A phase 1 study of bendamustine and melphalan conditioning for autologous stem cell transplantation in multiple myeloma. Academic Article uri icon

Overview

MeSH

  • Adult
  • Aged
  • Bendamustine Hydrochloride
  • Combined Modality Therapy
  • Dose-Response Relationship, Drug
  • Female
  • Humans
  • Male
  • Melphalan
  • Middle Aged
  • Transplantation, Autologous

MeSH Major

  • Antineoplastic Combined Chemotherapy Protocols
  • Hematopoietic Stem Cell Transplantation
  • Multiple Myeloma
  • Nitrogen Mustard Compounds
  • Transplantation Conditioning

abstract

  • Bendamustine has efficacy in multiple myeloma with a toxicity profile limited to myelosuppression. We hypothesized that adding bendamustine to autologous stem cell transplant conditioning in myeloma would enhance response without significant additional toxicity. We conducted a phase 1 trial adding escalating doses of bendamustine to the current standard conditioning of melphalan 200 mg/m(2). Twenty-five subjects were enrolled into 6 cohorts. A maximum tolerated dose was not encountered and the highest dose level cohort of bendamustine 225 mg/m(2) + melphalan 200 mg/m(2) was expanded to further evaluate safety. Overall, there was no transplant related mortality and only one grade 4 dose-limiting toxicity was observed. Median number of days to neutrophil and platelet engraftment were 11 (range, 9 to 14) and 13 (range, 10 to 21), respectively. Disease responses at day +100 posttransplantation were progression in 5 (21%), partial response in 1 (4%), very good partial response in 7 (33%), complete response in 1 (4%), and stringent complete response in 9 (38%). Six patients (24%) with pre-existing high-risk disease died from progressive myeloma during study follow-up, all at or beyond 100 days after autologous stem cell transplant. Bendamustine up to a dose of 225 mg/m(2) added to autologous stem cell transplantation conditioning with high-dose melphalan in patients with multiple myeloma did not exacerbate expected toxicities. Copyright © 2013 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

publication date

  • May 2013

has subject area

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols
  • Bendamustine Hydrochloride
  • Combined Modality Therapy
  • Dose-Response Relationship, Drug
  • Female
  • Hematopoietic Stem Cell Transplantation
  • Humans
  • Male
  • Melphalan
  • Middle Aged
  • Multiple Myeloma
  • Nitrogen Mustard Compounds
  • Transplantation Conditioning
  • Transplantation, Autologous

Research

keywords

  • Clinical Trial, Phase I
  • Journal Article

Identity

Language

  • eng

PubMed Central ID

  • PMC3985064

Digital Object Identifier (DOI)

  • 10.1016/j.bbmt.2013.02.013

PubMed ID

  • 23454184

Additional Document Info

start page

  • 831

end page

  • 837

volume

  • 19

number

  • 5