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I Vaxman (2021)
196Blood Cancer J, 11
J. Hernández‐Rivas, R. Ríos-Tamayo, C. Encinas, R. Alonso, J. Lahuerta (2022)
The changing landscape of relapsed and/or refractory multiple myeloma (MM): fundamentals and controversiesBiomarker Research, 10
MV Mateos (2022)
1371Leukemia, 36
T Atieh, S Atrash, M Mohan, L Shune, Z Mahmoudjafari, J Quick (2021)
Belantamab in combination with dexamethasone in patients with triple-class relapsed/refractory multiple myelomaBlood, 138
S. Dhanasiri, G. Hollier-Hann, C. Stothard, D. Dhanda, F. Davies, P. Rodríguez-Otero (2021)
Treatment Patterns and Outcomes in Triple-Class Exposed Patients With Relapsed and Refractory Multiple Myeloma: Findings From the Multinational ITEMISE Study.Clinical therapeutics
Nisha Joseph, Y. Tai, K. Anderson, S. Lonial (2021)
Novel Approaches to Treating Relapsed and Refractory Multiple Myeloma with a Focus on Recent Approvals of Belantamab Mafodotin and SelinexorClinical Pharmacology : Advances and Applications, 13
Tamir Shragai, H. Magen, N. Lavi, M. Gatt, S. Trestman, M. Zektser, C. Ganzel, Osnat Jarchowsky, T. Berger, T. Tadmor, M. Leiba, Katrin Hertzog-Tzarfaty, N. Horowitz, M. Shapira, D. Varssano, Yoav Berger, S. Frenkel, M. Krauthammer, I. Avivi, E. Luttwak, Y. Cohen (2022)
Real‐world experience with belantamab mafodotin therapy for relapsed/refractory multiple myeloma: A multicentre retrospective studyBritish Journal of Haematology, 200
J. Mikhael (2019)
Treatment Options for Triple-class Refractory Multiple Myeloma.Clinical lymphoma, myeloma & leukemia
(2022)
of Health and Human Services, National Institutes of Health, National Cancer Institute
P. Richardson, J. Miguel, P. Moreau, R. Hájek, M. Dimopoulos, J. Laubach, A. Palumbo, K. Luptakova, D. Romanus, T. Skácel, Shaji Kumar, K. Anderson (2018)
Interpreting clinical trial data in multiple myeloma: translating findings to the real-world settingBlood Cancer Journal, 8
SK Kumar (2017)
17046Nat Rev Dis Primers, 3
Shaji Kumar, V. Rajkumar, R. Kyle, M. Duin, P. Sonneveld, M. Mateos, F. Gay, K. Anderson (2017)
Multiple myelomaNature Reviews Disease Primers, 3
M. Mateos, K. Weisel, V. Stefano, H. Goldschmidt, M. Delforge, M. Mohty, M. Cavo, R. Vij, J. Lindsey-Hill, D. Dytfeld, E. Angelucci, A. Perrot, R. Benjamin, N. Donk, E. Ocio, C. Scheid, F. Gay, W. Roeloffzen, P. Rodríguez-Otero, A. Broijl, A. Potamianou, Caline Sakabedoyan, M. Semerjian, S. Keim, V. Strulev, Jordan Schecter, M. Vogel, R. Wapenaar, T. Nesheiwat, J. San-Miguel, P. Sonneveld, H. Einsele, P. Moreau (2022)
LocoMMotion: a prospective, non-interventional, multinational study of real-life current standards of care in patients with relapsed and/or refractory multiple myelomaLeukemia, 36
S. Lonial, Hans Lee, A. Badros, S. Trudel, A. Nooka, A. Chari, Al-Ola Abdallah, N. Callander, D. Sborov, A. Suvannasankha, K. Weisel, P. Voorhees, A. Hoos, E. Zhi, January Baron, T. Piontek, R. Jewell, J. Opalinska, I. Gupta, A. Cohen (2020)
Pivotal DREAMM-2 study: Single-agent belantamab mafodotin (GSK2857916) in patients with relapsed/refractory multiple myeloma (RRMM) refractory to proteasome inhibitors (PIs), immunomodulatory agents, and refractory and/or intolerant to anti-CD38 monoclonal antibodies (mAbs).Journal of Clinical Oncology, 38
J Mikhael (2020)
1Clin Lymphoma Myeloma Leuk, 20
PG Richardson (2018)
109Blood Cancer J, 8
Tahani Atieh, S. Atrash, N. Ahmed, Meera Mohan, W. Cui, L. Shune, Susana Hajjar, Zahra Mahmoudjafari, J. Quick, Anne Wishna, Justin Riffel, J. Mcguirk, G. Mohyuddin, Al-Ola Abdallah (2022)
Belantamab in Combination with Dexamethasone in Patients with Triple-class Relapsed/Refractory Multiple Myeloma.Clinical lymphoma, myeloma & leukemia
Kyriaki Tzogani, K. Penttilä, Johanna Lähteenvuo, Tuomo Lapveteläinen, Lucía Anglada, C. Prieto, B. Garcia-Ochoa, H. Enzmann, C. Gisselbrecht, J. Delgado, F. Pignatti (2020)
The EMA Review of Belantamab Mafodotin (Blenrep) for the Treatment of Adult Patients with Relapsed/Refractory Multiple Myeloma.The oncologist
A Alegre, G Benzo Callejo, R Alonso Fernández, J Martínez-López, A Jimenez-Ubieto, C Cuellar (2021)
Compassionate use of belantamab mafodotin for treatment of patients with relapsed/refractory multiple myeloma heavily treatedSpan Exp Blood, 138
Belantamab Eye Care Support Programme (GSK)
S Kurtin (2013)
5J Adv Pract Oncol, 4
F Fazio, M Brescini, G Lapietra, MT Petrucci (2021)
Belantamab mafodotin in heavily treated relapsed/refractory multiple myeloma patients: a case-series from a real-life experienceHemaSphere, 5
M. Hultcrantz, Jennifer Orozco, Tim Peterson, Andriy Derkach, H. Hassoun, N. Korde, Sydney Lu, S. Mailankody, D. Patel, U. Shah, C. Tan, K. Maclachlan, D. Chung, H. Landau, G. Shah, O. Lahoud, M. Scordo, O. Landgren, S. Giralt, A. Lesokhin (2021)
Belantamab Mafodotin in Patients with Relapsed/Refractory Multiple Myeloma, a Real-World ExperienceBlood
C. Chim, Shaji Kumar, R. Orlowski, G. Cook, P. Richardson, M. Gertz, S. Giralt, M. Mateos, X. Leleu, K. Anderson (2017)
Management of relapsed and refractory multiple myeloma: novel agents, antibodies, immunotherapies and beyondLeukemia, 32
S. Kurtin (2013)
Relapsed or Relapsed/Refractory Multiple Myeloma
National Institutes of Health, National Cancer Institute. Common terminology criteria for adverse events (CTCAE). Version 5
I. Demel, J. Bago, R. Hájek, T. Jelínek (2020)
Focus on monoclonal antibodies targeting B‐cell maturation antigen (BCMA) in multiple myeloma: update 2021British Journal of Haematology, 193
M. Becnel, Hans Lee (2020)
The role of belantamab mafodotin for patients with relapsed and/or refractory multiple myelomaTherapeutic Advances in Hematology, 11
K Tzogani (2021)
70Oncologist, 26
A. Alegre, Gonzalo Callejo, R. Fernández, J. Martínez-López, A. Jiménez-Ubieto, C. Cuellar, E. Askari, E. Prieto, C. Aláez, B. Aguado, A. Velasco, I. Krsnik, L. Llorente, Cristina Muñoz-Linares, Ana Morales, E. Mesa, Rebeca Iglesias, C. Martínez-Chamorro, A. Alonso, Carmen Jiménez-Montes, M. Blanchard (2021)
Compassionate Use of Belantamab Mafodotin for Treatment of Patients with Relapsed/Refractory Multiple Myeloma Heavily Treated. Spanish ExperienceBlood
S Lonial (2020)
207Lancet Oncol, 21
(2021)
Monoclonal antibodies in myeloma: optimizing targeted therapy
S. Lonial, Hans Lee, A. Badros, S. Trudel, A. Nooka, A. Chari, Al-Ola Abdallah, N. Callander, D. Sborov, A. Suvannasankha, K. Weisel, P. Voorhees, Lynsey Womersley, January Baron, T. Piontek, E. Lewis, J. Opalinska, I. Gupta, A. Cohen (2021)
Longer term outcomes with single‐agent belantamab mafodotin in patients with relapsed or refractory multiple myeloma: 13‐month follow‐up from the pivotal DREAMM‐2 studyCancer, 127
Christiane, Druml, Wolzt, Pleiner (2000)
World Medical Association Declaration of HelsinkiInternational Journal of Pharmaceutical Medicine, 14
NS Joseph (2021)
169Clin Pharmacol, 13
R. Iula, F. Trastulli, R. Pepa, A. D’Ambrosio, M. Romano, A. Leone, G. Gaeta, S. Palmieri, S. Rocco, F. Pane, F. Ferrara, L. Catalano (2022)
P20: POLYCENTRIC “REAL LIFE” STUDY OF BELANTAMAB MAFODOTIN FOR RELAPSED/REFRACTORY MULTIPLE MYELOMAHemaSphere, 6
I. Vaxman, J. Abeykoon, A. Dispenzieri, Shaji Kumar, F. Buadi, M. Lacy, D. Dingli, Y. Hwa, A. Fonder, M. Hobbs, C. Reeder, T. Sher, S. Hayman, T. Kourelis, R. Warsame, Eli Muchtar, N. Leung, W. Gonsalves, M. Siddiqui, R. Kyle, S. Rajkumar, Kirsten McCullough, P. Kapoor, M. Gertz (2021)
“Real-life” data of the efficacy and safety of belantamab mafodotin in relapsed multiple myeloma—the Mayo Clinic experienceBlood Cancer Journal, 11
A Chari (2020)
8Clin Lymphoma Myeloma Leuk, 20
J. Bladé, M. Beksaç, J. Caers, A. Jurczyszyn, M. Lilienfeld-Toal, P. Moreau, L. Rasche, L. Rosiñol, S. Usmani, E. Zamagni, P. Richardson (2022)
Extramedullary disease in multiple myeloma: a systematic literature reviewBlood Cancer Journal, 12
M. Hultcrantz, L. Anderson, F. Anwer, C. Gasparetto, M. Kocoglu, Eben Lichtman, C. Mo, R. Niesvizky, E. Lewis, Hong Li, S. Paul, S. Petrone, J. Kaufman (2021)
MM-392: Belantamab Mafodotin (Belamaf; GSK2857916) US Expanded Access Program (EAP) for Heavily Pre-Treated Patients with Relapsed/Refractory Multiple Myeloma (RRMM): Baseline CharacteristicsClinical Lymphoma, Myeloma & Leukemia, 21
(2013)
ethical principles for medical research involving human subjectsJAMA, 310
CS Chim (2018)
252Leukemia, 32
I Demel (2021)
705Br J Haematol, 193
Semira Sheikh, E. Lebel, S. Trudel (2020)
Belantamab mafodotin in the treatment of relapsed or refractory multiple myeloma.Future oncology
S. Lonial, Hans Lee, A. Badros, S. Trudel, A. Nooka, A. Chari, Al-Ola Abdallah, N. Callander, N. Lendvai, D. Sborov, A. Suvannasankha, K. Weisel, L. Karlin, E. Libby, B. Arnulf, T. Facon, C. Hulin, K. Kortüm, P. Rodríguez-Otero, S. Usmani, P. Hari, R. Baz, H. Quach, P. Moreau, P. Voorhees, I. Gupta, A. Hoos, E. Zhi, January Baron, T. Piontek, E. Lewis, R. Jewell, E. Dettman, R. Popat, S. Esposti, J. Opalinska, P. Richardson, A. Cohen (2019)
Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study.The Lancet. Oncology
A. Chari, D. Romanus, A. Palumbo, M. Blazer, E. Farrelly, A. Raju, Hui Huang, P. Richardson (2019)
Randomized Clinical Trial Representativeness and Outcomes in Real-World Patients: Comparison of 6 Hallmark Randomized Clinical Trials of Relapsed/Refractory Multiple Myeloma.Clinical lymphoma, myeloma & leukemia
Louise Kostos, W. Hong, Belinda Lee, B. Tran, S. Lok, A. Anton, G. Gard, Y. To, V. Wong, J. Shapiro, R. Wong, Shirley Wong, R. Boer, P. Gibbs (2021)
Cancer clinical trial vs real‐world outcomes for standard of care first‐line treatment in the advanced disease settingInternational Journal of Cancer, 149
M. Offidani, L. Corvatta, S. More’, A. Olivieri (2021)
Belantamab Mafodotin for the Treatment of Multiple Myeloma: An Overview of the Clinical Efficacy and SafetyDrug Design, Development and Therapy, 15
MR Becnel (2020)
204062072097981Ther Adv Hematol, 11
S Sheikh (2020)
2783Future Oncol, 16
S Lonial (2021)
4198Cancer, 127
IntroductionBelantamab mafodotin (BM) is a new anti-BCMA antibody–drug conjugate, recently approved for triple-class relapsed and refractory multiple myeloma (RRMM). We assessed real-world outcomes with BM in patients under the Spanish Expanded Access Program (EAP).MethodsWe conducted an observational, retrospective, multicenter study including RRMM patients who received ≥ 1 dose of BM (Nov 2019 to Jun 2021). The primary endpoint was overall response rate (ORR). Secondary endpoints were progression-free survival (PFS), overall survival (OS), and incidence of treatment-emergent adverse events (TEAEs).ResultsThirty-three patients were included with a median of 70 years of age (range, 46–79 years). Median time from diagnosis was 71 months (range, 10–858 months). Median prior lines was 5 (range, 3–8 lines); 90% of patients were triple-/quad-/penta-refractory; 48% showed high-risk cytogenetics. Median BM doses was 3 (range 1–16 doses), with a median follow-up of 11 months (6–15 months). ORR was 42.2% (≥ VGPR, 18.2%).Median PFS was 3 months (95% CI 0.92–5.08) in the overall population, and 11 months (HR 0.26; 95% CI 0.10–0.68) for patients who achieved ≥ PR. PFS was not significantly different according to age, cytogenetic risk, and prior therapy lines. OS was 424 days (95% CI 107–740). Non-hematological TEAEs (57.6% of patients; 30.3% ≥ G3) included keratopathy (51.5%; 21.2% ≥ G3) and patient-reported vision-related symptoms (45.5%). Keratopathy was resolved in 70.6% of patients. G3 hematological TEAEs was 18.2%, thrombocytopenia (21.2%). Dose reductions due to TEAEs: 30.3%; delays: 36.4%. Treatment discontinuation causes: progression (54.5%), toxicity (non-ocular; 6%/ocular; 6% /ocular + non-ocular toxicity; 3%), death (6%), and patient’s decision (3%).ConclusionsBM showed relevant anti-myeloma activity in RRMM with a manageable safety profile. These results corroborate those observed in the BM pivotal trial.
Oncology and Therapy – Springer Journals
Published: Mar 1, 2023
Keywords: Triple-class relapsed and refractory multiple myeloma; Belantamab mafodotin; Real-world outcomes; Effectiveness; Safety
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