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106 results on '"Larocca, Alessandra"'

1. Lysin (K)-specific demethylase 1 inhibition enhances proteasome inhibitor response and overcomes drug resistance in multiple myeloma

Author

Bandini, Cecilia, Mereu, Elisabetta, Paradzik, Tina, Labrador, Maria, Maccagno, Monica, Cumerlato, Michela, Oreglia, Federico, Prever, Lorenzo, Manicardi, Veronica, Taiana, Elisa, Ronchetti, Domenica, D’Agostino, Mattia, Gay, Francesca, Larocca, Alessandra, Besse, Lenka, Merlo, Giorgio Roberto, Hirsch, Emilio, Ciarrocchi, Alessia, Inghirami, Giorgio, Neri, Antonino, and Piva, Roberto

Published
2023
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4. Addition of elotuzumab to lenalidomide and dexamethasone for patients with newly diagnosed, transplantation ineligible multiple myeloma (ELOQUENT-1): an open-label, multicentre, randomised, phase 3 trial

Author

Dimopoulos, Meletios A, Richardson, Paul G, Bahlis, Nizar J, Grosicki, Sebastian, Cavo, Michele, Beksaç, Meral, Legieć, Wojciech, Liberati, Anna M, Goldschmidt, Hartmut, Belch, Andrew, Magen, Hila, Larocca, Alessandra, Laubach, Jacob P, Petrucci, Maria T, Reece, Donna, White, Darrell, Mateos, María-Victoria, Špička, Ivan, Lazaroiu, Mihaela, Berdeja, Jesús, Kaufman, Jonathan L, Jou, Ying-Ming, Ganetsky, Alex, Popa McKiver, Mihaela, Lonial, Sagar, Weisel, Katja, Sandhu, Irwindeep, Podhorecka, Monika, Palumbo, Antonio, Shacham-Abulafia, Adi, Vaxman, Iuliana, Shpilberg, Ofer, Besemer, Britta, Martelli, Maurizio, Foà, Roberto, De Fabritiis, Paolo, Caravita di Toritto, Tommaso, Gheorghita, Emanuil, Oriol, Albert, Rowlings, Philip, Emanuele, Angelucci, Carella, Angelo M, Offidani, Massimo, Bladé, Joan, Casado, Luis F, Oakervee, Heather, Panelli, Victoria, Meza, Luis, Kühr, Thomas, Granell, Miguel, Benson, Don, Nair, Rajesh, Holden, Viran, Reeves, James, Jr., Eek, Richard W, Walker, Patricia A, Catalano, John, Rosta, András, Lech-Marańda, Ewa, Samaras, Christy, Reiman, Anthony, Weaver, Robert, Acs, Peter, Grigg, Andrew, De Prijck, Bernard, Louzada, Martha, Minuk, Leonard, Sebag, Michael, Klausmann, Martine, Welslau, Manfred, Hellmann, Andrzej, Danaila, Catalin, Becker, Pamela, Bensinger, William, Porterfield, Bruce, Modiano, Manuel, Schultz, Stephen M, Manges, Robert, Lee, Huey-Shin Cindy, Gray, James X, Wright, Matthew P, Vekemans, Marie-Christine, Hamed, Aryan, Gasztonyi, Zoltán, Mikala, Gábor, Masszi, Tamás, Gamberi, Barbara, Kuliczkowski, Kazimierz, Usnarska-Zubkiewicz, Lidia, Bengoechea, Enrique, Gutiérrez, María AE, García, Miguel TH, San-Miguel, Jesús, Driessen, Christoph, Behl, Rajesh, Brenner, Warren, Gray, Carl, Hansen, Vincent, Moezi, Mehdi, Cortes, Hector V, Yen, Charles, Gressot, Laurent, Horvath, Noemi, D'Rozario, James M, Latimer, Maya, Kyrtsonis, Maria-Christine, Chubar, Evgeni, Mittelman, Moshe, Baldini, Luca, Tosi, Patrizia, Vacca, Angelo, Jędrzejczak, Wiesław W, Robak, Tadeusz, Lahuerta, Juan J, Carney, Jennifer, Chen, Franklin, Hirsch, Robert, Ruiz, Marco, Alencar, Alvaro, Jagasia, Madan, Kasbari, Samer, Kuriakose, Philip, Mahmood, Aftab, Chaudhry, Madhu, Cohen, Gary, Noga, Stephen, Roa, Sch, Jakubowiak, Andrzej, Rosenbaum, Cara, Delforge, Michel, Delrieu, Vanessa, Doyen, Chantal, Dries, Deeren, Demuynck, Hilde, Schots, Rik, Maisnar, Vladimir, Blau, Igor W, Dürk, Heinz A, Kerkhoff, Andrea, Kropff, Martin, Munder, Markus, Röllig, Christoph, Scheid, Christof, Symeonidis, Argiris S, Illés, Árpád, Coyne, Mark, O'Gorman, Peter, Hayden, Patrick, O'Dwyer, Michael, Ben-Yehuda, Dina, Braester, Andrei, Nemets, Anatoly, Lugassy, Gilles, Cohen, Yossi, Rahimi-Levene, Naomi, Bosi, Alberto, Pezzatti, Sara, Rossini, Fausto, Pogliani, Enrico M, Pinto, Antonello, Komarnicki, Mieczysław, Borsaru, Gabriela, Stoia, Razvan, Afanasyev, Boris, Goñi, María A, Carboneras, Ana V, Ali, Sarah, Rubenstein, S. Eric, Caputto, Salvador, Cosgriff, Thomas, Fanning, Suzanne, Khojasteh, Ali, Liman, Andrew, Malcolm, Albert, Vrindavanam, Nandagopal, Patel, Ravindranath, Belani, Rajesh, Shieh, Marie, Stockerl-Goldstein, Keith, Strnad, Charles, Stuart, Robert, Chhabra, Saurabh, Costa, Luciano, Jhangiani, Haresh, Augustson, Bradley, Filshie, Robin, Johnston, Amanda, Hertzberg, Mark S, Mineur, Philippe, Fox, Susan, Kotb, Rami, Dao, Vi, LeBlanc, Richard, Gregora, Evzen, Brioli, Annamaria, Mügge, Lars-Olof, Hänel, Mathias, Langer, Christian, Kapsali, Eleni, Briasoulis, Evangelos, Kyriakou, Despoina, Hardan, Izhar, Horowitz, Netanel A, Clotilde, Cangialosi, Fabbiano, Francesco, Castagnari, Barbara, Ciceri, Fabio, Musuraca, Gerardo, Deptała, Andrzej, Kłoczko, Janusz, Balea, Marius, Vladareanu, Ana-Maria, Rossiev, Victor, Alegre, Adrián, Encinas, Cristina, Gayoso, Jorge, Pabst, Thomas, Rabin, Neil, Arledge, Sherri, Cabanillas, Fernando, Catlett, Joseph, Chidiac, Tarek, Clarkson, David, Dhodapkar, Madhav, Geils, George, Jr., Khan, Cyrus MA, Sahovic, Entezam, Khasawneh, Mohamad, Sehgal, Rajesh, Ballester, Oscar, Levy, Moshe, Fay, Joseph, Liem, Kiem, Lunning, Matthew, Vose, Julie, Faber, Edward, Jr., MacFarlane, Donald, Hohl, Raymond, Mahmood, Tariq, Bhaskar, Birbal, Mims, Martha, Oliff, Ira, Paner, Agne, Maciejewski, John, Padmanabhan, Arvinda, Richard, Robert, Sanyal, Amit, Schiller, Gary, Staszewski, Harry, Stevens, Don, Vaughn, Christopher, and Windsor, Kevin

Published
2022
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5. Genomic and immune determinants of resistance to daratumumab-based therapy in relapsed refractory multiple myeloma.

Author

Ziccheddu, Bachisio, Giannotta, Claudia, D'Agostino, Mattia, Bertuglia, Giuseppe, Saraci, Elona, Oliva, Stefania, Genuardi, Elisa, Papadimitriou, Marios, Diamond, Benjamin, Corradini, Paolo, Coffey, David, Landgren, Ola, Bolli, Niccolò, Bruno, Benedetto, Boccadoro, Mario, Massaia, Massimo, Maura, Francesco, and Larocca, Alessandra

Subjects
REGULATORY T cells, WHOLE genome sequencing, T-cell exhaustion, KILLER cells, MULTIPLE myeloma
Abstract

Targeted immunotherapy combinations, including the anti-CD38 monoclonal antibody (MoAb) daratumumab, have shown promising results in patients with relapsed/refractory multiple myeloma (RRMM), leading to a considerable increase in progression-free survival. However, a large fraction of patients inevitably relapse. To understand this, we investigated 32 relapsed MM patients treated with daratumumab, lenalidomide, and dexamethasone (Dara-Rd; NCT03848676). We conducted an integrated analysis using whole-genome sequencing (WGS) and flow cytometry in patients with RRMM. WGS before and after treatment pinpointed genomic drivers associated with early progression, including RPL5 loss, APOBEC mutagenesis, and gain of function structural variants involving MYC and chromothripsis. Flow cytometry on 202 blood samples, collected every 3 months until progression for 31 patients, revealed distinct immune changes significantly impacting clinical outcomes. Progressing patients exhibited significant depletion of CD38-positive NK cells, persistence of T-cell exhaustion, and reduced depletion of regulatory T cells over time. These findings underscore the influence of immune composition and daratumumab-induced immune changes in promoting MM resistance. Integrating genomics and flow cytometry unveiled associations between adverse genomic features and immune patterns. Overall, this study sheds light on the intricate interplay between genomic complexity and the immune microenvironment driving resistance to Dara-Rd in patients with RRMM. [ABSTRACT FROM AUTHOR]

Published
2024
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6. Pembrolizumab plus pomalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma (KEYNOTE-183): a randomised, open-label, phase 3 trial

Author

Nicol, Andrew, Grigoriadis, George, Catalano, John, LeBlanc, Richard, Elemary, Mohamed, Bahlis, Nizar, Facon, Thierry, Karlin, Lionel, Ribrag, Vincent, Attal, Michel, Goldschmidt, Hartmut, Engelhardt, Monika, Weisel, Katja, Mackensen, Andreas, Nagler, Arnon, Ben Yehuda, Dina, Avivi, Irit, Benyamini, Noam, Magen-Nativ, Hila, Palumbo, Antonio, Cavo, Michele, Tobinai, Kensei, Iida, Shinsuke, Chou, Takaai, Suzuki, Kenshi, Kosugi, Hiroshi, Taniwaki, Masafumi, Sunami, Kazutaka, Matsumoto, Morio, Ando, Kiyoshi, Ganly, Peter, Blacklock, Hilary, Simpson, David, George, Anupkumar, Schjesvold, Fredrik, Gjertsen, Bjorn, Lahuerta, Juan, Blade, Joan, Oriol Rocafiguera, Albert, Mateos, Maria, Rodriguez-Otero, Paula, Larson, Sarah, Atanackovic, Djordje, Devarakonda, Srinivas, Bitran, Jacob, Zonder, Jeffrey, Morganstein, Neil, Hay, Mohammad, Chanan-Khan, Asher, Saylors, Gene, Kio, Ebenezer, Oliff, Ira, Kirkel, Dean, Shtivelband, Mikhail, Yuen, Carrie, Yee, Andrew, Shah, Jatin, Htut, Myo, Raza, Shahzad, Chhabra, Saurabh, Stiff, Patrick, Hari, Parameswaran, Bank, Bruce, Malek, Ehsan, Gasparetto, Cristina, Faroun, Ycaoub, Sherbenou, Daniel, Kreisle, William, Singhal, Seema, Rosenblatt, Jacalyn, Usmani, Saad, Lee, Wes, Safah, Hana, Lutzky, Jose, Suh, Jason, Pan, Dorothy, Baron, Ari, Manges, Robert, Steis, Ronald, Oliveira, Moacyr, Moreb, Jan, Callander, Natalie, Anz, Bertrand, Raptis, Anastasios, Stampleman, Laura, Melear, Jason, Boyd, Thomas, Garbo, Lawrence, Klein, Leonard, Shao, Spencer, Lyons, Roger, McIntyre, Kristi, Tarantolo, Stefano, Yasenchak, Christopher, Yimer, Habte, Mateos, Maria-Victoria, Oriol, Albert, Larocca, Alessandra, Usmani, Saad Z, Jagannath, Sundar, Ocio, Enrique M, San Miguel, Jesus, Kher, Uma, Farooqui, Mohammed, Liao, Jason, Marinello, Patricia, and Lonial, Sagar

Published
2019
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7. Pembrolizumab plus lenalidomide and dexamethasone for patients with treatment-naive multiple myeloma (KEYNOTE-185): a randomised, open-label, phase 3 trial

Author

Lim, Andrew, Grigoriadis, George, Walker, Trish, Nicol, Andrew, LeBlanc, Richard, Reece, Donna, Elemary, Mohamed, Boudreault Pedneault, Jean Samuel, Karlin, Lionel, Facon, Thierry, Attal, Michel, Weisel, Katja, Engelhardt, Monika, Mackensen, Andreas, Quinn, John, Avivi, Irit, Cohen, Amos, Magen-Nativ, Hila, Benyamini, Noam, Cavo, Michele, Larocca, Alessandra, Takezako, Naoki, Suzuki, Kenshi, Kosugi, Hiroshi, Matsumoto, Morio, Iida, Shinsuke, Ishikawa, Takayuki, Kondo, Yukio, Sunami, Kazutaka, Ando, Kiyoshi, Teshima, Takanori, Chou, Takaaki, Iwasaki, Hiromi, Miki, Hirokazu, Matsumura, Itaru, Onishi, Yasushi, Izutsu, Koji, Kizaki, Masahiro, George, Anupkumar, Blacklock, Hillary, Simpson, David, Schjesvold, Fredrik, Waage, Anders, Samoilova, Olga, Nikitin, Evgeniy, Chagorova, Tatiana, McDonald, Andrew, Patel, Moosa, Oriol Rocafiguera, Albert, San Miguel Izquierdo, Jesus, Mateos, Maria, Streetly, Matthew, Forsyth, Peter, Jackson, Graham, Jenkins, Stephen, Rifkin, Robert, Yimer, Habte, McCroskey, Robert, Martincic, Danko, Tarantolo, Stefano, Larson, Sarah, Faroun, Yacoub, Vaughn, Jennifer, Baz, Rachid, Saylors, Gene, Neppalli, Amarendra, Raptis, Anastasios, Fung, Henry, Janosky, Maxwell, Stevens, Don, Coleman, Morton, Costa, Dennis, Cross, Scott, Fanning, Suzanne, Berges, Daniel Farray, Harris, Thomas, Zackon, Ira, Atanackovic, Djordje, Lee, Kelvin, Oliff, Ira, Lee, Wes, Bensinger, William, Lutzky, Jose, Baron, Ari, Hayek, Fadi, Kirschner, Eli, Bharany, Neeraj, Overton, Lindsay, Mannem, Siva, Harroff, Allyson, Jain, Sharad, Roque, Tammy, McIntyre, Kristi, Yasencha, Christopher K, Houck, William, Usmani, Saad Zafar, Oriol, Albert, Rifkin, Robert M, Yimer, Habte Aragaw, McCroskey, Robert Donald, Lim, Andrew Boon Ming, Jagannath, Sundar, Lonial, Sagar, Ghori, Razi Uddin, Farooqui, Mohammed Z H, Marinello, Patricia, and San-Miguel, Jesus

Published
2019
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8. Pomalidomide, bortezomib, and dexamethasone for patients with relapsed or refractory multiple myeloma previously treated with lenalidomide (OPTIMISMM): a randomised, open-label, phase 3 trial

Author

Abildgaard, Niels, Adler, Howard, Altuntas, Fevzi, Akay, Olga Meltem, Amin, Bipinkumar, Anagnostopoulos, Achilleas, Anderson, Larry, Anttila, Pekka, Araujo, Carla, Arce-Lara, Carlos, Aydin, Yildiz, Basu, Supratik, Battini, Ramakrishna, Beeker, Thaddeus, Benboubker, Lotfi, Ben-Yehuda, Dina, Bladé, Joan, Blau, Igor Wolfgang, Boccia, Ralph, Burke, Lillian, Byeff, Peter, Cascavilla, Nicola, Cavo, Michele, Chantry, Andrew, Charles, Yen, Chaudhry, Arvind, Corso, Alessandro, Coyne, Mark, De Arriba, Felipe, Delimpasi, Sosana, Desjardins, Pierre, Dhakal, Binod, Di Bartolomeo, Paolo, Di Raimondo, Francesco, Dürig, Jan, Engelhardt, Monika, Escoffre-Barbe, Martine, Esteves, Graca, Flogegard, Max, Gabrail, Nashat, Gamberi, Barbara, Garrison, Mitchell, Gay, Julie, Gisslinger, Heinz, Goldschmidt, Hartmut, Goncalves, Cristina, Gressot, Laurent, Grosicki, Sebastian, Hanna, Wahid, Hayden, Patrick, Henriques Bernardo, Maria Manuela, Hermann, Robert, Holden, Viran, Honkalehto, Kirsti, Huben, Marianne, Huffman, John, Hunter, Hannah, Hus, Marek, Jagasia, Madan, Jagganath, Sundar, Janakiram, Murali, Jaiyesimi, Ishmael, Jenner, Matthew, João, Cristina, Johnson, Peter, Jurcyszyn, Artur, Kalayoğlu Beşişik, Sevgi, Kambhampati, Suman, Kanate, Abraham, Karadoğan, Ihsan, Khojasteh, Ali, Kirkel, Dean, Komarnicki, Mieczyslaw, Krauth, Maria-Theresa, Kuriakose, Phillip, Larocca, Alessandra, Lauri, Birgitta, Leleu, Xavier, Lucio, Paulo, Luppi, Mario, Mangiacavalli, Silvia, Mariette, Clara, Matsue, Kosei, Mellqvist, Ulf-Henri, Mendeleeva, Larisa, Meshad, Michael, Miller, Carole, Mohrbacher, Ann, Moreau, Philippe, Morelli, Anna Maria, Müldür, Ercan, Naassan, Anthony, Nahi, Hareth, Nair, Rajesh, O'Dwyer, Mike, Öngören Aydin, Seniz, Openshaw, Thomas, O'Rourke, Timothy, Osswald, Michael, Overton, Lindsay, Pati, Asmin, Pavic, Michel, Pegourie, Brigitte, Pehlivan, Mustafa, Pierola, Ana Alfonso, Plesner, Torben, Pluta, Andrzej, Rabin, Neil, Ramasamy, Karthik, Rambaldi, Alessandro, Rodriguez, Paula, Röllig, Christoph, Rosenblatt, Jacalyn, Rosenbluth, Jonathan, Salomo, Morten, Samoylova, Olga, Sastre Moral, Jose, Sati, Hamdi, Selleri, Carmine, Shafeek, Salim, Shinagawa, Atsushi, Sleckman, Bethany, Smith, Clay, Sonmez, Mehmet, Stone, Chester, Streetly, Matthew, Suzuki, Kenshi, Taetle, Raymond, Tafuri, Agostino, Takezako, Naoki, Teke, Hava Üsküdar, Vapaatalo, Mirja, Vassilopoulos, George, Verma, Amit, Vidito, Sarah, Viterbo, Luisa, Vural, Filiz, Wang, Xiang Sean, Yağci, Munci, Yee, Andrew, Richardson, Paul G, Oriol, Albert, Beksac, Meral, Liberati, Anna Marina, Galli, Monica, Schjesvold, Fredrik, Lindsay, Jindriska, Weisel, Katja, White, Darrell, Facon, Thierry, San Miguel, Jesus, Sunami, Kazutaka, O'Gorman, Peter, Sonneveld, Pieter, Robak, Pawel, Semochkin, Sergey, Schey, Steve, Yu, Xin, Doerr, Thomas, Bensmaine, Amine, Biyukov, Tsvetan, Peluso, Teresa, Zaki, Mohamed, Anderson, Kenneth, and Dimopoulos, Meletios

Published
2019
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10. Melflufen in relapsed/refractory multiple myeloma refractory to prior alkylators: A subgroup analysis from the OCEAN study.

Author

Schjesvold, Fredrik H., Ludwig, Heinz, Mateos, Maria‐Victoria, Larocca, Alessandra, Abdulhaq, Haifaa, Norin, Stefan, Thuresson, Marcus, Bakker, Nicolaas A., Richardson, Paul G., and Sonneveld, Pieter

Subjects
MULTIPLE myeloma, STEM cell transplantation, REFRACTORY materials, SUBGROUP analysis (Experimental design), OCEAN
Abstract

Melphalan flufenamide (melflufen), a first‐in‐class alkylating peptide‐drug conjugate, plus dexamethasone demonstrated superior progression‐free survival (PFS), but not overall survival (OS), versus pomalidomide plus dexamethasone in relapsed/refractory multiple myeloma in the OCEAN study. Time to progression (TTP) <36 months after a prior autologous stem cell transplantation (ASCT) was a negative prognostic factor for OS with melflufen. This post hoc exploratory analysis evaluated patients refractory to prior alkylators (e.g., cyclophosphamide and melphalan) in OCEAN. In 153 patients refractory to prior alkylators (melflufen, n = 78; pomalidomide, n = 75), the melflufen and pomalidomide arms had similar median PFS (5.6 months [95% CI, 4.2–8.3] vs. 4.7 months [95% CI, 3.1–7.3]; hazard ratio [HR], 0.92 [95% CI, 0.63–1.33]) and OS (23.4 months [95% CI, 14.4–31.7] vs. 20.0 months [95% CI, 12.0–28.7]; HR, 0.92 [95% CI, 0.62–1.38]). Among alkylator‐refractory patients with a TTP ≥ 36 months after a prior ASCT or no prior ASCT (melflufen, n = 54; pomalidomide, n = 53), the observed median PFS and OS were longer in the melflufen arm than the pomalidomide arm. The safety profile of melflufen was consistent with previous reports. These results suggest that melflufen is safe and effective in patients with alkylator‐refractory disease, suggesting differentiated activity from other alkylators. [ABSTRACT FROM AUTHOR]

Published
2024
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11. Early mortality in myeloma patients treated with first-generation novel agents thalidomide, lenalidomide, bortezomib at diagnosis: A pooled analysis

Author

Bringhen, Sara, Offidani, Massimo, Palmieri, Salvatore, Pisani, Francesco, Rizzi, Rita, Spada, Stefano, Evangelista, Andrea, Di Renzo, Nicola, Musto, Pellegrino, Marcatti, Magda, Vallone, Roberto, Storti, Sergio, Bernardini, Annalisa, Centurioni, Riccardo, Aitini, Enrico, Palmas, Angelo, Annibali, Ombretta, Angelucci, Emanuele, Ferrando, Paola, Baraldi, Anna, Rocco, Stefano, Andriani, Alessandro, Siniscalchi, Agostina, De Stefano, Valerio, Meneghini, Vittorio, Palumbo, Antonio, Grammatico, Sara, Boccadoro, Mario, and Larocca, Alessandra

Published
2018
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12. Prognostic or predictive value of circulating cytokines and angiogenic factors for initial treatment of multiple myeloma in the GIMEMA MM0305 randomized controlled trial

Author

Saltarella, Ilaria, Morabito, Fortunato, Giuliani, Nicola, Terragna, Carolina, Omedè, Paola, Palumbo, Antonio, Bringhen, Sara, De Paoli, Lorenzo, Martino, Enrica, Larocca, Alessandra, Offidani, Massimo, Patriarca, Francesca, Nozzoli, Chiara, Guglielmelli, Tommasina, Benevolo, Giulia, Callea, Vincenzo, Baldini, Luca, Grasso, Mariella, Leonardi, Giovanna, Rizzo, Manuela, Falcone, Antonietta Pia, Gottardi, Daniela, Montefusco, Vittorio, Musto, Pellegrino, Petrucci, Maria Teresa, Dammacco, Franco, Boccadoro, Mario, Vacca, Angelo, and Ria, Roberto

Published
2019
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14. Geriatric assessment predicts survival and toxicities in elderly myeloma patients: an International Myeloma Working Group report

Author

Palumbo, Antonio, Bringhen, Sara, Mateos, Maria-Victoria, Larocca, Alessandra, Facon, Thierry, Kumar, Shaji K., Offidani, Massimo, McCarthy, Philip, Evangelista, Andrea, Lonial, Sagar, Zweegman, Sonja, Musto, Pellegrino, Terpos, Evangelos, Belch, Andrew, Hajek, Roman, Ludwig, Heinz, Stewart, A. Keith, Moreau, Philippe, Anderson, Kenneth, Einsele, Hermann, Durie, Brian.G.M., Dimopoulos, Meletios A., Landgren, Ola, San Miguel, Jesus F., Richardson, Paul, Sonneveld, Pieter, and Rajkumar, S. Vincent

Published
2015
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15. Second primary malignancies with lenalidomide therapy for newly diagnosed myeloma: a meta-analysis of individual patient data

Author

Palumbo, Antonio, Bringhen, Sara, Kumar, Shaji K, Lupparelli, Giulia, Usmani, Saad, Waage, Anders, Larocca, Alessandra, van der Holt, Bronno, Musto, Pellegrino, Offidani, Massimo, Petrucci, Maria T, Evangelista, Andrea, Zweegman, Sonja, Nooka, Ajay K, Spencer, Andrew, Dimopoulos, Meletios A, Hajek, Roman, Cavo, Michele, Richardson, Paul, Lonial, Sagar, Ciccone, Giovannino, Boccadoro, Mario, Anderson, Kenneth, Barlogie, Bart, Sonneveld, Pieter, and McCarthy, Philip L

Published
2014
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16. New Strategies for the Treatment of Older Myeloma Patients.

Author

Larocca, Alessandra, Cani, Lorenzo, Bertuglia, Giuseppe, Bruno, Benedetto, and Bringhen, Sara

Subjects
*MULTIPLE myeloma treatment, *MULTIPLE myeloma diagnosis, *FRAIL elderly, *TREATMENT effectiveness, *DISEASE relapse, *DISEASE management, *COMORBIDITY, *OLD age
Abstract

Simple Summary: While novel therapies have improved outcomes in multiple myeloma (MM), physicians are calling for greater caution when managing this hematologic malignancy in older patients due to their fragility, which increases their vulnerability to toxic events. Additionally, this patient population may be excluded from clinical trials due to comorbidities, whereby available data are not always applicable in real-word clinical practice. This review delves into available frailty assessment tools that can be used to identify patients who are unfit or frail and tailor therapy to achieve better outcomes while minimizing toxicity. Current therapeutic strategies for managing transplant-ineligible patients with newly diagnosed MM and relapsed or refractory MM are also described, with the aim of guiding physicians when selecting treatment options. Multiple myeloma (MM) mostly affects older patients, who represent a highly heterogeneous population. In the last few years, the introduction of novel agents led to a significant improvement in the outcome of MM patients. Nonetheless, this positive trend is less likely to occur in all older patients due to comorbidities/disabilities and major susceptibility to toxic events. Furthermore, older patients with major comorbidities are usually excluded or underrepresented in most registrational clinical trials. In this context, physicians have called for greater caution in the management of the disease. Several scores allow for the identification of frail and unfit patients and establish the possibility of tailoring therapy, reducing toxicity. This review explores the available tools for the assessment of frailty and what has been done to improve the discriminative power of the available scores. Thereafter, it describes the main therapeutic strategies for the management of transplant-ineligible (NTE) newly diagnosed (ND) MM patients and relapsed/refractory (RR) MM patients, in order to better guide physicians in choosing treatment options and to suggest possible strategies for more frail patients. [ABSTRACT FROM AUTHOR]

Published
2023
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17. Pomalidomide, cyclophosphamide, and prednisone for relapsed/refractory multiple myeloma: a multicenter phase 1/2 open-label study

Author

Larocca, Alessandra, Montefusco, Vittorio, Bringhen, Sara, Rossi, Davide, Crippa, Claudia, Mina, Roberto, Galli, Monica, Marcatti, Magda, La Verde, Giacinto, Giuliani, Nicola, Magarotto, Valeria, Guglielmelli, Tommasina, Rota-Scalabrini, Delia, Omedé, Paola, Santagostino, Alberto, Baldi, Ileana, Carella, Angelo Michele, Boccadoro, Mario, Corradini, Paolo, and Palumbo, Antonio

Published
2013
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19. Lenalidomide and low‐dose dexamethasone (Rd) versus bortezomib, melphalan, prednisone (VMP) in elderly newly diagnosed multiple myeloma patients: A comparison of two prospective trials

Author

Gentile, Massimo, Magarotto, Valeria, Offidani, Massimo, Musto, Pellegrino, Bringhen, Sara, Teresa Petrucci, Maria, Gay, Francesca, Larocca, Alessandra, Uccello, Giuseppina, Petrungaro, Annamaria, Vigna, Ernesto, Greco, Rosa, Grazia Recchia, Anna, Tripepi, Giovanni, Ria, Roberto, Di Raimondo, Francesco, Palumbo, Antonio, and Morabito, Fortunato

Published
2017
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20. Normalization of the Immunological Microenvironment and Sustained Minimal Residual Disease Negativity: Do We Need Both for Long-Term Control of Multiple Myeloma?

Author

Bertuglia, Giuseppe, Cani, Lorenzo, Larocca, Alessandra, Gay, Francesca, and D'Agostino, Mattia

Subjects
MULTIPLE myeloma, CYTOLOGY, PLASMA cells, BONE marrow, IMMUNE system, CELL proliferation
Abstract

Over the past two decades, the treatment landscape for multiple myeloma (MM) has progressed significantly, with the introduction of several new drug classes that have greatly improved patient outcomes. At present, it is well known how the bone marrow (BM) microenvironment (ME) exerts an immunosuppressive action leading to an exhaustion of the immune system cells and promoting the proliferation and sustenance of tumor plasma cells. Therefore, having drugs that can reconstitute a healthy BM ME can improve results in MM patients. Recent findings clearly demonstrated that achieving minimal residual disease (MRD) negativity and sustaining MRD negativity over time play a pivotal prognostic role. However, despite the achievement of MRD negativity, patients may still relapse. The understanding of immunologic changes in the BM ME during treatment, complemented by a deeper knowledge of plasma cell genomics and biology, will be critical to develop future therapies to sustain MRD negativity over time and possibly achieve an operational cure. In this review, we focus on the components of the BM ME and their role in MM, on the prognostic significance of MRD negativity and, finally, on the relative contribution of tumor plasma cell biology and BM ME to long-term disease control. [ABSTRACT FROM AUTHOR]

Published
2022
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21. Efficacy and safety of once-weekly bortezomib in multiple myeloma patients

Author

Bringhen, Sara, Larocca, Alessandra, Rossi, Davide, Cavalli, Maide, Genuardi, Mariella, Ria, Roberto, Gentili, Silvia, Patriarca, Francesca, Nozzoli, Chiara, Levi, Anna, Guglielmelli, Tommasina, Benevolo, Giulia, Callea, Vincenzo, Rizzo, Vincenzo, Cangialosi, Clotilde, Musto, Pellegrino, De Rosa, Luca, Liberati, Anna Marina, Grasso, Mariella, Falcone, Antonietta P., Evangelista, Andrea, Cavo, Michele, Gaidano, Gianluca, Boccadoro, Mario, and Palumbo, Antonio

Published
2010
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23. Bortezomib, melphalan, prednisone (VMP) versus melphalan, prednisone, thalidomide (MPT) in elderly newly diagnosed multiple myeloma patients: A retrospective case-matched study

Author

Morabito, Fortunato, Bringhen, Sara, Larocca, Alessandra, Wijermans, Pierre, Victoria Mateos, Maria, Gimsing, Peter, Mazzone, Carla, Gottardi, Daniela, Omedè, Paola, Zweegman, Sonja, José Lahuerta, Juan, Zambello, Renato, Musto, Pellegrino, Magarotto, Valeria, Schaafsma, Martijn, Oriol, Albert, Juliusson, Gunnar, Cerrato, Chiara, Catalano, Lucio, Gentile, Massimo, Isabel Turel, Ana, Marina Liberati, Anna, Cavalli, Maide, Rossi, Davide, Passera, Roberto, Rosso, Stefano, Beksac, Meral, Cavo, Michele, Waage, Anders, San Miguel, Jesus, Boccadoro, Mario, Sonneveld, Pieter, Palumbo, Antonio, and Offidani, Massimo

Published
2014
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24. MET dysregulation is a hallmark of aggressive disease in multiple myeloma patients

Author

Rocci, Alberto, Gambella, Manuela, Aschero, Simona, Baldi, Ileana, Trusolino, Livio, Cavallo, Federica, Gay, Francesca, Larocca, Alessandra, Magarotto, Valeria, Omedè, Paola, Isaia, Gianluca, Bertotti, Andrea, Liberati, Anna M., Catalano, Lucio, De Rosa, Luca, Musto, Pellegrino, Vallone, Roberto, Falcone, Antonietta, Drandi, Daniela, Ladetto, Marco, Comoglio, Paolo M., Boccadoro, Mario, and Palumbo, Antonio

Published
2014
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28. Patient‐reported outcomes in relapsed/refractory multiple myeloma treated with melflufen plus dexamethasone: analyses from the Phase II HORIZON study.

Author

Larocca, Alessandra, Leleu, Xavier, Touzeau, Cyrille, Bladé, Joan, Paner, Agne, Mateos, María‐Victoria, Cavo, Michele, Maisel, Christopher, Alegre, Adrían, Oriol, Albert, Raptis, Anastasios, Rodriguez‐Otero, Paula, Mazumder, Amitabha, Laubach, Jacob, Nadeem, Omar, Sandberg, Anna, Orre, Marie, Torrång, Anna, Bakker, Nicolaas A., and Richardson, Paul G.

Subjects
*MULTIPLE myeloma, *PATIENT reported outcome measures, *PHYSICAL mobility, *QUALITY of life, *DEXAMETHASONE
Abstract

Summary: 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. Assessment of patient reported‐outcome measures from the pivotal, Phase II HORIZON study (OP‐106; NCT02963493) in patients with RRMM (n = 64) demonstrated that melphalan flufenamide (melflufen) plus dexamethasone treatment preserved HRQoL. Patients had clinically meaningful improvements, even after eight treatment cycles, in relevant scales such as global health status/QoL, physical functioning, emotional functioning, pain, and fatigue. Patients with triple‐class–refractory disease (n = 50) displayed similar improvements. Patient‐reported outcome deterioration was delayed for a substantial amount of time in patients who experienced a response to melflufen plus dexamethasone treatment relative to patients who did not experience a response. These findings support the notion that treatment with melflufen plus dexamethasone may sustain or improve HRQoL over time in patients with RRMM, including in patients with triple‐class–refractory disease for whom outcomes are generally worse. The clinical benefits observed in patients from the HORIZON trial are encouraging and supportive of translation into real‐world practice. [ABSTRACT FROM AUTHOR]

Published
2022
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29. Prognostic gene expression analysis in a retrospective, multinational cohort of 155 multiple myeloma patients treated outside clinical trials.

Author

Chen, Yan‐Ting, Valent, Erik T., van Beers, Erik H., Kuiper, Rowan, Oliva, Stefania, Haferlach, Torsten, Chng, Wee‐Joo, van Vliet, Martin H., Sonneveld, Pieter, and Larocca, Alessandra

Subjects
RNA analysis, RESEARCH, STATISTICS, CONFIDENCE intervals, MULTIVARIATE analysis, RETROSPECTIVE studies, MICROARRAY technology, MEDICAL cooperation, RISK assessment, CANCER patients, GENE expression profiling, SURVIVAL analysis (Biometry), DESCRIPTIVE statistics, MULTIPLE myeloma, STATISTICAL models, CYTOGENETICS, TUMOR markers, PROPORTIONAL hazards models, DISEASE risk factors
Abstract

Objectives: Typically, prognostic capability of gene expression profiling (GEP) is studied in the context of clinical trials, for which 50%‐80% of patients are not eligible, possibly limiting the generalizability of findings to routine practice. Here, we evaluate GEP analysis outside clinical trials, aiming to improve clinical risk assessment of multiple myeloma (MM) patients. Methods: A total of 155 bone marrow samples from MM patients were collected from which RNA was analyzed by microarray. Sixteen previously developed GEP‐based markers were evaluated, combined with survival data, and studied using Cox proportional hazard regression. Results: Gene expression profiling‐based markers SKY92 and the PR‐cluster were shown to be independent prognostic factors for survival, with hazard ratios and 95% confidence interval of 3.6 [2.0‐6.8] (P <.001) and 5.8 [2.7‐12.7] (P <.01) for overall survival (OS). A multivariate model proved only SKY92 and the PR‐cluster to be independent prognostic factors compared to cytogenetic high‐risk patients, the International Staging System (ISS), and revised ISS. A substantial number of high‐risk individuals could be further identified when SKY92 was added to the cytogenetic, ISS, or R‐ISS. In the cytogenetic standard‐risk group, ISS I/II, and R‐ISS I/II, 13%, 23%, and 23% of patients with adverse survivals were identified. Conclusions: For the first time, this study confirmed the prognostic value of GEP markers outside clinical trials. Conventional prognostic models to define high‐risk MM are improved by the incorporation of GEP markers. [ABSTRACT FROM AUTHOR]

Published
2022
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34. Management of patients with multiple myeloma beyond the clinical-trial setting: understanding the balance between efficacy, safety and tolerability, and quality of life.

Author

Terpos, Evangelos, Mikhael, Joseph, Hajek, Roman, Chari, Ajai, Zweegman, Sonja, Lee, Hans C., Mateos, María-Victoria, Larocca, Alessandra, Ramasamy, Karthik, Kaiser, Martin, Cook, Gordon, Weisel, Katja C., Costello, Caitlin L., Elliott, Jennifer, Palumbo, Antonio, and Usmani, Saad Z.

Abstract

Treatment options in multiple myeloma (MM) are increasing with the introduction of complex multi-novel-agent-based regimens investigated in randomized clinical trials. However, application in the real-world setting, including feasibility of and adherence to these regimens, may be limited due to varying patient-, treatment-, and disease-related factors. Furthermore, approximately 40% of real-world MM patients do not meet the criteria for phase 3 studies on which approvals are based, resulting in a lack of representative phase 3 data for these patients. Therefore, treatment decisions must be tailored based on additional considerations beyond clinical trial efficacy and safety, such as treatment feasibility (including frequency of clinic/hospital attendance), tolerability, effects on quality of life (QoL), and impact of comorbidities. There are multiple factors of importance to real-world MM patients, including disease symptoms, treatment burden and toxicities, ability to participate in daily activities, financial burden, access to treatment and treatment centers, and convenience of treatment. All of these factors are drivers of QoL and treatment satisfaction/compliance. Importantly, given the heterogeneity of MM, individual patients may have different perspectives regarding the most relevant considerations and goals of their treatment. Patient perspectives/goals may also change as they move through their treatment course. Thus, the ‘efficacy’ of treatment means different things to different patients, and treatment decision-making in the context of personalized medicine must be guided by an individual’s composite definition of what constitutes the best treatment choice. This review summarizes the various factors of importance and practical issues that must be considered when determining real-world treatment choices. It assesses the current instruments, methodologies, and recent initiatives for analyzing the MM patient experience. Finally, it suggests options for enhancing data collection on patients and treatments to provide a more holistic definition of the effectiveness of a regimen in the real-world setting. [ABSTRACT FROM AUTHOR]

Published
2021
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36. Health-related quality-of-life results from the phase 3 OPTIMISMM study: pomalidomide, bortezomib, and low-dose dexamethasone versus bortezomib and low-dose dexamethasone in relapsed or refractory multiple myeloma.

Author

Weisel, Katja, Dimopoulos, Meletios, Moreau, Philippe, Yagci, Munci, Larocca, Alessandra, Kanate, Abraham S., Vural, Filiz, Cascavilla, Nicola, Basu, Supratik, Johnson, Peter, Byeff, Peter, Hus, Marek, Rodríguez-Otero, Paula, Muelduer, Ercan, Anttila, Pekka, Hayden, Patrick J., Krauth, Maria-Theresa, Lucio, Paulo, Ben-Yehuda, Dina, and Mendeleeva, Larisa

Subjects
MULTIPLE myeloma, BORTEZOMIB, DEXAMETHASONE, TREATMENT effectiveness, DRUG side effects
Abstract

In the randomized phase-3 OPTIMISMM study, the addition of pomalidomide to bortezomib and low-dose dexamethasone (PVd) resulted in significant improvement in progression-free survival (PFS) in lenalidomide-pretreated patients with relapsed or refractory multiple myeloma (RRMM), including lenalidomide refractory patients. Here, we report health-related quality of life (HRQoL) results from this trial. Patients received PVd or Vd in 21-day cycles until disease progression or discontinuation. HRQoL was assessed using the EORTC QLQ-C30, QLQ-MY20, and EQ-5D-3L instruments on day 1 of each treatment cycle. Mean score changes for global QoL, physical functioning, fatigue, side effects of treatment domains, and EQ-5D-3L index were generally stable over time across treatment arms. The proportion of patients who experienced clinically meaningful worsening in global QoL and other domains of interest was similar. These HRQoL results with PVd along with previously demonstrated improvement in PFS vs Vd continue to support its use in patients with RRMM. [ABSTRACT FROM AUTHOR]

Published
2020
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37. Clinical Applications and Future Directions of Minimal Residual Disease Testing in Multiple Myeloma.

Author

Oliva, Stefania, D'Agostino, Mattia, Boccadoro, Mario, and Larocca, Alessandra

Subjects
MULTIPLE myeloma, BONE marrow, NUCLEOTIDE sequencing, LIFE expectancy, FLOW cytometry
Abstract

In the last years, the life expectancy of multiple myeloma (MM) patients has substantially improved thanks to the availability of many new drugs. Our ability to induce deep responses has improved as well, and the treatment goal in patients tolerating treatment moved from the delay of progression to the induction of the deepest possible response. As a result of these advances, a great scientific effort has been made to redefine response monitoring, resulting in the development and validation of high-sensitivity techniques to detect minimal residual disease (MRD). In 2016, the International Myeloma Working Group (IMWG) updated MM response categories defining MRD-negative responses both in the bone marrow (assessed by next-generation flow cytometry or next-generation sequencing) and outside the bone marrow. MRD is an important factor independently predicting prognosis during MM treatment. Moreover, using novel combination therapies, MRD-negative status can be achieved in a fairly high percentage of patients. However, many questions regarding the clinical use of MRD status remain unanswered. MRD monitoring can guide treatment intensity, although well-designed clinical trials are needed to demonstrate this potential. This mini-review will focus on currently available techniques and data on MRD testing and their potential future applications. [ABSTRACT FROM AUTHOR]

Published
2020
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38. Minimal residual disease by flow cytometry and allelic-specific oligonucleotide real-time quantitative polymerase chain reaction in patients with myeloma receiving lenalidomide maintenance: A pooled analysis.

Author

Gambella, Manuela, Omedé, Paola, Spada, Stefano, Muccio, Vittorio Emanuele, Gilestro, Milena, Saraci, Elona, Grammatico, Sara, Larocca, Alessandra, Conticello, Concetta, Bernardini, Annalisa, Gamberi, Barbara, Troia, Rossella, Liberati, Anna Marina, Offidani, Massimo, Rocci, Alberto, Palumbo, Antonio, Cavo, Michele, Sonneveld, Pieter, Boccadoro, Mario, and Oliva, Stefania

Subjects
POLYMERASE chain reaction, REVERSE transcriptase polymerase chain reaction, FLOW cytometry, OLIGONUCLEOTIDE synthesis, ONCOLOGY, MULTIPLE myeloma, PROGRESSION-free survival
Abstract

Background: Minimal residual disease (MRD) is one of the most relevant prognostic factors in patients with multiple myeloma (MM); however, the impact of maintenance therapy on MRD levels remains unclear. Among patients with newly diagnosed MM (NDMM) who received lenalidomide maintenance until they developed disease progression, the role of MRD status as a predictor of progression-free survival (PFS) was evaluated by multiparameter flow cytometry (MFC) and allelic-specific oligonucleotide real-time quantitative polymerase chain reaction (ASO-RQ-PCR) analysis.Methods: Seventy-three patients with NDMM enrolled in the RV-MM-EMN-441 (clinical trials.gov identifier, NCT01091831) and RV-MM-COOP-0556 (clinicaltrials.gov identifier, NCT01208766; European Myeloma Network EMN02/HO95 MM Trial) phase 3 trials who achieved at least a very good partial response after intensification/consolidation were included. The median patient age was 57 years (interquartile range, 53-61 years), and all patients received lenalidomide maintenance until they developed progression. MRD was evaluated on bone marrow after intensification/consolidation, after 6 courses of maintenance, and every 6 months thereafter until clinical relapse using both ASO-RQ-PCR (sensitivity, 10-5 ) and MFC (sensitivity, from 10-4 to 10-5 ).Results: After intensification/consolidation, 33 of 72 patients (46%) achieved a molecular complete response (m-CR), and 44 of 70 (63%) achieved a flow complete response (flow-CR). Almost 27% of patients who were MRD-positive after consolidation became MRD-negative during maintenance. After a median follow-up of 38 months, PFS was prolonged in patients who achieved negative MRD status during maintenance according to results from both ASO-RQ-PCR analysis (hazard ratio, 0.29; 95% confidence interval, 0.14-0.62; P = .0013) and MFC (hazard ratio, 0.19; 95% confidence interval, 0.09-0.41; P < .001). The impact of negative MRD status on PFS was similar in all subgroups (ASCT and no-ASCT; International Staging System stages I, II, and III; high-risk and standard-risk cytogenetics), and the two techniques were highly correlated.Conclusions: MRD status is a stronger predictor of PFS than standard risk factors, and lenalidomide maintenance further increases the rate of negative MRD results. [ABSTRACT FROM AUTHOR]

Published
2019
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41. Management of adverse events induced by next-generation immunomodulatory drug and proteasome inhibitors in multiple myeloma.

Author

Salvini, Marco, Bonello, Francesca, Boccadoro, Mario, and Larocca, Alessandra

Abstract

Introduction: In the last decade the introduction of novel agents has strongly improved multiple myeloma prognosis by doubling median overall survival. Unfortunately disease relapse is very common and patients may become refractory to previous drugs. Therefore, new therapeutic strategies are urgently needed. Areas covered: We have reviewed the available data on next generation novel agents, particularly immunomodulatory drug pomalidomide and proteasome inhibitors carfilzomib and ixazomib, the latter being the first-in-class orally available. We focused on adverse events associated with such agents and described how they should be managed. The main grade ≥3 adverse events correlated with these drugs are hematologic, myelosuppression-related and reversible; non-hematologic grade ≥3 toxicities are less frequent, with an incidence of <10%. Expert commentary: These agents showed to have a good tolerability. The great majority of adverse events are easily manageable with dose-adjustment and appropriate treatment, and drug discontinuation is not frequent. Favorable safety profile and high efficacy, especially in combination, confer to these drugs a central role in development of new lines of therapy against multiple myeloma. Further investigation is certainly needed to determine the best combinations including these agents. [ABSTRACT FROM AUTHOR]

Published
2017
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43. Nuances in the Management of Older People With Multiple Myeloma.

Author

Pawlyn, Charlotte, Gay, Francesca, Larocca, Alessandra, Roy, Vivek, and Ailawadhi, Sikander

Abstract

Multiple myeloma is a disease of the elderly, with about a third of patients at diagnosis older than 75 years of age. Yet, the population of elderly patients is heterogeneous: older patients are more likely to have comorbidities and frailties complicating both their initial diagnosis and subsequent management, but these are not consistent across the group. Furthermore, patients with comorbidities and frailty are generally underrepresented in clinical trials. Despite the survival of myeloma patients increasing following the introduction of novel agents, older patients continue to have worse outcomes with increased treatment-related toxicity. Treatment tolerability is not defined by age alone, rather a combination of age, physical function, cognitive function, and comorbidities. These factors all influence patients' tolerability of treatment and therefore treatment efficacy and should also be considered when reviewing the results of clinical trials. It is the nuances of determining how these factors interact that should influence initial treatment and ongoing management decisions and these will be discussed here. [ABSTRACT FROM AUTHOR]

Published
2016
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46. MM-171: Melflufen Plus Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma (RRMM) Exposed or Refractory to Prior Alkylators: A Pooled Analysis of the O-12-M1 and HORIZON Studies.

Author

Rodríguez-Otero, Paula, Mateos, María-Victoria, Oriol, Albert, Larocca, Alessandra, Blade, Joan, Cavo, Michele, Leleu, Xavier, Nadeem, Omar, Hiemenz, John W, Hassoun, Hani, Touzeau, Cyrille, Alegre, Adrián, Paner, Agne, Maisel, Christopher, Mazumder, Amitabha, Raptis, Anastasios, Thuresson, Marcus, Harmenberg, Johan, Harlin, Olof, and Richardson, Paul G

Published
2021
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47. Continuous Therapy Versus Fixed Duration of Therapy in Patients With Newly Diagnosed Multiple Myeloma.

Author

Palumbo, Antonio, Gay, Francesca, Cavallo, Federica, Di Raimondo, Francesco, Larocca, Alessandra, Hardan, Izhar, Nagler, Arnon, Petrucci, Maria T., Hajek, Roman, Pezzatti, Sara, Delforge, Michel, Patriarca, Francesca, Donato, Francesca, Cerrato, Chiara, Nozzoli, Chiara, Zhinuan Yu, Boccadifuoco, Luana, Caravita, Tommaso, Benevolo, Giulia, and Guglielmelli, Tommasina

Published
2015
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48. Predicting poor peripheral blood stem cell collection in patients with multiple myeloma receiving pre-transplant induction therapy with novel agents and mobilized with cyclophosphamide plus granulocyte-colony stimulating factor: results from a Gruppo Italiano Malattie EMatologiche dell'Adulto Multiple Myeloma Working Party study

Author

Musto, Pellegrino, Simeon, Vittorio, Grossi, Alberto, Gay, Francesca, Bringhen, Sara, Larocca, Alessandra, Guariglia, Roberto, Pietrantuono, Giuseppe, Villani, Oreste, D'Arena, Giovanni, Cuomo, Carmela, Musto, Clelia, Morabito, Fortunato, Petrucci, Maria Teresa, Offidani, Massimo, Zamagni, Elena, Tacchetti, Paola, Conticello, Concetta, Milone, Giuseppe, and Palumbo, Antonio

Subjects
MULTIPLE myeloma treatment, CYCLOPHOSPHAMIDE, GRANULOCYTE-colony stimulating factor, STEM cell transplantation, AUTOTRANSPLANTATION, CD34 antigen, BONE marrow transplantation, BLOOD cell count
Abstract

Introduction: A still not well defined proportion of patients with multiple myeloma (MM) and eligible for autologous stem cell transplantation (AuSCT) fails to mobilize CD34+ peripheral blood stem cells (PBSC) at all or to collect an adequate number for a safe procedure or sufficient for multiple transplants. These so-called "poor-mobilizers" are difficult to be predicted, due to marked difference across previous heterogeneous studies. Methods: We aimed to develop a method based on simple clinical parameters for predicting unsuccessful (<2 × 106/kg) or sub-optimal (<5 × 106/kg) collections of CD34+ PBSC in newly diagnosed MM patients eligible for AuSCT, treated with novel agents and receiving an homogeneous mobilizing therapy with cyclophosphamide and granulocyte-colony stimulating factor (G-CSF). To this purpose, 1,348 patients enrolled in five consecutive Italian clinical trials were retrospectively analysed. Age, baseline low peripheral blood cell counts, use of lenalidomide, and haematological toxicity developed during induction were taken into account as possible factors associated with poor mobilization. Results: Overall, 280 patients (20.8%) showed either sub-optimal (167 patients, 12.4%) or unsuccessful (113 patients, 8.4%) collections. All analysed parameters negatively influenced the procedure, but only age and haematological toxicity during induction maintained their significance at multivariate analysis. Based on ordinal logistic regression model, we constructed a risk heat-map where the four parameters were pooled and weighted according to their relevance as single or combined variables. This model was predictive for different probabilities of failure, suboptimal or optimal outcomes Conclusions: We found that about one fifth of newly diagnosed MM fails to collect an adequate number of PBSC. Our model, based on a large group of patients treated frontline with novel agents and receiving the most popular mobilizing approach currently employed in Europe, is applicable in individual subjects and may contribute to the early identification of "poor mobilizer" phenotypes [ABSTRACT FROM AUTHOR]

Published
2015
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49. Bortezomib-Melphalan-Prednisone-Thalidomide Followed by Maintenance With Bortezomib-Thalidomide Compared With Bortezomib-Melphalan-Prednisone for Initial Treatment of Multiple Myeloma: Updated Follow-Up and Improved Survival.

Author

Palumbo, Antonio, Bringhen, Sara, Larocca, Alessandra, Rossi, Davide, Di Raimondo, Francesco, Magarotto, Valeria, Patriarca, Francesca, Levi, Anna, Benevolo, Giulia, Vincelli, Iolanda Donatella, Grasso, Mariella, Franceschini, Luca, Gottardi, Daniela, Zambello, Renato, Montefusco, Vittorio, Falcone, Antonietta Pia, Omedé, Paola, Marasca, Roberto, Morabito, Fortunato, and Mina, Roberto

Published
2014
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50. International Myeloma Working Group Consensus Statement for the Management, Treatment, and Supportive Care of Patients With Myeloma Not Eligible for Standard Autologous Stem-Cell Transplantation.

Author

Palumbo, Antonio, Rajkumar, S. Vincent, San Miguel, Jesus F., Larocca, Alessandra, Niesvizky, Ruben, Morgan, Gareth, Landgren, Ola, Hajek, Roman, Einsele, Hermann, Anderson, Kenneth C., Dimopoulos, Meletios A., Richardson, Paul G., Cavo, Michele, Spencer, Andrew, Stewart, A. Keith, Kazuyuki Shimizu, Lonial, Sagar, Sonneveld, Pieter, Durie, Brian G. M., and Moreau, Philippe

Published
2014
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