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9 p, 1.5 MB |
Isatuximab, carfilzomib, and dexamethasone in patients with relapsed multiple myeloma : updated results from IKEMA, a randomized Phase 3 study
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Martin, Thomas (University of California at San Francisco, USA) ;
Dimopoulos, Meletios (University of Athens, Greece) ;
Mikhael, Joseph (Translational Genomics Research Institute. City of Hope Cancer Center, Phoenix, USA) ;
Yong, Kwee (University College Hospital, London, UK) ;
Capra, Marcelo (Centro Integrado de Hematologia e Oncologia. Hospital Mãe de Deus, Porto Alegre, Brazil) ;
Facon, Thierry (Lille University Hospital, France) ;
Hajek, Roman (University of Ostrava, Czech Republic) ;
Špička, Ivan (Department of Hematology. 1st Faculty of Medicine. Charles University and General Hospital, Prague, Czech Republic) ;
Baker, Ross (Murdoch University, Perth, Australia) ;
Kim, Kihyun (Sungkyunkwan University School of Medicine, Seoul, South Korea) ;
Martinez, Gracia (Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Brazil) ;
Min, Chang-Ki (The Catholic University of Korea) ;
Pour, Ludek (University Hospital Brno (República Txeca)) ;
Leleu, Xavier (Service d'Hématologie et Thérapie Cellulaire. CHU and CIC Inserm, France) ;
Oriol, Albert (Institut Germans Trias i Pujol. Institut de Recerca contra la Leucèmia Josep Carreras) ;
Koh, Youngil (Seoul National University Hospital, Seoul, South Korea) ;
Suzuki, Kenshi (Japanese Red Cross Medical Center, Tokyo, Japan) ;
Casca, France (Ividata Life Science, Levallois-Perret, France) ;
Macé, Sandrine (Sanofi, R&D, Chilly-Mazarin, France) ;
Risse, Marie-Laure (Sanofi, R&D, Vitry-sur-Seine, France) ;
Moreau, Philippe (University Hospital Hôtel-Dieu, Nantes, France)
Longer-term outcomes with the anti-CD38 antibody isatuximab in combination with carfilzomib-dexamethasone (Isa-Kd) were evaluated in the randomized Phase 3 trial IKEMA (NCT03275285), in a prespecified, follow-up analysis of progression-free survival (PFS, primary study endpoint), final complete response (CR) using Hydrashift Isa immunofixation assay, minimal residual disease (MRD) negativity, and safety. [...]
2023 -  10.1038/s41408-023-00797-8
Blood Cancer Journal, Vol. 13 Núm. 1 (december 2023)
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10 p, 306.4 KB |
Patient-reported outcomes in relapsed/refractory multiple myeloma treated with melflufen plus dexamethasone : analyses from the Phase II HORIZON study
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Larocca, Alessandra (Azienda Ospedaliero - Universitaria Città della Salute e della Scienza) ;
Leleu, Xavier (CHU de Poitiers) ;
Touzeau, Cyrille (Université d'Angers) ;
Bladé Creixenti, Juan (Institut d'Investigacions Biomèdiques August Pi i Sunyer) ;
Paner, Agne (Rush University Medical Center) ;
Mateos, M. V (Instituto de Investigación Biomédica de Salamanca) ;
Cavo, Michele (Bologna University School of Medicine) ;
Maisel, Christopher (Baylor Scott & White Charles A) ;
Alegre, Adrian (Hospital Universitario de la Princesa (Madrid)) ;
Oriol, Albert (Institut Germans Trias i Pujol. Institut de Recerca contra la Leucèmia Josep Carreras) ;
Raptis, Anastasios (niversity of Pittsburgh School of Medicine) ;
Rodriguez-Otero, Paula (Clínica Universidad de Navarra) ;
Mazumder, Amitabha (The Oncology Institute of Hope and Innovation) ;
Laubach, Jacob (Harvard Medical School) ;
Nadeem, Omar (Harvard Medical School) ;
Sandberg, Anna (Oncopeptides AB (Suècia)) ;
Orre, Marie (Oncopeptides AB (Suècia)) ;
Torrång, Anna (SDS Life Science (Suècia)) ;
Bakker, Nicolaas A (Oncopeptides AB) ;
Richardson, Paul G.. (Harvard Medical School) ;
Universitat Autònoma de Barcelona
Relapsed/refractory multiple myeloma (RRMM) is known to have a high burden of disease and complications associated with refractoriness to prior lines of therapy. Severe pain and fatigue symptoms and impairments in physical and emotional functioning have been strongly linked to reduced health-related quality of life (HRQoL) in patients with RRMM. [...]
2022 - 10.1111/bjh.17887
British Journal of Haematology, Vol. 196 Núm. 3 (february 2022) , p. 639-648
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13 p, 449.0 KB |
Melflufen and dexamethasone in heavily pretreated relapsed and refractory multiple myeloma
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Richardson, Paul G.. (Dana-Farber Cancer Institute (Boston, Estats Units d'Amèrica). Harvard Medical School) ;
Oriol, Albert (Institut Germans Trias i Pujol. Institut de Recerca contra la Leucèmia Josep Carreras) ;
Larocca, Alessandra (Università di Torino. Azienda Ospedaliero-Universitaria Città della Salute e della Scienza) ;
Bladé Creixenti, Juan (Hospital Clínic i Provincial de Barcelona) ;
Cavo, Michele (Seràgnoli Institute of Hematology. Bologna University School of Medicine) ;
Rodriguez-Otero, Paula (Clínica Universidad de Navarra) ;
Leleu, Xavier (CHU de Poitiers) ;
Nadeem, Omar (Dana-Farber Cancer Institute (Boston, Estats Units d'Amèrica). Harvard Medical School) ;
Hiemenz, John W. (Division of Hematology-Oncology. Department of Medicine. University of Florida) ;
Hassoun, Hani (Memorial Sloan Kettering Cancer Center) ;
Touzeau, Cyrille (Université de Nantes) ;
Alegre, Adrian (Hospital Universitario de la Princesa (Madrid)) ;
Paner, Agne (Rush University Medical Center) ;
Maisel, Christopher (Baylor Scott & White Charles A. Sammons Cancer Center) ;
Mazumder, Amitabha (Oncology Institute of Hope and Innovation) ;
Raptis, Anastasios (Universityof Pittsburgh School of Medicine) ;
Moreb, Jan S. (Novant Health Hematology. Novant Health Forsyth Medical Center) ;
Anderson, Kenneth C. (Dana-Farber Cancer Institute (Boston, Estats Units d'Amèrica). Harvard Medical School) ;
Laubach, Jacob P. (Dana-Farber Cancer Institute (Boston, Estats Units d'Amèrica). Harvard Medical School) ;
Thuresson, Sara (Oncopeptides AB) ;
Thuresson, Marcus (Oncopeptides AB) ;
Byrne, Catriona (Oncopeptides AB) ;
Harmenberg, Johan (Oncopeptides AB) ;
Bakker, Nicolaas A. (Oncopeptides AB) ;
Mateos, M. V (Hospital Clínico Universitario (Salamanca))
PURPOSE Melphalan flufenamide (melflufen) is a first-in-class peptide-drug conjugate that targets aminopeptidases and rapidly and selectively releases alkylating agents into tumor cells. The phase II HORIZON trial evaluated the efficacy of melflufen plus dexamethasone in relapsed and refractory multiple myeloma (RRMM), a population with an important unmet medical need. [...]
2021 - 10.1200/JCO.20.02259
Journal of Clinical Oncology, Vol. 39 Núm. 7 (january 2021) , p. 757-767
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13 p, 861.9 KB |
Ixazomib as postinduction maintenance for patients with newly diagnosed multiple myeloma not undergoing autologous stem cell transplantation : The phase III TOURMALINE-MM4 trial
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Dimopoulos, Meletios (The National and Kapodistrian University of Athens) ;
Špička, I. (Charles University. Faculty of Medicine in Hradec Králové) ;
Quach, H. (St Vincent's Hospital (Sydney)) ;
Oriol, Albert (Institut Germans Trias i Pujol. Institut de Recerca contra la Leucèmia Josep Carreras) ;
Hájek, R. (Department of Hemato-oncology. University Hospital Ostrava. University of Ostrava. Faculty of Medicine) ;
Garg, M. (Leicester General Hospital (Leicester, Regne Unit)) ;
Beksac, M. (Department of Hematology. Ankara University) ;
Bringhen, S. (Division of Hematology. University of Torino. Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino) ;
Katodritou, E. (Department of Hematology. Theagenion Cancer Hospital) ;
Chng, W. J. (Department of Hematology-Oncology. National University Cancer Institute. National University Health System. Yong Loo Lin School of Medicine. Cancer Science Institute of Singapore. National University of Singapore) ;
Leleu, Xavier (Pôle Régional de Cancérologie. Department of Haematology. Centre Hospitalier Universitaire La Milétrie-Poitiers) ;
Iida, S. (Department of Hematology and Oncology. Nagoya City University. Graduate School of Medical Sciences) ;
Mateos, M. V. (Hospital Universitario de Salamanca. Centro de Investigación del Cáncer) ;
Morgan, G. (Perlmutter Cancer Center. NYU Langone Health) ;
Vorog, A. (Millennium Pharmaceuticals. Inc.. Takeda Pharmaceutical Company Limited) ;
Labotka, R. (Millennium Pharmaceuticals. Inc.. Takeda Pharmaceutical Company Limited) ;
Wang, B. (Millennium Pharmaceuticals. Inc.. Takeda Pharmaceutical Company Limited) ;
Palumbo, A. (Millennium Pharmaceuticals. Inc.. Takeda Pharmaceutical Company Limited) ;
Lonial, S. (Department of Hematology and Medical Oncology. Winship Cancer Institute of Emory University) ;
Universitat Autònoma de Barcelona
PURPOSE Maintenance therapy prolongs progression-free survival (PFS) in patients with newly diagnosed multiple myeloma (NDMM) not undergoing autologous stem cell transplantation (ASCT) but has generally been limited to immunomodulatory agents. [...]
2020 - 10.1200/JCO.20.02060
Journal of Clinical Oncology, Vol. 38 Núm. 34 (january 2020) , p. 4030-4041
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12 p, 1.8 MB |
Efficacy and safety of weekly carfilzomib (70 mg/m2), dexamethasone, and daratumumab (KdD70) is comparable to twice-weekly KdD56 while being a more convenient dosing option : a cross-study comparison of the CANDOR and EQUULEUS studies
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Leleu, Xavier (Service d'Hématologie et Thérapie cellulaire. CHU and Inserm) ;
Beksac, M. (Department of Hematology. Ankara University) ;
Chou, T. (Niigata Cancer Center Hospital) ;
Dimopoulos, Meletios (Hematology and Medical Oncology. Department of Clinical Therapeutics. National and Kapodistrian University of Athens School of Medicine) ;
Yoon, S. S. (Department of Internal Medicine. Seoul National University) ;
Prince, H. M. (Epworth Healthcare and Sir Peter MacCallum Department of Oncology. University of Melbourne) ;
Pour, L. (University Hospital Brno (República Txeca)) ;
Shelekhova, T. (Clinic of Professional Pathology) ;
Chari, Ajai (Icahn School of Medicine at Mount Sinai (Nova York, Estats Units d'Amèrica). Tisch Cancer Institute) ;
Khurana, M. (Clinical Development. Oncology. Amgen Inc) ;
Zhang, J. (Global Biostatistical Science. Amgen Inc) ;
Obreja, M. (Global Biostatistical Science. Amgen Inc) ;
Qi, M. (Hematology and Oncology. Janssen Research and Development. LLC) ;
Oriol, Albert (Institut Germans Trias i Pujol. Institut de Recerca contra la Leucèmia Josep Carreras) ;
Siegel, D. (John Theurer Cancer Center. Hackensack University Medical Center) ;
Universitat Autònoma de Barcelona
The regimen of carfilzomib, daratumumab, and dexamethasone (KdD) shows activity in patients with relapsed/refractory multiple myeloma. KdD at the twice-weekly 56 mg/m carfilzomib dose (KdD56) was used in the randomized phase 3 CANDOR study (NCT03158688), whereas KdD at the once-weekly 70 mg/m carfilzomib dose (KdD70) was used in the phase 1 b EQUULEUS study (NCT01998971). [...]
2020 - 10.1080/10428194.2020.1832672
Leukemia and Lymphoma, 2020
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11 p, 1.3 MB |
Melflufen for relapsed and refractory multiple myeloma
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Oriol, Albert (Institut Germans Trias i Pujol. Institut de Recerca contra la Leucèmia Josep Carreras) ;
Larocca, Alessandra (Azienda Ospedaliero-Universitaria Città Della Salute E Della Scienza Di Torino. University of Torino) ;
Leleu, Xavier (Department of Hematology. CHU De Poitiers) ;
Hájek, R (Department of Hemato-Oncology. University of Ostrava and Faculty of Medicine. University of Ostrava) ;
Hassoun, Hani (Memorial Sloan Kettering Cancer Center) ;
Rodríguez-Otero, P. (Clínica Universidad de Navarra) ;
Paner, A. (Division of Hematology. Oncology and Stem Cell Transplant. Rush University Medical Center) ;
Schjesvold, F. H. (Oslo Myeloma Center. Oslo University Hospital and K.G. Jebsen Centre for B-Cell Malignancies. University of Oslo) ;
Gullbo, J. (Department of Medical Sciences. Division of Clinical Pharmacology. Uppsala University) ;
Richardson, Paul G.. (Dana-Farber Cancer Institute (Boston, Estats Units d'Amèrica). Jerome Lipper Multiple Myeloma Center) ;
Universitat Autònoma de Barcelona
Introduction: The overall survival of patients with multiple myeloma has improved with the advent of novel agents; however, multiple myeloma remains incurable. Combinations of standard-of-care agents such as immunomodulators, proteasome inhibitors, and anti-CD38 monoclonal antibodies are increasingly used in earlier lines of therapy. [...]
2020 - 10.1080/13543784.2020.1808884
Expert Opinion on Investigational Drugs, Vol. 29 Núm. 10 (february 2020) , p. 1069-1078
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8 p, 788.7 KB |
A randomized phase III study of carfilzomib vs low-dose corticosteroids with optional cyclophosphamide in relapsed and refractory multiple myeloma (FOCUS)
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Hájek, R. (University Hospital Ostrava) ;
Masszi, T. (St László Hospital (Hongria)) ;
Petrucci, M. T. (Sapienza Università di Roma) ;
Palumbo, A. (Università di Torino) ;
Rosiñol, L. (Hospital Clínic i Provincial de Barcelona) ;
Nagler, Arnon. (Chaim Sheba Medical Center (Israel)) ;
Yong, K. L. (University College London Cancer Institute) ;
Oriol, Albert (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol) ;
Minarik, J. (University Hospital Olomouc (Olomouc, República Txeca)) ;
Pour, L. (University Hospital Ostrava) ;
Dimopoulos, Meletios (The National and Kapodistrian University of Athens) ;
Maisnar, V. (Charles University. Faculty of Medicine in Hradec Králové) ;
Rossi, Davide (Amedeo Avogadro University of Eastern Piedmont) ;
Kasparu, H. (Ordensklinikum Linz Elisabethinen) ;
Van Droogenbroeck, J. (AZ Sint-Jan, Brugge, Belgium) ;
Yehuda, D. B. (Hadassah Medical Center, Jerusalem, Israel) ;
Hardan, I. (Meir Medical Center, Kfar-Saba, Israel) ;
Jenner, M. (University Hospital Southampton NHS Foundation Trust (Regne Unit)) ;
Calbecka, M. (Nicolaus Copernicus Hospital, Toruń Poland) ;
Dávid, M. (University of Pécs, Hungary) ;
de la Rubia, Javier (Hospital Universitari i Politècnic La Fe (València)) ;
Drach, J. (Medical University of Vienna) ;
Gasztonyi, Z. (Petz Aladár Megyei Oktató Kórház, Vasvári Pál, Hungary) ;
Górnik, S. (Zamojski Szpital Niepubliczny, Zamosc, Poland) ;
Leleu, Xavier (Hopital Huriez, CHRU, Lille, France) ;
Munder, M. (University Medicine Mainz, Germany) ;
Offidani, M. (Clinica di Ematologia Azienda Ospedaliero-Universitaria, Ospedali Riuniti di Ancona, Italy) ;
Zojer, N. (Center for Oncology, Hematology with Outpatient Department and Palliative Care, Wilhelminenspital, Vienna, Austria) ;
Rajangam, K. (Onyx Pharmaceuticals, Inc.) ;
Chang, Y. L. (Onyx Pharmaceuticals, Inc.) ;
San-Miguel, J. F. (Clínica Universidad de Navarra. Centro de Investigación Médica Aplicada) ;
Ludwig, H. (Wilhelminen Cancer Research Institute (Viena, Àustria))
This randomized, phase III, open-label, multicenter study compared carfilzomib monotherapy against low-dose corticosteroids and optional cyclophosphamide in relapsed and refractory multiple myeloma (RRMM). [...]
2017 - 10.1038/leu.2016.176
Leukemia, Vol. 31 (2017) , p. 107-114
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