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51. Belantamab mafodotin in combination with novel agents in relapsed/refractory multiple myeloma: DREAMM-5 study design

Author

MS Hematologie, Infection & Immunity, Regenerative Medicine and Stem Cells, Cancer, Nooka, Ajay K, Weisel, Katja, van de Donk, Niels Wcj, Routledge, David, Otero, Paula Rodriguez, Song, Kevin, Quach, Hang, Callander, Natalie, Minnema, Monique C, Trudel, Suzanne, Jackson, Nicola A, Ahlers, Christoph M, Im, Ellie, Cheng, Shinta, Smith, L, Hareth, Nahi, Ferron-Brady, Geraldine, Brouch, Maria, de Oca, Rocio Montes, Paul, Sofia, Holkova, Beata, Gupta, Ira, Kremer, Brandon E, Richardson, Paul, MS Hematologie, Infection & Immunity, Regenerative Medicine and Stem Cells, Cancer, Nooka, Ajay K, Weisel, Katja, van de Donk, Niels Wcj, Routledge, David, Otero, Paula Rodriguez, Song, Kevin, Quach, Hang, Callander, Natalie, Minnema, Monique C, Trudel, Suzanne, Jackson, Nicola A, Ahlers, Christoph M, Im, Ellie, Cheng, Shinta, Smith, L, Hareth, Nahi, Ferron-Brady, Geraldine, Brouch, Maria, de Oca, Rocio Montes, Paul, Sofia, Holkova, Beata, Gupta, Ira, Kremer, Brandon E, and Richardson, Paul

Published
2021

52. Assessment of Periodontal Health Status among the Male Adult Population with a Dual Habit of Smoking and Gutkha Chewing: A Cross-Sectional Study.

Author

B. J., Janardhana Amaranath, Gupta, Shruti, Kumar, Shravan, Das, Neelam, Gupta, Ira, and Pratik, Shashwat

Subjects
SMOKING, ORAL hygiene, MASTICATION, CROSS-sectional method, GINGIVAL recession, PERIODONTAL disease
Abstract

Aims and Objective: The aim of this study was to assess the periodontal health status in subjects having dual habits of smoking and gutkha chewing among the male population of Kanpur City, Central Uttar Pradesh (UP). Materials and Methods: A total number of 500 male subjects were included, divided into three study groups: group I-164 subjects with a dual habit of smoking and gutkha chewing, group II-170 gutkha chewers, and group III-166 smokers. Case history, clinical examination, and the following clinical parameters were recorded--oral hygiene index (OHI-S), gingival index (GI), bleeding index, clinical attachment loss (CAL), gingival recession, and furcation involvement. Result: In this study, the proportion of severe CAL was maximum in dual habit (78%) followed by smokers (70.5%) and then gutkha chewers (40.0%). A significant difference was observed in the proportion of CAL status between smokers, gutkha, and dual habit cases (P < 0.001). The result revealed that the dual habit group had more severe periodontal disease than smokers and gutkha chewers. Conclusion: Overall, it was concluded that periodontal health status was found to be very poor in both smokers and gutkha chewers, but the subjects in the dual habit group were found to have extremely poor periodontal health status. [ABSTRACT FROM AUTHOR]

Published
2023
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53. Relationship between corneal exam findings, best-corrected visual acuity (BCVA), and ocular symptoms in patients with relapsed or refractory multiple myeloma (RRMM) receiving belantamab mafodotin (belamaf).

Author

Terpos, Evangelos, primary, Badros, Ashraf, additional, Popat, Rakesh, additional, Rodríguez-Otero, Paula, additional, Farooq, Asim, additional, Jeng, Bennie, additional, Degli Esposti, Simona, additional, Lewis, Eric, additional, Gupta, Ira, additional, Opalinska, Joanna, additional, Palumbo, Antonio, additional, and Trudel, Suzanne, additional

Published
2021
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59. Infusion-Related Reactions (IRRs) in the DREAMM-2 Study of Single-Agent Belantamab Mafodotin (Belamaf) in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)

Author

Nooka, Ajay, primary, Lee, Hans C., additional, Badros, Ashraf Z., additional, Voorhees, Peter, additional, Hultcrantz, Malin, additional, Karlin, Lionel, additional, Arnulf, Bertrand, additional, Richardson, Paul G., additional, Zhi, Eric, additional, Baron, January, additional, Piontek, Trisha, additional, Lewis, Eric, additional, Opalinska, Joanna, additional, Gupta, Ira, additional, Cohen, Adam D., additional, and Lonial, Sagar, additional

Published
2020
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60. Ocular Health of Patients with Relapsed/Refractory Multiple Myeloma (RRMM): Baseline Data from the DREAMM-2 Trial of Belantamab Mafodotin (Belamaf)

Author

Popat, Rakesh, primary, Kazantzi, Aikaterini, additional, Farooq, Asim, additional, Thulasi, Praneetha, additional, Lonial, Sagar, additional, Jakubowiak, Andrzej, additional, Badros, Ashraf Z., additional, Jeng, Bennie H., additional, Opalinska, Joanna, additional, Baron, January, additional, Piontek, Trisha, additional, Byrne, Julie, additional, Womersley, Lynsey, additional, Gupta, Ira, additional, and Degli Esposti, Simona, additional

Published
2020
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61. DREAMM-6: Safety, Tolerability and Clinical Activity of Belantamab Mafodotin (Belamaf) in Combination with Bortezomib/Dexamethasone (BorDex) in Relapsed/Refractory Multiple Myeloma (RRMM)

Author

Popat, Rakesh, primary, Nooka, Ajay, additional, Stockerl-Goldstein, Keith, additional, Abonour, Rafat, additional, Ramaekers, Ryan, additional, Khot, Amit, additional, Forbes, Adam, additional, Lee, Cindy, additional, Augustson, Bradley, additional, Spencer, Andrew, additional, Mateos, Maria-Victoria, additional, Chopra, Bikramjit, additional, Rogers, Rachel, additional, Smith, Deborah A, additional, Davidge, Jacqueline, additional, Montes de Oca, Rocio, additional, Ferron-Brady, Geraldine, additional, Yeakey, Anne, additional, Talekar, Mala, additional, Kremer, Brandon E., additional, Gupta, Ira, additional, and Quach, Hang, additional

Published
2020
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62. Dreamm-5 Platform Trial: Belantamab Mafodotin (Belamaf) in Combination with Four Different Novel Agents in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)

Author

Richardson, Paul G., primary, Nooka, Ajay, additional, Quach, Hang, additional, Trudel, Suzanne, additional, Routledge, David, additional, Song, Kevin, additional, Nahi, Hareth, additional, Paul, Sofia, additional, Khan, Josephine, additional, Brouch, Maria, additional, Ferron-Brady, Geraldine, additional, Yeakey, Anne, additional, Shelton, Chris, additional, Montes de Oca, Rocio, additional, Smith, L. Mary, additional, Im, Ellie, additional, Ahlers, Christoph M, additional, Paul, Elaine M, additional, Holkova, Beata, additional, Gupta, Ira, additional, Kremer, Brandon E., additional, and Rodriguez-Otero, Paula, additional

Published
2020
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63. DREAMM-8: A Phase III Study of the Efficacy and Safety of Belantamab Mafodotin with Pomalidomide and Dexamethasone (B-Pd) Vs Pomalidomide Plus Bortezomib and Dexamethasone (PVd) in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)

Author

Trudel, Suzanne, primary, Davis, Randy, additional, Lewis, Nicole M., additional, Bakshi, Kalpana K., additional, Chopra, Bikramjit, additional, Montes de Oca, Rocio, additional, Ferron-Brady, Geraldine, additional, Eliason, Laurie, additional, Kremer, Brandon E., additional, Gupta, Ira, additional, and Wu, Frank S., additional

Published
2020
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64. DREAMM-7: A Phase III Study of the Efficacy and Safety of Belantamab Mafodotin (Belamaf) with Bortezomib, and Dexamethasone (B-Vd) in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)

Author

Rifkin, Robert M., primary, Boyd, Kevin, additional, Grosicki, Sebastian, additional, Kim, Kihyun, additional, Di Raimondo, Francesco, additional, Dimopoulos, Meletios A, additional, Weisel, Katja, additional, Arnulf, Bertrand, additional, Hajek, Roman, additional, Hungria, Vania T. M., additional, Spencer, Andrew, additional, Davis, Randy, additional, Riccio, Antonio, additional, Kim, Chanbin, additional, Wilkes, Jodie, additional, Rutledge, Ruth, additional, Talekar, Mala, additional, Kremer, Brandon E., additional, Gupta, Ira, additional, and Mateos, Maria-Victoria, additional

Published
2020
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65. DREAMM-2: Single-Agent Belantamab Mafodotin (Belamaf) Effects on Patient-Reported Outcome (PRO) Measures in Patients with Relapsed/Refractory Multiple Myeloma (RRMM)

Author

Popat, Rakesh, primary, Lonial, Sagar, additional, Voorhees, Peter M., additional, Degli Esposti, Simona, additional, Gupta, Ira, additional, Opalinska, Joanna, additional, Sapra, Sandhya, additional, Gorsh, Boris, additional, He, Zangdong, additional, Kleinman, David M, additional, Schaumberg, Debra, additional, Loubert, Angely, additional, Meunier, Juliette, additional, Regnault, Antoine, additional, and Eliason, Laurie, additional

Published
2020
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66. MM-219: Pivotal DREAMM-2 Study: Single-Agent Belantamab Mafodotin (Belamaf; GSK2857916) in Patients with Relapsed/Refractory Multiple Myeloma (RRMM) Refractory to Proteasome Inhibitors and Immunomodulatory Agents, and Refractory and/or Intolerant to Anti-CD38 Monoclonal Antibodies (mAbs), Including Subgroups with Renal Impairment (RI) and High-Risk (HR) Cytogenetics

Author

Lonial, Sagar, primary, Lee, Hans Chulhee, additional, Badros, Ashraf, additional, Trudel, Suzanne, additional, Nooka, Ajay K, additional, Chari, Ajai, additional, Abdallah, Al-Ola, additional, Callander, Natalie Scott, additional, Sborov, Douglas Weston, additional, Suvannasankha, Attaya, additional, Weisel, Katja, additional, Voorhees, Peter M, additional, Hultcrantz, Malin, additional, Libby, Edward N, additional, Richardson, Paul G, additional, Otero, Paula Rodriguez, additional, Besemer, Britta, additional, Facon, Thierry, additional, Hoos, Axel, additional, Zhi, Eric, additional, Baron, January, additional, Piontek, Trisha, additional, Jewell, Roxanne C, additional, Lewis, Eric, additional, Opalinska, Joanna, additional, Gupta, Ira, additional, and Cohen, Adam D, additional

Published
2020
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67. MM-250: Impact of Prolonged Dose Delays on Response with Belantamab Mafodotin (Belamaf; GSK2857916) Treatment in the DREAMM-2 Study: 13-Month Follow-Up

Author

Cohen, Adam D, primary, Lee, Hans C, additional, Trudel, Suzanne, additional, Abdallah, Al-Ola, additional, Callander, Natalie, additional, Libby, Edward, additional, Karlin, Lionel, additional, Lonial, Sagar, additional, Womersley, Lynsey, additional, Baron, January, additional, Lewis, Eric, additional, Nungesser, Katlyn, additional, Gupta, Ira, additional, and Opalinska, Joanna, additional

Published
2020
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70. 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).

Author

Lonial, Sagar, primary, Lee, Hans Chulhee, additional, Badros, Ashraf, additional, Trudel, Suzanne, additional, Nooka, Ajay K., additional, Chari, Ajai, additional, Abdallah, Al-Ola A., additional, Callander, Natalie Scott, additional, Sborov, Douglas Weston, additional, Suvannasankha, Attaya, additional, Weisel, Katja, additional, Voorhees, Peter Michael, additional, Hoos, Axel, additional, Zhi, Eric, additional, Baron, January, additional, Piontek, Trisha, additional, Jewell, Roxanne C., additional, Opalinska, Joanna, additional, Gupta, Ira, additional, and Cohen, Adam D., additional

Published
2020
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71. DREAMM-2: Single-agent belantamab mafodotin (GSK2857916) in patients with relapsed/refractory multiple myeloma (RRMM) and renal impairment.

Author

Lee, Hans Chulhee, primary, Cohen, Adam D., additional, Chari, Ajai, additional, Hultcrantz, Malin, additional, Nooka, Ajay K., additional, Callander, Natalie Scott, additional, Suvannasankha, Attaya, additional, Badros, Ashraf, additional, Libby, Edward N., additional, Trudel, Suzanne, additional, Richardson, Paul G., additional, Sborov, Douglas Weston, additional, Rodríguez Otero, Paula, additional, Lonial, Sagar, additional, Zhi, Eric, additional, Lewis, Eric, additional, Gupta, Ira, additional, and Opalinska, Joanna, additional

Published
2020
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72. DREAMM-5 platform trial: Belantamab mafodotin in combination with novel agents in patients with relapsed/refractory multiple myeloma (RRMM).

Author

Richardson, Paul G., primary, Biswas, Swethajit, additional, Holkova, Beata, additional, Jackson, Nicola, additional, Netherway, Thelma, additional, Paul, Sofia, additional, Ferron-Brady, Geraldine, additional, Yeakey, Anne, additional, Shelton, Chris, additional, Montes de Oca, Rocio, additional, Ahlers, Christoph Matthias, additional, Ballas, Marc S., additional, Paul, Elaine Marie, additional, Gupta, Ira, additional, Opalinska, Joanna, additional, and Luptakova, Katarina, additional

Published
2020
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73. DREAMM-6: Safety and tolerability of belantamab mafodotin in combination with bortezomib/dexamethasone in relapsed/refractory multiple myeloma (RRMM).

Author

Nooka, Ajay K., primary, Stockerl-Goldstein, Keith, additional, Quach, Hang, additional, Forbes, Adam, additional, Mateos, Maria-Victoria, additional, Khot, Amit, additional, Tan, Alan, additional, Abonour, Rafat, additional, Chopra, Bikramjit, additional, Rogers, Rachel, additional, Ferron-Brady, Geraldine, additional, Davidge, Jacqueline, additional, Frey, Steve, additional, Yeakey, Anne, additional, Talekar, Mala, additional, Luptakova, Katarina, additional, Gupta, Ira, additional, and Popat, Rakesh, additional

Published
2020
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74. DREAMM-2: Single-agent belantamab mafodotin (GSK2857916) in patients with relapsed/refractory multiple myeloma (RRMM) and high-risk (HR) cytogenetics.

Author

Cohen, Adam D., primary, Trudel, Suzanne, additional, Lonial, Sagar, additional, Libby, Edward N., additional, Lee, Hans Chulhee, additional, Besemer, Britta, additional, Facon, Thierry, additional, Nooka, Ajay K., additional, Callander, Natalie Scott, additional, Chari, Ajai, additional, Gupta, Ira, additional, Paul, Sofia, additional, Opalinska, Joanna, additional, and Richardson, Paul G., additional

Published
2020
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78. Dreamm-5: Platform Trial Evaluating Belantamab Mafodotin (a BCMA-directed Immuno-conjugate) in Combination with Novel Agents in Relapsed or Refractory Multiple Myeloma (RRMM)

Author

Richardson, Paul G., primary, Biswas, Swethajit, additional, Holkova, Beata, additional, Jackson, Nicola, additional, Netherway, Thelma, additional, Bao, Weichao, additional, Ferron-Brady, Geraldine, additional, Yeakey, Anne, additional, Shelton, Chris, additional, Montes De Oca, Rocio, additional, Ahlers, Chris, additional, Franco, Sonia, additional, Ballas, Marc, additional, Paul, Elaine, additional, Luptakova, Katarina, additional, Gupta, Ira, additional, and Opalinska, Joanna, additional

Published
2019
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79. Gingival Enlargement in a Case of Variant Jones Syndrome: a Case Report

Author

DA, Roopa, Singh, Shinkhala, Gupta, Ira, and Gopal, Saumiya

Subjects
Gingival enlargement, Case Report, Jones syndrome, Gingivectomy
Abstract

Gingival enlargement can be caused by a variety of etiological factors like inflammation, drugs, and systemic diseases or can be presented as a part of a syndrome. One such syndrome is Jones Syndrome, which is associated with gingival enlargement and progressive hearing loss. We present here a case of fifteen-year-old boy with gingival enlargement, hearing loss, and generalized alveolar bone loss and diagnosed as Jones syndrome. The diagnosis was made based on history, clinical, radiographic, and histopathological findings. Gingival enlargement was surgically managed using gingivectomy and no recurrence was observed. The patient showed remarkable esthetical and functional improvement.

Published
2016

80. Recovery of Ocular Events with Longer-Term Follow-up in the DREAMMM-2 Study of Single-Agent Belantamab Mafodotin (Belamaf) in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)

Author

Lonial, Sagar, Nooka, Ajay, Thulasi, Praneetha, Badros, Ashraf Z., Jeng, Bennie H., Callander, Natalie S., Sborov, Douglas, Zaugg, Brian E., Popat, Rakesh, Degli Esposti, Simona, Byrne, Julie, Opalinska, Joanna, Baron, January, Piontek, Trisha, Gupta, Ira, Dana, Reza, Farooq, Asim, and Jakubowiak, Andrzej

Published
2020
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81. Mutant Isocitrate Dehydrogenase (mIDH) Inhibitors, Enasidenib or Ivosidenib, in Combination with Azacitidine (AZA): Preliminary Results of a Phase 1b/2 Study in Patients with Newly Diagnosed Acute Myeloid Leukemia (AML)

Author

DiNardo, Courtney D., primary, Stein, Anthony S., additional, Fathi, Amir T., additional, Montesinos, Pau, additional, Odenike, Olatoyosi, additional, Kantarjian, Hagop M., additional, Stone, Richard M., additional, Koralek, Daniel O., additional, Van Oostendorp, Jason, additional, Gong, Jing, additional, Gupta, Ira, additional, and Vyas, Paresh, additional

Published
2017
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82. Enasidenib Monotherapy Is Effective and Well-Tolerated in Patients with Previously Untreated Mutant- IDH2 (m IDH2) Acute Myeloid Leukemia (AML)

Author

Pollyea, Daniel A., primary, Tallman, Martin S., additional, De Botton, Stephane, additional, DiNardo, Courtney D., additional, Kantarjian, Hagop M., additional, Collins, Robert H., additional, Stein, Anthony S., additional, Xu, Qiang, additional, Tosolini, Alessandra, additional, Gupta, Ira, additional, Agresta, Samuel V., additional, and Stein, Eytan M., additional

Published
2017
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83. Ivosidenib or Enasidenib Combined with Standard Induction Chemotherapy Is Well Tolerated and Active in Patients with Newly Diagnosed AML with an IDH1 or IDH2 Mutation: Initial Results from a Phase 1 Trial

Author

Stein, Eytan M., primary, DiNardo, Courtney D., additional, Mims, Alice S., additional, Savona, Michael R., additional, Pratz, Keith, additional, Stein, Anthony S., additional, Fathi, Amir T., additional, Stone, Richard M., additional, Pollyea, Daniel A., additional, Odenike, Olatoyosi, additional, Lowenberg, Bob, additional, Döhner, Hartmut, additional, Schiller, Gary J., additional, Gupta, Ira V., additional, Nabhan, Salah, additional, Zhang, Vickie, additional, Almon, Caroline, additional, Cooper, Michael, additional, and Tallman, Martin S., additional

Published
2017
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84. Types of bone destruction and its severity in chronic periodontitis patients with tobacco smoking habit using periapical radiographs and transgingival probing: A cross-sectional study.

Author

Amaranath, B, Das, Neelam, Gupta, Ira, Gupta, Rohit, John, Bijoy, and Devi, Munishwar

Abstract

Background: Tobacco smoking is an independent risk factor for periodontal disease which increases periodontal pocketing, attachment loss, as well as bone loss leading to varied severity and bone destruction in the form of horizontal and vertical patterns. Aim: The aim of the present study is to determine and measure the types and severity of bone destruction in chronic periodontitis (CP) patients with tobacco smoking habit using intraoral periapical (IOPA) radiographs and transgingival probing. Materials and Methods: A total of 60 male participants with CP were included in the study. Group A comprised 30 heavy cigarette smokers and Group B comprised 30 nonsmokers. Clinical parameters such as plaque index (PI), probing pocket depth (PPD), and clinical attachment loss (CAL) were recorded. Amount and pattern of bone loss were assessed using IOPA and transgingival probing. Results: The mean values of PI, PPD, and CAL were 2.50 ± 0.28 mm, 9.33 ± 1.42 mm, and 10.2 ± 1.62 mm, respectively, for cigarette smokers, which were found to be higher and statistically significant as compared to nonsmokers. Cigarette smokers showed more bone destruction than nonsmokers in respect to maxillary molars 4.42 ± 1.31 mm and incisors 3.90 ± 1.10 mm as compared to nonsmokers. Types of bone destruction were more of vertical patterns (93.3%) in cigarette smokers. Conclusions: Tobacco smoking was associated with severe attachment loss. Tobacco smoking not only affects soft tissues but also hard tissues such as bone. Palatal sides of maxillary molars showed significantly higher bone loss and also had more percentage of vertical patterns of bone loss compared to nonsmokers. IOPA and transgingival probing may be used as noninvasive methods for the determination of types and severity of bone destruction in CP patients with or without tobacco smoking habit. [ABSTRACT FROM AUTHOR]

Published
2020
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85. Enasidenib (AG-221), a Potent Oral Inhibitor of Mutant Isocitrate Dehydrogenase 2 (IDH2) Enzyme, Induces Hematologic Responses in Patients with Myelodysplastic Syndromes (MDS)

Author

Stein, Eytan M., primary, Fathi, Amir T., additional, DiNardo, Courtney D, additional, Pollyea, Daniel A, additional, Swords, Ronan T, additional, Roboz, Gail J., additional, Collins, Robert, additional, Sekeres, Mikkael A., additional, Stone, Richard M., additional, Attar, Eyal C, additional, Tosolini, Alessandra, additional, Xu, Qiang, additional, Amatangelo, Michael, additional, Gupta, Ira, additional, Knight, Robert D., additional, De Botton, Stéphane, additional, Tallman, Martin S., additional, and Kantarjian, Hagop M., additional

Published
2016
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86. Health-related quality of life and patient-reported outcomes of ofatumumab plus fludarabine and cyclophosphamide versus fludarabine and cyclophosphamide in the COMPLEMENT 2 trial of patients with relapsed CLL

Author

Robak, Tadeusz, primary, Warzocha, Krzysztof, additional, Govind Babu, K., additional, Kulyaba, Yaroslav, additional, Kuliczkowski, Kazimierz, additional, Abdulkadyrov, Kudrat, additional, Loscertales, Javier, additional, Kryachok, Iryna, additional, Kłoczko, Janusz, additional, Rekhtman, Grygoriy, additional, Homenda, Wojciech, additional, Błoński, Jerzy Z., additional, McKeown, Astrid, additional, Chang, Chai-Ni, additional, Bal, Vasudha, additional, Lisby, Steen, additional, Gupta, Ira V., additional, and Grosicki, Sebastian, additional

Published
2016
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87. Ofatumumab plus fludarabine and cyclophosphamide in relapsed chronic lymphocytic leukemia: results from the COMPLEMENT 2 trial

Author

Robak, Tadeusz, primary, Warzocha, Krzysztof, additional, Govind Babu, K., additional, Kulyaba, Yaroslav, additional, Kuliczkowski, Kazimierz, additional, Abdulkadyrov, Kudrat, additional, Loscertales, Javier, additional, Kryachok, Iryna, additional, Kłoczko, Janusz, additional, Rekhtman, Grygoriy, additional, Homenda, Wojciech, additional, Błoński, Jerzy Z., additional, McKeown, Astrid, additional, Gorczyca, Michele M., additional, Carey, Jodi L., additional, Chang, Chai-Ni, additional, Lisby, Steen, additional, Gupta, Ira V., additional, and Grosicki, Sebastian, additional

Published
2016
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88. Health-related quality of life and patient-reported outcomes of ofatumumab plus chlorambucil versus chlorambucil monotherapy in the COMPLEMENT 1 trial of patients with previously untreated CLL

Author

Hillmen, Peter, primary, Janssens, Ann, additional, Babu, K. Govind, additional, Kloczko, Janusz, additional, Grosicki, Sebastian, additional, Manson, Stephanie, additional, McKeown, Astrid, additional, Gupta, Ira, additional, Chang, Chai-Ni, additional, and Offner, Fritz, additional

Published
2016
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89. A phase 2, multicenter study investigating ofatumumab and bendamustine combination in patients with untreated or relapsed CLL

Author

Flinn, Ian W., primary, Panayiotidis, Panayiotis, additional, Afanasyev, Boris, additional, Janssens, Ann, additional, Grosicki, Sebastian, additional, Homenda, Wojciech, additional, Smolej, Lukas, additional, Kuliczkowski, Kazimierz, additional, Doubek, Michael, additional, Domnikova, Natalia, additional, West, Sarah L., additional, Chang, Chai‐Ni, additional, Barker, Alison M., additional, Gupta, Ira V., additional, Wright, Oliver J., additional, and Offner, Fritz, additional

Published
2016
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91. Phase III, randomized study of ofatumumab versus physicians’ choice of therapy and standard versus extended-length ofatumumab in patients with bulky fludarabine-refractory chronic lymphocytic leukemia

Author

Österborg, Anders, primary, Udvardy, Miklós, additional, Zaritskey, Andrey, additional, Andersson, Per-Ola, additional, Grosicki, Sebastian, additional, Mazur, Grzegorz, additional, Kaplan, Polina, additional, Steurer, Michael, additional, Schuh, Anna, additional, Montillo, Marco, additional, Kryachok, Iryna, additional, Middeke, Jan Moritz, additional, Kulyaba, Yaroslav, additional, Rekhtman, Grygoriy, additional, Gorczyca, Michele, additional, Daly, Siobhan, additional, Chang, Chai-Ni, additional, Lisby, Steen, additional, and Gupta, Ira, additional

Published
2016
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93. Health-Related Quality of Life and Patient-Reported Outcomes in Patients Receiving Ofatumumab in Combination with Fludarabine and Cyclophosphamide (FC) Versus FC Alone in the Complement 2 Trial

Author

Robak, Tadeusz, primary, Warzocha, Krzysztof, additional, Babu, K Govind, additional, Kulyaba, Yaroslav, additional, Kuliczkowski, Kazimierz, additional, Abdulkadyrov, Kudrat, additional, Loscertales, Javier, additional, Kryachok, Iryna, additional, Kloczko, Janusz, additional, Rekhtman, Grygoriy, additional, Homenda, Wojciech, additional, Blonski, Jerzy, additional, McKeown, Astrid, additional, Chang, Chai-Ni, additional, Manson, Stephanie C, additional, Lisby, Steen, additional, Gupta, Ira V., additional, and Grosicki, Sebastian, additional

Published
2015
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97. Health-related quality of life and patient-reported outcomes of ofatumumab plus fludarabine and cyclophosphamide versus fludarabine and cyclophosphamide in the COMPLEMENT 2 trial of patients with relapsed CLL.

Author

Robak, Tadeusz, Warzocha, Krzysztof, Govind Babu, K., Kulyaba, Yaroslav, Kuliczkowski, Kazimierz, Abdulkadyrov, Kudrat, Loscertales, Javier, Kryachok, Iryna, Kłoczko, Janusz, Rekhtman, Grygoriy, Homenda, Wojciech, Błoński, Jerzy Z., McKeown, Astrid, Chang, Chai-Ni, Bal, Vasudha, Lisby, Steen, Gupta, Ira V., and Grosicki, Sebastian

Subjects
QUALITY of life, FLUDARABINE, CYCLOPHOSPHAMIDE, CHRONIC lymphocytic leukemia treatment, CHRONIC lymphocytic leukemia, RITUXIMAB, CANCER risk factors, THERAPEUTICS
Abstract

Chronic lymphocytic leukemia (CLL) is an incurable disease. Quality of life during treatment and periods of subsequent remission is therefore vital. Health-related quality of life (HRQoL) was compared in relapsed CLL during and after treatment with ofatumumab combined with fludarabine and cyclophosphamide versus fludarabine and cyclophosphamide alone. The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 v3 and QLQ-CLL16 were used to assess HRQoL in this open-label, phase 3 study. Improvements in prespecified domains of patient-reported outcomes (Global Health Status [GHS]/HRQoL and B symptom scores) were recorded in both treatment arms after three cycles and were sustained after 18 months of follow-up. The two treatment arms were not significantly different at the nominal 0.05 level for GHS/HRQoL (p = .7278) or B symptoms (p = .5968). Small improvements in quality of life were maintained after therapy. The addition of ofatumumab was without any adverse impact on HRQoL (NCT00824265). [ABSTRACT FROM PUBLISHER]

Published
2017
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98. Ofatumumab plus fludarabine and cyclophosphamide in relapsed chronic lymphocytic leukemia: results from the COMPLEMENT 2 trial.

Author

Robak, Tadeusz, Warzocha, Krzysztof, Govind Babu, K., Kulyaba, Yaroslav, Kuliczkowski, Kazimierz, Abdulkadyrov, Kudrat, Loscertales, Javier, Kryachok, Iryna, Kłoczko, Janusz, Rekhtman, Grygoriy, Homenda, Wojciech, Błoński, Jerzy Z., McKeown, Astrid, Gorczyca, Michele M., Carey, Jodi L., Chang, Chai-Ni, Lisby, Steen, Gupta, Ira V., and Grosicki, Sebastian

Subjects
CHRONIC lymphocytic leukemia treatment, CANCER relapse, FLUDARABINE, CYCLOPHOSPHAMIDE, CANCER invasiveness
Abstract

In this multicenter, open-label, phase III study, patients with relapsed chronic lymphocytic leukemia (CLL) were randomized (1:1) to receive ofatumumab plus fludarabine and cyclophosphamide (OFA + FC) or FC alone; the primary endpoint being progression-free survival (PFS) assessed by an independent review committee (IRC). Between March 2009 and January 2012, 365 patients were randomized (OFA + FC:n = 183; FC:n = 182). Median IRC-assessed PFS was 28.9 months with OFA + FC versus 18.8 months with FC (hazard ratio = 0.67; 95% confidence interval, 0.51–0.88;p = .0032). Grade ≥3 adverse events (≤60 days after last dose) were reported in 134 (74%) OFA + FC-treated patients compared with 123 (69%) FC-treated patients. Of these, neutropenia was the most common (89 [49%] vs. 64 [36%]). OFA + FC improved PFS with manageable safety for patients with relapsed CLL compared with FC alone, thus providing an alternative treatment option for patients with relapsed CLL. Trial registration:www.clinicaltrials.gov(NCT00824265). [ABSTRACT FROM PUBLISHER]

Published
2017
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99. Gene Mutations and Treatment Outcome in CLL Patients Treated with Chlorambucil (Chl) or Ofatumumab-Chl (O-Chl): Results from the Phase III Study COMPLEMENT1 (OMB110911)

Author

Tausch, Eugen, primary, Galler, Christina, additional, Schlenk, Richard, additional, Hillmen, Peter, additional, Offner, Fritz, additional, Janssens, Ann, additional, Govindbabu, K, additional, Mayer, Jiri, additional, Grosicki, Sebastian, additional, Panagiotidis, Panagiotis, additional, Mertens, Daniel, additional, McKeown, Astrid, additional, Gupta, Ira, additional, Döhner, Hartmut, additional, and Stilgenbauer, Stephan, additional

Published
2014
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100. Ofatumumab (OFA) Vs. Physician’s Choice (PC) of Therapy in Patients (pts) with Bulky Fludarabine Refractory (BFR) Chronic Lymphocytic Leukaemia (CLL): Results of the Phase III Study OMB114242

Author

Österborg, Anders, primary, Udvardy, Miklós, additional, Zaritskey, Andrey, additional, Andersson, Per-Ola, additional, Grosicki, Sebastian, additional, Mazur, Grzegorz, additional, Kaplan, Polina, additional, Steurer, Michael, additional, Schuh, Anna, additional, Montillo, Marco, additional, Kryachok, Iryna, additional, Middeke, Jan Moritz, additional, Kulyaba, Yaroslav, additional, Rekhtman, Grygoriy, additional, Gorczyca, Michele, additional, Daly, Siobhan, additional, Chai-Ni, Chang, additional, Lisby, Steen, additional, and Gupta, Ira, additional

Published
2014
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