Phase 3 study of subcutaneous bortezomib, thalidomide, and prednisolone consolidation after subcutaneous bortezomib-based induction and autologous stem cell transplantation in patients with previously untreated multiple myeloma: the VCAT study. Issue 9 (29th July 2019)

• Record Type: Journal Article
• Authors: Horvath, Noemi; Spencer, Andrew; Kenealy, Melita; Joshua, Douglas; Campbell, Philip J; Lee, Je-Jung; Hou, Jian; Qiu, Lugui; Kalff, Anna; Khong, Tiffany; Londhe, Anil; Siggins, Sarah; van Kooten Losio, Maximiliano; Eisbacher, Michael; Prince, H. Miles
• Is Part Of: Leukemia & lymphoma. Volume 60:Issue 9(2019)
• Page Start: 2122
• Page End: 2133
• Publication Date: 2019-07-29
• Subjects: Bortezomib -- multiple myeloma -- consolidation -- phase 3; Leukemia -- Periodicals; Lymphomas -- Periodicals; 616.99419
• DOI: 10.1080/10428194.2019.1579322
• Languages: English
• ISSNs: 1042-8194

Abstract

Abstract: Efficacy and safety of bortezomib-based consolidation following ASCT were investigated in newly diagnosed multiple myeloma patients from Australia, Korea, and China. Patients received three cycles of bortezomib-cyclophosphamide-dexamethasone induction followed by high-dose therapy/ASCT, then were randomized (1:1) to consolidation with TP (thalidomide 100 mg/d for ≤12 months/until disease progression; prednisolone 50 mg on alternate days indefinitely/until disease progression; n = 100) or VTP (subcutaneous bortezomib 1.3 mg/m 2 every 2 weeks for 32 weeks, plus TP; n = 103). The hypothesized difference in CR + VGPR rate (after ≤12 months consolidation therapy) was not met. The rate of CR + VGPR was numerically higher with VTP versus TP; however, this was not statistically significant (85.7% versus 77.1%; rate difference 8.6%; 95% confidence interval −2.3%–19.5%; p = .122). Secondary efficacy outcomes were similar between treatment arms. Addition of bortezomib to TP consolidation was associated with limited additional toxicity but did not significantly improve efficacy versus TP. Trial registration: ClinicalTrials.gov identifier: NCT01539083.