This is part of a frontline trial we have with 400 patients. From a long time ago the len doses were based on healthy volunteers with renal failure and it ended up with a very strict reducing dose schedule in the different levels of renal function and that has led to people with newly diagnosed myeloma with renal failure which are a bad prognostic group they really need urgent treatment to reduce their light chains they get insufficient treatment because of this very strict len reducing doses according to the SPC...
This is part of a frontline trial we have with 400 patients. From a long time ago the len doses were based on healthy volunteers with renal failure and it ended up with a very strict reducing dose schedule in the different levels of renal function and that has led to people with newly diagnosed myeloma with renal failure which are a bad prognostic group they really need urgent treatment to reduce their light chains they get insufficient treatment because of this very strict len reducing doses according to the SPC. In 2018, the Mayo Clinic published in Relapsed Myeloma that you can give much higher doses of lenalidomide in these patients without any problems, without any tolerance problems. So in our frontline trial, which has said sort of different agenda we use these doses so we used 25 milligrams daily the standard dose down to an eGFR of 30 and then below 30 even in dialysis we include the patients with all kind of renal failures in this in this trial we use 50 milligrams daily instead of a very low dose which is in the SPC. What we have shown in this study is that this is perfectly tolerable. The renal response is much bigger than what has been seen in len studies with renal failure. So I think it’s a quite big population so I think we sort of can conclude that we should actually adapt these higher doses of len in the frontline renal failure patients, and it’s important for them to get a renal response quick, and it will probably affect their prognosis in the long run. But we’re not sort of investigating that, we’re just investigating the tolerance and the renal response, and that looks really well in this study.
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