来那度胺
医学
多发性骨髓瘤
硼替佐米
地塞米松
内科学
不利影响
肿瘤科
胃肠病学
外科
作者
Andrzej Jakubowiak,Kent A. Griffith,Donna Reece,Craig C. Hofmeister,Sagar Lonial,Todd Zimmerman,Erica Campagnaro,Robert Schlossman,Jacob P. Laubach,Noopur Raje,Tara Anderson,Melissa A. Mietzel,Colleen K Harvey,Sandra Wear,Jennifer Barrickman,Craig Tendler,Dixie Lee Esseltine,Susan L. Kelley,Mark Kaminski,Kenneth C. Anderson,Paul G. Richardson
出处
期刊:Blood
[American Society of Hematology]
日期:2011-07-21
卷期号:118 (3): 535-543
被引量:81
标识
DOI:10.1182/blood-2011-02-334755
摘要
Abstract This phase 1/2 trial evaluated combination lenalidomide, bortezomib, pegylated liposomal doxorubicin, and dexamethasone (RVDD) in newly diagnosed multiple myeloma (MM) patients. Patients received RVDD at 4 dose levels, including the maximum tolerated dose (MTD). Patients with a very good partial response or better (≥ VGPR) after cycle 4 proceeded to autologous stem cell transplantation or continued treatment. The primary objectives were MTD evaluation and response to RVDD after 4 and 8 cycles. Seventy-two patients received a median of 4.5 cycles. The MTDs were lenalidomide 25 mg, bortezomib 1.3 mg/m2, pegylated liposomal doxorubicin 30 mg/m2, and dexamethasone 20/10 mg, as established with 3-week cycles. The most common adverse events were fatigue, constipation, sensory neuropathy, and infection; there was no treatment-related mortality. Response rates after 4 and 8 cycles were 96% and 95% partial response or better, 57% and 65% ≥ VGPR, and 29% and 35% complete or near-complete response, respectively. After a median follow-up of 15.5 months, median progression-free survival (PFS) and overall survival (OS) were not reached. The estimated 18-month PFS and OS were 80.8% and 98.6%, respectively. RVDD was generally well tolerated and highly active, warranting further study in newly diagnosed MM patients. This trial was registered at www.clinicaltrials.gov as NCT00724568.
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