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1. Multiple myeloma

Author

Malard, Florent, Neri, Paola, Bahlis, Nizar J., Terpos, Evangelos, Moukalled, Nour, Hungria, Vania T. M., Manier, Salomon, and Mohty, Mohamad

Published
2024
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2. COVID-19 in multiple myeloma patients: frequencies and risk factors for hospitalization, ventilatory support, intensive care admission and mortality –cooperative registry from the Grupo Brasileiro de Mieloma Multiplo (GBRAM)

Author

Garnica, Marcia, Crusoe, Edvan De Queiroz, Ribeiro, Glaciano, Bittencourt, Rosane, Magalhães, Roberto José Pessoa, Zanella, Karla Richter, Hallack Neto, Abrahão Elias, Lima, Juliana Souza, Solo, Caroline Bonamin, Souza, Emmanuella Graciott, Fernandes, Andre Magalhaes, Maiolino, Angelo, and Hungria, Vania

Published
2024
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3. Brazilian Real-Life Experience of Multiple Myeloma (MMyBRAve): Improvement in Outcomes, But Remaining Diagnostic and Therapeutic Gaps

Author

Hungria, Vania, Bittencourt, Rosane Isabel, Martinez, Gracia Aparecida, Santos, Juliana de Andrade, de Almeida, Denise Ramos, Figueiredo, Vera Lucia de Piratininga, de Farias, Danielle Leão Cordeiro, Zanella, Karla Richter, Muniz, Larissa Barchi, Senra, Juliana Tosta, Abreu, Rodrigo Martins, and Mattos, Éderson Roberto

Published
2024
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4. 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

Author

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, and Weisel, Katja

Published
2023
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8. Rates of Influenza and Pneumococcal Vaccination and Correlation With Survival in Multiple Myeloma Patients

Author

Thompson, Michael A., Boccadoro, Mario, Leleu, Xavier, Vela-Ojeda, Jorge, van Rhee, Frits, Weisel, Katja C., Rifkin, Robert M., Usmani, Saad Z., Hájek, Roman, Cook, Gordon, Abonour, Rafat, Armour, Mira, Morgan, Kathryn E., Yeh, Su-Peng, Costello, Caitlin L., Berdeja, Jesus G., Davies, Faith E., Zonder, Jeffrey A., Lee, Hans C., Omel, Jim, Spencer, Andrew, Terpos, Evangelos, Hungria, Vania T.M., Puig, Noemi, Fu, Chengcheng, Ferrari, Renda H., Ren, Kaili, Stull, Dawn Marie, and Chari, Ajai

Published
2023
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9. Guidelines on the diagnosis and management of multiple myeloma treatment: Associação Brasileira de Hematologia e Hemoterapia e Terapia Celular Project guidelines: Associação Médica Brasileira – 2022. Part I

Author

Maiolino, Angelo, Crusoé, Edvan de Queiroz, Martinez, Gracia Aparecida, Braga, Walter Moisés Tobias, de Farias, Danielle Leão Cordeiro, Bittencourt, Rosane Isabel, Neto, Jorge Vaz Pinto, Ribeiro, Glaciano Nogueira, Bernardo, Wanderley Marques, Tristão, Luca, Magalhaes, Roberto J.P., and Hungria, Vânia Tietsche de Moraes

Published
2022
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10. Prognostic value of minimal residual disease negativity in myeloma: combined analysis of POLLUX, CASTOR, ALCYONE, and MAIA

Author

Cavo, Michele, San-Miguel, Jesus, Usmani, Saad Z., Weisel, Katja, Dimopoulos, Meletios A., Avet-Loiseau, Hervé, Paiva, Bruno, Bahlis, Nizar J., Plesner, Torben, Hungria, Vania, Moreau, Philippe, Mateos, Maria-Victoria, Perrot, Aurore, Iida, Shinsuke, Facon, Thierry, Kumar, Shaji, van de Donk, Niels W.C.J., Sonneveld, Pieter, Spencer, Andrew, Krevvata, Maria, Heuck, Christoph, Wang, Jianping, Ukropec, Jon, Kobos, Rachel, Sun, Steven, Qi, Mia, and Munshi, Nikhil

Published
2022
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12. Patient-reported outcomes (PROs) from the DREAMM-7 randomized phase 3 study comparing belantamab mafodotin, bortezomib, and dexamethasone (BVd) vs daratumumab, bortezomib, and dexamethasone (DVd) in patients with relapsed/refractory multiple myeloma (RRMM).

Author

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

Published
2024
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13. Proceedings from the First Onco Summit: LATAM Chapter, 19–20 May 2023, Rio de Janeiro, Brazil.

Author

Hungria, Vania, Sureda, Anna, Campelo, Garcia Rosario, Salvino, Marco Aurélio, and Ramasamy, Karthik

Subjects
*TREATMENT of lung tumors, *MULTIPLE myeloma treatment, *HODGKIN'S disease treatment, *INTERPROFESSIONAL relations, *CANCER patient medical care, *CLINICAL medicine research, *CONFERENCES & conventions, *ONCOLOGISTS, *DRUG development
Abstract

Simple Summary: The first Onco Summit: The Latin American (LATAM) Chapter was held from 19–20 May 2023, in Rio de Janeiro, Brazil. This educational initiative aimed to discuss the current challenges in cancer care, both globally and in LATAM, and foster the exchange of best practices to address these challenges. The Summit brought together more than 30 international and regional experts and more than 300 oncology specialists to deliberate on the advancements and barriers in oncology, with a focus on strategies tailored to the specific needs of LATAM. This report provides an overview of the key discussions among cancer specialists at the Summit. The Onco Summit 2023: The Latin American (LATAM) Chapter took place over two days, from 19–20 May 2023, in Brazil. The event aimed to share the latest updates across various oncology disciplines, address critical clinical challenges, and exchange best practices to ensure optimal patient treatment. More than 30 international and regional speakers and more than 300 oncology specialists participated in the Summit. The Summit discussions centered on common challenges and therapeutic advances in cancer care, with a specific focus on the unique obstacles faced in LATAM and examples of adaptable strategies to address these challenges. The Summit also facilitated the establishment of a network of oncologists, hematologists, and scientists in LATAM, enabling collaboration to improve cancer care, both in this region and globally, through drug development and clinical research. This report summarizes the key discussions from the Summit for the global and LATAM oncology community. [ABSTRACT FROM AUTHOR]

Published
2024
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14. Impact of prior lenalidomide or proteasome inhibitor exposure on the effectiveness of ixazomib–lenalidomide–dexamethasone for relapsed/refractory multiple myeloma: A pooled analysis from the INSURE study.

Author

Lee, Hans C., Ramasamy, Karthik, Macro, Margaret, Davies, Faith E., Abonour, Rafat, van Rhee, Frits, Hungria, Vania T. M., Puig, Noemi, Ren, Kaili, Silar, Jiri, Enwemadu, Victoria, Cherepanov, Dasha, and Leleu, Xavier

Subjects
MULTIPLE myeloma, PROTEASOME inhibitors, LENALIDOMIDE, BORTEZOMIB, REFRACTORY materials, PROGRESSION-free survival
Abstract

Objectives: To characterize the impact of prior exposure and refractoriness to lenalidomide or proteasome inhibitors (PIs) on the effectiveness and safety of ixazomib–lenalidomide–dexamethasone (IRd) in relapsed/refractory multiple myeloma (RRMM). Methods: INSURE is a pooled analysis of adult RRMM patients who had received IRd in ≥2 line of therapy from three studies: INSIGHT MM, UVEA‐IXA, and REMIX. Results: Overall, 391/100/68 were lenalidomide‐naïve/−exposed/−refractory and 37/411/110 were PI‐naïve/−exposed/−refractory. Median duration of therapy (DOT) was 15.3/15.6/4.7 months and median progression‐free survival (PFS) was 21.6/25.8/5.6 months in lenalidomide‐naïve/exposed/refractory patients. Median DOT and PFS in PI‐naïve/exposed/refractory patients were 20.4/15.2/6.9 months and not reached/19.8/11.4 months, respectively. The proportion of lenalidomide‐naïve/exposed/refractory patients in INSIGHT and UVEA‐IXA who discontinued a study drug due to adverse events (AEs) was ixazomib, 31.6/28.2/28.0% and 18.6/6.7/10.5%; lenalidomide, 21.9/28.2/16.0% and 16.1/6.7/10.5%; dexamethasone, 18.4/20.5/16.0% and 10.6/0/10.5%, respectively. The proportion of PI‐naïve/exposed/refractory patients in INSIGHT and UVEA‐IXA who discontinued a study drug due to AEs was: ixazomib, 44.4/28.8/27.8% and 22.2/16.7/15.7%; lenalidomide, 33.3/22.0/19.4% and 16.7/15.9/11.8%; dexamethasone, 33.3/17.4/16.7% and 16.7/9.5/7.8%, respectively. REMIX AE discontinuation rates were unavailable. Conclusion: IRd appeared to be effective in RRMM patients in routine clinical practice regardless of prior lenalidomide or PI exposure, with better outcomes seen in lenalidomide‐ and/or PI‐nonrefractory versus refractory patients. [ABSTRACT FROM AUTHOR]

Published
2024
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15. 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, primary, Robak, Pawel, additional, Hus, Marek, additional, Xia, Zhongjun, additional, Zherebtsova, Vera, additional, Ward, Christopher, additional, Ho, P. Joy, additional, Hajek, Roman, additional, Kim, Kihyun, additional, Dimopoulos, Meletios A., additional, Cerchione, Claudio, additional, Riccio, Antonio, additional, McKeown, Astrid, additional, Rogers, Rachel, additional, Baig, Hena, additional, Eccersley, Lydia, additional, Roy-Ghanta, Sumita, additional, Opalinska, Joanna, additional, and Hungria, Vania, additional

Published
2024
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16. A Brazilian Real-Life Experience of Multiple Myeloma Patients: Final Results from the Mmybrave Multicenter Observational Study

Author

Hungria, Vania Tietsche de Moraes, primary, Bittencourt, Rosane Isabel, additional, Martinez, Gracia Aparecida, additional, Santos, Juliana de Andrade, additional, Almeida, Denise Ramos de, additional, Figueiredo, Vera Lucia de Piratininga, additional, Farias, Danielle Leão Cordeiro de, additional, Zanella, Karla Richter, additional, Muniz, Larissa Barchi, additional, Senra, Juliana Tosta, additional, Abreu, Rodrigo Martins, additional, and Mattos, Ederson Roberto, additional

Published
2024
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17. COVID-19 in multiple myeloma patients: frequencies and risk factors for hospitalization, ventilatory support, intensive care admission and mortality –cooperative registry from the Grupo Brasileiro de Mieloma Multiplo (GBRAM)

Author

Garnica, Marcia, primary, Crusoe, Edvan De Queiroz, additional, Ribeiro, Glaciano, additional, Bittencourt, Rosane, additional, Magalhães, Roberto José Pessoa, additional, Zanella, Karla Richter, additional, Hallack Neto, Abrahão Elias, additional, Lima, Juliana Souza, additional, Solo, Caroline Bonamin, additional, Souza, Emmanuella Graciott, additional, Fernandes, Andre Magalhaes, additional, Maiolino, Angelo, additional, and Hungria, Vania, additional

Published
2023
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18. P-052 LINKER-MM3, a phase 3, open-label, randomized study of linvoseltamab versus elotuzumab, pomalidomide, and dexamethasone (EPd) in relapsed/refractory multiple myeloma (RRMM)

Author

Weisel, Katja, primary, Hungria, Vania, additional, Quach, Hang, additional, Yoon, Sung-Soo, additional, Rodriguez-Otero, Paula, additional, Sinha, Arijit, additional, Boyapati, Anita, additional, Lyon, Charlotte, additional, Moore, Vygngley, additional, Inocencio, Tim, additional, Harnett, James, additional, Chi, Lei, additional, Lorenc, Karen Rodriguez, additional, Kroog, Glenn, additional, and Voorhees, Peter, additional

Published
2023
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19. 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)

Author

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

Published
2023
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20. P-140 Multiple myeloma in Latin America cancer registry: the MYLACRE study

Author

Hungria, Vania, primary, Gaiolla, Rafael, additional, Galvez, Kenny, additional, Remaggi, Guillermina, additional, Schutz, Natalia, additional, Bittencourt, Rosane, additional, Maiolino, Angelo, additional, Quintero, Guillermo, additional, Cugliari, Maria, additional, Braga, Walter Tobias, additional, Villarim, Carolina, additional, Crusoé, Edvan, additional, Enrico, Alicia, additional, Pei, Huiling, additional, Fernandez, Mariana, additional, Saes, Jaqueline, additional, and Trufelli, Damila, additional

Published
2023
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21. MM-510 Patient-Reported Outcomes in Patients With Relapsed or Refractory Multiple Myeloma (RRMM) Treated With Belantamab Mafodotin (Belamaf) Versus Pomalidomide Plus Low-Dose Dexamethasone (Pd) in the DREAMM-3 Study

Author

Hungria, Vania, primary, Weisel, Katja, additional, Currie, Brooke, additional, Perera, Sue, additional, Sule, Neal, additional, He, Wei, additional, Davy, Katherine, additional, McKeown, Astrid, additional, Sapra, Sandhya, additional, Nelsen, Linda, additional, Li, Mary, additional, Barale, Sophie, additional, Boyle, Julia, additional, McPoyle, Kaytlyn, additional, and Dimopoulos, Meletios Athanasios, additional

Published
2023
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22. 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)

Author

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

Published
2023
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23. POSTER: MM-510 Patient-Reported Outcomes in Patients With Relapsed or Refractory Multiple Myeloma (RRMM) Treated With Belantamab Mafodotin (Belamaf) Versus Pomalidomide Plus Low-Dose Dexamethasone (Pd) in the DREAMM-3 Study

Author

Hungria, Vania, primary, Weisel, Katja, additional, Currie, Brooke, additional, Perera, Sue, additional, Sule, Neal, additional, He, Wei, additional, Davy, Katherine, additional, McKeown, Astrid, additional, Sapra, Sandhya, additional, Nelsen, Linda, additional, Li, Mary, additional, Barale, Sophie, additional, Boyle, Julia, additional, McPoyle, Kaytlyn, additional, and Dimopoulos, Meletios Athanasios, additional

Published
2023
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24. P954: MULTIPLE MYELOMA IN LATIN AMERICA CANCER REGISTRY: THE MYLACRE STUDY

Author

Hungria, Vania, primary, Gaiolla, Rafael, additional, Galvez, Kenny, additional, Remaggi, Guillermina, additional, Schutz, Natalia, additional, Bittencourt, Rosane, additional, Maiolino, Angelo, additional, Quintero, Guillermo, additional, Silvana Cugliari, Maria, additional, Moises Tobias, Walter, additional, Colaco Villarim, Carolina, additional, Crusoe, Edvan, additional, Ines Enrico, Alicia, additional, Pei, Huiling, additional, Fernandez, Mariana, additional, Saes, Jaqueline, additional, and Trufelli, Damila, additional

Published
2023
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25. 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)

Author

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

Published
2023
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26. P964: PATIENT (PT)-REPORTED OUTCOMES IN PTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA (RRMM) TREATED WITH BELANTAMAB MAFODOTIN (BELAMAF) VS POMALIDOMIDE/LOW DOSE DEXAMETHASONE (PD) IN THE DREAMM-3 STUDY

Author

Hungria, Vania, primary, Weisel, Katja, additional, Currie, Brooke, additional, Perera, Sue, additional, Sule, Neal, additional, He, Wei, additional, Mckeown, Astrid, additional, Sapra, Sandhya, additional, Nelsen, Linda, additional, LI, Mary, additional, Barale, Sophie, additional, Boyle, Julia, additional, Mcpoyle, Kaytlyn, additional, and Dimopoulos, Meletios A., additional

Published
2023
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27. PB2133: TRIAL IN PROGRESS: LINKER-MM3, A PHASE 3, OPEN-LABEL, RANDOMIZED STUDY OF LINVOSELTAMAB VERSUS ELOTUZUMAB, POMALIDOMIDE, AND DEXAMETHASONE (EPD) IN RELAPSED/REFRACTORY MULTIPLE MYELOMA (RRMM)

Author

Weisel, Katja, primary, Hungria, Vania, additional, Quach, Hang, additional, Yoon, Sung-Soo, additional, Rodríguez-Otero, Paula, additional, Kroog, Glenn, additional, Sinha, Arijit, additional, Boyapati, Anita, additional, Lyon, Charlotte, additional, Lorenc, Karen Rodriguez, additional, Inocencio, Timothy, additional, Harnett, James, additional, Chi, Lei, additional, Moore, Vygngley, additional, and Voorhees, Peter, additional

Published
2023
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28. Overall Survival With Daratumumab, Bortezomib, and Dexamethasone in Previously Treated Multiple Myeloma (CASTOR):A Randomized, Open-Label, Phase III Trial

Author

Sonneveld, Pieter, Chanan-Khan, Asher, Weisel, Katja, Nooka, Ajay K., Masszi, Tamas, Beksac, Meral, Spicka, Ivan, Hungria, Vania, Munder, Markus, Mateos, Maria-Victoria, Mark, Tomer M., Levin, Mark-David, Ahmadi, Tahamtan, Qin, Xiang, Garvin Mayo, Wendy, Gai, Xue, Carey, Jodi, Carson, Robin, Spencer, Andrew, Sonneveld, Pieter, Chanan-Khan, Asher, Weisel, Katja, Nooka, Ajay K., Masszi, Tamas, Beksac, Meral, Spicka, Ivan, Hungria, Vania, Munder, Markus, Mateos, Maria-Victoria, Mark, Tomer M., Levin, Mark-David, Ahmadi, Tahamtan, Qin, Xiang, Garvin Mayo, Wendy, Gai, Xue, Carey, Jodi, Carson, Robin, and Spencer, Andrew

Abstract

PURPOSE At the primary analysis of CASTOR (median follow-up, 7.4 months), daratumumab plus bortezomib and dexamethasone (D-Vd) significantly prolonged progression-free survival versus bortezomib and dexamethasone (Vd) alone in relapsed or refractory multiple myeloma (RRMM). We report updated efficacy and safety results at the final analysis for overall survival (OS). METHODS CASTOR was a multicenter, randomized, open-label, phase III study during which eligible patients with ≥ 1 line of prior therapy were randomly assigned to Vd (up to eight cycles) with or without daratumumab (until disease progression). After positive primary analysis and protocol amendment, patients receiving Vd were offered daratumumab monotherapy after disease progression. RESULTS At a median (range) follow-up of 72.6 months (0.0-79.8), significant OS benefit was observed with D-Vd (hazard ratio, 0.74; 95% CI, 0.59 to 0.92; P = .0075). Median OS was 49.6 months with D-Vd versus 38.5 months with Vd. Prespecified subgroup analyses demonstrated an OS advantage with D-Vd versus Vd for most subgroups, including patients age ≥ 65 years and patients with one or two prior lines of therapy, International Staging System stage III disease, high-risk cytogenetic abnormalities, and prior bortezomib treatment. The most common (≥ 10%) grade 3/4 treatment-emergent adverse events with D-Vd versus Vd were thrombocytopenia (46.1% v 32.9%), anemia (16.0% v 16.0%), neutropenia (13.6% v 4.6%), lymphopenia (10.3% v 2.5%), and pneumonia (10.7% v 10.1%). CONCLUSION D-Vd significantly prolonged OS in patients with RRMM, with the greatest OS benefit observed in patients with one prior line of therapy. To our knowledge, our results, together with the OS benefit observed with daratumumab plus lenalidomide and dexamethasone in the phase III POLLUX study, demonstrate for the first time an OS benefit with daratumumab-containing regimens in RRMM (ClinicalTrials.gov identifier: NCT0213

Published
2023

29. Overall Survival with Daratumumab, Bortezomib, and Dexamethasone in Previously Treated Multiple Myeloma (CASTOR): A Randomized, Open-Label, Phase III Trial

Author

Janssen Research and Development, Sonneveld, Pieter, Chanan-Khan, Asher A., Weisel, Katja C., Nooka, Ajay, Masszi, Tamas, Beksac, Meral, Špička, Ivan, Hungria, Vania, Munder, Markus, Mateos, Maria Victoria, Mark, Tomer M., Levin, Mark-David, Ahmadi, Tahamtan, Qin, Xiang, Garvin Mayo, Wendy, Gai, Xue, Carey, Jodi, Carson, Robin, Spencer, Andrew, Janssen Research and Development, Sonneveld, Pieter, Chanan-Khan, Asher A., Weisel, Katja C., Nooka, Ajay, Masszi, Tamas, Beksac, Meral, Špička, Ivan, Hungria, Vania, Munder, Markus, Mateos, Maria Victoria, Mark, Tomer M., Levin, Mark-David, Ahmadi, Tahamtan, Qin, Xiang, Garvin Mayo, Wendy, Gai, Xue, Carey, Jodi, Carson, Robin, and Spencer, Andrew

Abstract

[Purpose]: At the primary analysis of CASTOR (median follow-up, 7.4 months), daratumumab plus bortezomib and dexamethasone (D-Vd) significantly prolonged progression-free survival versus bortezomib and dexamethasone (Vd) alone in relapsed or refractory multiple myeloma (RRMM). We report updated efficacy and safety results at the final analysis for overall survival (OS). [Methods]: CASTOR was a multicenter, randomized, open-label, phase III study during which eligible patients with ≥ 1 line of prior therapy were randomly assigned to Vd (up to eight cycles) with or without daratumumab (until disease progression). After positive primary analysis and protocol amendment, patients receiving Vd were offered daratumumab monotherapy after disease progression. [Results]: At a median (range) follow-up of 72.6 months (0.0-79.8), significant OS benefit was observed with D-Vd (hazard ratio, 0.74; 95% CI, 0.59 to 0.92; P = .0075). Median OS was 49.6 months with D-Vd versus 38.5 months with Vd. Prespecified subgroup analyses demonstrated an OS advantage with D-Vd versus Vd for most subgroups, including patients age ≥ 65 years and patients with one or two prior lines of therapy, International Staging System stage III disease, high-risk cytogenetic abnormalities, and prior bortezomib treatment. The most common (≥ 10%) grade 3/4 treatment-emergent adverse events with D-Vd versus Vd were thrombocytopenia (46.1% v 32.9%), anemia (16.0% v 16.0%), neutropenia (13.6% v 4.6%), lymphopenia (10.3% v 2.5%), and pneumonia (10.7% v 10.1%). [Conclusion]: D-Vd significantly prolonged OS in patients with RRMM, with the greatest OS benefit observed in patients with one prior line of therapy. To our knowledge, our results, together with the OS benefit observed with daratumumab plus lenalidomide and dexamethasone in the phase III POLLUX study, demonstrate for the first time an OS benefit with daratumumab-containing regimens in RRMM (ClinicalTrials.gov identifier: NCT02136134 [CASTOR]).

Published
2023

30. Rates of Influenza and Pneumococcal Vaccination and Correlation With Survival in Multiple Myeloma Patients

Author

Millennium Pharmaceuticals, Takeda Pharmaceutical Company, Thompson, Michael A., Boccadoro, Mario, Leleu, Xavier, Vela-Ojeda, Jorge, Rhee, Frits van, Weisel, Katja C., Rifkin, Robert M., Usmani, Saad Z., Hajek, Roman, Cook, Gordon, Abonour, Rafat, Armour, Mira, Morgan, Kathryn E., Yeh, Su-Peng, Costello, Caitlin L., Berdeja, Jesús G., Davies, Faith E., Zonder, Jeffrey A., Lee, Hans C., Omel, Jim, Spencer, Andrew, Terpos, Evangelos, Hungria, Vania T.M., Puig, Noemi, Fu, Chengcheng, Ferrari, Renda H., Ren, Kaili, Stull, Dawn Marie, Chari, Ajai, Millennium Pharmaceuticals, Takeda Pharmaceutical Company, Thompson, Michael A., Boccadoro, Mario, Leleu, Xavier, Vela-Ojeda, Jorge, Rhee, Frits van, Weisel, Katja C., Rifkin, Robert M., Usmani, Saad Z., Hajek, Roman, Cook, Gordon, Abonour, Rafat, Armour, Mira, Morgan, Kathryn E., Yeh, Su-Peng, Costello, Caitlin L., Berdeja, Jesús G., Davies, Faith E., Zonder, Jeffrey A., Lee, Hans C., Omel, Jim, Spencer, Andrew, Terpos, Evangelos, Hungria, Vania T.M., Puig, Noemi, Fu, Chengcheng, Ferrari, Renda H., Ren, Kaili, Stull, Dawn Marie, and Chari, Ajai

Abstract

[Background]: Infections are a common reason for hospitalization and death in multiple myeloma (MM). Although pneumococcal vaccination (PV) and influenza vaccination (FV) are recommended for MM patients, data on vaccination status and outcomes are limited in MM., [Materials and Methods]: We utilized data from the global, prospective, observational INSIGHT MM study to analyze FV and PV rates and associated outcomes of patients with MM enrolled 2016-2019., [Results]: Of the 4307 patients enrolled, 2543 and 2500 had study-entry data on FV and PV status. Overall vaccination rates were low (FV 39.6%, PV 30.2%) and varied by region. On separate multivariable analyses of overall survival (OS) by Cox model, FV in the prior 2 years and PV in the prior 5 years impacted OS (vs. no vaccination; FV: HR, 0.73; 95% CI, 0.60-0.90; P = .003; PV: HR, 0.51; 95% CI, 0.42-0.63; P < .0001) when adjusted for age, region, performance status, disease stage, cytogenetics at diagnosis, MM symptoms, disease status, time since diagnosis, and prior transplant. Proportions of deaths due to infections were lower among vaccinated versus non-vaccinated patients (FV: 9.8% vs. 15.3%, P = .142; PV: 9.9% vs. 18.0%, P = .032). Patients with FV had generally lower health resource utilization (HRU) versus patients without FV; patients with PV had higher or similar HRU versus patients without PV., [Conclusion]: Vaccination is important in MM and should be encouraged. Vaccination status should be recorded in prospective clinical trials as it may affect survival. This trial was registered at www.clinicaltrials.gov as #NCT02761187.

Published
2023

32. Belantamab Mafodotin, Bortezomib, and Dexamethasone for Multiple Myeloma.

Author

Hungria, Vania and Mateos, Maria-Victoria

Subjects
*MULTIPLE myeloma, *PROGRESSION-free survival, *BORTEZOMIB, *DARATUMUMAB, *DEXAMETHASONE
Abstract

The article in the New England Journal of Medicine discusses the use of belantamab mafodotin, bortezomib, and dexamethasone for multiple myeloma treatment. The authors found that patients who received this triplet combination therapy had longer progression-free survival compared to those who received a different treatment. However, a high percentage of patients in the belantamab mafodotin group experienced ocular adverse events, requiring treatment delays. The authors suggest further research to understand the long-term effects and outcomes of this treatment. [Extracted from the article]

Published
2024
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33. Overall Survival With Daratumumab, Bortezomib, and Dexamethasone in Previously Treated Multiple Myeloma (CASTOR): A Randomized, Open-Label, Phase III Trial

Author

Sonneveld, Pieter, primary, Chanan-Khan, Asher, additional, Weisel, Katja, additional, Nooka, Ajay K., additional, Masszi, Tamas, additional, Beksac, Meral, additional, Spicka, Ivan, additional, Hungria, Vania, additional, Munder, Markus, additional, Mateos, Maria-Victoria, additional, Mark, Tomer M., additional, Levin, Mark-David, additional, Ahmadi, Tahamtan, additional, Qin, Xiang, additional, Garvin Mayo, Wendy, additional, Gai, Xue, additional, Carey, Jodi, additional, Carson, Robin, additional, and Spencer, Andrew, additional

Published
2022
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34. A Brazilian Real-Life Experience of Multiple Myeloma Patients: Final Results from the Mmybrave Multi-Center Study

Author

Hungria, Vania T.M., primary, Bittencourt, Rosane, additional, Martinez, Gracia, additional, Santos, Juliana De Andrade, additional, Almeida, Denise Ramos de, additional, Figueiredo, Vera Lúcia De Piratininga, additional, De Farias, Danielle Leao Cordeiro, additional, Zanella, Karla Richter, additional, Muniz, Larissa Barchi, additional, Carvalho, Pedro, additional, Senra, Juliana, additional, Abreu, Rodrigo Martins, additional, and Mattos, Éderson Roberto, additional

Published
2022
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35. Demographic and Clinical Characteristics of Multiple Myeloma Patients in Latin America

Author

Hungria, Vania T.M., primary, Trufelli, Damila, additional, Saes, Jaqueline, additional, Nakajima, Karina, additional, Leonel, Lays, additional, Gaiolla, Rafael, additional, Galvez, Kenny, additional, Remaggi, Guillermina, additional, Bittencourt, Rosane, additional, Maiolino, Angelo, additional, Schutz, Natalia Paola, additional, and Quintero, Guillermo, additional

Published
2022
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36. Global Treatment Standard in Multiple Myeloma Remains Elusive: Updated Results from the INSIGHT MM Global, Prospective, Observational Study

Author

Puig, Noemi, primary, Hungria, Vania T.M., additional, Chari, Ajai, additional, Davies, Faith E., additional, Cook, Gordon, additional, Hájek, Roman, additional, Morgan, Kathryn E., additional, Omel, Jim, additional, Terpos, Evangelos, additional, Thompson, Michael A., additional, Usmani, Saad, additional, Vela-Ojeda, Jorge, additional, Weisel, Katja, additional, Armour, Mira, additional, Ren, Kaili, additional, Cherepanov, Dasha, additional, Stull, Dawn Marie, additional, and Berdeja, Jesus, additional

Published
2022
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37. Isatuximab in Combination with Lenalidomide and Dexamethasone in Patients with High-Risk Smoldering Multiple Myeloma: Updated Safety Run-in Results from the Randomized Phase 3 Ithaca Study

Author

Mateos, Maria-Victoria, primary, Rodriguez Otero, Paula, additional, Koh, Youngil, additional, Martinez-Lopez, Joaquin, additional, Parmar, Gurdeep, additional, Prince, H. Miles, additional, Quach, Hang, additional, Ribas, Paz, additional, Hermansen, Emil, additional, Hungria, Vania T.M., additional, Besisik, Sevgi Kalayoglu, additional, Kim, Jin Seok, additional, Leleu, Xavier, additional, Pečeliūnas, Valdas, additional, Schjesvold, Fredrik, additional, Sevindik, Omur G., additional, Lavrova, Tatiana, additional, Dubin, Franck, additional, Devisme, Christine, additional, Lepine, Lucie, additional, Macé, Sandrine, additional, Morisse, Mony, additional, and Ghobrial, Irene, additional

Published
2022
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38. Daratumumab (Dara), Cyclophosphamide, Thalidomide and Dexamethasone for Transplant Eligible Newly Diagnosed Multiple Myeloma (TE NDMM) Patients: Response Rate Impacts on PFS

Author

De Queiroz Crusoe, Edvan, primary, Leal, Joanna, additional, Santos, Juliana Andrade, additional, Santos, Herbert Henrique de Melo, additional, Santos, Allan de souza, additional, Lucas, Larissa Ferreira, additional, Almeida, Alessandro de M., additional, Chaves, Marcos, additional, Dutra, Daniela Dourado, additional, Hungria, Vania T.M., additional, Salvino, Marco Aurelio, additional, and Arruda, Maria da Gloria B., additional

Published
2022
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40. P-260: Daratumumab (DARA) plus bortezomib and dexamethasone (D-Vd) or lenalidomide and dexamethasone (D-Rd) in relapsed or refractory multiple myeloma (RRMM): subgroup analyses of CASTOR and POLLUX

Author

Mateos, María-Victoria, primary, Richardson, Paul, additional, Weisel, Katja, additional, Moreau, Philippe, additional, San-Miguel, Jesus, additional, Goldschmidt, Hartmut, additional, Orlowski, Robert, additional, Sonneveld, Pieter, additional, Reece, Donna E., additional, Suzuki, Kenshi, additional, Bahlis, Nizar, additional, Yoon, Sung-Soo, additional, Spencer, Andrew, additional, Nooka, Ajay, additional, Hungria, Vania, additional, Plesner, Torben, additional, Yehuda, Dina Ben, additional, Pei, Huiling, additional, Mayo, Wendy Garvin, additional, Gai, Xue, additional, Carey, Jodi, additional, Carson, Robin, additional, and Dimopoulos, Meletios A., additional

Published
2022
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41. P-130: Brazilian ineligible multiple myeloma patients: real world data from a prospective multicenter platform

Author

Crusoe, Edvan, primary, Ribeiro, Glaciano, additional, Zanella, Karla, additional, Perobelli, Leila, additional, Centrone, Renato, additional, Souza, Emanuella, additional, Bittencourt, Rosane, additional, Magalhaes, Roberto, additional, Moreno, Fabio, additional, Saraiva, Joao, additional, Cantadori, Lucas, additional, Ovigli, Danielle, additional, Higashi, Fabiana, additional, araujo, Cleder, additional, Braga, Walter, additional, Gusmao, Breno, additional, Hallack, Abrahao, additional, Sola, Caroline, additional, Matinez, Gracia, additional, Castro, Nelson, additional, Souto, Joao, additional, Soares, Luiza, additional, Mattos, Ederson, additional, Maiolino, Angelo, additional, and Hungria, Vania, additional

Published
2022
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44. 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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45. 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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47. 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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48. 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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50. The Brazilian association of hematology, hemotherapy, and cell therapy (ABHH) and its absolute commitment to ethics and absence of conflicts of interest

Author

de Souza, Carmino Antonio, Rego, Eduardo Magalhães, Ribeiro, Glaciano Nogueira, Magalhães, Silvia Maria Meira, da Silva, Celso Arrais Rodrigues, Passos, Leny Nascimento da Motta, Covas, Dimas Tadeu, Tavares, Renato Sampaio, Hungria, Vania T.de Moraes, Crusoé, Edvan de Queiroz, Marques, José Francisco Comenalli, Jr, Chiattone, Carlos Sérgio, Langhi, Dante, Junior, Neto, Jorge Vaz Pinto, Laforga, Violete Petitto, and Maiolino, Angelo

Published
2024
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