Document Detail


Phase I/II trial assessing bendamustine plus bortezomib combination therapy for the treatment of patients with relapsed or refractory multiple myeloma.
MedLine Citation:
PMID:  23150919     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Bendamustine, active in multiple myeloma (MM), is a bifunctional mechlorethamine derivative with alkylating properties. Bortezomib, approved to treat MM, is effective in combination with alkylators. The tolerability and efficacy of bendamustine plus bortezomib in relapsed/refractory MM was assessed in an open-label, dose-escalating, phase I/II study. Patients aged ≥18 years received intravenous bendamustine 50, 70, or 90 mg/m(2) (days 1 and 4) plus bortezomib 1·0 mg/m(2) (days 1, 4, 8, and 11) for up to eight 28-day cycles. No dose-limiting toxicity was observed after cycle 1; bendamustine 90 mg/m(2) plus bortezomib 1·0 mg/m(2) was designated the maximum tolerated dose (MTD). The most common grade 3/4 adverse events were leucopenia (58%), neutropenia (50%), lymphopenia (45%), and thrombocytopenia (30%). Primary efficacy measure was overall response rate (ORR), which was the combined complete response (CR), very good partial response (VGPR), partial response (PR), and minimal response (MR). ORR was 48% (one CR, two VGPR, nine PR, and seven MR) for all 40 enrolled patients, 52% (16/31) at the MTD (90 mg/m(2) ), and 42% and 46% for prior use of bortezomib (n = 31) or alkylators (n = 28) respectively. Bendamustine plus bortezomib was well tolerated with promising efficacy in this heavily pretreated population.
Authors:
James R Berenson; Ori Yellin; Alberto Bessudo; Ralph V Boccia; Stephen J Noga; Donald S Gravenor; Dipti Patel-Donnelly; Robert S Siegel; Tarun Kewalramani; Edward J Gorak; Youram Nassir; Regina A Swift; Debra Mayo
Related Documents :
24090529 - The usual treatment of trigeminal autonomic cephalalgias.
23609389 - Tolerability, pharmacokinetics, and pharmacodynamics of single-dose almorexant, an orex...
23929659 - Clinical pharmacokinetics, pharmacodynamics, safety and tolerability of darexaban, an o...
18162319 - Peripheral administration of cdp-choline and its cholinergic metabolites increases seru...
24224579 - A new algorithm for weekly phenprocoumon dose variation in a southern brazilian populat...
24134659 - Safety, tolerability, and pharmacokinetics of 6-month daily dosing of an oral formulati...
8836109 - Oligoradionuclidetherapy using radiolabelled antisense oligodeoxynucleotide phosphoroth...
10898429 - Electrical behavior of t-wave polarity alternans in patients with congenital long qt sy...
11555179 - Disposition of oxytetracycline in pigs after i.m. administration of two long-acting for...
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-11-15
Journal Detail:
Title:  British journal of haematology     Volume:  -     ISSN:  1365-2141     ISO Abbreviation:  Br. J. Haematol.     Publication Date:  2012 Nov 
Date Detail:
Created Date:  2012-11-15     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0372544     Medline TA:  Br J Haematol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
© 2012 Blackwell Publishing Ltd.
Affiliation:
Oncotherapeutics, West Hollywood, CA, USA; James R. Berenson, MD, Inc., Los Angeles, CA, USA; Institute for Myeloma and Bone Cancer Research, Los Angeles, CA, USA.
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Descriptor/Qualifier:

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


Previous Document:  Identification of Patients with Painful Diabetic Peripheral Neuropathy Who Have a Favorable Cost Pro...
Next Document:  A Review on One-Dimensional Ternary Germanate Nanomaterials.