Bortezomib, Melphalan, Prednisone and Thalidomide (VMPT) Followed by Maintenance with Bortezomib and Thalidomide for Initial Treatment of Elderly Multiple Myeloma Patients

• Published in: Blood 2009-11, Vol.114 (22), p.128-128
• Main Authors: Palumbo, Antonio, Bringhen, Sara, Rossi, Davide, Ria, Roberto, Offidani, Massimo, Patriarca, Francesca, Nozzoli, Chiara, Levi, Anna, Guglielmelli, Tommasina, Benevolo, Giulia, Callea, Vincenzo, Olivero, Barbara, Morabito, Fortunato, Grasso, Mariella, Marasca, Roberto, Rizzo, Manuela, Falcone, Antonietta Pia, Gottardi, Daniela, Montefusco, Vittorio, Musolino, Caterina, Zambello, Renato, Cangialosi, Clotilde, Pietrantuono, Giuseppe, Magarotto, Valeria, Petrucci, Maria Teresa, Musto, Pellegrino, Ciccone, Giovannino, Di Raimondo, Francesco, Gaidano, Gianluca, Boccadoro, Mario
• Format: Article
• Language: English
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood.V114.22.128.128

Abstract 128 Background. In newly diagnosed myeloma patients the combination of bortezomib with melphalan-prednisone (VMP) was superior to MP. In relapsed-refractory patients the 4 drug combination bortezomib-melphalan-prednisone-thalidomide (VMPT) induced a high proportion of complete responses (CR). Aims. This prospective, randomized, phase III trial, compared VMPT with a maintenance regimen including bortezomib and thalidomide with VMP without a maintenance regiment. The primary end point was PFS. Methods. Patients (N=511) older than 65 years were randomly assigned to receive VMPT followed by maintenance with bortezomib and thalidomide (N=254) or VMP (N=257). Initially, patients were treated with nine 6-week cycles of VMPT (induction: bortezomib 1.3 mg/m2 days 1,4,8,11,22,25,29,32 in cycles 1–4 and days 1,8,22,29 in cycles 5–9; melphalan 9 mg/m2 days 1–4; prednisone 60 mg/m2 days 1–4 and thalidomide 50 mg days 1–42; maintenance: bortezomib 1.3 mg/m2 every 15 days and thalidomide 50 mg/day) or VMP (bortezomib, melphalan and prednisone at the same doses and schedules previously described without maintenance). In March 2007, the protocol was amended: both VMPT and VMP induction schedules were changed to nine 5-week cycles and bortezomib schedule was modified to weekly administration (1.3 mg/m2 days 1,8,15,22 in cycles 1–9). Results. All patients have been evaluated in intention-to-treat. Patient characteristics were similar in both groups, median age was 71 years. The response rates were always superior in the VMPT group: at least PR rate (86% vs 79%, p=0.02), at least VGPR rate (55% vs 47%, p=0.07) and CR rate (34% vs 21% p=0.0008), respectively. Maintenance treatment did not increase the best response achieved during VMPT induction. After a median follow-up of 17.8 months, the 2-year PFS was 70.0% in the VMPT group and 58.2% in the VMP group (HR=0.62, 95% CI 0.44–0.88, p=0.008). The achievement of CR significantly prolonged PFS in both VMPT (p