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- W2222906927 abstract "17537 Background: We previously treated 26 patients with relapsed/refractory multiple myeloma (MM) with thalidomide (Thal), dexamethasone (Dex) and zoledronic acid (Zol); dtZ regimen; and demonstrated an overall response rate of 75.0%. However, the rate immunofixation (IF)-negative complete remissions (CR) was only 7.7%. Recently, the bortezomib (Velcade) has been shown to be effective against MM. In this study, we added bortezomib (Vel) to dtZ (VTD-Z regimen) in a subgroup of patients to determine whether the CR rate can be improved. Methods: A non-randomized, single-arm study was conducted. Consecutive patients (n = 14) who either failed to achieve a partial response (PR) after 3 cycles; or CR after 9 cycles of dtZ were treated with 2 to 11 three-weekly cycles of VTD-Z; comprising: Vel 1.3 mg/m 2 on days 1, 4, 8 and 11; Thal 50 mg ON; Dex 20 mg OM on days 1 to 4, 8 to 11, 15 to 18; and Zol 4 mg on day 1. The primary study objective was to determine the maximal response rates (RR). The end-point of the study was maximum response, graded by Bladè’s criteria. Results: Fourteen patients (3 males, 11 females; median age 63.3 years) were studied. Complex karyotypes, including 5 patients with deletion of chromosome 13 (del(13)), were present in 11 patients at diagnosis. The overall RR was 92.9% (13 out of 14), of which 42.9% (6) achieved CR (p < 0.001, chi-squared test). In addition, 21.4% (3) achieved near-CR (nCR), and 28.6% (4) achieved PR. There were no minimal responders (MR) and 1 (7.1%) non-responder (NR). Two patients who achieved CR had del(13). Painful grade 3 peripheral neuropathy was observed in 2 (14.3%) patients. Grade 1 and 2 peripheral neuropathy was observed in another 4 (25.0%) of patients; transient grade 3 thrombocytopenia was observed in 5 (35.7%) patients; and papular rashes were observed in 3 (21.4%) patients. The single NR was the only death that occurred during the period of study. Conclusions: Our study demonstrates that the VTD-Z regimen is exceptionally effective and safe in patients with relapsed/refractory MM. Addition of Vel to dtZ significantly increases the CR rate from 7.7% to 42.9%. These data suggest that combination of these 4 drugs may be at least additive, if not, even synergistic. No significant financial relationships to disclose." @default.
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- W2222906927 date "2006-06-20" @default.
- W2222906927 modified "2023-09-24" @default.
- W2222906927 title "Addition of bortezomib to thalidomide, dexamethasone and zoledronic acid (VTD-Z regimen) significantly improves complete remission rates in patients with relapsed/refractory multiple myeloma" @default.
- W2222906927 doi "https://doi.org/10.1200/jco.2006.24.18_suppl.17537" @default.
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