Retreatment and prolonged therapy with subcutaneous bortezomib in patients with relapsed multiple myeloma: A randomized, controlled, phase III study
European Journal of Haematology Aug 16, 2017
Terpos E, et al. Â The effects of experimental retreatment with subcutaneous bortezomib plus dexamethasone (VD) followed by prolonged bortezomib therapy vs. standard VD retreatment were examined in patients with relapsed/refractory multiple myeloma. Based on the data obtained, there was no significant benefit noted with experimental vs. standard VD retreatment therapy.
Methods
- The clinicians randomized patients (2:1) to receive either experimental (n = 53) or standard (n = 27) retreatment, stratified by the number of prior therapy lines.
Results
- It was reported that the study was terminated prematurely with insufficient enrollment to adequately compare the retreatment therapies.
- In addition, results should be considered descriptive.
- The median progression-free survival (primary endpoint) was 7.2 months (95% confidence interval 5.7Â9.0) vs. 7.8 months (4.9Â11.7), after a median follow-up of 21.2 and 20.0 months in the experimental and standard arms, respectively.
- For experimental and standard retreatment regimens, the overall response rate was 66% and 52%, respectively.
- The most common and most differentially observed grade ≥3 adverse event (experimental: 9% vs. standard: 22%) was thrombocytopenia.
- They reported any-grade peripheral neuropathies (including peripheral sensory neuropathies) in 23% vs. 37% of patients.
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