Article (Scientific journals)
Bortezomib and high-dose melphalan conditioning regimen in frontline multiple myeloma: an IFM randomized phase 3 study.
Roussel, Murielle; Lauwers-Cances, Valérie; Macro, Margaret et al.
2022In Blood, 139 (18), p. 2747-2757
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Keywords :
69G8BD63PP (Bortezomib); Q41OR9510P (Melphalan); Antineoplastic Combined Chemotherapy Protocols/adverse effects; Bortezomib/adverse effects; Humans; Melphalan/adverse effects; Multiple Myeloma/drug therapy/etiology; Transplantation, Autologous
Abstract :
[en] High-dose melphalan (HDM) and transplantation are recommended for eligible patients with multiple myeloma. No other conditioning regimen has proven to be more effective and/or safer. We previously reported in a phase 2 study that bortezomib can safely and effectively be combined with HDM (Bor-HDM), with a 32% complete response (CR) rate after transplantation. These data supported a randomized phase 3 trial. Randomization was stratified according to risk and response to induction: 300 patients were enrolled, and 154 were allocated to the experimental arm (ie, arm A) with bortezomib (1 mg/m2 intravenously [IV]) on days -6, -3, +1, and +4 and melphalan (200 mg/m2 IV) on day -2. The control arm (ie, arm B) consisted of HDM alone (200 mg/m2 IV). There were no differences in stringent CR + CR rates at day 60 posttransplant (primary end point): 22.1% in arm A vs 20.5% in arm B (P = .844). There were also no differences in undetectable minimum residual disease rates: 41.3% vs 39.4% (P = .864). Median progression-free survival was 34.0 months for arm A vs 29.6 months for arm B (adjusted HR, 0.82; 95% CI, 0.61-1.13; P = .244). The estimated 3-year overall survival was 89.5% in both arms (hazard ratio, 1.28; 95% CI, 0.62-2.64; P = .374). Sixty-nine serious adverse events occurred in 18.7% of Bor-HDM-treated patients (vs 13.1% in HDM-treated patients). The proportion of grade 3/4 AEs was similar within the 2 groups (72.0% vs 73.1%), mainly (as expected) blood and gastrointestinal disorders; 4% of patients reported grade 3/4 or painful peripheral neuropathy in arm A (vs 1.5% in arm B). In this randomized phase 3 study, a conditioning regimen with Bor-HDM did not improve efficacy end points or outcomes compared with HDM alone. The original trial was registered at www.clinicaltrials.gov as #NCT02197221.
Disciplines :
Hematology
Author, co-author :
Roussel, Murielle ;  Service d'hématologie, Centre Hospitalo-universitaire (CHU) de Toulouse, Institut  ; USMR, Centre Hospitalo-universitaire (CHU) de Toulouse, Toulouse, France.
Lauwers-Cances, Valérie;  USMR, Centre Hospitalo-universitaire (CHU) de Toulouse, Toulouse, France.
Macro, Margaret;  Centre Hospitalo-universitaire (CHU) Côte de Nacre, Caen, France.
Leleu, Xavier;  Centre Hospitalo-universitaire (CHU) La Mileterie, INSERM CIC 1402, Poitiers,
Royer, Bruno;  Centre Hospitalo-universitaire (CHU) Amiens sud, Amiens, France. ; Hôpital St Louis, Paris, France.
Hulin, Cyrille;  Centre Hospitalo-universitaire (CHU) Haut Lévêque, Bordeaux, France.
Karlin, Lionel;  Hospices Civils de Lyon, Pierre Bénite, France.
Perrot, Aurore ;  Service d'hématologie, Centre Hospitalo-universitaire (CHU) de Toulouse, Institut  ; USMR, Centre Hospitalo-universitaire (CHU) de Toulouse, Toulouse, France. ; Centre Hospitalo-universitaire (CHU) Côte de Nacre, Caen, France. ; Centre Hospitalo-universitaire (CHU) La Mileterie, INSERM CIC 1402, Poitiers,  ; Centre Hospitalo-universitaire (CHU) Amiens sud, Amiens, France. ; Centre Hospitalo-universitaire (CHU) Haut Lévêque, Bordeaux, France. ; Hospices Civils de Lyon, Pierre Bénite, France. ; Centre Hospitalo-universitaire (CHU), Vandoeuvre Les Nancy, France.
Touzeau, Cyrille;  Centre Hospitalo-universitaire (CHU) Hôtel Dieu, Nantes, France.
Chrétien, Marie-Lorraine;  Centre Hospitalo-universitaire (CHU), Dijon, France.
Rigaudeau, Sophie;  CH A. Mignot, Versailles, France.
Dib, Mamoun;  Hôpital du Bocage, Angers, France.
Nicolas-Virelizier, Emmanuelle;  Centre Léon Bérard, Lyon, France.
Escoffre-Barbe, Martine;  Centre Hospitalo-universitaire (CHU) Pontchaillou, Rennes, France.
Belhadj, Karim;  Centre Hospitalo-universitaire (CHU) Henri Mondor, Créteil, France.
Mariette, Clara;  Hôpital A. Michallon, Grenoble, France.
Stoppa, Anne-Marie;  Institut Paoli Calmettes, Marseille, France.
Araujo, Carla;  Centre Hospitalier de la côte basque, Bayonne, France.
Doyen, Chantal;  Centre Hospitalo-universitaire (CHU) UCL Namur site Godinne, Yvoir, Belgium.
Fontan, Jean;  Centre Hospitalo-universitaire (CHU), Besançon, France.
Kolb, Brigitte;  Hopital Robert Debré, Reims Cedex, France.
Garderet, Laurent;  Hôpital Saint Antoine, Paris, France. ; Hematology Hôpital Avicenne, Bobigny, France.
Brechignac, Sabine;  Hematology Hôpital Avicenne, Bobigny, France.
Malfuson, Jean-Valère;  Hôpital d'instruction des armées Percy, Clamart, France.
Jaccard, Arnaud;  Centre Hospitalo-universitaire (CHU) Dupuytren, Limoges, France.
Lenain, Pascal;  Centre Henri Becquerel, Rouen, France.
Borel, Cécile;  Service d'hématologie, Centre Hospitalo-universitaire (CHU) de Toulouse, Institut
Hebraud, Benjamin;  Service d'hématologie, Centre Hospitalo-universitaire (CHU) de Toulouse, Institut
Benbrahim, Omar;  Hôpital La Source, Orléans, France.
Dorvaux, Véronique;  Hôpital Notre Dame de Bon Secours, Metz-Thionville, France.
Manier, Salomon;  CHRU-Hôpital Claude Huriez, Lille, France.
Augeul-Meunier, Karine;  Institut De Cancérologie De La Loire St Priest-en-Jarez.
Vekemans, Marie-Christiane;  Cliniques universitaires Saint-Luc, UCL, Brussels, Belgium.
Randriamalala, Edouard;  Groupe Hospitalier Réunion, La Réunion, France.
Chaoui, Driss;  Centre Hospitalier, Argenteuil, France.
Caers, Jo  ;  Centre Hospitalier Universitaire de Liège - CHU > > Service d'hématologie clinique
Chaleteix, Carine;  Centre Hospitalo-universitaire (CHU) d'Estaing, Clermont-Ferrand, France.
Benboubker, Lofti ;  Hôpital Bretonneau, Tours, France.
Vincent, Laure;  Hôpital St Eloi, Montpellier, France.
Glaisner, Sylvie;  Hôpital René Huguenin, St. Cloud, France.
Zunic, Patricia;  Cliniques universitaires Saint-Luc, UCL, Brussels, Belgium.
Slama, Borhane;  Centre Hospitalier H. Duffaut, Avignon, France.
Eveillard, Jean-Richard;  Hôpital A. Morvan, Brest, France.
Humbrecht-Kraut, Catherine;  CH Louis Pasteur, Colmar, France.
Morel, Véronique;  Hôpital de la Pitié Salpêtrière, Paris, France.
Mineur, Philippe;  Grand Hôpital De Charleroi, Gilly, Belgium.
Eisenmann, Jean-Claude;  Hôpital E Muller, Mulhouse, France.
Demarquette, Hélène;  Centre hospitalier, Dunkerque, France.
Richez, Valentine;  Centre Hospitalo-universitaire (CHU) L'Archet, Nice, France.
Vignon, Marguerite;  Hôpital Cochin, Paris, France.
Caillot, Denis;  Centre Hospitalo-universitaire (CHU), Dijon, France.
Facon, Thierry;  CHRU-Hôpital Claude Huriez, Lille, France.
Moreau, Philippe;  Centre Hospitalo-universitaire (CHU) Hôtel Dieu, Nantes, France.
Colin, Anne-Laurène;  Pharmacovigilance des essais, Centre Hospitalo-universitaire (CHU) de Toulouse,
Olivier, Pascale;  Pharmacovigilance des essais, Centre Hospitalo-universitaire (CHU) de Toulouse,
Wuilleme, Soraya;  Hématologie Biologique, Centre Hospitalo-universitaire (CHU) Hôtel Dieu, Nantes,
Avet-Loiseau, Hervé ;  UGM, Centre Hospitalo-universitaire (CHU) de Toulouse, Institut Universitaire du
Corre, Jill ;  UGM, Centre Hospitalo-universitaire (CHU) de Toulouse, Institut Universitaire du
Attal, Michel;  Service d'hématologie, Centre Hospitalo-universitaire (CHU) de Toulouse, Institut
More authors (49 more) Less
Language :
English
Title :
Bortezomib and high-dose melphalan conditioning regimen in frontline multiple myeloma: an IFM randomized phase 3 study.
Publication date :
05 May 2022
Journal title :
Blood
ISSN :
0006-4971
eISSN :
1528-0020
Publisher :
American Society of Hematology, Washington, Us dc
Volume :
139
Issue :
18
Pages :
2747-2757
Peer reviewed :
Peer Reviewed verified by ORBi
Commentary :
© 2022 by The American Society of Hematology.
Available on ORBi :
since 03 January 2023

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