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

TitleA phase 1 study of bendamustine and melphalan conditioning for autologous stem cell transplantation in multiple myeloma.
Publication TypeJournal Article
Year of Publication2013
AuthorsMark TM, Reid W, Niesvizky R, Gergis U, Pearse R, Mayer S, Greenberg J, Coleman M, van Besien K, Shore T
JournalBiol Blood Marrow Transplant
Volume19
Issue5
Pagination831-7
Date Published2013 May
ISSN1523-6536
KeywordsAdult, 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
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.

DOI10.1016/j.bbmt.2013.02.013
Alternate JournalBiol. Blood Marrow Transplant.
PubMed ID23454184
PubMed Central IDPMC3985064
Grant ListUL1 TR000457 / TR / NCATS NIH HHS / United States