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 NCT01539083.
Keywords:
Bortezomib; consolidation; multiple myeloma; phase 3.
Publication types
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Clinical Trial, Phase III
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Multicenter Study
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Randomized Controlled Trial
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Research Support, Non-U.S. Gov't
MeSH terms
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Administration, Oral
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Adult
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Aged
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Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
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Antineoplastic Combined Chemotherapy Protocols / adverse effects
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Bortezomib / administration & dosage
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Bortezomib / adverse effects
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Chemotherapy, Adjuvant / methods
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Consolidation Chemotherapy / adverse effects
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Consolidation Chemotherapy / methods*
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Cyclophosphamide / administration & dosage
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Cyclophosphamide / adverse effects
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Dexamethasone / administration & dosage
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Dexamethasone / adverse effects
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Disease-Free Survival
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Female
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Hematopoietic Stem Cell Transplantation*
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Humans
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Induction Chemotherapy / adverse effects
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Induction Chemotherapy / methods*
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Injections, Subcutaneous
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Male
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Middle Aged
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Multiple Myeloma / mortality
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Multiple Myeloma / therapy*
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Neoadjuvant Therapy / adverse effects
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Neoadjuvant Therapy / methods
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Prednisolone / administration & dosage
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Prednisolone / adverse effects
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Progression-Free Survival
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Thalidomide / administration & dosage
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Thalidomide / adverse effects
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Transplantation, Autologous
Substances
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Thalidomide
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Bortezomib
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Dexamethasone
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Cyclophosphamide
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Prednisolone
Associated data
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ClinicalTrials.gov/NCT01539083