Bortezomib (velcade)-thalidomide-dexamethasone (VTD) is superior to thalidomide-dexamethasone (TD) in patients with multiple myeloma (MM) progressing or relapsing after autologous transplantation

• Authors: GARDERET L.; IACOBELLI S.; MOREAU P.; DIB M.; CAILLOT D.; NIEDERWIESER D.; MASSZI T.; FONTAN J.; MICHALLET M.; GRATWOHL A.; MILONE G.; DOYEN C.; PEGOURIE B.; HÁJEK Roman; CASASSUS P.; KOLB B.; CHALETEIX C.; HERTENSTEIN B.; ONIDA F.; HEINZ L.; VEKEMANS MC.; KETTERER N.; DAGUENEL A.; KOENECKE C.; MOHTY M.; GORIN NC.; HAROUSSEAU JL.; DE WITTE T.; MORRIS C.; GAHRTON G.
• Year of publication: 2011
• Type: Conference abstract
• Description: An IFM and EBMT prospective, randomized, open label phase III, multicenter study, comparing VTD (arm A) with TD (arm B) for MM patients in first progression/relapse after at least one autologous transplantation. Primary end point:TTP. Bortezomib 1.3 mg/m2 on days 1, 4, 8 and 11, followed by a 10-day rest period (8 cycles) and then on days 1, 8, 15 and 22, followed by a 20-day rest period (4 cycles). In both arms:thalidomide:200mg/day for 1 year, dexamethasone:40 mg/day for 4 days every 3 weeks for 1 year. 267 patients (135 in arm A, 132 in arm B) and 157 events. Median age:61 years (range 29-76), ISS: I in 56 %, II in 27 %, III in 17 %, previous autologous transplants:one in 71 vs 69 patients and two or more in 64 vs 63 patients(A and B). Median followup:27 mo, median TTP:19.5 vs 13.8 mo (A and B), with a CI of relapse/progression at 2 years of 56% vs 71% (p=0.0011). Median PFS:18.6 vs 12.7 mo with a CI at 2 years of 37% vs 23% (A vs B, p=0.0011). First two years OS:72% vs 68% (p=0.18). First year CR and CR+PR:32% vs 12% and 90% vs 69% with VTD and TD (p=0.0001,and p=0.0001). Mean number of treatment cycles for the first 8 cycles:6.25 vs 6.88 and for the 12 cycles, 7.56 vs 9.93 (VTD and TD). Treatment discontinuation due to toxicity: 48 patients (VTD= 36, TD=12). 33 death during treatment period (VTD= 14, TD= 19). Thrombo-embolism; 6.6% vs 5.2%, p=ns while thrombocytopenia:16% vs 7%, p= 0.025 (events >= grade 3,VTD vs TD). VTD resulted in significantly longer TTP and PFS in patients relapsing after ASCT with an acceptable toxicity. Protocol EUDRACT number: 2005-001628-35.