For patients with multiple myeloma receiving bispecific antibodies who have had a slightly extended treatment interval beyond what the FDA label specifies, is repeat step-up dosing clinically necessary, or are there situations where it can be safely omitted?
What is your threshold for omitting repeat step-up dosing after a treatment-free interval for patients with MM on BsAb therapy?
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The data underpinning this label is what was done based on protocols that were written before much of the pharmacokinetics was known, and certainly before a pharmaceutical company was willing to adjust these safety practices; they would be severely financially penalized if safety events disrupt drug...
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Within the clinical trials, repeated step-up dosing was suggested if patients had an extended treatment-free interval. The definition of an extended free interval varies between bispecific antibodies, and depending on the time (e.g., >28 days through to >84 days), the recommendation is to either rep...
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This is a question that is relatively devoid of data to help guide decision-making. However, for patients who have a treatment interval that is slightly extended beyond the "safe" interval for administration of a bispecific antibody, my experience is that repeating step-up dosing is usually not nece...
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