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

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/m² 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.

Keywords:

• Bortezomib
• multiple myeloma
• consolidation
• phase 3

Acknowledgments

The authors would like to thank all patients and their families, and investigators at all study sites for their valuable contributions to the study.

Potential conflict of interest:

Disclosure forms provided by the authors are available with the full text of this article online at https://doi.org/10.1080/10428194.2019.1579322.

Noemi Horvath: Advisory board, funding for home chemotherapy and clinical trial support from Janssen Pharmaceutica. Andrew Spencer: Honorarium and research funding from Janssen and Celgene.

Additional information

Funding

Writing support during the development of this manuscript was provided by Helen Kitchen of FireKite, an Ashfield company, part of UDG Healthcare Plc, which was funded by Janssen Global Services, LLC, and Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited. Study funding support from Janssen Pharmaceutica NV.