内科学
来那度胺
耐火材料(行星科学)
肿瘤科
临床研究阶段
胃肠病学
沙利度胺
作者
Meletios A. Dimopoulos,Katja Weisel,Niels W.C.J. van de Donk,Karthik Ramasamy,Barbara Gamberi,Matthew Streetly,Massimo Offidani,Frank Bridoux,Javier de la Rubia,Maria-Victoria Mateos,Antonio Ardizzoia,Elisabeth Kueenburg,Shona Collins,Antonia Di Micco,Barbara Rosettani,Yan Li,Pamela Bacon,Pieter Sonneveld
标识
DOI:10.1200/jco.2017.76.1742
摘要
PurposeRenal impairment (RI) limits treatment options in patients with relapsed/refractory multiple myeloma (RRMM). Here, we prospectively studied pomalidomide plus low-dose dexamethasone (LoDEX) in patients with RRMM and moderate or severe RI, including those receiving hemodialysis.Patients and MethodsMM-013, a noncomparative, European phase II trial, enrolled three patient cohorts: moderate RI (cohort A; estimated glomerular filtration rate, 30 to < 45 mL/min/1.73 m2); severe RI (cohort B; estimated glomerular filtration rate, < 30 mL/min/1.73 m2); and severe RI that requires hemodialysis (cohort C). Patients received pomalidomide 4 mg/d on days 1 to 21 and LoDEX 20 or 40 mg once per week in 28-day cycles. The primary end point was overall response rate.ResultsOf 81 enrolled patients (33, 34, and 14 patients in cohorts A, B, and C, respectively), 13 were still receiving treatment at data cutoff (January 28, 2017). Overall response rates were 39.4%, 32.4%, and 14.3%, with a median duration of response of...
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