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

Kód výsledku v 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>

Nalezeny alternativní kódy

RIV/00843989:_____/17:E0106407

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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.

Název v anglickém jazyce

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

Popis výsledku anglicky

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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30205 - Hematology

Projekt

—

Návaznosti

V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Rok uplatnění

2017

Kód důvěrnosti údajů

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

Název periodika

BRITISH JOURNAL OF HAEMATOLOGY

ISSN

0007-1048

e-ISSN

1365-2141

Svazek periodika

178

Číslo periodika v rámci svazku

1

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

11

Strana od-do

61-71

Kód UT WoS článku

000404042700009

EID výsledku v databázi Scopus

2-s2.0-85017353559