Pomalidomide Shows Activity, Toxicity in Patients With Myeloma and Renal Impairment

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Pomalidomide, an immunomodulatory agent with anti-myeloma activity, is metabolized primarily by the liver, suggesting that patients with renal impairment can safely receive the drug.
Pomalidomide, an immunomodulatory agent with anti-myeloma activity, is metabolized primarily by the liver, suggesting that patients with renal impairment can safely receive the drug.

Pomalidomide plus low-dose dexamethasone may be effective, though highly toxic, among patients with relapsed/refractory multiple myeloma and renal impairment, according to research published in the Journal of Clinical Oncology.1

Renal impairment is found in up to 30% of patients with myeloma at diagnosis and is associated with a poor prognosis. Patients with renal impairment also have limited treatment options. Pomalidomide, an immunomodulatory agent with anti-myeloma activity, is metabolized primarily by the liver, suggesting that patients with renal impairment can safely receive the drug.

For this phase 2 trial, researchers evaluated the safety and efficacy of pomalidomide with low-dose dexamethasone among 81 relapsed/refractory myeloma patients with moderate renal impairment (cohort A, 33 patients), severe impairment (cohort B, 34 patients), or severe impairment requiring hemodialysis (cohort C, 14 patients). The median age was 72 years, 60.5% of all included patients were men, and 88.9% had stage III disease.

The median treatment duration was 5.5 months. Seven patients in cohort A, 5 in cohort B, and 1 in cohort C were still receiving treatment as of January 2017; 68 discontinued treatment. In cohorts A, B, and C, the overall response rates were 39.4%, 32.4%, and 14.3%, respectively; at 8.6 months' follow-up, the median overall survival was 16.4, 11.8, and 5.2 months, respectively.

No complete responses were observed. All patients in cohort C remained hemodialysis-dependent.

At least 1 serious treatment-related adverse event occurred in 63% of patients (54.5% in cohort A, 61.8% in cohort B, and 85.7% in cohort C). The most common grade 3 to 4 treatment-related adverse events were neutropenia (53.1% of all patients), anemia (35.8%), and infection (32.1%).

More than half (58%) of all patients interrupted pomalidomide treatment because of an adverse event.

The authors concluded that pomalidomide with 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.”

Reference

  1. Dimopoulos M, Weisel K, van de Donk NW, et al. Pomalidomide plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma and renal impairment: results from a phase II trial. J Clin Oncol. 2018 Feb 2. doi: 10.1200/JCO.2017.76.1742

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