High response rate to bortezomib with or without dexamethasone in patients with relapsed or refractory multiple myeloma: Results of a global phase 3b expanded access program

Joseph R. Mikhael, Andrew R. Belch, H. Miles Prince, Maria Nambo Lucio, Angelo Maiolino, Alessandro Corso, Maria Teresa Petrucci, Pellegrino Musto, Mieczyslaw Komarnicki, A. Keith Stewart

Research output: Contribution to journalArticle

91 Scopus citations

Abstract

Phase 2 trials have demonstrated that bortezomib ± dexamethasone is safe and effective in relapsed multiple myeloma (MM). In this multicentre, open-label, phase 3b trial, 638 patients with relapsed or refractory MM (median 3 prior therapies) received bortezomib 1.3 mg/m2 on days 1, 4, 8, and 11 of a maximum of eight 3-week cycles (median 5 cycles). Dexamethasone 20 mg/d was added the day of and day after each bortezomib dose for progressive disease after ≥2 cycles or for stable disease after ≥4 cycles. Responses were assessed based on M-protein changes. Overall response rate was 67%, including 11% complete (100% M-protein reduction), 22% very good partial (75-99% reduction), 18% partial (50-74% reduction), and 16% minimal response (25-49% reduction). Dexamethasone was added in 208 patients (33%), of whom 70 (34%) showed improved response. Median time to best response of minimal response or better was 84 d. Most common grade 3/4 adverse events were thrombocytopenia (39%), neutropenia (16%), anaemia (12%), diarrhoea (7%), and peripheral neuropathy (6%). Neuropathy (any grade) was seen in 25% of the patients and led to discontinuation in 5%. Bortezomib, alone and combined with dexamethasone, is safe and effective in heavily pretreated patients with relapsed or refractory MM.

Original languageEnglish (US)
Pages (from-to)169-175
Number of pages7
JournalBritish journal of haematology
Volume144
Issue number2
DOIs
StatePublished - Jan 1 2009

Keywords

  • Bortezomib
  • Dexamethasone
  • Expanded access
  • M-protein reduction
  • Multiple myeloma

ASJC Scopus subject areas

  • Hematology

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