daratumumab

Author

Mikhael, Joseph, Belhadj-Merzoug, Karim, Hulin, Cyrille, Vincent, Laure, Moreau, Philippe, Gasparetto, Cristina, Pour, Ludek, Spicka, Ivan, Vij, Ravi, Zonder, Jeffrey, Atanackovic, Djordje, Gabrail, Nashat, Martin, Thomas G., Perrot, Aurore, Bensfia, Samira, Weng, Qilong, Brillac, Claire, Semiond, Dorothée, Macé, Sandrine, Corzo, Kathryn P., and Leleu, Xavier

Published
2021
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36. P-159 Lenalidomide maintenance in R2-ISS stratified multiple myeloma patients - real world evidence

Author

Radocha, Jakub, primary, Jungova, Alexandra, additional, Pour, Ludek, additional, Špička, Ivan, additional, Minarik, Jiri, additional, Jelinek, Tomas, additional, Jindra, Pavel, additional, Stork, Martin, additional, Pika, Tomas, additional, Sedlak, Frantisek, additional, Popkova, Tereza, additional, Novakova, Denisa, additional, Sykora, Michal, additional, Pavlicek, Petr, additional, Heindorfer, Adriana, additional, Wrobel, Marek, additional, Gregora, Evzen, additional, Mikula, Peter, additional, Obernauerova, Jarmila, additional, Ullrychova, Jana, additional, Stejskal, Lukas, additional, Kessler, Petr, additional, Maisnar, Vladimir, additional, and Hájek, Roman, additional

Published
2023
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37. Treatment of primary plasma cell leukaemia with carfilzomib and lenalidomide-based therapy (EMN12/HOVON-129): final analysis of a non-randomised, multicentre, phase 2 study

Author

van de Donk, Niels W C J, primary, Minnema, Monique C, additional, van der Holt, Bronno, additional, Schjesvold, Fredrik, additional, Wu, Ka Lung, additional, Broijl, Annemiek, additional, Roeloffzen, Wilfried W H, additional, Gadisseur, Alain, additional, Pietrantuono, Giuseppe, additional, Pour, Ludek, additional, van der Velden, Vincent H J, additional, Lund, Thomas, additional, Offidani, Massimo, additional, Grasso, Mariella, additional, Giaccone, Luisa, additional, Razawy, Wida, additional, Tacchetti, Paola, additional, Mancuso, Katia, additional, Silkjaer, Trine, additional, Caers, Jo, additional, Zweegman, Sonja, additional, Hájek, Roman, additional, Benjamin, Reuben, additional, Vangsted, Annette Juul, additional, Boccadoro, Mario, additional, Gay, Francesca, additional, Sonneveld, Pieter, additional, and Musto, Pellegrino, additional

Published
2023
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38. P-075 Real-world evidence on prognostic value of minimal residual disease in multiple myeloma: Czech experience

Author

Jelinek, Tomas, primary, Muronova, Ludmila, additional, Zihala, David, additional, Sevcikova, Tereza, additional, Popkova, Tereza, additional, Plonkova, Hana, additional, Venglar, Ondrej, additional, Pour, Ludek, additional, Stork, Martin, additional, Rihova, Lucie, additional, Bezdekova, Renata, additional, Minarik, Jiri, additional, Novak, Martin, additional, Jungova, Alexandra, additional, Chena, David, additional, Straub, Jan, additional, Spacek, Martin, additional, Rezacova, Vladimira, additional, Soucek, Ondrej, additional, Maisnar, Vladimir, additional, Radocha, Jakub, additional, and Hájek, Roman, additional

Published
2023
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39. P-302 Anchor (OP-104): melflufen plus dexamethasone and daratumumab or bortezomib in relapsed/ refractory multiple myeloma (RRMM) – final efficacy and safety results

Author

Ocio, Enrique, primary, Efebera, Yvonne, additional, Hájek, Roman, additional, Straub, Jan, additional, Maisnar, Vladimir, additional, Eveillard, Jean-Richard, additional, Karlin, Lionel, additional, Mateos, Maria-Victoria, additional, Oriol, Albert, additional, Ribrag, Vincent, additional, Richardson, Paul, additional, Norin, Stefan, additional, Obermüller, Jakob, additional, Bakker, Nicolaas, additional, and Pour, Ludek, additional

Published
2023
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40. OA-48 Isatuximab plus carfilzomib and dexamethasone versus carfilzomib and dexamethasone in patients with relapsed multiple myeloma (IKEMA): final overall survival analysis

Author

Yong, Kwee, primary, Martin, Thomas, additional, Dimopoulos, Meletios, additional, Mikhael, Joseph, additional, Capra, Marcelo, additional, Facon, Thierry, additional, Hájek, Roman, additional, Špička, Ivan, additional, Baker, Ross, additional, Kim, Kihyun, additional, Martinez, Gracia, additional, Min, Chang-Ki, additional, Pour, Ludek, additional, Leleu, Xavier, additional, Oriol, Albert, additional, Koh, Youngil, additional, Suzuki, Kenshi, additional, Casca, France, additional, Macé, Sandrine, additional, Risse, Marie-Laure, additional, and Moreau, Philippe, additional

Published
2023
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41. P-296 Lighthouse: melflufen, daratumumab, and dexamethasone versus daratumumab in relapsed/refractory multiple myeloma refractory to an imid and a proteasome inhibitor or with ≥3 prior lines of therapy

Author

Mateos, Maria-Victoria, primary, Szarejko, Monika, additional, Bila, Jelena, additional, Schjesvold, Fredrik, additional, Špička, Ivan, additional, Maisnar, Vladimir, additional, Jurczyszyn, Artur, additional, Grudeva-Popova, Zhanet, additional, Hájek, Roman, additional, Usenko, Hanna, additional, Thuresson, Marcus, additional, Norin, Stefan, additional, Jarefors, Sara, additional, Richardson, Paul, additional, and Pour, Ludek, additional

Published
2023
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42. P876: ANCHOR (OP-104): MELFLUFEN PLUS DEXAMETHASONE AND DARATUMUMAB OR BORTEZOMIB IN RELAPSED/REFRACTORY MULTIPLE MYELOMA—FINAL EFFICACY AND SAFETY RESULTS

Author

Miguel, Enrique Maria Ocio San, primary, Efebera, Yvonne A., additional, Hájek, Roman, additional, Straub, Jan, additional, Maisnar, Vladimir, additional, Eveillard, Jean-Richard, additional, Karlin, Lionel, additional, Mateos, Maria-Victoria, additional, Oriol, Albert, additional, Ribrag, Vincent, additional, Richardson, Paul, additional, Norin, Stefan, additional, Obermüller, Jakob, additional, Bakker, Nicolaas A., additional, and Pour, Ludek, additional

Published
2023
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43. P1294: REAL-WORLD OUTCOMES OF 2149 NEWLY DIAGNOSED TRANSPLANT-ELIGIBLE MULTIPLE MYELOMA PATIENTS

Author

Popková, Tereza, primary, Pour, Ludek, additional, Spicka, Ivan, additional, Radocha, Jakub, additional, Jungova, Alexandra, additional, Minarik, Jiri, additional, Pavlíček, Petr, additional, Jelínek, Tomas, additional, Krejčí, Marta, additional, Straub, Jan, additional, Maisnar, Vladimir, additional, Dekojová, Tereza, additional, Pika, Tomáš, additional, Soukup, Jan, additional, Pospíšilová, Lenka, additional, and Hájek, Roman, additional

Published
2023
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44. Ixazomib significantly prolongs progression-free survival in high-risk relapsed/refractory myeloma patients

Author

Avet-Loiseau, Hervé, Bahlis, Nizar J., Chng, Wee-Joo, Masszi, Tamas, Viterbo, Luisa, Pour, Ludek, Ganly, Peter, Palumbo, Antonio, Cavo, Michele, Langer, Christian, Pluta, Andrzej, Nagler, Arnon, Kumar, Shaji, Ben-Yehuda, Dina, Rajkumar, S. Vincent, San-Miguel, Jesus, Berg, Deborah, Lin, Jianchang, van de Velde, Helgi, Esseltine, Dixie-Lee, di Bacco, Alessandra, Moreau, Philippe, and Richardson, Paul G.

Published
2017
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45. More Than 2% of Circulating Tumor Plasma Cells Defines Plasma Cell Leukemia-Like Multiple Myeloma

Author

European Commission, Ministry of Health of the Czech Republic, Technical University of Ostrava, Ministry of Education, Youth and Sports (Czech Republic), Centro de Investigación Biomédica en Red Cáncer (España), Instituto de Salud Carlos III, Cancer Research UK, European Research Council, Jelínek, Tomáš, Bezdekova, Renata, Žihala, David, Sevcikova, Tereza, Anilkumar Sithara, Anjana, Pospisilova, Sarka, Sevcikova, Sabina, Polackova, Petra, Stork, Martin, Knechtova, Zdenka, Venglar, Ondrej, Kapustova, Veronika, Popkova, Tereza, Muronova, Ludmila, Chyra, Zuzana, Hrdinka, Matous, Simicek, Michal, Garcés, Juan José, Puig, Noemi, Cedena, Maria-Teresa, Jurczyszyn, Artur, Castillo, Jorge J., Penka, Miroslav, Radocha, Jakub, Mateos, Maria Victoria, San-Miguel, Jesús, Paiva, Bruno, Pour, Ludek, Rihova, Lucie, Hajek, Roman, European Commission, Ministry of Health of the Czech Republic, Technical University of Ostrava, Ministry of Education, Youth and Sports (Czech Republic), Centro de Investigación Biomédica en Red Cáncer (España), Instituto de Salud Carlos III, Cancer Research UK, European Research Council, Jelínek, Tomáš, Bezdekova, Renata, Žihala, David, Sevcikova, Tereza, Anilkumar Sithara, Anjana, Pospisilova, Sarka, Sevcikova, Sabina, Polackova, Petra, Stork, Martin, Knechtova, Zdenka, Venglar, Ondrej, Kapustova, Veronika, Popkova, Tereza, Muronova, Ludmila, Chyra, Zuzana, Hrdinka, Matous, Simicek, Michal, Garcés, Juan José, Puig, Noemi, Cedena, Maria-Teresa, Jurczyszyn, Artur, Castillo, Jorge J., Penka, Miroslav, Radocha, Jakub, Mateos, Maria Victoria, San-Miguel, Jesús, Paiva, Bruno, Pour, Ludek, Rihova, Lucie, and Hajek, Roman

Abstract

[Purpose]: Primary plasma cell leukemia (PCL) is the most aggressive monoclonal gammopathy. It was formerly characterized by $ 20% circulating plasma cells (CTCs) until 2021, when this threshold was decreased to $ 5%. We hypothesized that primary PCL is not a separate clinical entity, but rather that it represents ultra-high-risk multiple myeloma (MM) characterized by elevated CTC levels. [Methods]: We assessed the levels of CTCs by multiparameter flow cytometry in 395 patients with newly diagnosed transplant-ineligible MM to establish a cutoff for CTCs that identifies the patients with ultra-high-risk PCL-like MM. We tested the cutoff on 185 transplant-eligible patients with MM and further validated on an independent cohort of 280 transplant-ineligible patients treated in the GEM-CLARIDEX trial. The largest published real-world cohort of patients with primary PCL was used for comparison of survival. Finally, we challenged the current 5% threshold for primary PCL diagnosis. [Results]: Newly diagnosed transplant-ineligible patients with MM with 2%-20% CTCs had significantly shorter progression-free survival (3.1 v 15.6 months; P , .001) and overall survival (14.6 v 33.6 months; P 5 .023) than patients with , 2%. The 2% cutoff proved to be applicable also in transplant-eligible patients with MM and was successfully validated on an independent cohort of patients from the GEM-CLARIDEX trial. Most importantly, patients with 2%-20% CTCs had comparable dismal outcomes with primary PCL. Moreover, after revealing a low mean difference between flow cytometric and morphologic evaluation of CTCs, we showed that patients with 2%-5% CTCs have similar outcomes as those with 5%-20% CTCs. [Conclusions]: Our study uncovers that $ 2% CTCs is a biomarker of hidden primary PCL and supports the assessment of CTCs by flow cytometry during the diagnostic workup of MM.

Published
2023

46. Treatment of primary plasma cell leukaemia with carfilzomib and lenalidomide-based therapy (EMN12/HOVON-129): final analysis of a non-randomised, multicentre, phase 2 study

Author

MS Hematologie, Cancer, Infection & Immunity, Regenerative Medicine and Stem Cells, van de Donk, Niels W C J, Minnema, Monique C, van der Holt, Bronno, Schjesvold, Fredrik, Wu, Ka Lung, Broijl, Annemiek, Roeloffzen, Wilfried W H, Gadisseur, Alain, Pietrantuono, Giuseppe, Pour, Ludek, van der Velden, Vincent H J, Lund, Thomas, Offidani, Massimo, Grasso, Mariella, Giaccone, Luisa, Razawy, Wida, Tacchetti, Paola, Mancuso, Katia, Silkjaer, Trine, Caers, Jo, Zweegman, Sonja, Hájek, Roman, Benjamin, Reuben, Vangsted, Annette Juul, Boccadoro, Mario, Gay, Francesca, Sonneveld, Pieter, Musto, Pellegrino, MS Hematologie, Cancer, Infection & Immunity, Regenerative Medicine and Stem Cells, van de Donk, Niels W C J, Minnema, Monique C, van der Holt, Bronno, Schjesvold, Fredrik, Wu, Ka Lung, Broijl, Annemiek, Roeloffzen, Wilfried W H, Gadisseur, Alain, Pietrantuono, Giuseppe, Pour, Ludek, van der Velden, Vincent H J, Lund, Thomas, Offidani, Massimo, Grasso, Mariella, Giaccone, Luisa, Razawy, Wida, Tacchetti, Paola, Mancuso, Katia, Silkjaer, Trine, Caers, Jo, Zweegman, Sonja, Hájek, Roman, Benjamin, Reuben, Vangsted, Annette Juul, Boccadoro, Mario, Gay, Francesca, Sonneveld, Pieter, and Musto, Pellegrino

Published
2023

47. Carfilzomib and dexamethasone versus bortezomib and dexamethasone for patients with relapsed or refractory multiple myeloma (ENDEAVOR): a randomised, phase 3, open-label, multicentre study

Author

Dimopoulos, Meletios A, Moreau, Philippe, Palumbo, Antonio, Joshua, Douglas, Pour, Ludek, Hájek, Roman, Facon, Thierry, Ludwig, Heinz, Oriol, Albert, Goldschmidt, Hartmut, Rosiñol, Laura, Straub, Jan, Suvorov, Aleksandr, Araujo, Carla, Rimashevskaya, Elena, Pika, Tomas, Gaidano, Gianluca, Weisel, Katja, Goranova-Marinova, Vesselina, Schwarer, Anthony, Minuk, Leonard, Masszi, Tamás, Karamanesht, Ievgenii, Offidani, Massimo, Hungria, Vania, Spencer, Andrew, Orlowski, Robert Z, Gillenwater, Heidi H, Mohamed, Nehal, Feng, Shibao, and Chng, Wee-Joo

Published
2016
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48. Isatuximab in combination with cemiplimab in patients with relapsed/refractory multiple myeloma: A phase 1/2 study

Author

Lesokhin, Alexander, primary, LeBlanc, Richard, additional, Dimopoulos, Meletios A., additional, Capra, Marcelo, additional, Carlo‐Stella, Carmelo, additional, Karlin, Lionel, additional, Castilloux, Jean‐Francois, additional, Forsberg, Peter, additional, Parmar, Gurdeep, additional, Tosikyan, Axel, additional, Pour, Ludek, additional, Ribrag, Vincent, additional, Ribolla, Rossella, additional, Abdallah, Al‐Ola, additional, Le Roux, Nadia, additional, Dong, Liyan, additional, van de Velde, Helgi, additional, Mayrargue, Laurent, additional, Lépine, Lucie, additional, Macé, Sandrine, additional, and Moreau, Philippe, additional

Published
2023
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49. Chemotherapy plus lenalidomide versus autologous transplantation, followed by lenalidomide plus prednisone versus lenalidomide maintenance, in patients with multiple myeloma: a randomised, multicentre, phase 3 trial

Author

Gay, Francesca, Oliva, Stefania, Petrucci, Maria Teresa, Conticello, Concetta, Catalano, Lucio, Corradini, Paolo, Siniscalchi, Agostina, Magarotto, Valeria, Pour, Luděk, Carella, Angelo, Malfitano, Alessandra, Petrò, Daniela, Evangelista, Andrea, Spada, Stefano, Pescosta, Norbert, Omedè, Paola, Campbell, Philip, Liberati, Anna Marina, Offidani, Massimo, Ria, Roberto, Pulini, Stefano, Patriarca, Francesca, Hajek, Roman, Spencer, Andrew, Boccadoro, Mario, and Palumbo, Antonio

Published
2015
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50. Treatment of Primary Plasma Cell Leukemia with Carfilzomib and Lenalidomide-Based Therapy: Results of the Final Analysis of the Prospective Phase 2 EMN12/HOVON-129 Study for Patients Aged 18-65 Years

Author

Van De Donk, Niels W.C.J., primary, Minnema, Monique C., additional, van der Holt, Bronno, additional, Schjesvold, Fredrik, additional, Wu, Ka Lung, additional, Capra, Andrea, additional, Broijl, Annemiek, additional, Roeloffzen, Wilfried W.H., additional, Gadisseur, Alain, additional, Pietrantuono, Giuseppe, additional, Pour, Ludek, additional, van der Velden, Vincent H.J., additional, Lund, Thomas, additional, Offidani, Massimo, additional, Grasso, Mariella, additional, Giaccone, Luisa, additional, Cavo, Michele, additional, Silkjaer, Trine, additional, Caers, Jo, additional, Zweegman, Sonja, additional, Hájek, Roman, additional, Benjamin, Reuben, additional, Vangsted, Annette Juul, additional, Boccadoro, Mario, additional, Gay, Francesca, additional, Sonneveld, Pieter, additional, and Musto, Pellegrino, additional

Published
2022
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