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multiple my7eloma;bortezomib and melphalan Article Summary

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Berenson JR et al. – Bortezomib plus melphalan is a steroid- and immunomodulatory drug-free treatment alternative for relapsed/refractory multiple myeloma (MM) pts who are elderly or with significant comorbidity

Methods

  • Study of safety and efficacy of bortezomib plus melphalan in relapsed/refractory MM
  • Administration of bortezomib (0.7, 1, or 1.3 mg/m2) on days 1, 4, 8, and 11 and oral melphalan (0.025–0.25 mg/kg) on days 1–4 of a 28-day cycle
  • Hematologic toxicities defined maximum tolerated dose: bortezomib 1 mg/m2 and melphalan 0.10 mg/kg
  • Cohorts with higher bortezomib (1.3 mg/m2) and lower melphalan (0.025 and 0.10 mg/kg) doses added due to dose-limiting toxicities of melphalan (more myelosuppressive)

Results
  • Responses in 32/46 (70%) evaluable pts: 2 complete (4%), 5 near-complete (11%), 16 partial (35%), 9 minimal (20%)
  • Complete and near-complete responses only with higher bortezomib doses
  • Response rates were similar in pts with prior melphalan or bortezomib
  • Median progression-free survival: 9 mo; overall survival: 32 mo
  • Most common grade 3/4 hematologic adverse events (AEs): neutropenia (31%/0%), thrombocytopenia (25%/2%), anemia (13%/0)

 

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