Lenalidomide and dexamethasone in patients with relapsed multiple myeloma and impaired renal function: PrE1003, a PrECOG study

被引：20

作者：

Mikhael, Joseph ^{[1
,2
]}

Manola, Judith ^{[3
]}

Dueck, Amylou C. ^{[1
]}

Hayman, Suzanne ^{[4
]}

Oettel, Kurt ^{[5
]}

Kanate, Abraham S. ^{[6
]}

Lonial, Sagar ^{[7
]}

Rajkumar, S. Vincent ^{[4
]}

机构：

[1] Mayo Clin, Phoenix, AZ 85013 USA

[2] Int Myeloma Fdn, Los Angeles, CA 91607 USA

[3] Dana Farber Canc Inst, Boston, MA 02115 USA

[4] Mayo Clin, Rochester, MN USA

[5] Gundersen Hlth Syst, La Crosse, WI USA

[6] West Virginia Univ, Mary Babb Randolph Canc Ctr, Morgantown, WV USA

[7] Emory Univ, Winship Canc Inst, Atlanta, GA 30322 USA

来源：

BLOOD CANCER JOURNAL | 2018年 / 8卷

关键词：

PLUS DEXAMETHASONE; THERAPY; DISEASE; SAFETY;

D O I：

10.1038/s41408-018-0110-7

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Renal insufficiency is common in patients with relapsed multiple myeloma and can often limit choice of therapy. Lenalidomide, a critical agent in the treatment of relapsed multiple myeloma, is renally cleared., This phase I/II trial evaluated the efficacy and safety of lenalidomide with dexamethasone in patients with relapsed multiple myeloma and renal insufficiency. Three groups were treated, with creatinine clearance 30-60 cc/hr (group A), CrCl < 30 not on dialysis (group B), and patients on dialysis (group C) at escalating doses of lenalidomide. A total of 63 patients were treated and no DLTs were observed in phase I. All three groups were able to escalate to full dose lenalidomide 25 mg daily 21/28 days, although due to reduced accrual the phase II component was not entirely completed for groups B and C. Adverse events were as expected, including anemia, diarrhea and fatigue. Ten patients experienced grade 3-4 pneumonia. Overall response rate was 54% across all groups. PFS was 7.5 months and OS was 19.7 months. Lenalidomide can be given at full dose 25 mg daily 21/28 in patients with a CrCl > 30, and can be given daily to those with CrCl < 30, even when on dialysis, at doses of at least 15 mg daily.

引用

页数：8

共 25 条

[1]

(2018)

[2]

Rajkumar V., Myeloma today: disease definitions and treatment advances, Am. J. Hematol., 91, (2016)

[3]

van Beurden-Tan C.H.Y., Et al., Systematic literature review and network meta-analysis of treatment outcomes in relapsed and/or refractory multiple myeloma, J. Clin. Oncol., 35, pp. 1312-1319, (2017)

[4]

Kazancioglu R., Risk factors for chronic kidney disease: an update, Kidney Int Suppl. (2011), 3, pp. 368-371, (2013)

[5]

Niesvizky R., Et al., Lenalidomide-induced myelosuppression is associated with renal dysfunction: adverse events evaluation of treatment-naive patients undergoing front-line lenalidomide and dexamethasone therapy, Br. J. Haematol., 138, pp. 640-643, (2007)

[6]

Chen N., Et al., Pharmacokinetics of lenalidomide in subjects with various degrees of renal impairment and in subjects on hemodialysis, J. Clin. Pharmacol., 47, pp. 1466-1475, (2007)

[7]

Riccardi A., Et al., Changing clinical presentation of multiple myeloma, Eur. J. Cancer, 27, pp. 1401-1405, (1991)

[8]

Abbott K.C., Agodoa L.Y., Multiple myeloma and light chain-associated nephropathy at end-stage renal disease in the United States: patient characteristics and survival, Clin. Nephrol., 56, pp. 207-210, (2001)

[9]

Tsakiris D.J., Et al., Incidence and outcome of patients starting renal replacement therapy for end-stage renal disease due to multiple myeloma or light-chain deposit disease: an ERA-EDTA Registry study, Nephrol. Dial. Transplant., 25, pp. 1200-1206, (2010)

[10]

Nasr S.H., Et al., Clinicopathologic correlations in multiple myeloma: a case series of 190 patients with kidney biopsies, Am. J. Kidney Dis., 59, pp. 786-794, (2012)

← 1 2 3 →