ASH 2016 | Pomalidomide with dexamethasone in relapsed/refractory multiple myeloma with renal impairment
Katja Weisel, MD, from the University Hospital Tübingen, Tübingen, Germany, discusses the safety of pomalidomide with low-dose dexamethasone in patients with relapsed/refractory multiple myeloma and renal impairment at the American Society of Hematology (ASH) Congress 2016 in San Diego, CA. She explains that that this Phase II multi-center trial (NCT02045017) included relapsed multiple myeloma patients who had received at least one previous treatment, were previously exposed to lenalidomide and had a creatinine clearance of less than 45 ml/min. Prof. Weisel describes the safety data she presented at ASH 2016, which was based on the first 81 patients, who were grouped by renal impairment severity, including patients with severe renal impairments (less than 30 ml/min creatinine clearance rate) and patients on hemodialysis. All patients initially received 4 mg pomalidomide and 40 mg dexamethasone, with patients aged over 75 years receiving 20 mg dexamethasone. Safety analysis revealed a relative dose intensity of 0.9 – 1.0, indicating that nearly all patients continued taking the starting dose, while patients on hemodialysis had a relative dose intensity of 1.0. The expected toxicity of pomalidomide in combination with low-dose dexamethasone was seen, with around half of patients developing Grade III or IV neutropenia and a quarter of patients had Grade III or IV thrombocytopenia. Prof. Weisel explains that the most common non-hematologic toxicities were infections and pneumonia, found in around 30% of patients. However, no clear signal of increased toxicity with more severe renal impairment or patients under hemodialysis was observed. This was somehow expected as pomalidomide is not renally excreted but hepatically metabolized, but she argues that this is the required evidence supporting the use of this pomalidomide regiment in patients with all grades of renal impairment, with no initial dose reduction required. Data on response and survival in this trial are expected next year.
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