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4. Bortezomib-thalidomide-dexamethasone is superior to thalidomide-dexamethasone as consolidation therapy after autologous hematopoietic stem cell transplantation in patients with newly diagnosed multiple myeloma

Author

Cavo, Michele, Pantani, Lucia, Petrucci, Maria Teresa, Patriarca, Francesca, Zamagni, Elena, Donnarumma, Daniela, Crippa, Claudia, Boccadoro, Mario, Perrone, Giulia, Falcone, Antonietta, Nozzoli, Chiara, Zambello, Renato, Masini, Luciano, Furlan, Anna, Brioli, Annamaria, Derudas, Daniele, Ballanti, Stelvio, Dessanti, Maria Laura, De Stefano, Valerio, Carella, Angelo Michele, Marcatti, Magda, Nozza, Andrea, Ferrara, Felicetto, Callea, Vincenzo, Califano, Catello, Pezzi, Annalisa, Baraldi, Anna, Grasso, Mariella, Musto, Pellegrino, and Palumbo, Antonio

Published
2012
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6. Melphalan 200 mg/m2 versus melphalan 100 mg/m2 in newly diagnosed myeloma patients: a prospective, multicenter phase 3 study

Author

Palumbo, Antonio, Bringhen, Sara, Bruno, Benedetto, Falcone, Antonietta Pia, Liberati, Anna Marina, Grasso, Mariella, Ria, Roberto, Pisani, Francesco, Cangialosi, Clotilde, Caravita, Tommaso, Levi, Anna, Meloni, Giovanna, Nozza, Andrea, Pregno, Patrizia, Gabbas, Attilio, Callea, Vincenzo, Rizzo, Manuela, Annino, Luciana, De Stefano, Valerio, Musto, Pellegrino, Baldi, Ileana, Cavallo, Federica, Petrucci, Maria Teresa, Massaia, Massimo, and Boccadoro, Mario

Published
2010
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10. Bortezomib, cyclophosphamide, dexamethasone versus lenalidomide, cyclophosphamide, dexamethasone in multiple myeloma patients at first relapse

Author

Montefusco, Vittorio, primary, Corso, Alessandro, additional, Galli, Monica, additional, Ardoino, Ilaria, additional, Pezzatti, Sara, additional, Carniti, Cristina, additional, Patriarca, Francesca, additional, Gherlinzoni, Filippo, additional, Zambello, Renato, additional, Sammassimo, Simona, additional, Marcatti, Magda, additional, Nozza, Andrea, additional, Crippa, Claudia, additional, Cafro, Anna Maria, additional, Baldini, Luca, additional, and Corradini, Paolo, additional

Published
2020
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11. Predictive value of early 18F-fluorodeoxyglucose positron emission tomography (FDG-PET) during salvage chemotherapy in relapsing/refractory Hodgkin lymphoma (HL) treated with high-dose chemotherapy

Author

Castagna, Luca, Bramanti, Stefania, Balzarotti, Monica, Sarina, Barbara, Todisco, Elisabetta, Anastasia, Antonella, Magagnoli, Massimo, Mazza, Rita, Nozza, Andrea, Giordano, Laura, Rodari, Marcello, Rinifilo, Eva, Chiti, Arturo, and Santoro, Armando

Published
2009
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18. Which Is the Best Mobilizing Regimen in POEMS Syndrome? a Retrospective Italian Study of Two Haematological Centres

Author

Autore, Francesco, primary, Piccirillo, Nicola, additional, Nozza, Andrea, additional, Innocenti, Idanna, additional, Putzulu, Rossana, additional, Chiusolo, Patrizia, additional, Sora, Federica, additional, Zini, Gina, additional, Bacigalupo, Andrea, additional, Castagna, Luca, additional, Sica, Simona, additional, Bramanti, Stefania, additional, and Laurenti, Luca, additional

Published
2018
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21. Bortezomib, Cyclophosphamide, Dexamethasone Versus Lenalidomide, Cyclophosphamide, Dexamethasone in Multiple Myeloma Patients at First Relapse

Author

Montefusco, Vittorio, primary, Corso, Alessandro, additional, Galli, Monica, additional, Ardoino, Ilaria, additional, Pezzatti, Sara, additional, Carniti, Cristina, additional, Patriarca, Francesca, additional, Gherlinzoni, Filippo, additional, Zambello, Renato, additional, Sammassimo, Simona, additional, Marcatti, Magda, additional, Nozza, Andrea, additional, Crippa, Claudia, additional, Cafro, Anna Maria, additional, Baldini, Luca, additional, and Corradini, Paolo, additional

Published
2018
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22. Bortezomib/Cyclophosphamide/Dexamethasone Versus Lenalidomide/Cyclophosphamide/Dexamethasone in Multiple Myeloma Patients at First Relapse: Final Results of a Phase III Study

Author

Montefusco, Vittorio, primary, Corso, Alessandro, additional, Galli, Monica, additional, Tagliabue, Elena, additional, Pezzatti, Sara, additional, Patriarca, Francesca, additional, Gherlinzoni, Filippo, additional, Zambello, Renato, additional, Sammassimo, Simona, additional, Marcatti, Magda, additional, Nozza, Andrea, additional, Crippa, Claudia, additional, Cafro, Anna Maria, additional, Baldini, Luca, additional, and Corradini, Paolo, additional

Published
2017
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25. Bortezomib-thalidomide-dexamethasone is superior to thalidomide-dexamethasone as consolidation therapy following autologous hematopoietic stem-cell transplantation in patients with newly diagnosed multiple myeloma

Author

Cavo, Michele, Pantani, Lucia, Petrucci, Maria Teresa, Patriarca, Francesca, Zamagni, Elena, Donnarumma, Daniela, Crippa, Claudia, Boccadoro, Mario, Perrone, Giulia, Falcone, Antonietta, Nozzoli, Chiara, Zambello, Renato, Masini, Luciano, Furlan, Anna, Brioli, Annamaria, Derudas, Daniele, Ballanti, Stelvio, Dessanti, Maria Laura, De Stefano, Valerio, Carella, Angelo Michele, Marcatti, Magda, Nozza, Andrea, Ferrara, Felicetto, Callea, Vincenzo, Califano, Catello, Pezzi, Annalisa, Baraldi, Anna, Grasso, Mariella, Musto, Pellegrino, Palumbo, Antonio COLLABORATORI: Tosi, P, Motta, Mr, Rizzi, S, Fanin, R, Buttignol, S, Foà, R, Levi, A, Calabrese, E, Rambaldi, A, Galli, M, Rossi, G, Ferrari, S, Bringhen, S, Leoni, P, Offidani, M, Polloni, C, Corradini, P, Montefusco, V, Torelli, G, Narni, Franco, Fioritoni, G, Spadano, A, Cortelazzo, S, Pescosta, N, Billio, A, Lambertenghi Deliliers, G, Baldini, L, Onida, F, Annaloro, C, La Nasa, G, Ledda, A, Zaccaria, A, Cellini, C, De Fabritiis, P, Caravita, T, Siniscalchi, A, Cascavilla, N, Bosi, A, Semenzato, G, Gugliotta, L, Merli, F, Gherlinzoni, F, Angelucci, E, Martelli, M, Petti, Mc, Pisani, F, Leone, G, Rossi, E, Za, T, Fianchi, L, Catania, G, Spriano, M, Ciceri, F, Peccatori, J, Girlanda, S, Santoro, A, Castagna, L, Palmieri, S, Nobile, F, D'Arco, Am, Levis, A, Primon, V, Tamiazzo, S, Guardigni, L, Pasini, S, Gallamini, A, Pietrantuono, G, Martorelli, Mc, Fattori, P, Pasquini, E, Galieni, P, Ruggieri, M, Morandi, S, Tajana, M, Amadori, D, Ronconi, S, Cangini, D, Ceccolini, M, Gobbi, M, Ballerini, F, Pane, F, Catalano, L, Cangialosi, C, Vallisa, D, Lazzaro, A, Paladini, G, De Sabbata, G, Mozzana, R, Ciambelli, F, Pinotti, G, Rodeghiero, F, Elice, F, Cantore, N, Volpe, S, Pavone, V, Mele, A, Pogliani, E, Rossini, F, Liberati, A, Majolino, I, De Rosa, L, Amadori, S, Rizzo, M, Lauria, F, Gozzetti, A, Aglietta, M, Capaldi, A, Quarta, G, Mele, G, Storti, S, Fraticelli, V, Morabito, F, Gentile, C, Capalbo, S, Gianni, A, Magni, M, Mettivier, V, Nunziata, G, Rizzoli, V, Giuliani, N, Crugnola, M, Bernasconi, C, Fregoni, V, Visani, G, Olivieri, A, Pizzuti, M, La Verde, G, Moscetti, A, Avvisati, G, Tirindelli, M, Longinotti, M, Podda, L, Gallo, E, Pregno, P, Dammacco, F, Perosa, F, Russo, D, Roccaro, A, Bacigalupo, A, Dominietto, A, Musolino, C, Quartarone, E., Cavo M, Pantani L, Petrucci MT, Patriarca F, Zamagni E, Donnarumma D, Crippa C, Boccadoro M, Perrone G, Falcone A, Nozzoli C, Zambello R, Masini L, Furlan A, Brioli A, Derudas D, Ballanti S, Dessanti ML, De Stefano V, Carella AM, Marcatti M, Nozza A, Ferrara F, Callea V, Califano C, Pezzi A, Baraldi A, Grasso M, Musto P, Palumbo A., Cavo, Michele, Pantani, Lucia, Petrucci, Maria Teresa, Patriarca, Francesca, Zamagni, Elena, Donnarumma, Daniela, Crippa, Claudia, Boccadoro, Mario, Perrone, Giulia, Falcone, Antonietta, Nozzoli, Chiara, Zambello, Renato, Masini, Luciano, Furlan, Anna, Brioli, Annamaria, Derudas, Daniele, Ballanti, Stelvio, Dessanti, Maria Laura, De Stefano, Valerio, Carella, Angelo Michele, Marcatti, Magda, Nozza, Andrea, Ferrara, Felicetto, Callea, Vincenzo, Califano, Catello, Pezzi, Annalisa, Baraldi, Anna, Grasso, Mariella, Musto, Pellegrino, Palumbo, Antonio, Cavo, M, Pantani, L, Petrucci, M, Patriarca, F, Zamagni, E, Donnarumma, D, Crippa, C, Boccadoro, M, Perrone, G, Falcone, A, Nozzoli, C, Zambello, R, Masini, L, Furlan, A, Brioli, A, Derudas, D, Ballanti, S, Dessanti, M, De Stefano, V, Carella, A, Marcatti, M, Nozza, A, Ferrara, F, Callea, V, Califano, C, Pezzi, A, Baraldi, A, Grasso, M, Musto, P, Palumbo, A, Tosi, P, Motta, M, Rizzi, S, Fanin, R, Buttignol, S, Foà, R, Levi, A, Calabrese, E, Rambaldi, A, Galli, M, Rossi, G, Ferrari, S, Bringhen, S, Leoni, P, Offidani, M, Polloni, C, Corradini, P, Montefusco, V, Torelli, G, Narni, F, Fioritoni, G, Spadano, A, Cortelazzo, S, Pescosta, N, Billio, A, Lambertenghi Deliliers, G, Baldini, L, Onida, F, Annaloro, C, La Nasa, G, Ledda, A, Zaccaria, A, Cellini, C, De Fabritiis, P, Caravita, T, Siniscalchi, A, Cascavilla, N, Bosi, A, Semenzato, G, Gugliotta, L, Merli, F, Gherlinzoni, F, Angelucci, E, Martelli, M, Petti, M, Pisani, F, Leone, G, Rossi, E, Za, T, Fianchi, L, Catania, G, Spriano, M, Ciceri, F, Peccatori, J, Girlanda, S, Santoro, A, Castagna, L, Palmieri, S, Nobile, F, D'Arco, A, Levis, A, Primon, V, Tamiazzo, S, Guardigni, L, Pasini, S, Gallamini, A, Pietrantuono, G, Martorelli, M, Fattori, P, Pasquini, E, Galieni, P, Ruggieri, M, Morandi, S, Tajana, M, Amadori, D, Ronconi, S, Cangini, D, Ceccolini, M, Gobbi, M, Ballerini, F, Pane, F, Catalano, L, Cangialosi, C, Vallisa, D, Lazzaro, A, Paladini, G, De Sabbata, G, Mozzana, R, Ciambelli, F, Pinotti, G, Rodeghiero, F, Elice, F, Cantore, N, Volpe, S, Pavone, V, Mele, A, Pogliani, E, Rossini, F, Liberati, A, Majolino, I, De Rosa, L, Amadori, S, Rizzo, M, Lauria, F, Gozzetti, A, Aglietta, M, Capaldi, A, Quarta, G, Mele, G, Storti, S, Fraticelli, V, Morabito, F, Gentile, C, Capalbo, S, Gianni, A, Magni, M, Mettivier, V, Nunziata, G, Rizzoli, V, Giuliani, N, Crugnola, M, Bernasconi, C, Fregoni, V, Visani, G, Olivieri, A, Pizzuti, M, La Verde, G, Moscetti, A, Avvisati, G, Tirindelli, M, Longinotti, M, Podda, L, Gallo, E, Pregno, P, Dammacco, F, Perosa, F, Russo, D, Roccaro, A, Bacigalupo, A, Dominietto, A, Musolino, C, and Quartarone, E

Subjects
Male, Boronic Acid, medicine.medical_treatment, PLUS DEXAMETHASONE, Phases of clinical research, Kaplan-Meier Estimate, Hematopoietic stem cell transplantation, Biochemistry, Antineoplastic Agent, Bortezomib-thalidomide-dexamethasone, Bortezomib, Immunosuppressive Agent, Autologous stem-cell transplantation, MULTIPLE MYELOMA, Antineoplastic Combined Chemotherapy Protocols, thalidomide-dexamethasone, Multiple myeloma, RANDOMIZED PHASE-3, LENALIDOMIDE, STEM CELL TRANSPLANTATION, Hematopoietic Stem Cell Transplantation, PHASE-III TRIAL, Hematology, Middle Aged, CHEMOTHERAPY, Prognosis, Boronic Acids, Combined Modality Therapy, Thalidomide, Transplantation, Autologou, Pyrazines, HIGH-DOSE MELPHALAN, INDUCTION TREATMENT, Female, Autologous, Immunosuppressive Agents, Pyrazine, Human, medicine.drug, MAINTENANCE THERAPY, medicine.medical_specialty, DOXORUBICIN, Antineoplastic Agents, Hormonal, Prognosi, Immunology, Urology, Antineoplastic Agents, dexamethasone, Transplantation, Autologous, Disease-Free Survival, Dexamethasone, Humans, Multiple Myeloma, Cell Biology, medicine, Autologous transplantation, METAANALYSIS, Transplantation, Antineoplastic Combined Chemotherapy Protocol, Hormonal, business.industry, medicine.disease, Surgery, business, Settore MED/15 - Malattie del Sangue
Abstract

In a randomized, phase 3 study, superior complete/near-complete response (CR/nCR) rates and extended progression-free survival were demonstrated with bortezomib-thalidomide-dexamethasone (VTD) versus thalidomide-dexamethasone (TD) as induction therapy before, and consolidation after, double autologous stem cell transplantation for newly diagnosed myeloma patients (intention-to-treat analysis; VTD, n = 236; TD, n = 238). This per-protocol analysis (VTD, n = 160; TD, n = 161) specifically assessed the efficacy and safety of consolidation with VTD or TD. Before starting consolidation, CR/nCR rates were not significantly different in the VTD (63.1%) and TD arms (54.7%). After consolidation, CR (60.6% vs 46.6%) and CR/nCR (73.1% vs 60.9%) rates were significantly higher for VTD-treated versus TD-treated patients. VTD consolidation significantly increased CR and CR/nCR rates, but TD did not (McNemar test). With a median follow-up of 30.4 months from start of consolidation, 3-year progression-free survival was significantly longer for the VTD group (60% vs 48% for TD). Grade 2 or 3 peripheral neuropathy (8.1% vs 2.4%) was more frequent with VTD (grade 3, 0.6%) versus TD consolidation. The superior efficacy of VTD versus TD as induction was retained despite readministration as consolidation therapy after double autologous transplantation. VTD consolidation therapy significantly contributed to improved clinical outcomes observed for patients randomly assigned to the VTD arm of the study. The study is registered at www.clinicaltrials.gov as #NCT01134484.

Published
2012

26. Bendamustine in relapsed/refractory multiple myeloma: the “real-life” side of the moon

Author

Musto, Pellegrino, primary, Fraticelli, Vincenzo Ludovico, additional, Mansueto, Giovanna, additional, Madonna, Emanuela, additional, Nozza, Andrea, additional, Andriani, Alessandro, additional, Mussetti, Alberto, additional, Ballanti, Stelvio, additional, Bongarzoni, Velia, additional, Baraldi, Anna, additional, Patriarca, Francesca, additional, Vincelli, Donatella, additional, Falcone, Antonietta, additional, Derudas, Daniele, additional, Califano, Catello, additional, Zambello, Renato, additional, Mele, Giuseppe, additional, Fragasso, Alberto, additional, Baldini, Luca, additional, and Storti, Sergio, additional

Published
2015
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27. Superior PFS2 with VTD Vs TD for Newly Diagnosed, Transplant Eligible, Multiple Myeloma (MM) Patients: Updated Analysis of Gimema MMY-3006 Study

Author

Tacchetti, Paola, primary, Pantani, Lucia, additional, De Stefano, Valerio, additional, Zamagni, Elena, additional, Peccatori, Jacopo, additional, Pezzi, Annalisa, additional, Califano, Catello, additional, Nozza, Andrea, additional, Tosi, Patrizia, additional, Terragna, Carolina, additional, Ciambelli, Fabrizio, additional, Cangini, Delia, additional, Galieni, Piero, additional, Cangialosi, Clotilde, additional, De Sabbata, Giovanni, additional, Elice, Francesca, additional, Palumbo, Antonio, additional, and Cavo, Michele, additional

Published
2014
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28. Bendamustine As Salvage Therapy in Multiple Myeloma: A Retrospective, Multicenter Study From the Italian Compassionate Use Program in 78 Heavily Pre-Treated Patients.

Author

Musto, Pellegrino, primary, Fraticelli, Vincenzo Ludovico, additional, Mansueto, Giovanna, additional, D'Arena, Giovanni, additional, Petrilli, Maria Pia, additional, Gasbarrino, Cristiana, additional, Farina, Giuliana, additional, Guariglia, Roberto, additional, Martorelli, Maria Carmen, additional, Villani, Oreste, additional, Pietrantuono, Giuseppe, additional, Catalano, Lucio, additional, Madonna, Emanuela, additional, Nozza, Andrea, additional, Andriani, Alessandro, additional, Montefusco, Vittorio, additional, Mussetti, Alberto, additional, Lipari, Maria Grazia, additional, Ballanti, Stelvio, additional, Bongarzoni, Velia, additional, Tamiazzo, Stefania, additional, Patriarca, Francesca, additional, Vincelli, Donatella, additional, Falcone, Antonietta, additional, Derudas, Daniele, additional, Califano, Catello, additional, Zambello, Renato, additional, Mele, Giuseppe, additional, Fragasso, Alberto, additional, Baldini, Luca, additional, Palumbo, Antonio, additional, and Storti, Sergio, additional

Published
2012
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29. Response-adjusted ISS (RaISS) is a simple and reliable prognostic scoring system for predicting progression-free survival in transplanted patients with multiple myeloma

Author

Corso, Alessandro, primary, Galli, Monica, additional, Mangiacavalli, Silvia, additional, Rossini, Fausto, additional, Nozza, Andrea, additional, Pascutto, Cristiana, additional, Montefusco, Vittorio, additional, Baldini, Luca, additional, Cafro, Anna Maria, additional, Crippa, Claudia, additional, Cazzola, Mario, additional, and Corradini, Paolo, additional

Published
2011
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30. Bortezomib- and Thalidomide-Induced Peripheral Neuropathy (PN) in Multiple Myeloma (MM): Clinical and Molecular Analysis of 474 Patients Treated with Thalidomide-Dexamethasone (TD) or Bortezomib-TD (VTD)

Author

Tacchetti, Paola, primary, Terragna, Carolina, additional, Catania, Gioacchino, additional, Marcatti, Magda, additional, Nozza, Andrea, additional, Ferrara, Felicetto, additional, Nobile, Francesco, additional, Califano, Catello, additional, Baraldi, Anna, additional, Gallamini, Andrea, additional, Musto, Pellegrino, additional, Tosi, Patrizia, additional, Galieni, Piero, additional, Pezzi, Annalisa, additional, Lanza, Francesco, additional, Ceccolini, Michela, additional, Ballerini, Filippo, additional, Catalano, Lucio, additional, Cangialosi, Clotilde, additional, Lazzaro, Antonio, additional, Paladini, Giorgio, additional, Mozzana, Ruggero, additional, Zannetti, Beatrice Anna, additional, Pinotti, Graziella, additional, Elice, Francesca, additional, Baccarani, Michele, additional, Boccadoro, Mario, additional, Cavaletti, Guido, additional, and Cavo, Michele, additional

Published
2011
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31. Pilot Study with Lenalidomide in Patients with POEMS Syndrome

Author

Nozza, Andrea, primary, Terenghi, Fabrizia, additional, Mazza, Rita, additional, Orazio, Eduardo Nobile, additional, Adami, Fausto, additional, Merlini, Giampaolo, additional, Briani, Chiara, additional, Palladini, Giovanni, additional, Grasso, Mariella, additional, Gandolfi, Sara, additional, Carlo-Stella, Carmelo, additional, and Santoro, Armando, additional

Published
2011
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32. Role of Reduced-Intensity Conditioning Followed by Allogeneic Stem Cell Transplantation In Patients with Multiple Myeloma Relapsing After Autograft: a Donor Versus No Donor Analysis

Author

Patriarca, Francesca, primary, Einsele, Hermann, additional, Spina, Francesco, additional, Bruno, Benedetto, additional, Nozzoli, Chiara, additional, Isola, Miriam, additional, Sperotto, Alessandra, additional, Nozza, Andrea, additional, Morabito, Fortunato, additional, Stuhler, Gernot, additional, Festuccia, Moreno, additional, Bosi, Alberto, additional, Fanin, Renato, additional, and Corradini, Paolo, additional

Published
2010
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33. The Association of a Salvage Treatment Containing Novel Agents Followed by Allogeneic Stem Cell Transplantation with Reduced-Intensity Conditioning Regimen Improves Overall Survival and Time-to-Progression in Multiple Myeloma Patiens Relapsing After Autologous Stem Cell Transplantation: A Multicentric Retrospective Study Based On Donor Availability.

Author

Patriarca, Francesca, primary, Einsele, Hermann, additional, Spina, Francesco, additional, Nozzoli, Chiara, additional, Nozza, Andrea, additional, Sperotto, Alessandra, additional, Morabito, Fortunato, additional, Stuhler, Gernot, additional, Knop, Stefan, additional, Cerno, Michela, additional, Bosi, Alberto, additional, Fanin, Renato, additional, and Corradini, Paolo, additional

Published
2009
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34. Better Outcome with Tandem High DOSE CHEMOTHERAPY and AUTOLOGOUS STEM CELLS TRANSPLANT IN Relapsed/Refractory HODGKIN LYMPHOMA PATIENTS Which Reached COMPLETE REMISSION AFTER Ifosfamide- Gemcitabine-Vinorelbine Scheme (IGEV).

Author

Anastasia, Antonella, primary, Balzarotti, Monica, additional, Magagnoli, Massimo, additional, Spina, Michele, additional, Mazza, Rita, additional, Castagna, L., additional, Nozza, Andrea, additional, Bramanti, Stefania, additional, Giordano, Laura, additional, Tirelli, Umberto, additional, and Santoro, Armando, additional

Published
2009
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35. A Phase III Study of Enoxaparin vs Aspirin vs Low-Dose Warfarin as Thromboprophylaxis for Newly Diagnosed Myeloma Patients Treated with Thalidomide Based-Regimens.

Author

Palumbo, Antonio, primary, Cavo, Michele, additional, Bringhen, Sara, additional, Cavalli, Maide, additional, Patriarca, Francesca, additional, Rossi, Davide, additional, Tacchetti, Paola, additional, Pescosta, Norbert, additional, Crippa, Claudia, additional, Galli, Monica, additional, Spadano, Tonino, additional, Carella, Angelo Michele, additional, Caravita, Tommaso, additional, Cellini, Claudia, additional, Ledda, Antonio, additional, Pisani, Francesco, additional, Peccatori, Jacopo, additional, Elice, Francesca, additional, Nozza, Andrea, additional, Stefano, Valerio De, additional, Rosa, Luca De, additional, Liberati, Anna Marina, additional, Ciambelli, Fabrizio, additional, Sabbata, Giovanni De, additional, Catalano, Lucio, additional, Larocca, Alessandra, additional, Morabito, Fortunato, additional, Zamagni, Elena, additional, Offidani, Massimo, additional, Tosi, Patrizia, additional, and Boccadoro, Mario, additional

Published
2009
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36. Melphalan 200 Mg/m2 (Mel200) Versus Melphalan 100 Mg/m2 (Mel100) in Newly Diagnosed Myeloma Patients: A Prospective, Randomized Phase III Study

Author

Boccadoro, Mario, primary, Bringhen, Sara, additional, Petrucci, Maria Teresa, additional, Falcone, Antonietta, additional, Liberati, Anna Marina, additional, Ria, Roberto, additional, Grasso, Mariella, additional, Montanaro, Marco, additional, Pregno, Patrizia, additional, Nozza, Andrea, additional, Pisani, Francesco, additional, Caravita, Tommaso, additional, Cangialosi, Clotilde, additional, Calabrese, Elisabetta, additional, Larocca, Alessandra, additional, Cavallo, Federica, additional, Ruggeri, Marina, additional, Musto, Pellegrino, additional, Foà, Robert, additional, and Palumbo, Antonio, additional

Published
2008
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37. Superior Rate of Complete Response with up-Front Velcade-Thalidomide-Dexamethasone Versus Thalidomide-Dexamethasone in Newly Diagnosed Multiple Myeloma Is Not Affected by Adverse Prognostic Factors, Including High-Risk Cytogenetic Abnormalities.

Author

Cavo, Michele, primary, Testoni, Nicoletta, primary, Terragna, Carolina, primary, Marzocchi, Giulia, primary, Durante, Sandra, primary, Zambello, Renato, primary, Nozzoli, Chiara, primary, Pantani, Lucia, primary, Tacchetti, Paola, primary, Masini, Luciano, primary, Ceccolini, Michela, primary, Agostini, Paola, primary, Zamagni, Elena, primary, De Stefano, Valerio, primary, Tosi, Patrizia, primary, Derudas, Daniele, primary, Dessanti, Laura, primary, Ballanti, Stelvio, primary, Palmieri, Salvatore, primary, Nozza, Andrea, primary, Catania, Gioacchino, primary, Peccatori, Jacopo, primary, D’Arco, Alfonso, primary, Musto, Pellegrino, primary, Grasso, Mariella, primary, Pallotti, Maria Caterina, primary, Pasini, Silvana, primary, Fattori, Pier Paolo, primary, Baraldi, Anna, primary, Cangini, Delia, primary, Ballerini, Filippo, primary, Petrucci, Alessandro, primary, and Baccarani, Michele, primary

Published
2008
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38. A Prospective, Randomized, Phase III Study of Melphalan 200 mg/m2 (Mel200) Versus Melphalan 100 mg/m2 (Mel100) in Newly Diagnosed Myeloma Patients.

Author

Palumbo, Antonio, primary, Bringhen, Sara, additional, Petrucci, Maria Teresa, additional, Falcone, Antonietta, additional, Liberati, Anna Marina, additional, Lauta, Vito Michele, additional, Grasso, Mariella, additional, Montanaro, Marco, additional, Pisani, Francesco, additional, Caravita, Tommaso, additional, Cangialosi, Clotilde, additional, Pregno, Patrizia, additional, Nozza, Andrea, additional, Calabrese, Elisabetta, additional, Gay, Francesca, additional, Cavallo, Federica, additional, Omedè, Paola, additional, Musto, Pellegrino, additional, Foà, Robin, additional, and Boccadoro, Mario, additional

Published
2007
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39. A Prospective, Randomized, Phase III Study of Melphalan 200 mg/m2 (MEL200) Versus Melphalan 100 mg/m2 (MEL100) in Newly Diagnosed Myeloma Patients.

Author

Palumbo, Antonio, primary, Bringhen, Sara, additional, Petrucci, Maria Teresa, additional, Falcone, Antonietta, additional, Liberati, Anna Marina, additional, Grasso, Mariella, additional, Pisani, Francesco, additional, Caravita, Tommaso, additional, Pregno, Patrizia, additional, Nozza, Andrea, additional, Omedè, Paola, additional, Falco, Patrizia, additional, Musto, Pellegrino, additional, Foà, Robin, additional, and Boccadoro, Mario, additional

Published
2006
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40. Tandem high‐dose chemotherapy and autologous stem cell transplantation in refractory/relapsed Hodgkin's lymphoma: A monocenter prospective study

Author

Castagna, Luca, primary, Magagnoli, Massimo, additional, Balzarotti, Monica, additional, Sarina, Barbara, additional, Siracusano, Licia, additional, Nozza, Andrea, additional, Todisco, Elisabetta, additional, Bramanti, Stefania, additional, Mazza, Rita, additional, Russo, Filippo, additional, Timofeeva, Inna, additional, and Santoro, Armando, additional

Published
2006
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42. Factors Affecting Outcome of Patients with Refractory/Relapsed Hodgkin’s Disease (HD) Treated with IGEV Chemotherapy (CT) and High Dose Consolidation Therapy (HDT) with Stem Cell Rescue.

Author

Balzarotti, Monica, primary, Spina, Michele, additional, Magagnoli, Massimo, additional, Chisesi, Teodoro, additional, Pinto, Antonello, additional, Castagna, Luca, additional, Demarco, Monica, additional, Michieli, Mariagrazia, additional, Nozza, Andrea, additional, Tirelli, Umberto, additional, and Santoro, Armando, additional

Published
2005
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43. Feasibility and toxicity of high-dose therapy (HDT) supported by peripheral blood stem cells in elderly patients with multiple myeloma and non-Hodgkin's lymphoma: Survey from a single institution

Author

Magagnoli, Massimo, primary, Castagna, Luca, additional, Balzarotti, Monica, additional, Sarina, Barbara, additional, Timofeeva, Inna, additional, Bertuzzi, Alexia, additional, Compasso, Silvana, additional, Nozza, Andrea, additional, Siracusano, Licia, additional, and Santoro, Armando, additional

Published
2003
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45. Letter to the Editor

Author

Magagnoli, Massimo, primary, Balzarotti, Monica, additional, Castagna, Luca, additional, Rahal, Daoud, additional, Siracusano, Licia, additional, Nozza, Andrea, additional, and Santoro, Armando, additional

Published
2003
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46. CD34+ dose-driven administration of granulocyte colony-stimulating factor after high-dose chemotherapy in lymphoma patients.

Author

Todisco, Elisabetta, Castagna, Luca, Sarina, Barbara, Mazza, Rita, Magagnoli, Massimo, Balzarotti, Monica, Nozza, Andrea, Siracusano, Licia, Timofeeva, Inna, Anastasia, Antonella, Demarco, Monica, and Santoro, Armando

Subjects
GRANULOCYTE-colony stimulating factor, DRUG therapy, THERAPEUTICS, STEM cell transplantation, LYMPHOMA treatment, PATIENTS
Abstract

Our goal was to optimize use of granulocyte colony-stimulating factor (G-CSF) after high-dose chemotherapy and autologous peripheral blood stem-cell transplantation in lymphoma patients, limiting G-CSF administration to patients infusing a suboptimal CD34+ cell number. Of 124 consecutive patients with histologically proven Hodgkin's and non-Hodgkin's lymphoma from January 2001 to June 2004, 60 patients (group 1) given ≥5 × 106/kg CD34+ cells received no G-CSF; 64 patients (group 2) given ≤5 × 106/kg CD34+ cells received G-CSF from day +5 after stem-cell reinfusion. The median times to reach 0.5 × 109/L and 1.0 × 109/L neutrophils were, respectively, 3 and 4 d shorter in G-CSF group and this difference was statistically significant ( P = 0.0014; P = 0.0001). In terms of antibiotic and antimycotic requirements, gastrointestinal toxicity, days of hospitalization, and transfusion requirements, no differences were demonstrated between the two groups. No statistically significant difference was demonstrated for the total number of febrile episodes (52 for group 1; 53 for group 2; P = 0.623) and the median number of febrile days (2 d for both groups). Myeloid reconstitution values for both groups agree with published results for autotransplanted patients treated with G-CSF from 7 to 14 d. Also, major clinical events, antibiotic, antimycotic, and transfusion requirements, and hospital stay were similar to published findings. Our data suggest that G-CSF administration can be safely optimized, used only for patients infused with a suboptimal CD34+ cell dose. [ABSTRACT FROM AUTHOR]

Published
2007
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47. Melphalan 200 mg/m2versus melphalan 100 mg/m2in newly diagnosed myeloma patients: a prospective, multicenter phase 3 study

Author

Palumbo, Antonio, Bringhen, Sara, Bruno, Benedetto, Falcone, Antonietta Pia, Liberati, Anna Marina, Grasso, Mariella, Ria, Roberto, Pisani, Francesco, Cangialosi, Clotilde, Caravita, Tommaso, Levi, Anna, Meloni, Giovanna, Nozza, Andrea, Pregno, Patrizia, Gabbas, Attilio, Callea, Vincenzo, Rizzo, Manuela, Annino, Luciana, De Stefano, Valerio, Musto, Pellegrino, Baldi, Ileana, Cavallo, Federica, Petrucci, Maria Teresa, Massaia, Massimo, and Boccadoro, Mario

Abstract

High-dose (200 mg/m2, MEL200) and intermediate-dose melphalan (100 mg/m2, MEL100) showed significant activity in myeloma. In a phase 3 study, 298 patients were randomly assigned to receive 2 autologous transplantations after conditioning with MEL200 or MEL100. Ninety-six of 149 (64%) completed MEL200 and 103 of 149 (69%) MEL100. Best response to MEL200 was: complete remission 22 of 149 (15%); partial remission 95 of 149 (64%), for an overall response rate of 79%. Best response to MEL100 was: complete remission 12 of 149 (8%); partial remission 95 of 149 (64%), for an overall response rate of 72%. Overall survival did not differ (P= .13); median progression-free survival (31.4 vs 26.2 months, P= .01), median time to progression (34.4 vs 27.0 months, P= .014) were longer in the MEL200. Treatment-related mortality was 3.1% in the MEL200 and 2.9% in the MEL100 group. Severe neutropenia and infections were marginally superior, whereas severe thrombocytopenia, mucositis, gastrointestinal adverse events, and the overall occurrence of at least 1 nonhematologic grade 3 or 4 adverse event were significantly higher in the MEL200 cohort. We conclude that MEL200 leads to longer remission duration and should be considered the standard conditioning regimen for autologous transplantation. This study was registered at www.clinicaltrials.govas #NCT00950768.

Published
2010
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49. Melphalan 200 Mg/m2(Mel200) VersusMelphalan 100 Mg/m2(Mel100) in Newly Diagnosed Myeloma Patients: A Prospective, Randomized Phase III Study

Author

Boccadoro, Mario, Bringhen, Sara, Petrucci, Maria Teresa, Falcone, Antonietta, Liberati, Anna Marina, Ria, Roberto, Grasso, Mariella, Montanaro, Marco, Pregno, Patrizia, Nozza, Andrea, Pisani, Francesco, Caravita, Tommaso, Cangialosi, Clotilde, Calabrese, Elisabetta, Larocca, Alessandra, Cavallo, Federica, Ruggeri, Marina, Musto, Pellegrino, Foà, Robert, and Palumbo, Antonio

Abstract

Background.Several trials have shown the superiority of high-dose melphalan (usually 200 mg/m2, MEL200) versus standard therapy in myeloma patients. Intermediate-dose melphalan (100 mg/m2, MEL100) was also superior to the standard dose, but MEL100 has not been clinically compared with MEL200 in a randomized study. In this prospective, randomized, phase III trial, we compared the efficacy and toxicity of MEL200 and MEL100.

Published
2008
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50. A Prospective, Randomized, Phase III Study of Melphalan 200 mg/m2(Mel200) Versus Melphalan 100 mg/m2(Mel100) in Newly Diagnosed Myeloma Patients.

Author

Palumbo, Antonio, Bringhen, Sara, Petrucci, Maria Teresa, Falcone, Antonietta, Liberati, Anna Marina, Lauta, Vito Michele, Grasso, Mariella, Montanaro, Marco, Pisani, Francesco, Caravita, Tommaso, Cangialosi, Clotilde, Pregno, Patrizia, Nozza, Andrea, Calabrese, Elisabetta, Gay, Francesca, Cavallo, Federica, Omedè, Paola, Musto, Pellegrino, Foà, Robin, and Boccadoro, Mario

Abstract

Several trials have shown the superior impact of high-dose melphalan (usually 200 mg/m2, MEL200) versus standard therapy in myeloma patients. Intermediate-dose melphalan (100 mg/m2, MEL100) was also superior to the standard dose, but MEL100 has not been clinically compared with MEL200 in a randomized study. In this prospective, randomized, phase III trial, we compared the efficacy and toxicity of MEL200 and MEL100. The primary end points were complete remission (CR) rate, event-free survival (EFS) and incidence of gastrointestinal toxicity, infections and treatment-related mortality (TRM). Inclusion criteria were previously untreated myeloma, aged ≤ 65 and Durie and Salmon stage II or III. Exclusion criteria were abnormal pulmonar, cardiac, liver and renal function, HBV, HCV, or HIV positivity, concomitant cancer or psychiatric disease. The institutional review board approved the protocol and written informed consent was obtained from all patients. All patients received 2 cycles of 28-day-dexamethasone-doxorubicin-vincristine (doxorubicin 50 mg/m2day 1, vincristine 1 mg day 1, dexamethasone 40 mg days 1–4) and 2 cycles of cyclophosphamide (4 g/m2, day 1) followed by stem cell harvest. MEL200 patients was conditioned with 2 cycles of melphalan 200 mg/m2and MEL100 patients with 2 courses of melphalan 100 mg/m2, both followed by stem cell reinfusion. Two-hundred and ninety-eight patients (median age 57) were randomized, 149 to MEL200 and 149 to MEL100. All patients were evaluated for response, EFS and OS. Patient characteristics were similar in both groups. Chromosomal 13 was deleted in 69% of MEL200 and 45% of MEL100 patients (p=0.015). Ninety-six patients completed tandem MEL200; 103 tandem MEL100. In intention-to-treat analysis, the very good partial response rate was higher in MEL200 group (37% versus 21%, p=0.003), but CR was 15% in the MEL200 group and 8% in the MEL100 group (p=0.07). After a median follow-up of 30.5 months, the 3-years EFS was 46% in the MEL200 and 26% in the MEL100 group (HR=0.7, 95% CI 0.51–0.97, p=0.03). The 3-years overall survival (OS) was 81% in the MEL200 and 73% in the MEL100 group (HR=0.69, 95% CI 0.42–1.13, p=0.14). Duration of grade 4 neutropenia and thrombocytopenia was comparable, but a higher proportion of MEL200 patients required platelet transfusions (p=0.002). Grade 3–4 non-hematologic adverse events were more frequent in the MEL200 patients (38% versus 19%, p<0.0001). The incidence of grade 3–4 mucositis was 16% after MEL200 and 3% after MEL100 (p<0.0001). The incidence of severe gastrointestinal toxicity was 19% after MEL200 and 2% after MEL100 (p<0.0001). The incidence of grade 3–4 infections and of TRM was similar in both groups. In conclusion, MEL200 resulted in a significantly higher very good partial response rate. This translated in a superior EFS, but not OS.

Published
2007
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