title: VTD is superior to VCD prior to intensive therapy in multiple myeloma: results of the prospective IFM2013-04 trial.
abstract: The Intergroupe Francophone du Myélome conducted a randomized trial to compare bortezomib-thalidomide-dexamethasone (VTD) with bortezomib-cyclophosphamide-dexamethasone (VCD) as induction before high-dose therapy and autologous stem cell transplantation (ASCT) in patients with newly diagnosed multiple myeloma. Overall, a total of 340 patients were centrally randomly assigned to receive VTD or VCD. After 4 cycles, on an intent-to-treat basis, 66.3% of the patients in the VTD arm achieved at least a very good partial response (primary end point) vs 56.2% in the VCD arm (P = .05). In addition, the overall response rate was significantly higher in the VTD arm (92.3% vs 83.4% in the VCD arm; P = .01). Hematologic toxicity was higher in the VCD arm, with significantly increased rates of grade 3 and 4 anemia, thrombocytopenia, and neutropenia. On the other hand, the rate of peripheral neuropathy (PN) was significantly higher in the VTD arm. With the exception of hematologic adverse events and PN, other grade 3 or 4 toxicities were rare, with no significant differences between the VTD and VCD arms. Our data support the preferential use of VTD rather than VCD in preparation for ASCT. This trial was registered at www.clinicaltrials.gov as #NCT01564537 and at EudraCT as #2013-003174-27.
authors.affiliation: University Hospital, Nantes, France;
authors.forename: Philippe
authors.initials: P
authors.lastname: Moreau
authors.affiliation: University Hospital, Bordeaux, France;
authors.forename: Cyrille
authors.initials: C
authors.lastname: Hulin
authors.affiliation: University Hospital, Caen, France;
authors.forename: Margaret
authors.initials: M
authors.lastname: Macro
authors.affiliation: University Hospital, Dijon, France;
authors.forename: Denis
authors.initials: D
authors.lastname: Caillot
authors.affiliation: University Hospital, Clermont-Ferrand, France;
authors.forename: Carine
authors.initials: C
authors.lastname: Chaleteix
authors.affiliation: Institut Universitaire du Cancer de Toulouse-Oncopole, Toulouse, France;
authors.forename: Murielle
authors.initials: M
authors.lastname: Roussel
authors.affiliation: University Hospital Saint-Antoine, Paris, France;
authors.forename: Laurent
authors.initials: L
authors.lastname: Garderet
authors.affiliation: University Hospital, Amiens, France;
authors.forename: Bruno
authors.initials: B
authors.lastname: Royer
authors.affiliation: University Hospital Avicenne, Bobigny, France;
authors.forename: Sabine
authors.initials: S
authors.lastname: Brechignac
authors.affiliation: Centre Hospitalier Departemental, La Roche Sur Yon, France;
authors.forename: Mourad
authors.initials: M
authors.lastname: Tiab
authors.affiliation: University Hospital, Poitiers, France;
authors.forename: Mathieu
authors.initials: M
authors.lastname: Puyade
authors.affiliation: University Hospital, Rennes, France;
authors.forename: Martine
authors.initials: M
authors.lastname: Escoffre
authors.affiliation: Institut Paoli-Calmette, Marseille, France;
authors.forename: Anne-Marie
authors.initials: AM
authors.lastname: Stoppa
authors.affiliation: University Hospital, Lille, France;
authors.forename: Thierry
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authors.lastname: Facon
authors.affiliation: University Hospital, Grenoble, France;
authors.forename: Brigitte
authors.initials: B
authors.lastname: Pegourie
authors.affiliation: Centre Hospitalier Departemental, Argenteuil, France;
authors.forename: Driss
authors.initials: D
authors.lastname: Chaoui
authors.affiliation: University Hospital, Limoges, France;
authors.forename: Arnaud
authors.initials: A
authors.lastname: Jaccard
authors.affiliation: Centre Hospitalier Departemental, Avignon, France;
authors.forename: Borhane
authors.initials: B
authors.lastname: Slama
authors.affiliation: University Hospital, Bordeaux, France;
authors.forename: Gerald
authors.initials: G
authors.lastname: Marit
authors.affiliation: Centre Hospitalier Departmental, Le Mans, France;
authors.forename: Karim
authors.initials: K
authors.lastname: Laribi
authors.affiliation: Centre Hospitalier Departmental, Vannes, France;
authors.forename: Pascal
authors.initials: P
authors.lastname: Godmer
authors.affiliation: Centre Hospitalier Departemental, Lorient, France;
authors.forename: Odile
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authors.lastname: Luycx
authors.affiliation: Centre Hospitalier Departemental, Mulhouse, France;
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Eisenmann
authors.affiliation: Centre Hospitalier Departemental, Saint-Brieuc, France;
authors.forename: Olivier
authors.initials: O
authors.lastname: Allangba
authors.affiliation: University Hospital, Angers, France;
authors.forename: Mamoun
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authors.lastname: Dib
authors.affiliation: Centre Hospitalier Departemental, Bayonne, France;
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authors.lastname: Araujo
authors.affiliation: University Hospital, Besancon, France;
authors.forename: Jean
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authors.lastname: Fontan
authors.affiliation: University Hospital, Creteil, France;
authors.forename: Karim
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authors.lastname: Belhadj
authors.affiliation: Centre Hospitalier Departemental, Dunkerque, France;
authors.forename: Marc
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authors.lastname: Wetterwald
authors.affiliation: University Hospital, Metz, France;
authors.forename: Véronique
authors.initials: V
authors.lastname: Dorvaux
authors.affiliation: University Hospital Saint-Louis, Paris, France;
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Fermand
authors.affiliation: Centre Hospitalier Departemantal, Perigueux, France;
authors.forename: Philippe
authors.initials: P
authors.lastname: Rodon
authors.affiliation: University Hospital, Reims, France;
authors.forename: Brigitte
authors.initials: B
authors.lastname: Kolb
authors.affiliation: Institut Curie, Paris, France;
authors.forename: Sylvie
authors.initials: S
authors.lastname: Glaisner
authors.affiliation: Hopital des Armées, Clamart, France; and.
authors.forename: Jean-Valere
authors.initials: JV
authors.lastname: Malfuson
authors.affiliation: Centre Henri Becquerel, Rouen, France.
authors.forename: Pascal
authors.initials: P
authors.lastname: Lenain
authors.affiliation: University Hospital, Nantes, France;
authors.forename: Laetitia
authors.initials: L
authors.lastname: Biron
authors.affiliation: University Hospital, Nantes, France;
authors.forename: Lucie
authors.initials: L
authors.lastname: Planche
authors.affiliation: University Hospital, Nantes, France;
authors.forename: Helene
authors.initials: H
authors.lastname: Caillon
authors.affiliation: Institut Universitaire du Cancer de Toulouse-Oncopole, Toulouse, France;
authors.forename: Herve
authors.initials: H
authors.lastname: Avet-Loiseau
authors.affiliation: University Hospital, Nantes, France;
authors.forename: Thomas
authors.initials: T
authors.lastname: Dejoie
authors.affiliation: Institut Universitaire du Cancer de Toulouse-Oncopole, Toulouse, France;
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authors.lastname: Attal
mesh_terms: D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D000069286:Bortezomib / Q000008:administration & dosage / Q000009:adverse effects; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D003907:Dexamethasone / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy*; D009503:Neutropenia / Q000139:chemically induced; D011446:Prospective Studies; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects; D013921:Thrombocytopenia / Q000139:chemically induced
chemical_list: D013792:Thalidomide; D000069286:Bortezomib; D003907:Dexamethasone; D003520:Cyclophosphamide