A combination regimen may be effective in patients with relapsed or refractory multiple myeloma and moderate to severe renal impairment, especially in those with advanced disease requiring hemodialysis.
Renal impairment in multiple myeloma limits the efficacy of available treatment options. Pomalidomide plus dexamethasone may serve as an effective treatment option for patients with such disease, but further research is needed.
Meletios Dimopoulos, National and Kapodistrian University (Athens, Greece), and colleagues conducted a prospective study to assess pomalidomide plus low-dose dexamethasone in patients with relapsed or refractory multiple myeloma and moderate to severe renal impairment, including those receiving hemodialysis. The phase II trial enrolled 81 patients in three patient cohorts: moderate renal impairment (cohort A; estimated glomerular filtration rate, 30 to < 45 mL/min/1.73 m2; n = 33); severe renal impairment (cohort B; estimated glomerular filtration rate, < 30 mL/min/1.73 m2; n = 34); and severe renal impairment that requires hemodialysis (cohort C; n = 14).
Patients received pomalidomide (4 mg/day) on days 1 to 21 and low-dose dexamethasone (20 or 40 mg once per week) in 28-day cycles. The primary endpoint of the study was overall response rate (ORR).
Among the total patient population, 13 patients were still receiving treatment at the data cutoff (January 28, 2017).
Below are the survival results of the study:
|ORR||Median Duration of Response (months)||Achieved Disease Control||Median Overall Survival (median follow-up, 8.6 months)|
|Cohort C||14.3%||Not estimable||78.6%||5.2|
Additionally, researchers reported that complete renal responses were observed only in cohort A (18.2%). No patients in cohort C became hemodialysis independent.
“Pomalidomide (4mg/day) plus low-dose dexamethasone is efficacious in patients with relapsed or refractory multiple myeloma with moderate or severe renal impairment, including those who had more advanced disease and required hemodialysis,” researchers wrote.
The safety profile was acceptable among the three cohorts, and no new safety signals were observed, they noted.—Zachary Bessette