达拉图穆马
地塞米松
硼替佐米
医学
多发性骨髓瘤
耐火材料(行星科学)
肿瘤科
内科学
临床试验
材料科学
复合材料
作者
Lisa Leypoldt,Maria Gavriatopoulou,Britta Besemer,Hans Salwender,Marc S. Raab,Axel Nogai,Cyrus Khandanpour,Volker Runde,Anna Jauch,Manola Zago,Peter Martus,Hartmut Goldschmidt,Carsten Bokemeyer,Meletios Α. Dimopoulos,Katja Weisel
出处
期刊:Cancers
[MDPI AG]
日期:2023-09-21
卷期号:15 (18): 4667-4667
被引量:1
标识
DOI:10.3390/cancers15184667
摘要
Renal function impairment (RI) is a common complication in multiple myeloma (MM). However, limited data exist on the safety and efficacy of anti-MM regimens in patients with severe RI, as these patients are frequently excluded from clinical trials. This investigator-initiated multicentric phase II GMMG-DANTE trial evaluated daratumumab, bortezomib, and dexamethasone (DVd) in relapsed or refractory (r/r) MM patients with severe RI. r/rMM patients with ≥1 prior treatment line and a GFR <30 mL/min/1.73 m2 or undergoing hemodialysis were eligible and received eight cycles of DVd followed by daratumumab maintenance. The trial closed prematurely after 22/36 planned patients. The primary endpoint was overall response rate (ORR). Median age of patients was 70 (range 55–89) years, with a median GFR of 20.1 mL/min/1.73 m2 (interquartile range, 9.4–27.3 mL/min/1.73 m2), and eight patients under hemodialysis. Median number of prior lines was two (range 1–10). The trial was successful, albeit with premature termination, as it met its primary endpoint, with an ORR of 67% (14/21). The rates of partial response, very good partial response, and complete response were 29%, 29%, and 10%, respectively (n = 6, 6, and 2). Fourteen patients (67%) achieved renal response. After median follow-up of 28 months, median progression-free survival was 10.4 months; median overall survival was not reached. Higher-grade toxicity was mainly hematologic, and non-hematologic toxicities ≥Grade 3 were mostly infections (24%). The prospective GMMG-DANTE trial investigating DVd exclusively in r/rMM patients with severe RI showed efficacy and safety to be comparable to data from patients without RI.
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