Affordable Access

deepdyve-link deepdyve-link
Publisher Website

Bortezomib salvage followed by a Phase I/II study of bortezomib plus high-dose melphalan and tandem autologous transplantation for patients with primary resistant myeloma.

Authors
  • Nishihori, Taiga
  • Alekshun, Todd J
  • Shain, Kenneth
  • Sullivan, Daniel M
  • Baz, Rachid
  • Perez, Lia
  • Pidala, Joseph
  • Kharfan-Dabaja, Mohamed A
  • Ochoa-Bayona, Jose L
  • Fernandez, Hugo F
  • Yarde, Danielle N
  • Oliveira, Vasco
  • Fulp, William
  • Han, Gang
  • Kim, Jongphil
  • Chen, Dung-Tsa
  • Raychaudhuri, Jyoti
  • Dalton, William
  • Anasetti, Claudio
  • Alsina, Melissa
Type
Published Article
Journal
British Journal of Haematology
Publisher
Wiley (Blackwell Publishing)
Publication Date
Jun 01, 2012
Volume
157
Issue
5
Pages
553–563
Identifiers
DOI: 10.1111/j.1365-2141.2012.09099.x
PMID: 22449149
Source
Medline
License
Unknown

Abstract

We conducted a Phase 1/2 study of bortezomib administered in combination with high-dose melphalan followed by tandem autologous transplants in patients with primary resistant multiple myeloma. Thirty patients received two cycles of salvage bortezomib followed by stem cell mobilization with granulocyte colony-stimulating factor and harvest. Melphalan 100 mg/m(2) per day on two consecutive days was administered, immediately followed by one dose of bortezomib (dose escalation) and stem cell infusion. The median beta 2-microglobulin was 4·35 mg/l (range: 1·8-11·4); albumin was 37 g/l (range: 3·1-4·9); high-risk karyotypes were noted in 45% of patients. The maximum planned dose of bortezomib at 1·3 mg/m(2) was well tolerated and a formal maximum tolerated dose was not determined. The peak of best overall response (≥partial response) and complete response rates after tandem transplants were 84% and 36%, respectively. With a median follow-up of 48 months, the median progression-free survival was 15 [95% confidence interval (CI): 11-21] months and the median overall survival was 35 (95% CI: 22-43) months. Correlative studies demonstrated decreased expression of BRCA2 (P = 0·0072) and FANCF (P = 0·0458) mRNA following bortezomib treatment. Bortezomib combined with high-dose melphalan is a well-tolerated conditioning with some activity in patients with resistant myeloma.

Report this publication

Statistics

Seen <100 times