Melphalan 200 mg/m2 versus melphalan 100 mg/m2 in newly diagnosed myeloma patients: A prospective, multicenter phase 3 study

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

Research output: Contribution to journalArticle

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. Ninetysix 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.gov as #NCT00950768.

Original languageEnglish
Pages (from-to)1873-1879
Number of pages7
JournalBlood
Volume115
Issue number10
DOIs
Publication statusPublished - Mar 11 2010

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Melphalan
Autologous Transplantation
Transplantation Conditioning
Mucositis
Neutropenia
Thrombocytopenia
Disease-Free Survival
Survival
Mortality
Infection
Therapeutics

ASJC Scopus subject areas

  • Hematology
  • Biochemistry
  • Cell Biology
  • Immunology

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Melphalan 200 mg/m2 versus melphalan 100 mg/m2 in newly diagnosed myeloma patients : A prospective, multicenter phase 3 study. / 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; Boccadoro, Mario.

In: Blood, Vol. 115, No. 10, 11.03.2010, p. 1873-1879.

Research output: Contribution to journalArticle

Palumbo, A, Bringhen, S, Bruno, B, Falcone, AP, Liberati, AM, Grasso, M, Ria, R, Pisani, F, Cangialosi, C, Caravita, T, Levi, A, Meloni, G, Nozza, A, Pregno, P, Gabbas, A, Callea, V, Rizzo, M, Annino, L, De Stefano, V, Musto, P, Baldi, I, Cavallo, F, Petrucci, MT, Massaia, M & Boccadoro, M 2010, 'Melphalan 200 mg/m2 versus melphalan 100 mg/m2 in newly diagnosed myeloma patients: A prospective, multicenter phase 3 study', Blood, vol. 115, no. 10, pp. 1873-1879. https://doi.org/10.1182/blood-2009-09-241737
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 ; Boccadoro, Mario. / Melphalan 200 mg/m2 versus melphalan 100 mg/m2 in newly diagnosed myeloma patients : A prospective, multicenter phase 3 study. In: Blood. 2010 ; Vol. 115, No. 10. pp. 1873-1879.
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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. Ninetysix 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.gov as #NCT00950768.",
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T1 - Melphalan 200 mg/m2 versus melphalan 100 mg/m2 in newly diagnosed myeloma patients

T2 - A prospective, multicenter phase 3 study

AU - Palumbo, Antonio

AU - Bringhen, Sara

AU - Bruno, Benedetto

AU - Falcone, Antonietta Pia

AU - Liberati, Anna Marina

AU - Grasso, Mariella

AU - Ria, Roberto

AU - Pisani, Francesco

AU - Cangialosi, Clotilde

AU - Caravita, Tommaso

AU - Levi, Anna

AU - Meloni, Giovanna

AU - Nozza, Andrea

AU - Pregno, Patrizia

AU - Gabbas, Attilio

AU - Callea, Vincenzo

AU - Rizzo, Manuela

AU - Annino, Luciana

AU - De Stefano, Valerio

AU - Musto, Pellegrino

AU - Baldi, Ileana

AU - Cavallo, Federica

AU - Petrucci, Maria Teresa

AU - Massaia, Massimo

AU - Boccadoro, Mario

PY - 2010/3/11

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N2 - 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. Ninetysix 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.gov as #NCT00950768.

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