Intravenous injection of bortezomib, melphalan and dexamethasone in refractory and relapsed multiple myeloma

Ann Oncol. 2013 Apr;24(4):1038-44. doi: 10.1093/annonc/mds531. Epub 2012 Nov 7.

Abstract

Background: A combination of bortezomib (1.3 mg/m(2)), melphalan (5 mg/m(2)), and dexamethasone (40 mg) (BMD), with all three drugs given as a contemporary intravenous administration, was retrospectively evaluated.

Patients and methods: Fifty previously treated (median 2 previous lines) patients with myeloma (33 relapsed and 17 refractory) were assessed. The first 19 patients were treated with a twice-a-week (days 1, 4, 8, 11, 'base' schedule) administration while, in the remaining 31 patients, the three drugs were administered once a week (days 1, 8, 15, 22, 'weekly' schedule).

Results: Side-effects were predictable and manageable, with prominent haematological toxicity, and a better toxic profile in 'weekly' schedule (36% versus 66% in 'base' schedule). The overall response rate was 62%. After median follow-up of 24.5 months (range 2.7-50 months), the median progression-free survival (PFS) was 21.6 with no difference between the two schedules and the median overall survival (OS) was 33.8 months. Independently from the adopted schedule, we found that also in a cohort of relapsed/refractory patients achieving at least partial remission improved PFS (35.2 versus 9 months) and OS (unreached median versus 18 months).

Conclusion: Taken together, our observations suggest that BMD is an effective regimen in advanced myeloma patients with acceptable toxicity.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Boronic Acids / administration & dosage*
  • Boronic Acids / adverse effects
  • Bortezomib
  • Dexamethasone / administration & dosage*
  • Dexamethasone / adverse effects
  • Disease-Free Survival
  • Drug Administration Schedule
  • Drug-Related Side Effects and Adverse Reactions / chemically induced
  • Drug-Related Side Effects and Adverse Reactions / pathology
  • Female
  • Follow-Up Studies
  • Humans
  • Injections, Intravenous
  • Male
  • Melphalan / administration & dosage*
  • Melphalan / adverse effects
  • Middle Aged
  • Multiple Myeloma / drug therapy*
  • Multiple Myeloma / pathology
  • Pyrazines / administration & dosage*
  • Pyrazines / adverse effects
  • Recurrence
  • Retrospective Studies
  • Treatment Outcome

Substances

  • Boronic Acids
  • Pyrazines
  • Bortezomib
  • Dexamethasone
  • Melphalan