Effects of single-agent bortezomib as post-transplant consolidation therapy on multiple myeloma-related bone disease: a randomized phase II study

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F61988987%3A17110%2F17%3AA1801R67" target="_blank" >RIV/61988987:17110/17:A1801R67 - isvavai.cz</a>

Alternative codes found

RIV/00843989:_____/17:E0106407

Result on the web

<a href="http://dx.doi.org/10.1111/bjh.14637" target="_blank" >http://dx.doi.org/10.1111/bjh.14637</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1111/bjh.14637" target="_blank" >10.1111/bjh.14637</a>

Result language

angličtina

Original language name

Effects of single-agent bortezomib as post-transplant consolidation therapy on multiple myeloma-related bone disease: a randomized phase II study

Original language description

This phase II study explored the effects of bortezomib consolidation versus observation on myeloma-related bone disease in patients who had a partial response or better after frontline high-dose therapy and autologous stem cell transplantation. Patients were randomized to receive four 35-day cycles of bortezomib 1.6 mg/m 2 intravenously on days 1, 8, 15 and 22, or an equivalent observation period, and followed up for disease status/survival. The modified intent-to-treat population included 104 patients (51 bortezomib, 53 observation). There were no meaningful differences in the primary endpoint of change from baseline to end of treatment in bone mineral density (BMD). End-of-treatment rates (bortezomib versus observation) of complete response/stringent complete response were 22% vs. 11% (P = 0.19), very good partial response or better of 80% vs. 68% (P = 0.17), and progressive disease of 8% vs. 23% (P = 0.06); median progression-free survival was 44.9 months vs. 21.8 months (P = 0.22). Adverse events observed >= 15% more frequently with bortezomib versus observation were diarrhoea (37% vs. 0), peripheral sensory neuropathy (20% vs. 4%), nausea (18% vs. 0) and vomiting (16% vs. 0). Compared with observation, bortezomib appeared to have little impact on bone metabolism/health, but was associated with trends for improved myeloma response and survival.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

—

OECD FORD branch

30205 - Hematology

Project

—

Continuities

V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Publication year

2017

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

BRITISH JOURNAL OF HAEMATOLOGY

ISSN

0007-1048

e-ISSN

1365-2141

Volume of the periodical

178

Issue of the periodical within the volume

1

Country of publishing house

GB - UNITED KINGDOM

Number of pages

11

Pages from-to

61-71

UT code for WoS article

000404042700009

EID of the result in the Scopus database

2-s2.0-85017353559