Please use this identifier to cite or link to this item: http://hdl.handle.net/11434/2044
Title: 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.
Epworth Authors: Prince, Miles
Other Authors: Horvath, Noemi
Spencer, Andrew
Kenealy, Melita
Joshua, Douglas
Campbell, Philip
Lee, Je
Hou, Jian
Qiu, Lugui
Kalff, Anna
Khong, Tiffany
Londhe, Anil
Siggins, Sarah
van Kooten Losio, Maximiliano
Eisbacher, Michael
Keywords: Bortezomib-Based Consolidation
Autologous Stem Cell Transplant (ASCT)
High-Dose Therapy
Subcutaneous Bortezomib
TP Consolidation
Multiple Myeloma
Phase 3 Study
Prednisolone Consolidation
VCAT Study
Epworth Centre for Immunotherapies and Snowdome Laboratories
Molecular Oncology and Cancer Immunology
Cancer Services Clinical Institute, Epworth HealthCare, Victoria, Australia
Issue Date: Sep-2019
Publisher: Taylor & Francis
Citation: Leukemia & lymphoma, 60(9), 2122–2133.
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.
URI: http://hdl.handle.net/11434/2044
DOI: 10.1080/10428194.2019.1579322
PubMed URL: https://pubmed.ncbi.nlm.nih.gov/30777794/
ISSN: 1042-8194
1029-2403
Journal Title: Leukemia & Lymphoma
Type: Journal Article
Affiliated Organisations: Department of Haematology, Royal Adelaide Hospital, Adelaide, Australia.
Department of Clinical Haematology, Alfred Health-Monash University, Melbourne, Australia.
Cabrini Health, Australia and Monash University, Melbourne, Australia.
Department of Haematology, Royal Prince Alfred Hospital, Australia; and Sydney University, Sydney, Australia.
Department of Haematology, Andrew Love Cancer Centre, Geelong, Australia.
Department of Hematology-Oncology, Chonnam National University Hwasun Hospital, Hwasun, Republic of Korea.
Department of Hematology, Shanghai Changzheng Hospital, Shanghai, China.
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China.
Janssen Research & Development LLC, Titusville, NJ, USA.
Janssen Cilag, Sydney, Australia.
Sir Peter MacCallum Department of Oncology, University of Melbourne, Melbourne, Australia.
Type of Clinical Study or Trial: Clinical Trial
Appears in Collections:Cancer Services

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