Search

Your search keyword '"VINCELLI, IOLANDA DONATELLA"' showing total 48 results
Start Over Author "VINCELLI, IOLANDA DONATELLA"
48 results on '"VINCELLI, IOLANDA DONATELLA"'

1. Prednisone vs high-dose dexamethasone in newly diagnosed adult primary immune thrombocytopenia: a randomized trial

Author

Mazzucconi, Maria Gabriella, Rodeghiero, Francesco, Avvisati, Giuseppe, De Stefano, Valerio, Gugliotta, Luigi, Ruggeri, Marco, Vianelli, Nicola, Fazi, Paola, Paoloni, Francesca, Sargentini, Valeria, Baldacci, Erminia, Ferretti, Antonietta, Martino, Bruno, Vincelli, Iolanda Donatella, Carli, Giuseppe, Fortuna, Stefania, Di Ianni, Mauro, Ranalli, Paola, Palandri, Francesca, Polverelli, Nicola, Lugli, Elisabetta, Rivolti, Elena, Patriarca, Andrea, Rago, Angela, D’Adda, Mariella, Gentile, Massimo, Siragusa, Sergio, Sibilla, Silvia, Carella, Angelo Michele, Rossi, Elena, Battistini, Roberta, Zaja, Francesco, Bocchia, Monica, Di Renzo, Nicola, Musto, Pellegrino, Crugnola, Monica, Giuffrida, Anna Chiara, Krampera, Mauro, Tafuri, Agostino, and Santoro, Cristina

Published
2024
Full Text
View/download PDF

2. Carfilzomib induction, consolidation, and maintenance with or without autologous stem-cell transplantation in patients with newly diagnosed multiple myeloma: pre-planned cytogenetic subgroup analysis of the randomised, phase 2 FORTE trial

Author

Mina, Roberto, Musto, Pellegrino, Rota-Scalabrini, Delia, Paris, Laura, Gamberi, Barbara, Palmas, Angelo, Aquino, Sara, de Fabritiis, Paolo, Giuliani, Nicola, De Rosa, Luca, Gozzetti, Alessandro, Cellini, Claudia, Bertamini, Luca, Capra, Andrea, Oddolo, Daniela, Vincelli, Iolanda Donatella, Ronconi, Sonia, Pavone, Vincenzo, Pescosta, Norbert, Cea, Michele, Fioritoni, Francesca, Ballanti, Stelvio, Grasso, Mariella, Zamagni, Elena, Belotti, Angelo, Boccadoro, Mario, and Gay, Francesca

Published
2023
Full Text
View/download PDF

3. Predictors of unsustained measurable residual disease negativity in patients with multiple myeloma

Author

D’Agostino, Mattia, primary, Bertuglia, Giuseppe, additional, Rota-Scalabrini, Delia, additional, Belotti, Angelo, additional, Morè, Sonia, additional, Corradini, Paolo, additional, Oliva, Stefania, additional, Ledda, Antonio, additional, Grasso, Mariella, additional, Pavone, Vincenzo, additional, Ronconi, Sonia, additional, Vincelli, Iolanda Donatella, additional, Ballanti, Stelvio, additional, Velluti, Cristina, additional, Cellini, Claudia, additional, Gozzetti, Alessandro, additional, Palmas, Angelo D., additional, Gamberi, Barbara, additional, Mancuso, Katia, additional, Paris, Laura, additional, Zambello, Renato, additional, Petrucci, Maria Teresa, additional, Bruno, Benedetto, additional, Musto, Pellegrino, additional, and Gay, Francesca, additional

Published
2024
Full Text
View/download PDF

4. Multiple Myeloma in 2023 Ways: From Trials to Real Life

Author

Fazio, Manlio, primary, Del Fabro, Vittorio, additional, Parrinello, Nunziatina Laura, additional, Allegra, Alessandro, additional, Markovic, Uroš, additional, Botta, Cirino, additional, Accardi, Fabrizio, additional, Vincelli, Iolanda Donatella, additional, Leotta, Salvatore, additional, Elia, Federica, additional, Esposito, Benedetta, additional, Garibaldi, Bruno, additional, Sapuppo, Gabriele, additional, Orofino, Alessandra, additional, Romano, Alessandra, additional, Palumbo, Giuseppe A., additional, Di Raimondo, Francesco, additional, and Conticello, Concetta, additional

Published
2023
Full Text
View/download PDF

5. A comparative effectiveness study of lipegfilgrastim in multiple myeloma patients after high dose melphalan and autologous stem cell transplant

Author

Martino, Massimo, Gori, Mercedes, Tripepi, Giovanni, Recchia, Anna Grazia, Cimminiello, Michele, Provenzano, Pasquale Fabio, Naso, Virginia, Ferreri, Anna, Moscato, Tiziana, Console, Giuseppe, Loteta, Barbara, Gallo, Giuseppe Alberto, Gentile, Massimo, Innao, Vanessa, Rossi, Marco, Morabito, Antonella, Vincelli, Iolanda Donatella, Mannina, Donato, and Pitino, Annalisa

Published
2020
Full Text
View/download PDF

6. Efficacy of biosimilar granulocyte colony-stimulating factor versus originator granulocyte colony-stimulating factor in peripheral blood stem cell mobilization in de novo multiple myeloma patients

Author

Martino, Massimo, Recchia, Anna Grazia, Moscato, Tiziana, Fedele, Roberta, Neri, Santo, Gentile, Massimo, Alati, Caterina, Vincelli, Iolanda Donatella, Piro, Eugenio, Penna, Giuseppa, Musolino, Caterina, Ronco, Francesca, Molica, Stefano, and Morabito, Fortunato

Published
2015
Full Text
View/download PDF

7. Choice of Tyrosine Kinase Inhibitor and Early Events during the First Year of Therapy in Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia (CML) Patients with Concomitant Diabetes: A "Campus CML" Study

Author

Capodanno, Isabella, primary, Tiribelli, Mario, additional, Miggiano, Maria Cristina, additional, Bucelli, Cristina, additional, Cavazzini, Francesco, additional, Leonetti Crescenzi, Sabrina, additional, Russo, Sabina, additional, Scalzulli, Emilia, additional, Bernardelli, Andrea, additional, Luciano, Luigiana, additional, Mulas, Olga, additional, Loglisci, Giuseppina, additional, Elena, Chiara, additional, Pizzano, Umberto, additional, Attolico, Immacolata, additional, Binotto, Gianni, additional, Crisà, Elena, additional, Sportoletti, Paolo, additional, Di Veroli, Ambra, additional, Scortechini, Anna Rita, additional, Leporace, Annapaola, additional, Basile, Maria, additional, Crugnola, Monica, additional, Stagno, Fabio, additional, Murgano, Pamela, additional, Rapezzi, Davide, additional, Luzi, Debora, additional, Iurlo, Alessandra, additional, Bocchia, Monica, additional, Fava, Carmen, additional, Malato, Alessandra, additional, Galimberti, Sara, additional, Vincelli, Iolanda Donatella, additional, Trawinska, Malgorzata Monika, additional, Pizzuti, Michele, additional, Caocci, Giovanni, additional, Bonifacio, Massimiliano, additional, Saglio, Giuseppe, additional, Specchia, Giorgina, additional, Breccia, Massimo, additional, and Latagliata, Roberto, additional

Published
2022
Full Text
View/download PDF

8. Bortezomib-Melphalan-Prednisone (VMP) Vs. Lenalidomide-Dexamethasone (Rd) in Transplant-Ineligible Real-Life Multiple Myeloma Patients: Updated Results of the Randomized Phase IV Real MM Trial

Author

Bringhen, Sara, primary, D'Agostino, Mattia, additional, Giuliani, Nicola, additional, Attucci, Irene, additional, Zambello, Renato, additional, Ronconi, Sonia, additional, Vincelli, Iolanda Donatella, additional, Allegra, Alessandro, additional, Leonardi, Giovanna, additional, Rossi, Giuseppe, additional, Cattel, Francesco, additional, Capra, Andrea, additional, Galieni, Piero, additional, Lombardo, Alessandra, additional, Bonello, Francesca, additional, Tosi, Patrizia, additional, Cavalli, Maide Maria, additional, Sciorsi, Elisa, additional, Mannina, Donato, additional, Ria, Roberto, additional, Patriarca, Francesca, additional, Cavo, Michele, additional, Mangiacavalli, Silvia, additional, Benevolo, Giulia, additional, Evangelista, Andrea, additional, Boccadoro, Mario, additional, Bruno, Benedetto, additional, and Larocca, Alessandra, additional

Published
2022
Full Text
View/download PDF

9. Long-Term Results in Multiple Myeloma After High-Dose Melphalan and Autologous Transplantation According to Response Categories in the Era of Old Drugs

Author

Martino, Massimo, Postorino, Maurizio, Gallo, Giuseppe Alberto, Messina, Giuseppe, Neri, Santo, Piro, Eugenio, Gentile, Massimo, Moscato, Tiziana, Monteleone, Renza, Fedele, Roberta, Mazzone, Carla, Console, Giuseppe, Penna, Giuseppa, Alati, Caterina, Vincelli, Iolanda Donatella, Irrera, Giuseppe, Musolino, Caterina, Ronco, Francesca, Molica, Stefano, and Morabito, Fortunato

Published
2014
Full Text
View/download PDF

10. Survival Risk Scores for Real-Life Relapsed/Refractory Multiple Myeloma Patients Receiving Elotuzumab or Carfilzomib In Combination With Lenalidomide and Dexamethasone as Salvage Therapy: Analysis of 919 Cases Outside Clinical Trials

Author

Morabito, Fortunato, primary, Zamagni, Elena, additional, Conticello, Concetta, additional, Pavone, Vincenzo, additional, Palmieri, Salvatore, additional, Bringhen, Sara, additional, Galli, Monica, additional, Mangiacavalli, Silvia, additional, Derudas, Daniele, additional, Rossi, Elena, additional, Ria, Roberto, additional, Catalano, Lucio, additional, Tacchetti, Paola, additional, Mele, Giuseppe, additional, Vincelli, Iolanda Donatella, additional, Martino, Enrica Antonia, additional, Vigna, Ernesto, additional, Bruzzese, Antonella, additional, Mendicino, Francesco, additional, Botta, Cirino, additional, Mele, Anna, additional, Pantani, Lucia, additional, Rocchi, Serena, additional, Garibaldi, Bruno, additional, Cascavilla, Nicola, additional, Ballanti, Stelvio, additional, Tripepi, Giovanni, additional, Frigeri, Ferdinando, additional, Falcone, Antonetta Pia, additional, Cangialosi, Clotilde, additional, Reddiconto, Giovanni, additional, Farina, Giuliana, additional, Barone, Marialucia, additional, Rizzello, Ilaria, additional, Iaccino, Enrico, additional, Mimmi, Selena, additional, Curci, Paola, additional, Gamberi, Barbara, additional, Musto, Pellegrino, additional, De Stefano, Valerio, additional, Musso, Maurizio, additional, Petrucci, Maria Teresa, additional, Offidani, Massimo, additional, Di Raimondo, Francesco, additional, Boccadoro, Mario, additional, Cavo, Michele, additional, Neri, Antonino, additional, and Gentile, Massimo, additional

Published
2022
Full Text
View/download PDF

11. Carfilzomib combined with lenalidomide and dexamethasone (KRd) as salvage therapy for multiple myeloma patients: italian, multicenter, retrospective clinical experience with 600 cases outside of controlled clinical trials.

Author

Martino, Enrica Antonia, Conticello, Concetta, Zamagni, Elena, Pavone, Vincenzo, Palmieri, Salvatore, Musso, Maurizio, Tacchetti, Paola, Mele, Anna, Catalano, Lucio, Vigna, Ernesto, Bruzzese, Antonella, Mendicino, Francesco, Botta, Cirino, Vincelli, Iolanda Donatella, Farina, Giuliana, Barone, Marialucia, Cangialosi, Clotilde, Mancuso, Katia, Rizziello, Ilaria, and Rocchi, Serena

Subjects
MULTIPLE myeloma, CLINICAL trials, SALVAGE therapy, LENALIDOMIDE, PROGRESSION-free survival, ARRHYTHMIA, HEART failure
Abstract

In combination with lenalidomide and dexamethasone (KRd), Carfilzomib has been approved for the treatment of relapsed and refractory multiple myeloma (RRMM) on ASPIRE trial. Efficacy and safety of the triplet are still the object of investigation by many groups to confirm ASPIRE results in the setting of RRMM treated in real‐life who don't meet trial restrictive inclusion criteria. Therefore, we report a retrospective multicenter analysis of 600 RRMM patients treated with KRd between December 2015 and December 2018. The median age was 64 years (range 33–85), and the median number of previous therapies was two (range 1–11). After a median of 11 KRd cycles, the overall response rate was 79.9%. The median progression‐free survival (PFS) was 22 months, and the 2‐year probability of PFS was 47.6%. Creatinine clearance<30 ml/min, >1 line of previous therapy, and high‐risk FISH were all associated with a poor prognosis in multivariate analysis. The median overall survival (OS) was 34.8 months; the 2‐year probability of OS was 63.5%. At multivariate analysis, creatinine clearance<30 ml/min, >1 line of previous therapy, and high‐risk FISH were significantly associated with poor prognosis. After a median follow‐up of 16 months (range 1–50), 259 withdrew from therapy. The main discontinuation reason was progressive disease (81.8%). Seventy‐four patients (12.3%) discontinued therapy for toxicity. The most frequent side effects were hematological (anemia 49.3%, neutropenia 42.7%, thrombocytopenia 42.5%) and cardiovascular (hypertension 14.5%, heart failure 2.5%, arrhythmias 3.6%). Our study confirms the safety and efficacy of KRd in the real‐life setting of RRMM patients and encourages its use in clinical practice. [ABSTRACT FROM AUTHOR]

Published
2022
Full Text
View/download PDF

12. OAB-004: Carfilzomib-based induction/consolidation with or without autologous transplant and Lenalidomide (R) or Carfilzomib-Lenalidomide (KR) maintenance: efficacy in high-risk patients of the FORTE study

Author

Mina, Roberto, primary, Zamagni, Elena, additional, Rota-Scalabrini, Delia, additional, Corradini, Paolo, additional, Grasso, Mariella, additional, Ballanti, Stelvio, additional, Giuliani, Nicola, additional, Rosa, Luca De, additional, Cellini, Claudia, additional, Vincelli, Iolanda Donatella, additional, Velluti, Cristina, additional, Capra, Andrea, additional, Cafro, Anna Maria, additional, Gozzetti, Alessandro, additional, Gentile, Massimo, additional, Aquino, Sara, additional, Palmas, Angelo, additional, Ledda, Antonio, additional, Petrucci, Maria Teresa, additional, Musto, Pellegrino, additional, Boccadoro, Mario, additional, and Gay, Francesca, additional

Published
2021
Full Text
View/download PDF

13. CART-Cell Therapy: Recent Advances and New Evidence in Multiple Myeloma

Author

Martino, Massimo, primary, Canale, Filippo Antonio, additional, Alati, Caterina, additional, Vincelli, Iolanda Donatella, additional, Moscato, Tiziana, additional, Porto, Gaetana, additional, Loteta, Barbara, additional, Naso, Virginia, additional, Mazza, Massimiliano, additional, Nicolini, Fabio, additional, Ghelli Luserna di Rorà, Andrea, additional, Simonetti, Giorgia, additional, Ronconi, Sonia, additional, Ceccolini, Michela, additional, Musuraca, Gerardo, additional, Martinelli, Giovanni, additional, and Cerchione, Claudio, additional

Published
2021
Full Text
View/download PDF

14. Impact of Gain and Amplification of 1q in Newly Diagnosed Multiple Myeloma Patients Receiving Carfilzomib-Based Treatment in the Forte Trial

Author

D'Agostino, Mattia, Ruggeri, Marina, Aquino, Sara, Giuliani, Nicola, Arigoni, Maddalena, Gentile, Massimo, Olivero, Martina, Vincelli, Iolanda Donatella, Capra, Andrea, Mussatto, Chiara, Ledda, Antonio, Tacchetti, Paola, Musolino, Caterina, Cellini, Claudia, Patriarca, Francesca, Ballanti, Stelvio, Calogero, Raffaele, Musto, Pellegrino, Boccadoro, Mario, and Gay, Francesca

Published
2020
Full Text
View/download PDF

15. Sequential Treatments in Chronic Phase Chronic Myeloid Leukemia (CML) Patients without Optimal Response after Frontline Nilotinib or Dasatinib: An Italian CML Campus Study

Author

Gugliotta, Gabriele, primary, Annunziata, Mario, additional, Capodanno, Isabella, additional, Rapezzi, Davide, additional, Attolico, Immacolata, additional, Vincelli, Iolanda Donatella, additional, Tiribelli, Mario, additional, Malato, Alessandra, additional, Pizzuti, Michele, additional, Accurso, Vincenzo, additional, Bonifacio, Massimiliano, additional, Galimberti, Sara, additional, Loglisci, Giuseppina, additional, Abruzzese, Elisabetta, additional, Bocchia, Monica, additional, Gozzini, Antonella, additional, Bergamaschi, Micaela, additional, Miggiano, Maria Cristina, additional, Tafuri, Agostino, additional, Sanpaolo, Grazia, additional, Binotto, Gianni, additional, Castagnetti, Fausto, additional, Specchia, Giorgina, additional, Di Raimondo, Francesco, additional, Cavo, Michele, additional, Rosti, Gianantonio, additional, Foà, Robin, additional, Saglio, Giuseppe, additional, Breccia, Massimo, additional, and Stagno, Fabio, additional

Published
2020
Full Text
View/download PDF

16. A Patient with Chronic Lymphocytic Leukemia, Chronic Myeloid Leukemia and Multiple Myeloma

Author

Vincelli, Iolanda Donatella, primary, Cufari, Patrizia, additional, Toscano, Carmelo, additional, Said, Al Sayyad, additional, Campello, Mauro, additional, Caruso, Giuseppina, additional, D'Errigo, Maria Grazia, additional, Bova, Irene, additional, Mammi', Corrado, additional, Ciolli, Stefania, additional, Martino, Massimo, additional, Oliva, Bianca, additional, Garreffa, Cristina, additional, and Martino, Bruno, additional

Published
2020
Full Text
View/download PDF

17. CLL-220: Modulation of Phenotypic and Functional Features of Immune Cells in Chronic Lymphocytic Leukemia Patients Treated with Ibrutinib

Author

Perutelli, Francesca, primary, Griggio, Valentina, additional, Vitale, Candida, additional, Mauro, Francesca Romana, additional, Salvetti, Chiara, additional, Boccellato, Elia, additional, Pietrasanta, Daniele, additional, Vincelli, Iolanda Donatella, additional, Ghia, Paolo, additional, Del Poeta, Giovanni, additional, Gaidano, Gianluca, additional, Gattei, Valter, additional, Foà, Robin, additional, Boccadoro, Mario, additional, and Coscia, Marta, additional

Published
2020
Full Text
View/download PDF

18. A comparative effectiveness study of lipegfilgrastim in multiple myeloma patients after high dose melphalan and autologous stem cell transplant

Author

Martino, Massimo, primary, Gori, Mercedes, additional, Tripepi, Giovanni, additional, Recchia, Anna Grazia, additional, Cimminiello, Michele, additional, Provenzano, Pasquale Fabio, additional, Naso, Virginia, additional, Ferreri, Anna, additional, Moscato, Tiziana, additional, Console, Giuseppe, additional, Loteta, Barbara, additional, Gallo, Giuseppe Alberto, additional, Gentile, Massimo, additional, Innao, Vanessa, additional, Rossi, Marco, additional, Morabito, Antonella, additional, Vincelli, Iolanda Donatella, additional, Mannina, Donato, additional, and Pitino, Annalisa, additional

Published
2019
Full Text
View/download PDF

19. Ibrutinib Treatment Mitigates Phenotypic Alterations of Non-Neoplastic Immune Cell Compartments in Chronic Lymphocytic Leukemia

Author

Griggio, Valentina, primary, Vitale, Candida, additional, Salvetti, Chiara, additional, Mauro, Francesca Romana, additional, Pietrasanta, Daniela, additional, Vincelli, Iolanda Donatella, additional, Scarfo, Lydia, additional, Del Poeta, Giovanni, additional, Gaidano, Gianluca, additional, Gattei, Valter, additional, Foà, Robin, additional, Boccadoro, Mario, additional, and Coscia, Marta, additional

Published
2019
Full Text
View/download PDF

20. Real-Rd - Real Life Italian Experience with Lenalidomide and Low-Dose Dexamethasone (Rd) As First Line Treatment of Newly-Diagnosed Multiple Myeloma Patients Not Eligible to Stem Cell Transplantation: Outcomes and Tolerability

Author

Pompa, Alessandra, primary, Conticello, Concetta, additional, Giannarelli, Diana, additional, Pettine, Loredana, additional, Paris, Laura, additional, Tognazzi, Lucia, additional, Marcatti, Magda, additional, Antonioli, Elisabetta, additional, Fioritoni, Francesca, additional, Bonalumi, Angela, additional, Mangiacavalli, Silvia, additional, Bertazzoni, Paola, additional, Vincelli, Iolanda Donatella, additional, Derudas, Daniele, additional, Siniscalchi, Agostina, additional, Pezzatti, Sara, additional, Zambello, Renato, additional, Citro, Annalisa, additional, Belotti, Angelo, additional, Lombardo, Alessandra, additional, Vozella, Federico, additional, Sementa, Adelina, additional, Consoli, Ugo, additional, Molteni, Alfredo, additional, Frungillo, Niccolò, additional, Gentile, Massimo, additional, Buda, Gabriele, additional, Aquino, Sara, additional, Palmieri, Salvatore, additional, Bongarzoni, Velia, additional, Inzoli, Alessandro, additional, Ferla, Valeria, additional, Rossi, Francesca Gaia, additional, Leotta, Valerio, additional, Romano, Alessandra, additional, Elia, Federica, additional, Del Fabro, Vittorio, additional, Montanaro, Guido, additional, Cavallaro, Francesca, additional, Galli, Monica, additional, and Baldini, Luca, additional

Published
2019
Full Text
View/download PDF

21. Tumor Circulating Plasma Cells Detected By Flow Cytometric Single Platform Method Correlate with Clinical Response to Therapy and Unfavorable Patients' Characteristics

Author

Muccio, Vittorio Emanuele, primary, Gilestro, Milena, additional, Saraci, Elona, additional, Capra, Andrea, additional, Costa, Alessandro, additional, Ruggeri, Marina, additional, Caltagirone, Simona, additional, Oddolo, Daniela, additional, Mussatto, Chiara, additional, Musto, Pellegrino, additional, Pantani, Lucia, additional, Pavone, Vincenzo, additional, Ronconi, Sonia, additional, Vincelli, Iolanda Donatella, additional, Cafro, Anna Maria, additional, Cellini, Claudia, additional, Innao, Vanessa, additional, Piro, Eugenio, additional, Gay, Francesca, additional, Boccadoro, Mario, additional, and Omedé, Paola, additional

Published
2019
Full Text
View/download PDF

22. Ibrutinib Treatment Mitigates Phenotypic Alterations of Non-Neoplastic Immune Cell Compartments in Chronic Lymphocytic Leukemia

Author

Griggio, Valentina, primary, Vitale, Candida, additional, Todaro, Maria, additional, Mauro, Francesca Romana, additional, Salvetti, Chiara, additional, Pietrasanta, Daniela, additional, Vincelli, Iolanda Donatella, additional, Scarfo, Lydia, additional, Del Poeta, Giovanni, additional, Gaidano, Gianluca, additional, Gattei, Valter, additional, Foà, Robin, additional, Boccadoro, Mario, additional, and Coscia, Marta, additional

Published
2018
Full Text
View/download PDF

23. Autologous Stem Cell Transplantation Versus Bortezomib-Melphalan-Prednisone for Newly Diagnosed Multiple Myeloma: Second Interim Analysis of the Phase 3 EMN02/HO95 Study

Author

Cavo, Michele, Hajek, Roman, Pantani, Lucia, Beksac, Meral, Oliva, Stefania, Dozza, Luca, Johnsen, Hans Erik, Petrucci, Maria Teresa, Mellqvist, Ulf-Henrik, Conticello, Concetta, Driessen, Christoph, Marzocchi, Giulia, Dimopoulos, Meletios A., Zweegman, Sonja, Wu, Ka Lung, Barbara Gamberi, Crippa, Claudia, Holt, Bronno, Offidani, Massimo, Wester, Ruth, Vincelli, Iolanda Donatella, Troia, Rossella, Cornelisse, Petra, Boccadoro, Mario, Sonneveld, Pieter, Hematology, CCA - Cancer biology and immunology, CCA - Imaging and biomarkers, and CCA - Cancer Treatment and quality of life

Abstract

BackgroundThe EMN02/HO95 trial is the largest multicenter, randomized, phase 3 study conducted in the novel agent era and aimed to prospectively compare (randomization 1, R1) autologous stem cell transplantation (ASCT) vs proteasome inhibitor-based intensification therapy, and (randomization 2) consolidation therapy vs no consolidation, followed by lenalidomide maintenance for newly diagnosed MM.MethodsAfter 3 to 4 cycles of bortezomib-based induction therapy and subsequent PBSC collection, patients aged ≤65 years were randomized (R1, stratification by ISS stage) to receive high-dose intensification treatment with melphalan at 200 mg/m2 (HDM) plus ASCT or standard-dose intensification treatment with bortezomib-melphalan-prednisone (VMP) for 4 additional 42-day cycles (each including 8 doses of bortezomib). Progression-free survival (PFS) from R1 was the primary study end point for R1. The preplanned second interim analysis of ASCT vs VMP was performed in July 2017 when at least 66% of required events had occurred, and results are herein reported.ResultsA total of 1503 patients were registered and 1192 were eligible for R1. Based on the allocation ratio for R1 depending on the single (1:1) vs double (1:1:1) HDM policy of each center, 695 patients were randomly assigned to ASCT and 497 patients to VMP. Median age was 58 years in both groups; ISS stage III was 20% in ASCT arm and 21% in VMP arm. FISH analysis of CD138+ bone marrow plasma cells was available in approximately 75% of patients in both groups. According to IMWG criteria, a high-risk (HiR) cytogenetic profile defined by t(4;14) ± t(14;16) ± del(17p) positivity (HiR-cyto) was detected in 25% of patients in both groups. Median follow-up from R1 was 38 (IQR: 29-47) months for the overall patient population and for each of the two treatment groups. On an intention-to-treat basis, median PFS was not yet reached in the ASCT group and was 44 months in the VMP group; 3-year estimate of PFS was 64% vs 57%, respectively (HR=0.76; 95% CI=0.64-0.91; P=0.002), which represented a 24% reduced risk of progression or death in the ASCT group compared with the VMP group. Prespecified subgroup analyses of PFS confirmed that the benefit associated with ASCT was not influenced by revised ISS (R-ISS) disease stage (stage II: P=0.006; stage III: P55 years: P=0.027; ≤55 years: P=0.038). The probability of achieving ≥ best VGPR was 84% in the ASCT group and was 75% in the VMP group (odds ratio=1.79; CI=1.32-2.35; P

Published
2017

24. A rare case of appendicular skeleton localization in a patient with chronic lymphocytic leukemia successfully treated with salvage radiation therapy

Author

Tuscano, Carmelo, primary, Vincelli, Iolanda Donatella, additional, Arico’, Demetrio, additional, Marchione, Anna Maria, additional, Versace, Paolo, additional, Stelitano, Caterina, additional, Porta, Natale, additional, Petrozza, Vincenzo, additional, Di Cristofano, Claudio, additional, Sceni, Giuseppe, additional, Ronco, Francesca, additional, Russi, Elvio Grazioso, additional, and Al Sayyad, Said, additional

Published
2018
Full Text
View/download PDF

25. Can we improve the conditioning regimen before autologous stem cell transplantation in multiple myeloma?

Author

Martino, Massimo, primary, Recchia, Anna Grazia, additional, Console, Giuseppe, additional, Gentile, Massimo, additional, Cimminiello, Michele, additional, Gallo, Giuseppe Alberto, additional, Ferreri, Anna, additional, Naso, Virginia, additional, Irrera, Giuseppe, additional, Messina, Giuseppe, additional, Moscato, Tiziana, additional, Vigna, Ernesto, additional, Vincelli, Iolanda Donatella, additional, and Morabito, Fortunato, additional

Published
2017
Full Text
View/download PDF

26. Heavy+Light Chain and Free Light Chain Assays at Baseline and During Follow-up in EMN02/HO95 Multiple Myeloma Clinical Trial

Author

Omedè, Paola, primary, Redoglia, Valter, additional, Astolfi, Monica, additional, Larocca, Alessandra, additional, Spada, Stefano, additional, Bourlot, Luigi, additional, Cavo, Michele, additional, Petrucci, Maria Teresa, additional, Di Raimondo, Francesco, additional, Patriarca, Francesca, additional, Rambaldi, Alessandro, additional, Rossi, Giuseppe, additional, Ballanti, Stelvio, additional, Gamberi, Barbara, additional, Vincelli, Iolanda Donatella, additional, Grasso, Mariella, additional, Liberati, Anna Marina, additional, Corradini, Paolo, additional, Sonneveld, Pieter, additional, Boccadoro, Mario, additional, and Palumbo, Antonio, additional

Published
2017
Full Text
View/download PDF

27. Impact of Treatment Intensification According to Patient Prognosis: A Pooled Analysis of 3 Randomized Phase III Trials

Author

D'Agostino, Mattia, primary, Spencer, Andrew, additional, Musto, Pellegrino, additional, Bringhen, Sara, additional, Angelucci, Emanuele, additional, Ciceri, Fabio, additional, Catalano, Lucio, additional, Salvini, Marco, additional, Baraldi, Anna, additional, Grandi, Sonia, additional, Rambaldi, Alessandro, additional, Bosi, Alberto, additional, Vincelli, Iolanda Donatella, additional, Omedè, Paola, additional, Grasso, Mariella, additional, Marasca, Roberto, additional, Cantonetti, Maria, additional, Bernardini, Annalisa, additional, Cascavilla, Nicola, additional, Patriarca, Francesca, additional, Troia, Rossella, additional, Ria, Roberto, additional, Liberati, Anna Marina, additional, Larocca, Alessandra, additional, di Toritto, Tommaso Caravita, additional, Hajek, Roman, additional, Palumbo, Antonio, additional, Boccadoro, Mario, additional, and Gay, Francesca, additional

Published
2017
Full Text
View/download PDF

28. Carfilzomib-Lenalidomide-Dexamethasone (KRd) Vs. Lenalidomide-Dexamethasone (Rd) in Newly Diagnosed Fit or Intermediate-Fit Multiple Myeloma Patients Not Eligible for Autologous Stem-Cell Transplantation (Phase III EMN20 Trial): Analysis of Sustained Undetectable Minimal Residual Disease (MRD)

Author

Bringhen, Sara, Antonioli, Elisabetta, Gamberi, Barbara, Bruno, Benedetto, Derudas, Daniele, Tosi, Patrizia, Fazio, Francesca, Mazza, Rita, Ronconi, Sonia, Corradini, Paolo, Lotti, Flavia, Cellini, Claudia, Falcone, Antonietta Pia, Galieni, Piero, Ria, Roberto, Belotti, Angelo, Mannina, Donato, Cafro, Anna Maria, Cangialosi, Clotilde, Vincelli, Iolanda Donatella, Lombardo, Alessandra, Larocca, Alessandra, Boccadoro, Mario, and D'Agostino, Mattia

Abstract

Background. Before the recent introduction of daratumumab (Dara) in the frontline setting, lenalidomide-dexamethasone (Rd) has represented a standard of care for transplant-ineligible (NTE), patients (pts) with newly diagnosed multiple myeloma (NDMM). Nonetheless, minimal residual disease negativity (MRD Neg) rate and median progression-free survival (PFS) with Rd were still relatively limited, as compared with 3/4-drug regimens, also including carfilzomib (K). The EMN20 trial (NCT04096066) is a randomized, multicenter study designed to compare weekly K in addition to Rd (KRd) with Rd in fit or intermediate-fit NTE NDMM pts, with the objective of attaining improved rates of PFS and 2-year MRD Neg through a triplet regimen.

Published
2023
Full Text
View/download PDF

29. Real-Life Data of Bosutinib Treatment for Chronic Myeloid Leukemia: The Multi-Center Experience of the Gruppo Di Miglioramento Sicilia-Calabria

Author

Santoro, Marco, Russo, Sabina, Vincelli, Iolanda Donatella, Cotzia, Emilia, Impera, Stefana, Leone, Vincenzo, Levato, Luciano, Mendicino, Francesco, Malato, Alessandra, Giuseppe, Mineo, Nocilli, Laura, Porretto, Ferdinando, Martino, Bruno, Siragusa, Sergio, and Tomaselli, Carmela Anna Maria

Abstract

Background and rationale:

Published
2023
Full Text
View/download PDF

30. Health-related quality of life and burden of fatigue in patients with primary immune thrombocytopenia by phase of disease

Author

Efficace, Fabio, primary, Mandelli, Franco, additional, Fazi, Paola, additional, Santoro, Cristina, additional, Gaidano, Gianluca, additional, Cottone, Francesco, additional, Borchiellini, Alessandra, additional, Carpenedo, Monica, additional, Simula, Maria Pina, additional, Di Giacomo, Valeria, additional, Bergamaschi, Micaela, additional, Vincelli, Iolanda Donatella, additional, Rodeghiero, Francesco, additional, Ruggeri, Marco, additional, Scaramucci, Laura, additional, Rambaldi, Alessandro, additional, Cascavilla, Nicola, additional, Forghieri, Fabio, additional, Petrungaro, Annamaria, additional, Ditonno, Paolo, additional, Caocci, Giovanni, additional, Cirrincione, Sonia, additional, and Mazzucconi, Maria Gabriella, additional

Published
2016
Full Text
View/download PDF

32. A Phase 2 Study of Bendamustine Plus Melphalan Conditioning for Second Autologous Stem Cell Transplantation in "De-Novo" Multiple Myeloma Patients in a Tandem Transplant Strategy

Author

Martino, Massimo, primary, Giuseppe, Messina, additional, Fedele, Roberta, additional, Irrera, Giuseppe, additional, Giuseppe, Console, additional, Gallo, Giuseppe Alberto, additional, Vincelli, Iolanda Donatella, additional, Ronco, Francesca, additional, Gentile, Massimo, additional, and Morabito, Fortunato, additional

Published
2015
Full Text
View/download PDF

33. A Patient with Chronic Lymphocytic Leukemia and Bone Localization: A Case Report

Author

Vincelli, Iolanda Donatella, primary, Cufari, Patrizia, additional, al Sayyad, Said, additional, Tuscano, Carmelo, additional, Porta, Natale, additional, di Cristofano, Claudio, additional, Petrozza, Vincenzo, additional, Aricò, Demetrio, additional, Stelitano, Caterina, additional, Ciolli, Stefania, additional, Iaria, Grazia, additional, Violi, Angela, additional, and Ronco, Francesca, additional

Published
2015
Full Text
View/download PDF

34. Fast and Non-Invasive Identification of Tumorigenic-Proliferative Biomarker in Myeloproliferative and Lymphoproliferative Disorders

Author

Vincelli, Iolanda Donatella, primary, Martino, Bruno, additional, Cuzzola, Maria, additional, Irrera, Giuseppe, additional, Cufari, Patrizia, additional, Martino, Massimo, additional, Gentile, Massimo, additional, Ciolli, Stefania, additional, Zaccuri, AnnaMaria, additional, Pontoriero, Daniela, additional, Rigolino, Carmela, additional, Violi, Angela, additional, and Ronco, Francesca, additional

Published
2015
Full Text
View/download PDF

35. Biosimilar Compared with Originator Filgrastim for Autologous Stems CELL Mobilisation: A Prospective-Historical Control Study in Multiple Myeloma REAL-Life Setting

Author

Martino, Massimo, primary, Moscato, Tiziana, additional, Vincelli, Iolanda Donatella, additional, Ronco, Francesca, additional, Fedele, Roberta, additional, Irrera, Giuseppe, additional, Console, Giuseppe, additional, Messina, Giuseppe, additional, Piro, Eugenio, additional, Molica, Stefano, additional, and Morabito, Fortunato, additional

Published
2014
Full Text
View/download PDF

37. 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, primary, Bringhen, Sara, additional, Larocca, Alessandra, additional, Rossi, Davide, additional, Di Raimondo, Francesco, additional, Magarotto, Valeria, additional, Patriarca, Francesca, additional, Levi, Anna, additional, Benevolo, Giulia, additional, Vincelli, Iolanda Donatella, additional, Grasso, Mariella, additional, Franceschini, Luca, additional, Gottardi, Daniela, additional, Zambello, Renato, additional, Montefusco, Vittorio, additional, Falcone, Antonietta Pia, additional, Omedé, Paola, additional, Marasca, Roberto, additional, Morabito, Fortunato, additional, Mina, Roberto, additional, Guglielmelli, Tommasina, additional, Nozzoli, Chiara, additional, Passera, Roberto, additional, Gaidano, Gianluca, additional, Offidani, Massimo, additional, Ria, Roberto, additional, Petrucci, Maria Teresa, additional, Musto, Pellegrino, additional, Boccadoro, Mario, additional, and Cavo, Michele, additional

Published
2014
Full Text
View/download PDF

38. A Simple Score, Based On Geriatric Assessment, Improves Prediction of Survival, and Risk Of Serious Adverse Events In Elderly Newly Diagnosed Multiple Myeloma Patients

Author

Larocca, Alessandra, primary, Bringhen, Sara, additional, Evangelista, Andrea, additional, Offidani, Massimo, additional, Ballanti, Stelvio, additional, Zaccaria, Alfonso, additional, Pescosta, Norbert, additional, Montefusco, Vittorio, additional, De Rosa, Luca, additional, Carella, Angelo Michele, additional, Baldini, Luca, additional, Aglietta, Massimo, additional, Vincelli, Iolanda Donatella, additional, Marasca, Roberto, additional, Pezzati, Sara, additional, Tosi, Patrizia, additional, Cocito, Federica, additional, Grasso, Mariella, additional, Fioritoni, Giuseppe, additional, Pavone, Vincenzo, additional, Musto, Pellegrino, additional, Grammatico, Sara, additional, Omedè, Paola, additional, Gay, Francesca, additional, Ciccone, Giovannino, additional, Boccadoro, Mario, additional, and Palumbo, Antonio, additional

Published
2013
Full Text
View/download PDF

39. Predictors of unsustained measurable residual disease negativity in patients with multiple myeloma

Author

D’Agostino, Mattia, Bertuglia, Giuseppe, Rota-Scalabrini, Delia, Belotti, Angelo, Morè, Sonia, Corradini, Paolo, Oliva, Stefania, Ledda, Antonio, Grasso, Mariella, Pavone, Vincenzo, Ronconi, Sonia, Vincelli, Iolanda Donatella, Ballanti, Stelvio, Velluti, Cristina, Cellini, Claudia, Gozzetti, Alessandro, Palmas, Angelo D., Gamberi, Barbara, Mancuso, Katia, Paris, Laura, Zambello, Renato, Petrucci, Maria Teresa, Bruno, Benedetto, Musto, Pellegrino, and Gay, Francesca

Abstract

•Amp(1q), HRCA ≥2, high CTC levels, and a longer time to reach first MRD negativity are significant predictors of unsustained MRD negativity.•Maintenance treatment with carfilzomib-lenalidomide reduces the risk of unsustained MRD negativity vs lenalidomide alone.

Published
2023
Full Text
View/download PDF

40. Lenalidomide Maintenance with or without Prednisone in Newly Diagnosed Myeloma Patients: A Pooled Analysis.

Author

Bonello, Francesca, Pulini, Stefano, Ballanti, Stelvio, Gentile, Massimo, Spada, Stefano, Annibali, Ombretta, Omedé, Paola, Ronconi, Sonia, Cangialosi, Clotilde, Podda, Luigi, Palmas, Angelo, Malfitano, Alessandra, Rivoli, Giulia, Belotti, Angelo, Ciambelli, Fabrizio, Vincelli, Iolanda Donatella, Cafro, Anna Maria, Innao, Vanessa, Palumbo, Antonio, and Sonneveld, Pieter

Subjects
ANTINEOPLASTIC agents, CANCER patients, COMBINATION drug therapy, DOSE-effect relationship in pharmacology, MULTIPLE myeloma, NEUTROPENIA, PREDNISONE, DISEASE relapse, DESCRIPTIVE statistics
Abstract

We conducted a pooled analysis of two phase III trials, RV-MM-EMN-441 and EMN01, to compare maintenance with lenalidomide-prednisone vs. lenalidomide in newly diagnosed transplant-eligible and -ineligible myeloma patients. Primary endpoints were progression-free survival, progression-free survival 2 and overall survival with both regimens. A secondary aim was to evaluate the impact of duration of maintenance on overall survival and on outcome after relapse. A total of 625 patients (lenalidomide-prednisone arm, n = 315; lenalidomide arm, n = 310) were analyzed. The median follow-up was 58 months. Median progression-free survival (25 vs. 19 months; p = 0.08), progression-free survival 2 (56 vs. 49 months; p = 0.9) and overall survival (73 months vs. NR; p = 0.08) were not significantly different between the two arms. Toxicity profiles of lenalidomide-prednisone and lenalidomide were similar, with the exception of neutropenia that was higher in the lenalidomide arm (grade ≥ 3: 9% vs. 19%, p < 0.001), without an increase in the rate of infections. Overall survival (median NR vs. 49 months, p < 0.001), progression-free survival from relapse (median 35 vs. 24 months, p = 0.004) and overall survival from relapse (median not reached vs. 41 months, p = 0.002) were significantly longer in patients continuing maintenance for ≥2 years. We showed that the addition of prednisone at 25 or 50 mg every other day (eod) to lenalidomide maintenance did not induce any significant advantage. [ABSTRACT FROM AUTHOR]

Published
2019
Full Text
View/download PDF

41. Tumor Microenvironment (TME) Regulation of Programmed Death-1 (PD1) Receptor and Its Ligands PDL1 and PDL2 in Chronic Lymphocytic Leukemia (CLL)

Author

Morabito, Fortunato, Bossio, Sabrina, Claudio Tripodo, Recchia, Anna, Stefano, Laura, Caruso, Nadia, Palummo, Angela, Storino, Francesca, Gentile, Massimo, Vigna, Ernesto, Petrungaro, Anna Maria, Vincelli, Iolanda Donatella, Fenoglio, Daniela, Filaci, Gilberto, Fais, Franco, Uccello, Giuseppina, Gulino, Alessandro, Vallone, Roberto, Manzoni, Martina, Neri, Antonino, Cutrona, Giovanna, Tassone, Pierfrancesco, and Ferrarini, Manlio

42. Tumor Microenvironment (TME) Regulation of Programmed Death-1 (PD1) Receptor and Its Ligands PDL1 and PDL2 in Chronic Lymphocytic Leukemia (CLL)

Author

Morabito, Fortunato, Bossio, Sabrina, Tripodo, Claudio, Recchia, Anna, De Stefano, Laura, Caruso, Nadia, Palummo, Angela, Storino, Francesca, Gentile, Massimo, Vigna, Ernesto, Petrungaro, Anna Maria, Vincelli, Iolanda Donatella, Fenoglio, Daniela, Filaci, Gilberto, Fais, Franco, Uccello, Giuseppina, Gulino, Alessandro, Vallone, Roberto, Manzoni, Martina, Neri, Antonino, Cutrona, Giovanna, Tassone, Pierfrancesco, and Ferrarini, Manlio

Abstract

The PD1 pathway is involved in the inactivation of immune effectors and is potentially reactive against neoplastic cells in the TME. T cells from CLL patients exhibit defective immunity, decreased proliferative capacity, and impaired effector function leading to T cell exhaustion. These functional defects coincide with higher CD244, CD160 and PD1 expression on T cells. In the Eμ-TCL1 transgenic CLL model, PDL1 checkpoint blockade restores immune dysfunction and impairs leukemia growth. PD1/PDL1 ligation also affects BCR signaling, and because PD1 is also expressed on CLL cells, PD1 interference might directly influence tumor growth and proliferation directly.We studied the 1) expression the PD1 receptor and its ligands and their correlation with TFTT; 2) role of the TME in controlling PD1 axis and miRNA expression; 3) role of the BCRi ibrutinib (IB) in the expression of the receptor and ligands.Early-stage CLL patients were prospectively enrolled at diagnosis (n=211, O-CLL1: clinicaltrial.govID:NCT00917540). Gene expression (GE) profiling was performed using the GeneChipVR Gene1.0 STArray (Affymetrix) and validated by qPCR (Thermofisher) and flow-cytometry (FC, BD Biosciences) in an independent subset of patients. CLL lymph node samples underwent in situimmunolocalization analyses. Autologous T-cells (AAT) were obtained by in vitroexposure of patient T-cells with anti CD3/CD28 Dynabeads (Thermofisher) and IL2 in co-culture with CLL cells. Cultures were monitored until substantial clumping was observed and tested for PD1 axis expression. HS5 stromal cells were used in co-culture experiments with B-CLL (ratio 1:100). MiR-424 expression was evaluated by qPCR using validated TaqMan® MicroRNA Assays (Thermofisher). In selected experiments IB was added to cell culture. PD1 GEP of circulating B-CLL cells was significantly higher than of ligands. No differences in GEP of PD1 or its ligands were observed stratifying cases based on CD38, ZAP-70, or FISH markers. Significantly higher PDL1 GE was detected in IGHV-M cases. GEP results were validated by qPCR on 27 independent CLL samples. The impact of GE of the PD1 axis on clinical outcomes in CLL cases (median follow-up 39 months, range 6−82 months) indicated TTFT was significantly shorter in cases with higher levels of PDL2, while no significant differences were detected based on higher or lower PD1 or PDL1 levels. Multivariate analysis indicated higher PDL2 gene expression retained an independent prognostic power (HR=1.9, 95%CI 1.1-3.4, P=.022) in predicting TTFT together with IGHV-UMstatus, B-lymphocytosis≥5000/mm3(P=.020), and CD38 expression (P=.021). In situimmunolocalization of CLL tissue infiltrates showed variable expression of PD1 that characterized small lymphoid elements, while PDL1 and PDL2 (PDL2>PDL1) characterized larger medium-sized elements within proliferation centers. Co-localization studies revealed PD1 co-expression of CD20+CLL cells and in scattered CD3+ cells. Both PDL1 and PDL2 were variably expressed in CD20+CLL cells; few T-cells and macrophages showed expression of both ligands within CLL infiltrates. FC analysis of CLL cells after AAT co-culture showed a higher percentage expression of circulating PD1 axis members (n=27, PDL1>>PDL2>PD1) compared to baseline indicating that the changes in PD1 axis expression may be due to events triggered by activation of the TME. In contrast, T cell populations had higher expression of CD3+, CD4+ and CD8+ cells bearing both PD1 and PDL1, while no substantial increment for either CD3+, CD4+ or CD8+/PDL2+ cells following AAT co-culture. GE analysis also showed a similar increase in PDLs (n=15, PDL2>>PDL1>PD1) expression with respect to non-activated B-CLL cells. Interestingly, a 48h co-culture of B-CLL with HS5 stromal cells (n=6) showed a similar increase in PD1 axis GE pattern as AAT cultures. Expression of miR-424 also decreased significantly (<80%) after AAT co-cultures (n=6), indicating its potential involvement in PDL1 regulation. IB reduced PD1/PDL1 gene and protein expression on CLL B-cells; the IB inhibitory effect was also observed only on CD8+ cells.We indicate that PDL2 expression characterizes a subset of high-risk early stage CLL patients. PD1 axis expression is characteristic of the CLL TME whereby modulatory co-stimulatory signals may be counteracted by IB. Further studies will examine the role of miR-424 regulation with this cellular context.

Published
2017
Full Text
View/download PDF

43. Carfilzomib combined with lenalidomide and dexamethasone (KRd) as salvage therapy for multiple myeloma patients: italian, multicenter, retrospective clinical experience with 600 cases outside of controlled clinical trials

Author

Enrica Antonia Martino, Concetta Conticello, Elena Zamagni, Vincenzo Pavone, Salvatore Palmieri, Maurizio Musso, Paola Tacchetti, Anna Mele, Lucio Catalano, Ernesto Vigna, Antonella Bruzzese, Francesco Mendicino, Cirino Botta, Iolanda Donatella Vincelli, Giuliana Farina, Marialucia Barone, Clotilde Cangialosi, Katia Mancuso, Ilaria Rizziello, Serena Rocchi, Antonietta Pia Falcone, Giuseppe Mele, Giovanni Reddiconto, Bruno Garibaldi, Enrico Iaccino, Giovanni Tripepi, Barbara Gamberi, Francesco Di Raimondo, Pellegrino Musto, Antonino Neri, Michele Cavo, Fortunato Morabito, Massimo Gentile, Martino, Enrica Antonia, Conticello, Concetta, Zamagni, Elena, Pavone, Vincenzo, Palmieri, Salvatore, Musso, Maurizio, Tacchetti, Paola, Mele, Anna, Catalano, Lucio, Vigna, Ernesto, Bruzzese, Antonella, Mendicino, Francesco, Botta, Cirino, Vincelli, Iolanda Donatella, Farina, Giuliana, Barone, Marialucia, Cangialosi, Clotilde, Mancuso, Katia, Rizziello, Ilaria, Rocchi, Serena, Falcone, Antonietta Pia, Mele, Giuseppe, Reddiconto, Giovanni, Garibaldi, Bruno, Iaccino, Enrico, Tripepi, Giovanni, Gamberi, Barbara, Di Raimondo, Francesco, Musto, Pellegrino, Neri, Antonino, Cavo, Michele, Morabito, Fortunato, and Gentile, Massimo

Subjects
Salvage Therapy, Cancer Research, Oncology, Humans, Hematology, General Medicine, KRd regimen, multiple myeloma, salvage therapy, Multiple Myeloma, Lenalidomide, Dexamethasone, Retrospective Studies
Abstract

In combination with lenalidomide and dexamethasone (KRd), Carfilzomib has been approved for the treatment of relapsed and refractory multiple myeloma (RRMM) on ASPIRE trial. Efficacy and safety of the triplet are still the object of investigation by many groups to confirm ASPIRE results in the setting of RRMM treated in real-life who don't meet trial restrictive inclusion criteria. Therefore, we report a retrospective multicenter analysis of 600 RRMM patients treated with KRd between December 2015 and December 2018. The median age was 64 years (range 33-85), and the median number of previous therapies was two (range 1-11). After a median of 11 KRd cycles, the overall response rate was 79.9%. The median progression-free survival (PFS) was 22 months, and the 2-year probability of PFS was 47.6%. Creatinine clearance30 ml/min,1 line of previous therapy, and high-risk FISH were all associated with a poor prognosis in multivariate analysis. The median overall survival (OS) was 34.8 months; the 2-year probability of OS was 63.5%. At multivariate analysis, creatinine clearance30 ml/min,1 line of previous therapy, and high-risk FISH were significantly associated with poor prognosis. After a median follow-up of 16 months (range 1-50), 259 withdrew from therapy. The main discontinuation reason was progressive disease (81.8%). Seventy-four patients (12.3%) discontinued therapy for toxicity. The most frequent side effects were hematological (anemia 49.3%, neutropenia 42.7%, thrombocytopenia 42.5%) and cardiovascular (hypertension 14.5%, heart failure 2.5%, arrhythmias 3.6%). Our study confirms the safety and efficacy of KRd in the real-life setting of RRMM patients and encourages its use in clinical practice.

Published
2022

44. Survival Risk Scores for Real-Life Relapsed/Refractory Multiple Myeloma Patients Receiving Elotuzumab or Carfilzomib In Combination With Lenalidomide and Dexamethasone as Salvage Therapy: Analysis of 919 Cases Outside Clinical Trials

Author

Fortunato Morabito, Elena Zamagni, Concetta Conticello, Vincenzo Pavone, Salvatore Palmieri, Sara Bringhen, Monica Galli, Silvia Mangiacavalli, Daniele Derudas, Elena Rossi, Roberto Ria, Lucio Catalano, Paola Tacchetti, Giuseppe Mele, Iolanda Donatella Vincelli, Enrica Antonia Martino, Ernesto Vigna, Antonella Bruzzese, Francesco Mendicino, Cirino Botta, Anna Mele, Lucia Pantani, Serena Rocchi, Bruno Garibaldi, Nicola Cascavilla, Stelvio Ballanti, Giovanni Tripepi, Ferdinando Frigeri, Antonetta Pia Falcone, Clotilde Cangialosi, Giovanni Reddiconto, Giuliana Farina, Marialucia Barone, Ilaria Rizzello, Enrico Iaccino, Selena Mimmi, Paola Curci, Barbara Gamberi, Pellegrino Musto, Valerio De Stefano, Maurizio Musso, Maria Teresa Petrucci, Massimo Offidani, Francesco Di Raimondo, Mario Boccadoro, Michele Cavo, Antonino Neri, Massimo Gentile, Morabito, Fortunato, Zamagni, Elena, Conticello, Concetta, Pavone, Vincenzo, Palmieri, Salvatore, Bringhen, Sara, Galli, Monica, Mangiacavalli, Silvia, Derudas, Daniele, Rossi, Elena, Ria, Roberto, Catalano, Lucio, Tacchetti, Paola, Mele, Giuseppe, Vincelli, Iolanda Donatella, Martino, Enrica Antonia, Vigna, Ernesto, Bruzzese, Antonella, Mendicino, Francesco, Botta, Cirino, Mele, Anna, Pantani, Lucia, Rocchi, Serena, Garibaldi, Bruno, Cascavilla, Nicola, Ballanti, Stelvio, Tripepi, Giovanni, Frigeri, Ferdinando, Falcone, Antonetta Pia, Cangialosi, Clotilde, Reddiconto, Giovanni, Farina, Giuliana, Barone, Marialucia, Rizzello, Ilaria, Iaccino, Enrico, Mimmi, Selena, Curci, Paola, Gamberi, Barbara, Musto, Pellegrino, De Stefano, Valerio, Musso, Maurizio, Petrucci, Maria Teresa, Offidani, Massimo, Di Raimondo, Francesco, Boccadoro, Mario, Cavo, Michele, Neri, Antonino, and Gentile, Massimo

Subjects
multiple myeloma, Cancer Research, carfilzomib, Oncology, lenalidomide, survival, elotuzumab, prognosi, prognostic score, relapsed/refractory
Abstract

The present study aimed to develop two survival risk scores (RS) for overall survival (OS, SRSKRd/EloRd) and progression-free survival (PFS, PRSKRd/EloRd) in 919 relapsed/refractory multiple myeloma (RRMM) patients who received carfilzomib, lenalidomide, and dexamethasone (KRd)/elotuzumab, lenalidomide, and dexamethasone (EloRd). The median OS was 35.4 months, with no significant difference between the KRd arm versus the EloRd arm. In the multivariate analysis, advanced ISS (HR = 1.31; P = 0.025), interval diagnosis–therapy (HR = 1.46; P = 0.001), number of previous lines of therapies (HR = 1.96; P < 0.0001), older age (HR = 1.72; P < 0.0001), and prior lenalidomide exposure (HR = 1.30; P = 0.026) remained independently associated with death. The median PFS was 20.3 months, with no difference between the two strategies. The multivariate model identified a significant progression/death risk increase for ISS III (HR = 1.37; P = 0.002), >3 previous lines of therapies (HR = 1.67; P < 0.0001), older age (HR = 1.64; P < 0.0001), and prior lenalidomide exposure (HR = 1.35; P = 0.003). Three risk SRSKRd/EloRd categories were generated: low-risk (134 cases, 16.5%), intermediate-risk (467 cases, 57.3%), and high-risk categories (213 cases, 26.2%). The 1- and 2-year OS probability rates were 92.3% and 83.8% for the low-risk (HR = 1, reference category), 81.1% and 60.6% (HR = 2.73; P < 0.0001) for the intermediate-risk, and 65.5% and 42.5% (HR = 4.91; P < 0.0001) for the high-risk groups, respectively. Notably, unlike the low-risk group, which did not cross the median timeline, the OS median values were 36.6 and 18.6 months for the intermediate- and high-risk cases, respectively. Similarly, three PRSKRd/EloRd risk categories were engendered. Based on such grouping, 338 (41.5%) cases were allocated in the low-, 248 (30.5%) in the intermediate-, and 228 (28.0%) in the high-risk groups. The 1- and 2-year PFS probability rates were 71.4% and 54.5% for the low-risk (HR = 1, reference category), 68.9% and 43.7% (HR = 1.95; P < 0.0001) for the intermediate-risk, and 48.0% and 27.1% (HR = 3.73; P < 0.0001) for the high-risk groups, respectively. The PFS median values were 29.0, 21.0, and 11.7 months for the low-, intermediate-, and high-risk cases. This analysis showed 2.7- and 4.9-fold increased risk of death for the intermediate- and high-risk cases treated with KRd/EloRd as salvage therapy. The combined progression/death risks of the two categories were increased 1.3- and 2.2-fold compared to the low-risk group. In conclusion, SRSKRd/EloRd and PRSKRd/EloRd may represent accessible and globally applicable models in daily clinical practice and ultimately represent a prognostic tool for RRMM patients who received KRd or EloRd.

Published
2022

45. Adjusted comparison between elotuzumab and carfilzomib in combination with lenalidomide and dexamethasone as salvage therapy for multiple myeloma patients

Author

Valerio De Stefano, Lucio Catalano, Lucia Pantani, Pellegrino Musto, Elena Rossi, Enrica Antonia Martino, Antonetta Pia Falcone, Ernesto Vigna, Iolanda Vincelli, Salvatore Palmieri, Paola Tacchetti, Fortunato Morabito, Sara Bringhen, Giovanni Tripepi, Maria Teresa Petrucci, Serena Rocchi, Bruno Garibaldi, Vincenzo Pavone, Francesco Di Raimondo, Giuliana Farina, Nicola Cascavilla, Monica Galli, Antonino Neri, Stelvio Ballanti, Silvia Mangiacavalli, Maurizio Musso, Ilaria Rizzello, Ferdinando Frigeri, Massimo Offidani, Clotilde Cangialosi, Massimo Gentile, Antonella Bruzzese, Elena Zamagni, Anna Mele, Cirino Botta, Mario Boccadoro, Daniele Derudas, Marialucia Barone, Nicola Di Renzo, Concetta Conticello, Giovanni Reddiconto, Roberto Ria, Michele Cavo, Giuseppe Mele, Morabito, Fortunato, Zamagni, Elena, Conticello, Concetta, Pavone, Vincenzo, Palmieri, Salvatore, Bringhen, Sara, Galli, Monica, Mangiacavalli, Silvia, Derudas, Daniele, Rossi, Elena, Ria, Roberto, Catalano, Lucio, Tacchetti, Paola, Mele, Giuseppe, Vincelli, Iolanda Donatella, Martino, Enrica Antonia, Vigna, Ernesto, Botta, Cirino, Bruzzese, Antonella, Mele, Anna, Pantani, Lucia, Rocchi, Serena, Garibaldi, Bruno, Cascavilla, Nicola, Ballanti, Stelvio, Tripepi, Giovanni, Frigeri, Ferdinando, Falcone, Antonetta Pia, Cangialosi, Clotilde, Reddiconto, Giovanni, Farina, Giuliana, Barone, Marialucia, Rizzello, Ilaria, Musto, Pellegrino, De Stefano, Valerio, Musso, Maurizio, Petrucci, Maria Teresa, Offidani, Massimo, Neri, Antonino, Di Renzo, Nicola, Di Raimondo, Francesco, Boccadoro, Mario, Cavo, Michele, and Gentile, Massimo

Subjects
Oncology, medicine.medical_specialty, Salvage therapy, Antibodies, Monoclonal, Humanized, Dexamethasone, Settore MED/15 - Malattie Del Sangue, chemistry.chemical_compound, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Elotuzumab, Lenalidomide, Multiple myeloma, Retrospective Studies, Salvage Therapy, carfilzomib, business.industry, Hazard ratio, Hematology, General Medicine, medicine.disease, Carfilzomib, elotuzumab, multiple myeloma, chemistry, Cohort, business, Oligopeptides, medicine.drug
Abstract

The lack of a randomized trial comparing carfilzomib (K) versus elotuzumab (Elo) associated with lenalidomide and dexamethasone (Rd) prompted us to assess the relative usefulness of one triplet over the other. Five independent retrospective cohorts of 883 relapsed/refractory multiple myeloma (RRMM) patients, including 300 EloRd and 583 KRd cases, outside clinical trials, entered this non-randomized comparison. KRd cohort accounted for a higher incidence of younger patients, cases with ≥3 lines of therapy, already exposed to lenalidomide, International Staging System (ISS) stage III, and abnormal lactic dehydrogenase (LDH) level compared with EloRd cohort. Moreover, cytogenetic risk categories, detected in roughly one-third of cases, were equally distributed between the two therapy arms. The probability of CR+VGPR response was significantly higher in KRd (n = 314, 53.9%) than in EloRd patients (n = 111, 37.0%). Likewise, the cumulative incidence function of CR+VGPR, taking into account the competitive risk of death, was significantly higher in KRd arm patients than those in the EloRd arm (p = .003). Moreover, KRd treatment significantly reduced the progression or death risk by 46% in an adjusted multivariate analysis (HR: 0.54, 95% CI 0.42-0.69, p .0001). Finally, in an adjusted illness-progression/death model, the effect of KRd versus EloRd was of higher magnitude among those who achieved CR+VGPR (-39% hazard ratio reduction, p = .02) than among those who achieved VGPR (-29% hazard ratio reduction, p = .007). With limitations characteristic to any retrospective analysis, this current clinical practice study's overall results demonstrated potential benefits of KRd therapy compared with EloRd. This observation may help the daily clinical practice.

Published
2021

46. Elotuzumab plus pomalidomide and dexamethasone in relapsed/refractory multiple myeloma: Extended follow-up of a multicenter, retrospective real-world experience with 321 cases outside of controlled clinical trials.

Author

Martino EA, Palmieri S, Galli M, Derudas D, Mina R, Della Pepa R, Zambello R, Vigna E, Bruzzese A, Mangiacavalli S, Zamagni E, Califano C, Musso M, Conticello C, Cerchione C, Mele G, Di Renzo N, Offidani M, Tarantini G, Casaluci GM, Rago A, Ria R, Uccello G, Barilà G, Palumbo G, Pettine L, Vincelli ID, Brunori M, Accardi F, Amico V, Amendola A, Fontana R, Bongarzoni V, Rossini B, Cotzia E, Gozzetti A, Rizzi R, Sgherza N, Reddiconto G, Maroccia A, Franceschini L, Bertuglia G, Nappi D, Barbieri E, Gamberi B, Petrucci MT, Di Raimondo F, Neri A, Morabito F, Musto P, and Gentile M

Subjects
Humans, Male, Female, Aged, Middle Aged, Retrospective Studies, Follow-Up Studies, Aged, 80 and over, Adult, Neoplasm Recurrence, Local drug therapy, Neoplasm Recurrence, Local pathology, Drug Resistance, Neoplasm, Survival Rate, Multiple Myeloma drug therapy, Multiple Myeloma mortality, Multiple Myeloma pathology, Dexamethasone administration & dosage, Dexamethasone adverse effects, Dexamethasone therapeutic use, Antibodies, Monoclonal, Humanized administration & dosage, Antibodies, Monoclonal, Humanized therapeutic use, Antibodies, Monoclonal, Humanized adverse effects, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Antineoplastic Combined Chemotherapy Protocols adverse effects, Thalidomide analogs & derivatives, Thalidomide administration & dosage, Thalidomide adverse effects, Thalidomide therapeutic use
Abstract

The ELOQUENT-3 trial demonstrated the superiority of the combination of elotuzumab, pomalidomide, and dexamethasone (EloPd) in terms of efficacy and safety, compared to Pd in relapsed/refractory multiple myeloma (RRMM), who had received at least two prior therapies, including lenalidomide and a proteasome inhibitor. The present study is an 18-month follow-up update of a previously published Italian real-life RRMM cohort of patients treated with EloPd. This revised analysis entered 319 RRMM patients accrued in 41 Italian centers. After a median follow-up of 17.7 months, 213 patients (66.4%) experienced disease progression or died. Median progression-free survival (PFS) and overall survival (OS) were 7.5 and 19.2 months, respectively. The updated multivariate analysis showed a significant reduction of PFS benefit magnitude both in advanced International Staging System (ISS) (II and III) stages and previous exposure to daratumumab cases. Instead, advanced ISS (II and III) stages and more than 2 previous lines of therapy maintained an independent prognostic impact on OS. Major adverse events included grade three-fourths neutropenia (24.9%), anemia (13.4%), lymphocytopenia (15.5%), and thrombocytopenia (10.7%), while infection rates and pneumonia were 19.3% and 8.7%, respectively. A slight increase in the incidence of neutropenia and lymphocytopenia was registered with longer follow-up. In conclusion, our real-world study still confirms that EloPd is a safe and possible therapeutic choice for RRMM. Nevertheless, novel strategies are desirable for those patients exposed to daratumumab., (© 2024 John Wiley & Sons Ltd.)

Published
2024
Full Text
View/download PDF

47. Predictors of unsustained measurable residual disease negativity in patients with multiple myeloma.

Author

D'Agostino M, Bertuglia G, Rota-Scalabrini D, Belotti A, Morè S, Corradini P, Oliva S, Ledda A, Grasso M, Pavone V, Ronconi S, Vincelli ID, Ballanti S, Velluti C, Cellini C, Gozzetti A, Palmas AD, Gamberi B, Mancuso K, Paris L, Zambello R, Petrucci MT, Bruno B, Musto P, and Gay F

Subjects
Humans, Lenalidomide therapeutic use, Treatment Outcome, Neoplasm, Residual, Prognosis, Multiple Myeloma drug therapy
Abstract

Abstract: The prognostic impact of achieving and in particular maintaining measurable residual disease (MRD) negativity in multiple myeloma is now established; therefore, identifying among MRD-negative patients the ones at higher risk of losing MRD negativity is of importance. We analyzed predictors of unsustained MRD negativity in patients enrolled in the FORTE trial (NCT02203643). MRD was performed by multiparameter flow cytometry (sensitivity of 10-5) at premaintenance and every 6 months thereafter. The cumulative incidence (CI) of MRD resurgence and/or progression was analyzed in MRD-negative patients. A total of 306 of 474 (65%) MRD-negative patients were analyzed. After a median follow-up of 50.4 months from MRD negativity, 185 of 306 (60%) patients were still MRD negative and progression free, 118 (39%) lost their MRD-negative status, and 3 patients (1%) died without progression. Amp1q vs normal (4-year CI, 63% vs 34), ≥2 concomitant high-risk cytogenetic abnormalities vs 0 (4-year CI, 59% vs 33%), circulating tumor cells at baseline (high vs low at 4-year CI, 62% vs 32%), and time-to-reach MRD negativity postconsolidation vs preconsolidation (4-year CI, 46% vs 35%) were associated with a higher risk of unsustained MRD negativity in a multivariate Fine-Gray model. During the first 2 years of maintenance, patients receiving carfilzomib-lenalidomide vs lenalidomide alone had a lower risk of unsustained MRD negativity (4-year CI, 20% vs 33%)., (© 2024 American Society of Hematology. Published by Elsevier Inc. All rights are reserved, including those for text and data mining, AI training, and similar technologies.)

Published
2024
Full Text
View/download PDF

Catalog

Books, media, physical & digital resources
See catalog results