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Objective Multiple myeloma remains incurable and retreatment with available therapies is of substantial interest. Methods This retrospective observational study included data from 35 patients treated initially and at the first relapse with bortezomib-containing regimens. Results Bortezomib retreatment provided a similar depth and time to response as first-line therapy; however, as could be expected, the duration of response was shorter with retreatment. The tolerability profile was similar with bortezomib as the first- and second-line therapy, with no evidence of cumulative toxicity. Conclusion These findings support bortezomib retreatment after a treatment-free interval of ≥6 months in patients who achieved at least a partial response to the first-line bortezomib-based therapy. [ABSTRACT FROM AUTHOR]

Aims: Studies have shown that bortezomib retreatment is effective in relapsed/refractory multiple myeloma (MM). The observational, prospective electronic VELCADE® OBservational Study (eVOBS) study assessed bortezomib‐based therapies for patients with MM in everyday practice. Here, we report on those patients receiving retreatment with bortezomib. Methods: Consenting adults scheduled to receive bortezomib for MM were enrolled at 162 sites across Europe, Canada, Brazil, Russia, and Turkey between 2006 and 2010. Retrospective data on prior therapies and prospective observational data after bortezomib initiation were captured electronically at baseline, after every bortezomib cycle, and every 12 weeks after discontinuation or progression. Investigator‐assessed responses and adverse events (AEs) were evaluated. Results: Ninety‐six of 873 patients enrolled to eVOBS received bortezomib as first retreatment for progressive disease during the prospective observation period. Median age was 62 years, 53% were male, and median number of prior therapies at retreatment was 4. Overall, 41% of patients initiated bortezomib retreatment in combination with dexamethasone, 16% in combination with lenalidomide, and 21% received monotherapy. Rate of partial response or better (≥PR) was 75% at initial bortezomib therapy, including 44% complete response (CR)/near CR (nCR); at retreatment, ≥PR rate was 46%, including 15% CR/nCR. Median progression‐free survival was 11.4 months (95% confidence interval [CI]: 9.1‐12.7) from start of initial bortezomib treatment and 6.4 months (95% CI: 4.4‐7.2) from start of retreatment. Median overall survival from start of retreatment was 17.6 months (95% CI: 14.4‐23.5). Of the 96 patients retreated with bortezomib, 77% reported an AE. Peripheral neuropathy during bortezomib retreatment occurred in 49% of patients, including 10% grade 3/4. Conclusion: These data suggest that retreatment with bortezomib is a feasible option for patients with relapsed/refractory MM. [ABSTRACT FROM AUTHOR]

Previous studies have shown that retreatment of relapsed/refractory multiple myeloma (MM) with a second course of bortezomib therapy could be effective in heavily pre-treated patients. In this study, the results of a multicentre, retrospective survey were reported involving patients in Switzerland with MM who responded to initial bortezomib therapy; 43 patients were enrolled and 42 were evaluated for response. The overall response rate (complete response [CR] + near CR [nCR] + partial response [PR]) to bortezomib retreatment was 64.3%, and the clinical benefit rate (CR + nCR + PR + stable disease) for retreatment was 83%. The response rate to bortezomib retreatment in the subgroup with a first treatment-free interval (TFI) >6 months was higher than that in the subgroup with first TFI ≤6 months (74.1% vs. 46.7%) and lower in patients who received concomitant dexamethasone with bortezomib retreatment (57.1% vs. 78.6%). The median overall survival (OS) from first diagnosis of MM was 9.3 years, and after retreatment with bortezomib the median OS was 1.7 years. In total, 85.7% of patients who achieved CR or nCR with initial bortezomib treatment achieved CR or nCR with retreatment. Bortezomib as retreatment was well tolerated, and the safety profile was consistent with previous studies of bortezomib in relapsed MM. The most common adverse drug reaction attributed to bortezomib was peripheral neuropathy in 5 patients. In conclusion, bortezomib retreatment was a well-tolerated, effective therapeutic option for relapsed MM patients in the Swiss clinical setting who have previously responded to bortezomib, particularly for those who experienced an initial TFI of >6 months.

Background: Several publications reported on the safety and efficacy of bortezomib, a novel first-in-class anti-cancer agent, in the treatment of relapsed/refractory multiple myeloma in controlled clinical trials. Complementary data on the experience with bortezomib in daily oncology practice are needed. We report on the use of bortezomib to treat patients with relapsed/refractory multiple myeloma in routine clinical practice., Methods: Patients were treated at investigators' discretion within a Compassionate Use Program, allowing third-line or subsequent treatment. Post-hoc safety and efficacy analysis of patient records was performed using predefined data capture forms. Marker response was defined as a decrease in paraprotein level of at least 25% as compared to baseline., Results: Eighty-eight patients entered the program involving 62 oncologists/ haematologists (62% institutional). Median patient age was 66 years [44-86], median time since diagnosis 4 years [0.5-14], median number of previous treatments 3 [2-6]. Marker response was observed in 61% of patients (17% CR/nCR). At the time of data collection, median 4.75 months [0.5-13] after last bortezomib injection, overall median response duration was 4.5 months [1.5-22], and response was ongoing in 45% of patients. The most frequently reported adverse events were thrombocytopenia (34%), peripheral neuropathy (31%), diarrhoea (20%) and fatigue (19%). Among the cases of peripheral neuropathy, 68% were due to aggravation of a pre-existing condition and the remaining cases to onset under bortezomib. No cases of bortezomib-related haemorrhage were reported., Conclusions: Our results in daily oncology practice confirm findings from clinical trials, demonstrating high response rates and predictable adverse events in patients with relapsed/refractory multiple myeloma treated with bortezomib.