Guidance for use of Pomalidomide in Relapsed/Refractory Myeloma Patients on Dialysis

A paper was just published in the that may be of interest to those multiple myeloma patients who are taking Pomalyst (pomalidomide) and who are undergoing dialysis treatment. The team of researchers from several US and European myeloma treatment centers report on a pooled study of patients from different clinical studies. Of specific interest to the research team was to understand the impact of renal (kidney) function in relapsed/refractory myeloma patients who take pomalidomide. The authors summarized their findings as follows :
PPK analyses demonstrated that moderate to severe renal impairment not requiring dialysis has no influence on pomalidomide clearance or plasma exposure, as compared to those patients with normal renal function, while pomalidomide exposure increased approximately 35% in patients with severe renal impairment requiring dialysis on non-dialysis days [Comment : in other words, dialysis will take approximately 35 % of pomalidomide from the bloodstream]. In addition, dialysis increased total body pomalidomide clearance from 5 L/h to 12 Lh, indicating that dialysis will significantly remove pomalidomide from the blood circulation. Thus, pomalidomide should be administered post-dialysis on the days of dialysis. [Emphasis added].
And for those who are interested : PPK stands for Population Pharmacokinetics and that means very fancy statistical analysis of drug concentrations in blood (plasma) of large groups of patients. And thats the easiest, although not complete, way I can explain that.
A paper was just published in the that may be of interest to those multiple myeloma patients who are taking Pomalyst (pomalidomide) and who are undergoing dialysis treatment. The team of researchers from several US and European myeloma treatment centers report on a pooled study of patients from different clinical studies. Of specific interest to the research team was to understand the impact of renal (kidney) function in relapsed/refractory myeloma patients who take pomalidomide. The authors summarized their findings as follows :
PPK analyses demonstrated that moderate to severe renal impairment not requiring dialysis has no influence on pomalidomide clearance or plasma exposure, as compared to those patients with normal renal function, while pomalidomide exposure increased approximately 35% in patients with severe renal impairment requiring dialysis on non-dialysis days [Comment : in other words, dialysis will take approximately 35 % of pomalidomide from the bloodstream]. In addition, dialysis increased total body pomalidomide clearance from 5 L/h to 12 Lh, indicating that dialysis will significantly remove pomalidomide from the blood circulation. Thus, pomalidomide should be administered post-dialysis on the days of dialysis. [Emphasis added].
And for those who are interested : PPK stands for Population Pharmacokinetics and that means very fancy statistical analysis of drug concentrations in blood (plasma) of large groups of patients. And thats the easiest, although not complete, way I can explain that.

about the author
Paul Kleutghen
I am a patient diagnosed in 2014 with primary plasma cell leukemia (pPCL), a rare and aggressive variant of multiple myeloma and have been very fortunate to find successful treatment at the division of Cellular Therapy at the Duke University Cancer Institute. My wife, Vicki, and I have two adult children and two grandsons who are the ‘lights of our lives’. Successful treatment has allowed Vicki and I to do what we love best : traveling the world, albeit it with some extra precautions to keep infections away. My career in the pharmaceutical industry has given me insights that I am currently putting to use as an advocate to lower drug pricing, especially prices for anti-cancer drugs. I am a firm believer that staying mentally active, physically fit, compliant to our treatment regimen and taking an active interest in our disease are keys to successful treatment outcomes.
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