A phase II study of V-BEAM as conditioning regimen before second auto-SCT for multiple myeloma

Bone Marrow Transplant. 2014 Nov;49(11):1366-70. doi: 10.1038/bmt.2014.163. Epub 2014 Jul 28.

Abstract

High-dose melphalan has been the standard conditioning regimen for auto-SCT in multiple myeloma (MM) for decades. A more effective conditioning regimen may induce deeper responses and longer remission duration. It is especially needed in the setting of second auto-SCT, which rarely achieves comparable results with the first auto-SCT using the same conditioning regimen. Here we conducted a phase II study to investigate the efficacy and safety of a conditioning regimen V-BEAM (bortezomib-BEAM) before second auto-SCT for multiple myeloma. Ten patients were enrolled from September 2012 to May 2013. The CR rate at day +100 after auto-SCT was 75%; all except for one patient remained in remission after a median follow-up of 6 months. Three patients developed Clostridium difficile infection. Two patients died within the first 30 days of auto-SCT from neutropenic colitis and overwhelming sepsis, respectively. Due to the high rate of morbidity and mortality, the study was terminated after 10 patients. In summary, although the conditioning regimen V-BEAM before second auto-SCT for MM provided promising responses, it was associated with unexpected treatment-related toxicity and should not be investigated further without modifications.

Publication types

  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Antineoplastic Combined Chemotherapy Protocols* / administration & dosage
  • Antineoplastic Combined Chemotherapy Protocols* / adverse effects
  • Autografts
  • Boronic Acids* / administration & dosage
  • Boronic Acids* / adverse effects
  • Bortezomib
  • Carmustine / administration & dosage
  • Carmustine / adverse effects
  • Cytarabine / administration & dosage
  • Cytarabine / adverse effects
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Melphalan / administration & dosage
  • Melphalan / adverse effects
  • Middle Aged
  • Multiple Myeloma* / mortality
  • Multiple Myeloma* / therapy
  • Podophyllotoxin / administration & dosage
  • Podophyllotoxin / adverse effects
  • Pyrazines* / administration & dosage
  • Pyrazines* / adverse effects
  • Stem Cell Transplantation*
  • Transplantation Conditioning* / adverse effects
  • Transplantation Conditioning* / methods

Substances

  • Boronic Acids
  • Pyrazines
  • Cytarabine
  • Bortezomib
  • Podophyllotoxin
  • Melphalan
  • Carmustine

Supplementary concepts

  • BEAM protocol