A phase I/II dose-escalation study investigating all-oral ixazomib-melphalanprednisone induction followed by single-agent ixazomib maintenance in transplant-ineligible newly diagnosed multiple myeloma

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F61988987%3A17110%2F18%3AA1901Z5A" target="_blank" >RIV/61988987:17110/18:A1901Z5A - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216208:11110/18:10380186 RIV/00843989:_____/18:E0107216 RIV/00064165:_____/18:10380186

Výsledek na webu

<a href="https://www.scopus.com/record/display.uri?eid=2-s2.0-85052862039&origin=resultslist&sort=plf-f&src=s&st1=A+phase+I%2fII+dose-escalation+study+investigating+all-oral+ixazomib-melphalanprednisone+induction+followed+by+single-agent+ixazomib+maintenance+in+t" target="_blank" >https://www.scopus.com/record/display.uri?eid=2-s2.0-85052862039&origin=resultslist&sort=plf-f&src=s&st1=A+phase+I%2fII+dose-escalation+study+investigating+all-oral+ixazomib-melphalanprednisone+induction+followed+by+single-agent+ixazomib+maintenance+in+t</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.3324/haematol.2017.185991" target="_blank" >10.3324/haematol.2017.185991</a>

Jazyk výsledku

angličtina

Název v původním jazyce

A phase I/II dose-escalation study investigating all-oral ixazomib-melphalanprednisone induction followed by single-agent ixazomib maintenance in transplant-ineligible newly diagnosed multiple myeloma

Popis výsledku v původním jazyce

This phase I/II dose-escalation study investigated the all-oral ixazomib-melphalan-prednisone regimen, followed by Tsingle-agent ixazomib maintenance, in elderly, transplant-ineligible patients with newly diagnosed multiple myeloma. Primary phase I objectives were to determine the safety and recommended phase II dose of ixazomib-melphalan-prednisone. The primary phase II objective was to determine the complete plus very good partial response rate. In phase I, patients were enrolled to 4 arms investigating weekly or twice-weekly ixazomib (13 28-day cycles or nine 42-day cycles) plus melphalan-prednisone. In phase II, an expansion cohort was enrolled at the recommended phase II ixazomib dose. Of the 61 patients enrolled, 26 received the recommended phase II dose (ixazomib 4.0 mg [days 1, 8, 15] plus melphalan-prednisone 60 mg/m 2 [days 1-4], 28-day cycles). Of 2 the 61 enrolled patients, 36 (13 of 26 in the recommended phase II dose cohort) received single-agent ixazomib maintenance (days 1, 8, 15; 28-day cycles). In phase I, 10/38 patients reported dose-limiting toxicities in cycle 1, including grade 3 and/or 4 neutropenia (n=6) and thrombocytopenia (n=4). Complete plus very good partial response rate was 48% (48% at recommended phase II dose), including 28% (22%) complete response or better; responses deepened during maintenance in 34% (33%) of evaluable patients. After median follow up of 43.6 months, median progression-free survival was 22.1 months. Adverse events were mainly hematologic events, gastrointestinal events, and peripheral neuropathy. This study demonstrates the feasibility, tolerability, and activity of ixazomib-melphalan-prednisone induction and single-agent ixazomib maintenance in transplant-ineligible newly diagnosed multiple myeloma patients.

Název v anglickém jazyce

A phase I/II dose-escalation study investigating all-oral ixazomib-melphalanprednisone induction followed by single-agent ixazomib maintenance in transplant-ineligible newly diagnosed multiple myeloma

Popis výsledku anglicky

This phase I/II dose-escalation study investigated the all-oral ixazomib-melphalan-prednisone regimen, followed by Tsingle-agent ixazomib maintenance, in elderly, transplant-ineligible patients with newly diagnosed multiple myeloma. Primary phase I objectives were to determine the safety and recommended phase II dose of ixazomib-melphalan-prednisone. The primary phase II objective was to determine the complete plus very good partial response rate. In phase I, patients were enrolled to 4 arms investigating weekly or twice-weekly ixazomib (13 28-day cycles or nine 42-day cycles) plus melphalan-prednisone. In phase II, an expansion cohort was enrolled at the recommended phase II ixazomib dose. Of the 61 patients enrolled, 26 received the recommended phase II dose (ixazomib 4.0 mg [days 1, 8, 15] plus melphalan-prednisone 60 mg/m 2 [days 1-4], 28-day cycles). Of 2 the 61 enrolled patients, 36 (13 of 26 in the recommended phase II dose cohort) received single-agent ixazomib maintenance (days 1, 8, 15; 28-day cycles). In phase I, 10/38 patients reported dose-limiting toxicities in cycle 1, including grade 3 and/or 4 neutropenia (n=6) and thrombocytopenia (n=4). Complete plus very good partial response rate was 48% (48% at recommended phase II dose), including 28% (22%) complete response or better; responses deepened during maintenance in 34% (33%) of evaluable patients. After median follow up of 43.6 months, median progression-free survival was 22.1 months. Adverse events were mainly hematologic events, gastrointestinal events, and peripheral neuropathy. This study demonstrates the feasibility, tolerability, and activity of ixazomib-melphalan-prednisone induction and single-agent ixazomib maintenance in transplant-ineligible newly diagnosed multiple myeloma patients.

Druh

J_SC - Článek v periodiku v databázi SCOPUS

CEP obor

—

OECD FORD obor

30204 - Oncology

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2018

Kód důvěrnosti údajů

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

Název periodika

HAEMATOL-HEMATOL J

ISSN

0390-6078

e-ISSN

—

Svazek periodika

103

Číslo periodika v rámci svazku

9

Stát vydavatele periodika

IT - Italská republika

Počet stran výsledku

9

Strana od-do

1518-1526

Kód UT WoS článku

—

EID výsledku v databázi Scopus

2-s2.0-85052862039