0000000000826494
AUTHOR
Andrew Cakana
Superiority of the Triple Combination of Bortezomib-Thalidomide-Dexamethasone Over the Dual Combination of Thalidomide-Dexamethasone in Patients With Multiple Myeloma Progressing or Relapsing After Autologous Transplantation: The MMVAR/IFM 2005-04 Randomized Phase III Trial From the Chronic Leukemia Working Party of the European Group for Blood and Marrow Transplantation.
Purpose This prospective multicenter phase III study compared the efficacy and safety of a triple combination (bortezomib-thalidomide-dexamethasone [VTD]) versus a dual combination (thalidomide-dexamethasone [TD]) in patients with multiple myeloma (MM) progressing or relapsing after autologous stem-cell transplantation (ASCT). Patients and Methods Overall, 269 patients were randomly assigned to receive bortezomib (1.3 mg/m2 intravenous bolus) or no bortezomib for 1 year, in combination with thalidomide (200 mg per day orally) and dexamethasone (40 mg orally once a day on 4 days once every 3 weeks). Bortezomib was administered on days 1, 4, 8, and 11 with a 10-day rest period (day 12 to day …
Matched-pairs analysis of outcomes with bortezomib, melphalan, and prednisone (VMP) treatment for previously untreated multiple myeloma (MM) using long-term follow-up data from the phase 3 VISTA and PETHEMA/GEM05 trials
(95% CI: 58-88%), respectively. A formal interim analysis of the Day 90 CR rate was conducted when 65 patients were evaluable, and at that time the Mel only arm was determined to be superior. The study was, therefore, stopped early by the Institutional DSMB. However, with a longer follow up Bu-Mel ultimately resulted in better PFS. Conclusions: Bu-Mel was associated with a significantly lower day 90 CR rate and a significantly higher rate of grade 3-4 non-hematologic toxicity, compared to Mel. However, after a median follow up of 15.7 months, PFS was significantly longer in the Bu-Mel arm. Figure 1 PFS from Day 90 by Treatment Arm