Melflufen or pomalidomide plus dexamethasone for patients with multiple myeloma refractory to lenalidomide (OCEAN): a randomised, head-to-head, open-label, phase 3 study

Authors: Schjesvold, Fredrik, Delimpasi, Sosana, Robak, Pawel, Coriu, Daniel, Nikolayeva, Anna, Tomczak, Waldemar, Pour, Ludek, Spicka, Ivan, Dimopoulos, Meletios-Athanasios, Masszi, Tamas, Doronin, Vadim, Minarik, Jiri, Salogub, Galina, Alekseeva, Yulia, Maisnar, Vladimir, Mikala, Gabor, Rosinol, Laura, Konstantinova, Tatiana, Lazzaro, Antonio, Liberati, Anna Marina, Symeonidis, Anargyros, Gatt, Moshe, Illes, Arpad, Abdulhaq, Haifaa, Dungarwalla, Moez, Grosicki, Sebastian, Hajek, Roman, Leleu, Xavier, Myasnikov, Alexander, Richardson, Paul G., Avivi, Irit, Deeren, Dries, Gironella, Mercedes, Hernandez-Garcia, Miguel Teodoro, Martinez Lopez, Joaquin, Newinger-Porte, Muriel, Ribas, Paz, Samoilova, Olga, Voog, Eric, Arnao-Herraiz, Mario, Carrillo-Cruz, Estrella, Corradini, Paolo, Dodlapati, Jyothi, Granell Gorrochategui, Miquel, Huang, Shang-Yi, Jenner, Matthew, Karlin, Lionel, Kim, Jin Seok, Kopacz, Agnieszka, Medvedeva, Nadezhda, Min, Chang-Ki, Mina, Roberto, Palk, Katrin, Shin, Ho-Jin, Sohn, Sang Kyun, Sonneveld, Pieter, Tache, Jason, Anagnostopoulos, Achilles, Arguiñano, Jose-Maria, Cavo, Michele, Filicko, Joanne, Garnes, Margaret, Halka, Janusz, Herzog-Tzarfati, Kathrin, Ipatova, Natalia, Kim, Kihyun, Krauth, Maria-Theresa, Kryuchkova, Irina, Lazaroiu, Mihaela Cornelia, Luppi, Mario, Proydakov, Andrei, Rambaldi, Alessandro, Rudzianskiene, Milda, Yeh, Su-Peng, Alcalá-Peña, Maria Magdalena, Alegre Amor, Adrian, Alizadeh, Hussain, Bendandi, Maurizio, Brearton, Gillian, Brown, Randall, Cavet, Jim, Dally, Najib, Egyed, Miklos, Hernández-Rivas, José Ángel, Kaare, Ain, Karsenti, Jean-Michel, Kloczko, Janusz, Kreisle, William, Lee, Je-Jung, Legiec, Wojciech, Machherndl-Spandl, Sigrid, Manda, Sudhir, Mateos, Maria-Victoria, Moiseev, Ivan, Moreb, Jan, Nagy, Zsolt, Nair, Santosh, Oriol-Rocafiguera, Albert, Osswald, Michael, Otero-Rodriguez, Paula, Peceliunas, Valdas, Plesner, Torben, Rey, Philippe, Rossi, Giuseppe, Stevens, Don, Suriu, Celia, Tarella, Corrado, Verlinden, Anke, Zannetti, Alain, Schjesvold, Fredrik H ^*, Pour, Luděk, Špička, Ivan, Mikala, Gábor, Rosiñol, Laura, Symeonidis, Argiris, Moody, Victoria, Thuresson, Marcus, Byrne, Catriona, Harmenberg, Johan, Bakker, Nicolaas A, Hájek, Roman, Richardson, Paul G

Source: In The Lancet Haematology February 2022 9(2):e98-e110

Melflufen plus dexamethasone in relapsed and refractory multiple myeloma (O-12-M1): a multicentre, international, open-label, phase 1–2 study

Authors: Richardson, Paul G ^*, Bringhen, Sara, Voorhees, Peter, Plesner, Torben, Mellqvist, Ulf-Henrik, Reeves, Brandi, Paba-Prada, Claudia, Zubair, Hanan, Byrne, Catriona, Chauhan, Dharminder, Anderson, Kenneth, Nordström, Eva, Harmenberg, Johan, Palumbo, Antonio, Sonneveld, Pieter

Source: In The Lancet Haematology May 2020 7(5):e395-e407

All-oral ixazomib, cyclophosphamide, and dexamethasone for transplant-ineligible patients with newly diagnosed multiple myeloma

Authors: Dimopoulos, Meletios A., Grosicki, Sebastian, Jędrzejczak, Wiesław W., Nahi, Hareth, Gruber, Astrid, Hansson, Markus, Gupta, Neeraj, Byrne, Catriona, Labotka, Richard, Teng, Zhaoyang, Yang, Huyuan, Grzasko, Norbert, Kumar, Shaji

Source: In European Journal of Cancer January 2019 106:89-98

Lenalidomide in combination with rituximab for patients with relapsed or refractory mantle-cell lymphoma: a phase 1/2 clinical trial

Authors: Wang, Michael, Fayad, Luis, Wagner-Bartak, Nicolaus, Zhang, Liang, Hagemeister, Fredrick, Neelapu, Sattva S, Samaniego, Felipe, McLaughlin, Peter, Fanale, Michelle, Younes, Anas, Cabanillas, Fernando, Fowler, Nathan, Newberry, Kate J, Sun, Luhong, Young, Ken H, Champlin, Richard, Kwak, Larry, Feng, Lei, Badillo, Maria, Bejarano, Maria, Hartig, Kimberly, Chen, Wendy, Chen, Yiming, Byrne, Catriona, Bell, Neda, Zeldis, Jerome, Romaguera, Jorge

Source: In Lancet Oncology July 2012 13(7):716-723

Lenalidomide therapy in myelofibrosis with myeloid metaplasia

Authors: Tefferi, Ayalew, Cortes, Jorge, Verstovsek, Srdan, Mesa, Ruben A., Thomas, Deborah, Lasho, Terra L., Hogan, William J., Litzow, Mark R., Allred, Jacob B., Jones, Dan, Byrne, Catriona, Zeldis, Jerome B., Ketterling, Rhett P., McClure, Rebecca F., Giles, Francis, Kantarjian, Hagop M.

Source: In Blood 15 August 2006 108(4):1158-1164

Melflufen plus dexamethasone in relapsed/refractory multiple myeloma: long‐term survival follow‐up from the Phase II study O‐12‐M1.

Authors: Bringhen, Sara, Voorhees, Peter M., Plesner, Torben, Mellqvist, Ulf‐Henrik, Reeves, Brandi, Sonneveld, Pieter, Byrne, Catriona, Nordström, Eva, Harmenberg, Johan, Obermüller, Jakob, Richardson, Paul G.

Source: British Journal of Haematology; Jun2021, Vol. 193 Issue 6, p1105-1109, 5p

Subject Terms: MULTIPLE myeloma, OVERALL survival, DEXAMETHASONE, SURVIVAL analysis (Biometry)

OCEAN (OP-103): Melflufen/Dexamethasone (Dex) Compared with Pomalidomide (Pom)/Dex in Patients (Pts) with Relapsed/Refractory Multiple Myeloma (RRMM) - Subgroup Analysis By Prior Alkylator Exposed/Refractory Status

Authors: Sonneveld, Pieter, Mateos, Maria-Victoria, Robak, Pawel J., Schjesvold, Fredrik H., Hajek, Roman, Richardson, Paul G., Harmenberg, Johan, Thuresson, Marcus, Byrne, Catriona, Dimopoulos, Meletios-Athanasios

Source: In Blood 23 November 2021 138 Supplement 1:4779-4779

OCEAN (OP-103): Melflufen/Dexamethasone Compared with Pomalidomide/Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma-Age Subgroup Analysis of Older Patients

Authors: Mateos, Maria-Victoria, Robak, Pawel J., Rosiñol, Laura, Symeonidis, Argiris, Sonneveld, Pieter, Thuresson, Marcus, Byrne, Catriona, Harmenberg, Johan, Hájek, Roman

Source: In Blood 23 November 2021 138 Supplement 1:2741-2741

OCEAN (OP-103): Melflufen/Dexamethasone (Dex) Compared with Pomalidomide (Pom)/Dex in Patients (Pts) with Relapsed/Refractory Multiple Myeloma (RRMM) - Safety and Tolerability Analyses

Authors: Richardson, Paul G., Schjesvold, Fredrik H., Abdulhaq, Haifaa, Coriu, Daniel, Lazzaro, Antonio, Sonneveld, Pieter, Kullenburg, Torbjörn, Harmenberg, Johan, Thuresson, Marcus, Byrne, Catriona, Mateos, María-Victoria

Source: In Blood 23 November 2021 138 Supplement 1:2732-2732

OAB-050: OCEAN (OP-103): a Phase 3, randomized, global, head-to-head comparison study of Melflufen and Dexamethasone (Dex) versus Pomalidomide (Pom) and Dex in Relapsed Refractory Multiple Myeloma (RRMM)

Authors: Schjesvold, Fredrik, Dimopoulos, Meletios-Athanasios, Delimpasi, Sosana, Robak, Pawef, Coriu, Daniel, Legiec, Wojciech, Pour, Luděk, Špička, Ivan, Masszi, Tamás, Doronin, Vadim, Minarik, Jiri, Salogub, Galina, Alexeeva, Yulia, Lazzaro, Antonio, Maisnar, Vladimir, Mikala, Gábor, Moody, Victoria, Thuresson, Marcus, Byrne, Catriona, Harmenberg, Johan, Hájek, Roman, Mateos, María-Victoria, Richardson, Paul G., Sonneveld, Pieter

Source: In Clinical Lymphoma, Myeloma and Leukemia October 2021 21 Supplement 2:S32-S32

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MM-133: HORIZON (OP-106): Melflufen Plus Dexamethasone in Relapsed/Refractory Multiple Myeloma (RRMM) Refractory to Pomalidomide and/or an Anti-CD38 Monoclonal Antibody (mAb) – Final Primary Analysis

Authors: Richardson, Paul G., Oriol, Albert, Larocca, Alessandra, Biade, Joan, Cavo, Michele, Rodriguez-Otero, Paula, Leleu, Xavier, Norkin, Maxim, Nadeem, Omar, Hiemenz, John W., Hassoun, Hani, Touzeau, Cyrille, Alegre, Adrián, Paner, Agne, Maisel, Christopher, Mazumder, Amitabha, Raptis, Anastasios, Puig, Noemí, Harmenberg, Johan, Byrne, Catriona, Thuresson, Sara, Obermüller, Jakob, Mateos, María-Victoria

Source: In Clinical Lymphoma, Myeloma and Leukemia September 2020 20 Supplement 1:S295-S296

Ixazomib maintenance therapy in newly diagnosed multiple myeloma: An integrated analysis of four phase I/II studies.

Authors: Dimopoulos, Meletios A., Laubach, Jacob P., Richardson, Paul G., Echeveste Gutierrez, Maria Asunción, Grzasko, Norbert, Hofmeister, Craig C., San‐Miguel, Jesus F., Kumar, Shaji, Labotka, Richard, Lu, Vickie, Berg, Deborah, Byrne, Catriona, Teng, Zhaoyang, Liu, Guohui, Velde, Helgi

Source: European Journal of Haematology; Jun2019, Vol. 102 Issue 6, p494-503, 10p

Subject Terms: MULTIPLE myeloma, HEMATOLOGICAL oncology, PROTEASOME inhibitors, DISEASE progression, ADVERSE health care events

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OP201: A Phase 1/2 Study of Melflufen and Dexamethasone in Patients with Immunoglobulin Light Chain (AL) Amyloidosis

Authors: Palladini, Giovanni, Schönland, Stefan O. ^*, Lentzsch, Suzanne ^*, Cibeira, M. Teresa ^*, Hajek, Roman, Jaccard, Arnaud ^*, Jamroziak, Krzysztof ^*, Kastritis, Eftathios ^*, Sanchorawala, Vaishali, Schjesvold, Fredrik H., Wechalekar, Ashutosh D, Thuresson, Sara ^*, Harmenberg, Johan ^*, Byrne, Catriona ^*, Merlini, Giampaolo

Source: In Blood 13 November 2019 134 Supplement 1:3163-3163

Clinical Activity of Melflufen in Patients with Triple-Class Refractory Multiple Myeloma and Poor-Risk Features in an Updated Analysis of HORIZON (OP-106), a Phase 2 Study in Patients with Relapsed/Refractory Multiple Myeloma Refractory to Pomalidomide and/or Daratumumab

Authors: Mateos, María-Victoria, Oriol, Albert ^*, Larocca, Alessandra, Rodriguez Otero, Paula ^*, Bladé, Joan ^*, Cavo, Michele ^*, Hassoun, Hani, Leleu, Xavier, Amor, Adrián Alegre ^*, Maisel, Christopher, Paner, Agne, Harmenberg, Johan ^*, Byrne, Catriona ^*, Thuresson, Sara ^*, Zubair, Hanan ^*, Richardson, Paul G.

Source: In Blood 13 November 2019 134 Supplement 1:1883-1883

Updated Progression-Free Survival (PFS) and Overall Survival (OS) with Melflufen and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma (RRMM): Results from the Phase 2 Study O-12-M1

Authors: Bringhen, Sara, Voorhees, Peter M. ^*, Plesner, Torben, Mellqvist, Ulf-Henrik, Reeves, Brandi, Sonneveld, Pieter, Byrne, Catriona ^*, Nordström, Eva ^*, Harmenberg, Johan ^*, Obermüller, Jakob ^*, Richardson, Paul G.

Source: In Blood 13 November 2019 134 Supplement 1:1839-1839