Drug Combination Tested in Those With Resistant Myeloma and Renal Impairment
Posted: Thursday, March 15, 2018
Although patients whose relapsed or refractory multiple myeloma is accompanied by renal impairment are often seen in clinical practice, relatively few research studies have addressed their treatment. That gap narrowed with the publication in the Journal of Clinical Oncology of notable results of a European phase II trial prospectively studying pomalidomide plus low-dose dexamethasone (LoDEX) in that population. The study was led by Meletios Dimopoulos, MD, of the National and Kapodistrian University of Athens, Athens, Greece; and Katja Weisel, MD, of the University Hospital of Tuebingen, Tuebingen, Germany.
“The current study [MM-013] is the first prospective trial to demonstrate that pomalidomide plus LoDEX can lead to disease stabilization, a clinically relevant outcome in patients with severe [renal impairment] and high disease burden,” explained the researchers.
A total of 81 enrolled patients were grouped into three cohorts: those with moderate renal impairment (cohort A, 33 patients), those with severe renal impairment (cohort B, 34 patients), and those receiving hemodialysis (cohort C, 14 patients). The cohorts’ overall response rates, the primary endpoint, were 39.4%, 32.4%, and 14.3% in cohorts A, B, and C, respectively. Disease control rates of 100%, 79.4%, and 78.6% in cohorts A, B, and C, respectively, were achieved. At a median follow-up of nearly 9 months, median overall survival was 16.4 months in those with moderate renal impairment, 11.8 months in those with severe renal impairment, and 5.2 months in those on hemodialysis.
As for toxicity, more grade 3 and 4 hematologic treatment-emergent adverse events were observed in those receiving hemodialysis (cohort C). No new safety signals were reported.
