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1. Safety and efficacy of inactivated varicella zoster virus vaccine in immunocompromised patients with malignancies: a two-arm, randomised, double-blind, phase 3 trial

Author

Cerana, S, Dictar, MO, Bonvehi, P, Tregnaghi, JP, Fein, L, Ashley, D, Singh, M, Hayes, T, Playford, G, Morrissey, O, Thaler, J, Kuehr, T, Greil, R, Pecherstorfer, M, Duck, L, Van Eygen, K, Aoun, M, De Prijck, B, Franke, FA, Barrios, CHE, Mendes, AVA, Serrano, SV, Garcia, RF, Moore, F, Camargo, JFC, Pires, LA, Alves, RS, Radinov, A, Oreshkov, K, Minchev, V, Hubenova, AI, Koynova, T, Ivanov, I, Rabotilova, B, Petrov, PA, Chilingirov, P, Karanikolov, S, Raynov, J, Grimard, D, McNeil, S, Kumar, D, Larratt, LM, Weiss, K, Delage, R, Diaz-Mitoma, FJ, Cano, PO, Couture, F, Carvajal, P, Yepes, A, Torres Ulloa, R, Fardella, P, Caglevic, C, Rojas, C, Orellana, E, Gonzalez, P, Acevedo, A, Galvez, KM, Gonzalez, ME, Franco, S, Restrepo, JG, Rojas, CA, Bonilla, C, Florez, LE, Ospina, AV, Manneh, R, Zorica, R, Vrdoljak, DV, Samarzija, M, Petruzelka, L, Vydra, J, Mayer, J, Cibula, D, Prausova, J, Paulson, G, Ontaneda, M, Palk, K, Vahlberg, A, Rooneem, R, Galtier, F, Postil, D, Lucht, F, Laine, F, Launay, O, Laurichesse, H, Duval, X, Cornely, OA, Camerer, B, Panse, J, Zaiss, M, Derigs, H-G, Menzel, H, Verbeek, M, Georgoulias, V, Mavroudis, D, Anagnostopoulos, A, Terpos, E, Cortes, D, Umanzor, J, Bejarano, S, Galeano, RW, Wong, RSM, Hui, P, Pedrazzoli, P, Ruggeri, L, Aversa, F, Bosi, A, Gentile, G, Rambaldi, A, Contu, A, Marei, L, Abbadi, A, Hayajneh, W, Kattan, J, Farhat, F, Chahine, G, Rutkauskiene, J, Marfil Rivera, LJ, Lopez Chuken, YA, Franco Villarreal, H, Lopez Hernandez, J, Blacklock, H, Lopez, RI, Alvarez, R, Gomez, AM, Quintana, TS, Moreno Larrea, MDC, Zorrilla, SJ, Alarcon, E, Samanez, FCA, Caguioa, PB, Tiangco, BJ, Mora, EM, Betancourt-Garcia, RD, Hallman-Navarro, D, Feliciano-Lopez, LJ, Velez-Cortes, HA, Cabanillas, F, Ganea, DE, Ciuleanu, TE, Ghizdavescu, DG, Miron, L, Cebotaru, CL, Cainap, CI, Anghel, R, Dvorkin, MV, Gladkov, OA, Fadeeva, NV, Kuzmin, AA, Lipatov, ON, Zbarskaya, II, Akhmetzyanov, FS, Litvinov, IV, Afanasyev, BV, Cherenkova, M, Lioznov, D, Lisukov, IA, Smirnova, YA, Kolomietz, S, Halawani, H, Goh, YT, Drgona, L, Chudej, J, Matejkova, M, Reckova, M, Rapoport, BL, Szpak, WM, Malan, DR, Jonas, N, Jung, CW, Lee, DG, Yoon, SS, Lopez Jimenez, J, Duran Martinez, I, Rodriguez Moreno, JF, Solano Vercet, C, de la Camara, R, Batlle Massana, M, Yeh, S-P, Chen, C-Y, Chou, H-H, Tsai, C-M, Chiu, C-H, Siritanaratkul, N, Norasetthada, L, Sriuranpong, V, Seetalarom, K, Akan, H, Dane, F, Ozcan, MA, Ozsan, GH, Kalayoglu Besisik, SF, Cagatay, A, Yalcin, S, Peniket, A, Mullan, SR, Dakhil, KM, Sivarajan, K, Suh, JJ-G, Sehgal, A, Marquez, F, Gomez, EG, Mullane, MR, Skinner, WL, Behrens, RJ, Trevarthe, DR, Mazurczak, MA, Lambiase, EA, Vidal, CA, Anac, SY, Rodrigues, GA, Baltz, B, Boccia, R, Wertheim, MS, Holladay, CS, Zenk, D, Fusselman, W, Wade III, JL, Jaslowsk, AJ, Keegan, J, Robinson, MO, Go, RS, Farnen, J, Amin, B, Jurgens, D, Risi, GF, Jr, Beatty, PG, Naqvi, T, Parshad, S, Hansen, VL, Ahmed, M, Steen, PD, Badarinath, S, Dekker, A, Scouros, MA, Young, DE, Graydon Harker, W, Kendall, SD, Citron, ML, Chedid, S, Posada, JG, Jr, Gupta, MK, Rafiyath, S, Buechler-Price, J, Sreenivasappa, S, Chay, CH, Burke, JM, Young, SE, Mahmood, A, Kugler, JW, Gerstner, G, Fuloria, J, Belman, ND, Geller, R, Nieva, J, Whittenberger, BP, Wong, BMY, Cescon, TP, Abesada-Terk, G, Jr, Guarino, MJ, Zweibach, A, Ibrahim, EN, Takahashi, G, Garrison, MA, Mowat, RB, Choi, BS, Oliff, IA, Singh, J, Guter, KA, Ayrons, K, Rowland, KM, Noga, SJ, Rao, SB, Columbie, A, Nualart, MT, Cecchi, GR, Campos, LT, Mohebtash, M, Flores, MR, Rothstein-Rubin, R, O'Connor, BM, Soori, G, Knapp, M, Miranda, FG, Goodgame, BW, Kassem, M, Belani, R, Sharma, S, Ortiz, T, Sonneborn, HL, Markowitz, AB, Wilbur, D, Meiri, E, Koo, VS, Jhangiani, HS, Wong, L, Sanani, S, Lawrence, SJ, Jones, CM, Murray, C, Papageorgiou, C, Gurtler, JS, Ascensao, JL, Venigalla, ML, D'Andrea, M, De Las Casas, C, Haile, DJ, Qazi, FU, Santander, JL, Thomas, MR, Rao, VP, Craig, M, Garg, RJ, Robles, R, Lyons, RM, Stegemoller, RK, Goel, S, Garg, S, Lowry, P, Lynch, C, Lash, B, Repka, T, Baker, J, Goueli, BS, Campbell, TC, Van Echo, DA, Lee, YJ, Reyes, EA, Senecal, FM, Donnelly, G, Byeff, P, Weiss, R, Reid, T, Roeland, E, Goel, A, Prow, DM, Brandt, DS, Kaplan, HG, Payne, JE, Boeckh, MG, Rosen, PJ, Mena, RR, Khan, R, Betts, RF, Sharp, SA, Morrison, VA, Fitz-Patrick, D, Congdon, J, Erickson, N, Abbasi, R, Henderson, S, Mehdi, A, Wos, EJ, Rehmus, E, Beltzer, L, Tamayo, RA, Mahmood, T, Reboli, AC, Moore, A, Brown, JM, Cruz, J, Quick, DP, Potz, JL, Kotz, KW, Hutchins, M, Chowhan, NM, Devabhaktuni, YD, Braly, P, Berenguer, RA, Shambaugh, SC, O'Rourke, TJ, Conkright, WA, Winkler, CF, Addo, FEK, Duic, JP, High, KP, Kutner, ME, Collins, R, Carrizosa, DR, Perry, DJ, Kailath, E, Rosen, N, Sotolongo, R, Shoham, S, Chen, T, Mullane, Kathleen M, Morrison, Vicki A, Camacho, Luis H, Arvin, Ann, McNeil, Shelly A, Durrand, Jessie, Campbell, Bernadette, Su, Shu-Chih, Chan, Ivan S F, Parrino, Janie, Kaplan, Susan S, Popmihajlov, Zoran, and Annunziato, Paula W

Published
2019
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2. Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma

Author

Morschhauser, Franck, Fowler, Nathan H, Feugier, Pierre, Bouabdallah, Reda, Tilly, Hervé, Palomba, M Lia, Fruchart, Christophe, Libby, Edward N, Casasnovas, Rene-Olivier, Flinn, Ian W, Haioun, Corinne, Maisonneuve, Hervé, Ysebaert, Loic, Bartlett, Nancy L, Bouabdallah, Kamal, Brice, Pauline, Ribrag, Vincent, Daguindau, Nicolas, Le Gouill, Steven, Pica, Gian M, Martin Garcia-Sancho, Alejandro, López-Guillermo, Armando, Larouche, Jean-François, Ando, Kiyoshi, Gomes da Silva, Maria, André, Marc, Zachée, Pierre, Sehn, Laurie H, Tobinai, Kensei, Cartron, Guillaume, Liu, David, Wang, Jianming, Xerri, Luc, Salles, Gilles A, Abdel-Samad N, Abdo-Matkiwsky M, Abraham J, Abrisqueta P, Anglaret B, Barnes JA, Benbrahim O, Bierman PJ, Bonnet C, Brault P, Bron D, Brooks BJ Jr, Byeff P, Casanova M, Cheung M, Choudhary Y, Comeau T, Cooper B, Couban S, Cox MC, Crump M, Deau Fischer B, Deconinck E, Deeren D, de la Cruz Vicente F, Delarue R, Del Campo R, Delmer A, Delwail V, Duggan PR, Eisenmann DJRM, El Yamani A, Eradat HA, Fabbro M, Farber C, Fisher DC, Fleischman RA, Fleck E, Fornecker LM, Foussard C, Gabarre J, Gaffar YA, Gallardo D, Ghazal H, Giagounidis A, Gill K, Glaisner S, Gonzalez H, Greenberg RH, Goubran Messiha H, Goy A, Gressin R, Gyan E, Hart LL, Hatake K, Hiddemann W, Hodossy B, Horkheimer I, Hoyer RJ, Huebel K, Ishikawa T, Izutsu K, Jardel H, Jhangiani HS, Johnson N, Joly B, Jourdan E, Kargar Samani K, Kato K, Kiguchi T, Kobayashi T, Kohser F, Koike M, Kouroukis C T, Laferriere N, Lamy de la Chapelle T, Landau DA, Lawler WE, Lemieux B, Levitan DA, Longree L, Lopez J, Mace J, Maerevoet M, Maigre M, Marjanovic Z, Michel J, Mounier C, Muntanola A, Ngirabacu MC, Nicolas-Virelizier E, Novelli S, Offner F, Palomera L, Pandit LH, Panwalkar A, Pierre P, Pignon JM, Pinto A, Plöger C, Pranger D, Quick DP, Reyes EA, Robin V, Robu D, Rodriguez Salazar MJ, Rosen PJ, Rosenbluth J, Sadot-Lebouvier S, Sangha R, Segota Z, Shapira I, Shtivelband M, Simon M, Soekler M, Soubeyran P, Taper J, Tereblo HR, Terol MJ, The AS, Ueda Y, van den Neste E, van Eygen K, van Hoof A, Vanstraelen G, Verner E, Warburton P, Yamamoto G, Yokoyama H, Zerazhi H, Zinzani PL., Morschhauser, Franck, Fowler, Nathan H, Feugier, Pierre, Bouabdallah, Reda, Tilly, Hervé, Palomba, M Lia, Fruchart, Christophe, Libby, Edward N, Casasnovas, Rene-Olivier, Flinn, Ian W, Haioun, Corinne, Maisonneuve, Hervé, Ysebaert, Loic, Bartlett, Nancy L, Bouabdallah, Kamal, Brice, Pauline, Ribrag, Vincent, Daguindau, Nicola, Le Gouill, Steven, Pica, Gian M, Martin Garcia-Sancho, Alejandro, López-Guillermo, Armando, Larouche, Jean-Françoi, Ando, Kiyoshi, Gomes da Silva, Maria, André, Marc, Zachée, Pierre, Sehn, Laurie H, Tobinai, Kensei, Cartron, Guillaume, Liu, David, Wang, Jianming, Xerri, Luc, Salles, Gilles A, Abdel-Samad N, Abdo-Matkiwsky M, Abraham J, Abrisqueta P, Anglaret B, Barnes JA, Benbrahim O, Bierman PJ, Bonnet C, Brault P, Bron D, Brooks BJ Jr, Byeff P, Casanova M, Cheung M, Choudhary Y, Comeau T, Cooper B, Couban S, Cox MC, Crump M, Deau Fischer B, Deconinck E, Deeren D, de la Cruz Vicente F, Delarue R, Del Campo R, Delmer A, Delwail V, Duggan PR, Eisenmann DJRM, El Yamani A, Eradat HA, Fabbro M, Farber C, Fisher DC, Fleischman RA, Fleck E, Fornecker LM, Foussard C, Gabarre J, Gaffar YA, Gallardo D, Ghazal H, Giagounidis A, Gill K, Glaisner S, Gonzalez H, Greenberg RH, Goubran Messiha H, Goy A, Gressin R, Gyan E, Hart LL, Hatake K, Hiddemann W, Hodossy B, Horkheimer I, Hoyer RJ, Huebel K, Ishikawa T, Izutsu K, Jardel H, Jhangiani HS, Johnson N, Joly B, Jourdan E, Kargar Samani K, Kato K, Kiguchi T, Kobayashi T, Kohser F, Koike M, Kouroukis C T, Laferriere N, Lamy de la Chapelle T, Landau DA, Lawler WE, Lemieux B, Levitan DA, Longree L, Lopez J, Mace J, Maerevoet M, Maigre M, Marjanovic Z, Michel J, Mounier C, Muntanola A, Ngirabacu MC, Nicolas-Virelizier E, Novelli S, Offner F, Palomera L, Pandit LH, Panwalkar A, Pierre P, Pignon JM, Pinto A, Plöger C, Pranger D, Quick DP, Reyes EA, Robin V, Robu D, Rodriguez Salazar MJ, Rosen PJ, Rosenbluth J, Sadot-Lebouvier S, Sangha R, Segota Z, Shapira I, Shtivelband M, Simon M, Soekler M, Soubeyran P, Taper J, Tereblo HR, Terol MJ, The AS, Ueda Y, van den Neste E, van Eygen K, van Hoof A, Vanstraelen G, Verner E, Warburton P, Yamamoto G, Yokoyama H, Zerazhi H, Zinzani PL., Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 (GRITA), Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Department of Lymphoma and Myeloma [Houston, TX, USA], The University of Texas M.D. Anderson Cancer Center [Houston], Service d'Hématologie [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Génomique et Médecine Personnalisée du Cancer et des Maladies Neuropsychiatriques (GPMCND), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Département d’Hématologie [Rouen], CHU Rouen, Normandie Université (NU)-Normandie Université (NU), Institut d'Hématologie de Basse-Normandie (IHBN), Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN)-Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-UNICANCER, Service d'Hématologie Clinique (CHU de Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Unité des hémopathies lymphoïdes [CHU Henri Mondor], CHU Henri Mondor, Service d’Onco-Hématologie [La Roche sur Yon], Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon (CHD Vendée), Service Hématologie - IUCT-Oncopole [CHU Toulouse], Pôle Biologie [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Pôle IUCT [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Service d'hématologie [CHU Bordeaux], CHU Bordeaux [Bordeaux]-Hôpital Haut-Lévêque [CHU Bordeaux], CHU Bordeaux [Bordeaux], Service d'onco-hématologie [AP-HP Hôpital Saint-Louis], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Département d'hématologie [Gustave Roussy], Institut Gustave Roussy (IGR), Centre Hospitalier Annecy-Genevois [Saint-Julien-en-Genevois], Regulation of Bcl2 and p53 Networks in Multiple Myeloma and Mantle Cell Lymphoma (CRCINA-ÉQUIPE 10), Centre de Recherche en Cancérologie et Immunologie Nantes-Angers (CRCINA), Université d'Angers (UA)-Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Centre hospitalier universitaire de Nantes (CHU Nantes)-Université d'Angers (UA)-Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Centre hospitalier universitaire de Nantes (CHU Nantes), Service d'Hématologie Clinique [Hôpital Hôtel Dieu, Nantes], Centre hospitalier universitaire de Nantes (CHU Nantes)-Hôpital Hôtel Dieu, Service Hématologie [CH Métropole Savoie, Chambery], Centre Hospitalier Métropole Savoie [Chambéry], Département d'Hématologie [CHU de Montpellier], Centre Hospitalier Universitaire de Montpellier (CHU Montpellier ), Département d'Hématologie [CH Lyon-Sud], Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), RELEVANCE Trial Investigators : Abdel-Samad N, Abdo-Matkiwsky M, Abraham J, Abrisqueta P, Anglaret B, Barnes JA, Benbrahim O, Bierman PJ, Bonnet C, Brault P, Bron D, Brooks BJ Jr, Byeff P, Casanova M, Cheung M, Choudhary Y, Comeau T, Cooper B, Couban S, Cox MC, Crump M, Deau Fischer B, Deconinck E, Deeren D, de la Cruz Vicente F, Delarue R, Del Campo R, Delmer A, Delwail V, Duggan PR, Eisenmann DJRM, El Yamani A, Eradat HA, Fabbro M, Farber C, Fisher DC, Fleischman RA, Fleck E, Fornecker LM, Foussard C, Gabarre J, Gaffar YA, Gallardo D, Ghazal H, Giagounidis A, Gill K, Glaisner S, Gonzalez H, Greenberg RH, Goubran Messiha H, Goy A, Gressin R, Gyan E, Hart LL, Hatake K, Hiddemann W, Hodossy B, Horkheimer I, Hoyer RJ, Huebel K, Ishikawa T, Izutsu K, Jardel H, Jhangiani HS, Johnson N, Joly B, Jourdan E, Kargar Samani K, Kato K, Kiguchi T, Kobayashi T, Kohser F, Koike M, Kouroukis C T, Laferriere N, Lamy de la Chapelle T, Landau DA, Lawler WE, Lemieux B, Levitan DA, Longree L, Lopez J, Mace J, Maerevoet M, Maigre M, Marjanovic Z, Michel J, Mounier C, Muntanola A, Ngirabacu MC, Nicolas-Virelizier E, Novelli S, Offner F, Palomera L, Pandit LH, Panwalkar A, Pierre P, Pignon JM, Pinto A, Plöger C, Pranger D, Quick DP, Reyes EA, Robin V, Robu D, Rodriguez Salazar MJ, Rosen PJ, Rosenbluth J, Sadot-Lebouvier S, Sangha R, Segota Z, Shapira I, Shtivelband M, Simon M, Soekler M, Soubeyran P, Taper J, Tereblo HR, Terol MJ, The AS, Ueda Y, van den Neste E, van Eygen K, van Hoof A, Vanstraelen G, Verner E, Warburton P, Yamamoto G, Yokoyama H, Zerazhi H, Zinzani PL., Bernardo, Elizabeth, CHU Henri Mondor [Créteil], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille)-Université de Lille, Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Université de Caen Normandie (UNICAEN), Normandie Université (NU), Centre Hospitalier Départemental Vendée, Service d'Hématologie [IUCT Toulouse], Université Fédérale Toulouse Midi-Pyrénées-Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT Oncopole - UMR 1037), CHU Toulouse [Toulouse]-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Toulouse [Toulouse]-Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN)-Centre hospitalier universitaire de Nantes (CHU Nantes)-Centre National de la Recherche Scientifique (CNRS)-Université d'Angers (UA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), and Université de Nantes (UN)-Université de Nantes (UN)-Centre hospitalier universitaire de Nantes (CHU Nantes)-Centre National de la Recherche Scientifique (CNRS)-Université d'Angers (UA)

Subjects
Adult, Male, medicine.medical_specialty, Neutropenia, Intention to Treat Analysi, Follicular lymphoma, [SDV.CAN]Life Sciences [q-bio]/Cancer, Gastroenterology, Skin Diseases, Disease-Free Survival, 03 medical and health sciences, 0302 clinical medicine, [SDV.CAN] Life Sciences [q-bio]/Cancer, Maintenance therapy, immune system diseases, Internal medicine, hemic and lymphatic diseases, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Survival rate, Lenalidomide, Lymphoma, Follicular, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocol, business.industry, Skin Disease, General Medicine, Middle Aged, medicine.disease, 3. Good health, Intention to Treat Analysis, Thalidomide, Survival Rate, Regimen, 030220 oncology & carcinogenesis, Rituximab, Female, business, Febrile neutropenia, 030215 immunology, medicine.drug, Human
Abstract

International audience; BACKGROUND:Rituximab plus chemotherapy has been shown to be effective in patients with advanced-stage, previously untreated follicular lymphoma; nevertheless, most patients will have a relapse. Combination immunotherapy with lenalidomide and rituximab is an immunomodulatory regimen that has shown promising activity in patients with indolent B-cell non-Hodgkin's lymphoma.METHODS:We conducted this multicenter, international, phase 3 superiority trial to evaluate rituximab plus lenalidomide, as compared with rituximab plus chemotherapy, in patients with previously untreated follicular lymphoma. Patients were randomly assigned to receive one of the two regimens, followed by maintenance monotherapy with rituximab. Treatment with rituximab plus lenalidomide consisted of 18 cycles of the two drugs, followed by rituximab maintenance therapy every 8 weeks for 12 cycles (six additional doses). Treatment with rituximab plus chemotherapy consisted of the investigator's choice of one of three rituximab-based regimens, followed by maintenance monotherapy with rituximab every 8 weeks for 12 cycles. The primary end points were complete response (confirmed or unconfirmed) at 120 weeks and progression-free survival.RESULTS:A total of 1030 patients were randomly assigned to receive rituximab plus lenalidomide (513 patients) or rituximab plus chemotherapy (517 patients). The rate of confirmed or unconfirmed complete response at 120 weeks was similar in the two groups: 48% (95% confidence interval [CI], 44 to 53) in the rituximab-lenalidomide group and 53% (95% CI, 49 to 57) in the rituximab-chemotherapy group (P=0.13). The interim 3-year rate of progression-free survival was 77% (95% CI, 72 to 80) and 78% (95% CI, 74 to 82), respectively. A higher percentage of patients in the rituximab-chemotherapy group had grade 3 or 4 neutropenia (32% vs. 50%) and febrile neutropenia of any grade (2% vs. 7%), and a higher percentage of patients in the rituximab-lenalidomide group had grade 3 or 4 cutaneous reactions (7% vs. 1%).CONCLUSIONS:Among patients with previously untreated follicular lymphoma, efficacy results were similar with rituximab plus lenalidomide and rituximab plus chemotherapy (with both regimens followed by rituximab maintenance therapy). The safety profile differed in the two groups. (Funded by Celgene; RELEVANCE ClinicalTrials.gov numbers, NCT01476787 and NCT01650701 , and EudraCT number, 2011-002792-42 .).

Published
2018

3. Safety and efficacy of inactivated varicella zoster virus vaccine in immunocompromised patients with malignancies: a two-arm, randomised, double-blind, phase 3 trial

Author

Mullane, Kathleen M, primary, Morrison, Vicki A, additional, Camacho, Luis H, additional, Arvin, Ann, additional, McNeil, Shelly A, additional, Durrand, Jessie, additional, Campbell, Bernadette, additional, Su, Shu-Chih, additional, Chan, Ivan S F, additional, Parrino, Janie, additional, Kaplan, Susan S, additional, Popmihajlov, Zoran, additional, Annunziato, Paula W, additional, Cerana, S, additional, Dictar, MO, additional, Bonvehi, P, additional, Tregnaghi, JP, additional, Fein, L, additional, Ashley, D, additional, Singh, M, additional, Hayes, T, additional, Playford, G, additional, Morrissey, O, additional, Thaler, J, additional, Kuehr, T, additional, Greil, R, additional, Pecherstorfer, M, additional, Duck, L, additional, Van Eygen, K, additional, Aoun, M, additional, De Prijck, B, additional, Franke, FA, additional, Barrios, CHE, additional, Mendes, AVA, additional, Serrano, SV, additional, Garcia, RF, additional, Moore, F, additional, Camargo, JFC, additional, Pires, LA, additional, Alves, RS, additional, Radinov, A, additional, Oreshkov, K, additional, Minchev, V, additional, Hubenova, AI, additional, Koynova, T, additional, Ivanov, I, additional, Rabotilova, B, additional, Petrov, PA, additional, Chilingirov, P, additional, Karanikolov, S, additional, Raynov, J, additional, Grimard, D, additional, McNeil, S, additional, Kumar, D, additional, Larratt, LM, additional, Weiss, K, additional, Delage, R, additional, Diaz-Mitoma, FJ, additional, Cano, PO, additional, Couture, F, additional, Carvajal, P, additional, Yepes, A, additional, Torres Ulloa, R, additional, Fardella, P, additional, Caglevic, C, additional, Rojas, C, additional, Orellana, E, additional, Gonzalez, P, additional, Acevedo, A, additional, Galvez, KM, additional, Gonzalez, ME, additional, Franco, S, additional, Restrepo, JG, additional, Rojas, CA, additional, Bonilla, C, additional, Florez, LE, additional, Ospina, AV, additional, Manneh, R, additional, Zorica, R, additional, Vrdoljak, DV, 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Published
2019
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4. Feasibility of Long-term Proteasome Inhibition in Multiple Myeloma by in-class Transition From Bortezomib to Ixazomib.

Author

Manda S, Yimer HA, Noga SJ, Girnius S, Yasenchak CA, Charu V, Lyons R, Aiello J, Bogard K, Ferrari RH, Cherepanov D, Demers B, Lu V, Whidden P, Kambhampati S, Birhiray RE, Jhangiani HS, Boccia R, and Rifkin RM

Subjects
Aged, Antineoplastic Combined Chemotherapy Protocols pharmacology, Boron Compounds pharmacology, Bortezomib pharmacology, Female, Glycine pharmacology, Glycine therapeutic use, Humans, Male, Multiple Myeloma mortality, Multiple Myeloma pathology, Progression-Free Survival, Proteasome Inhibitors pharmacology, Survival Analysis, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Boron Compounds therapeutic use, Bortezomib therapeutic use, Glycine analogs & derivatives, Multiple Myeloma drug therapy, Proteasome Inhibitors therapeutic use
Abstract

Background: The ongoing US MM-6 study is investigating in-class transition (iCT) from parenteral bortezomib-based induction to all-oral IRd (ixazomib-lenalidomide-dexamethasone) with the aim of increasing proteasome inhibitor (PI)-based treatment adherence and duration while maintaining patients' health-related quality of life (HRQoL) and improving outcomes., Patients and Methods: US community sites are enrolling non-transplant-eligible patients with newly diagnosed multiple myeloma (MM) with no evidence of progressive disease after 3 cycles of bortezomib-based therapy to receive IRd (up to 39 cycles or until progression or toxicity). The patients use mobile or wearable digital devices to collect actigraphy (activity and sleep) data and electronically complete HRQoL, treatment satisfaction and medication adherence questionnaires. The primary endpoint is progression-free survival. The key secondary endpoints include response rates and therapy duration., Results: At the data cutoff, 84 patients had been treated (median age 73 years; 44% aged ≥ 75 years; 49% men; 15% Black or African American; and 10% Hispanic or Latino). Of the 84 patients, 62% were continuing therapy. The mean duration of total PI therapy was 10.1 months and for the IRd regimen was 7.3 months. With an 8-month median follow-up, the 12-month progression-free survival rate was 86% (95% confidence interval, 73%-93%) from both the start of bortezomib-based treatment and the start of IRd. The overall response rate was 62% (complete response, 4%; very good partial response, 25%; partial response, 33%) after bortezomib-based induction and 70% (complete response, 26%; very good partial response, 29%; partial response, 15%) after iCT. The IRd safety profile was consistent with previous clinical trial data, and HRQoL and treatment satisfaction were maintained., Conclusion: The patients included in the US MM-6 study are representative of the real-world US MM population. The use of iCT might permit prolonged PI-based therapy with promising efficacy, without impacting patients' HRQoL or treatment satisfaction., (Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.)

Published
2020
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