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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?

How strictly should the labeled re-dosing window be followed in practice?
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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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3 Answers
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Medical Oncology · Winship Cancer Institute of Emory University
Answered on

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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Hematology · NYU Grossman School of Medicine
Answered on · Updated on

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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Hematology · University of Wisconsin
Answered on

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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