Pomalidomide and Low-Dose Dexamethasone in Patients With Multiple Myeloma and Renal Impairment
In a European phase II trial reported in the Journal of Clinical Oncology, Dimopoulos et al found that pomalidomide (Pomalyst) plus low-dose dexamethasone produced responses in patients with relapsed or refractory multiple myeloma and renal impairment.
Study Details
In the study, 81 patients with moderate renal impairment (cohort A = 33 patients; estimated glomerular filtration rate [eGFR] = 30 to < 45 mL/min/1.73 m2), severe renal impairment (cohort B = 34; eGFR = < 30 mL/min/1.73m2), or severe renal impairment requiring hemodialysis (cohort C = 14) received pomalidomide at 4 mg/d on days 1 to 21 and low-dose dexamethasone 20 or 40 mg once weekly in 28-day cycles. The primary endpoint was overall response rate.
Response Rates
Overall response rates in cohorts A, B, and C were 39.4%, 32.4%, and 14.3%, with median durations of response of 14.7 months, 4.6 months, and not estimable, respectively. Disease control was observed in 100%, 79.4%, and 78.6% of patients.
At data cutoff in January 2017, 13 patients were still receiving treatment, including 7 in cohort A, 5 in cohort B, and 1 in cohort C. At a median follow-up of 8.6 months, median overall survival was 16.4 months, 11.8 months, and 5.2 months, respectively.
Complete renal response—defined as sustained improvement of baseline eGFR—was observed only in cohort A (18.2%). No patients in cohort C became independent of hemodialysis. Pomalidomide pharmacokinetics was comparable across the 3 cohorts.
Adverse Events
The most common grade 3 or 4 hematologic adverse events across all cohorts were neutropenia (53.1%), anemia (35.8%), and thrombocytopenia (27.2%), with grade 3 or 4 events being more common in cohort C. Serious adverse events occurred in 54.5% of patients in cohort A, 61.8% of patients in cohort B, and 85.7% of patients in cohort C. Adverse events led to pomalidomide discontinuation in 12.1%, 17.6%, and 28.6% of patients.
The investigators concluded, “Pomalidomide 4 mg/d plus [low-dose dexamethasone] is efficacious in patients with relapsed/refractory multiple myeloma] with moderate or severe [renal impairment], including those who had more advanced disease and required hemodialysis. The safety profile was acceptable among the three groups, and no new safety signals were observed.”
The study was funded by Celgene Corporation.
Meletios Dimopoulos, MD, of the National and Kapodistrian University of Athens School of Medicine, is the corresponding author for the Journal of Clinical Oncology article.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
