A prospective, international phase 2 study of bortezomib retreatment in patients with relapsed multiple myeloma

Maria T. Petrucci, Pilar Giraldo, Paolo Corradini, Adriana Teixeira, Meletios A. Dimopoulos, Igor W. Blau, Johannes Drach, Ralf Angermund, Nathalie Allietta, Esther Broer, Vivien Mitchell, Joan Bladé

Research output: Contribution to journalArticlepeer-review

Abstract

Multiple myeloma (MM) typically follows a relapsing course with many patients requiring multiple therapies. This single-arm phase 2 study prospectively evaluated the efficacy and safety of bortezomib retreatment in MM patients who had relapsed after achieving at least a partial response (≥PR) to prior bortezomib-based therapy. Patients aged ≥18years, with measurable, secretory MM, who relapsed ≥6months after prior bortezomib treatment were eligible. Patients received up to eight cycles of bortezomib (±dexamethasone). The primary endpoint was best confirmed response at retreatment; secondary endpoints included duration of response (DOR), time to progression (TTP), and safety. Adverse events (AEs) were graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0. A total of 130 patients (median of two prior lines of therapy) were enrolled and received retreatment. At retreatment, 28% and 72% of patients received bortezomib and bortezomib-dexamethasone, respectively. Overall response rate was 40%. In patients who achieved ≥PR, median DOR and TTP were 6·5 and 8·4months, respectively. Thrombocytopenia was the most common grade ≥3 AE (35%). Forty percent of patients experienced neuropathy events, which improved and resolved in a median of 1·5 and 8·9months, respectively. In conclusion, bortezomib retreatment was effective and tolerable in relapsed MM patients, with no evidence of cumulative toxicities.

Original languageEnglish
Pages (from-to)649-659
Number of pages11
JournalBritish Journal of Haematology
Volume160
Issue number5
DOIs
Publication statusPublished - Mar 2013

Keywords

  • Bortezomib
  • Multiple myeloma
  • Phase 2
  • Relapsed
  • Retreatment

ASJC Scopus subject areas

  • Hematology

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