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ASH 2024 | The safety and efficacy of denosumab in patients with multiple myeloma and severe renal impairment
Evangelos Terpos, MD, PhD, University of Athens School of Medicine, Athens, Greece, discusses a study of the International Myeloma Working Group (IMWG) Bone Subcommittee that evaluated the safety and efficacy of denosumab in patients with multiple myeloma (MM) and severe renal impairment. Prof. Terpos highlights the importance of this study as it addresses a significant gap in the literature and demonstrates that the agent is effective in this population while also identifying a notable side effect of hypocalcemia, which requires special attention. This interview took place at the 66th ASH Annual Meeting and Exposition, held in San Diego, CA.
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Transcript (AI-generated)
This is, I think, an important study of the International Myeloma Working Group of the Bone Subcommittee of the IMWG, because we have no data in the literature for patients who receive denosumab and have severe renal impairment. It is very important because a lot of countries have given approval to denosumab, especially for patients with renal impairment, but in the main study that compared denosumab and zoledronic acid, patients with creatinine clearance below 30 were excluded because the zoledronic acid cannot be given in these patients...
This is, I think, an important study of the International Myeloma Working Group of the Bone Subcommittee of the IMWG, because we have no data in the literature for patients who receive denosumab and have severe renal impairment. It is very important because a lot of countries have given approval to denosumab, especially for patients with renal impairment, but in the main study that compared denosumab and zoledronic acid, patients with creatinine clearance below 30 were excluded because the zoledronic acid cannot be given in these patients. So we wanted to check what is the efficacy and the safety of denosumab in this specific population who was excluded from the study, patients with creatinine clearance below 30 or even patients who are in hemodialysis.
So within the centers of the International Myeloma Working Group, we managed to have now more than 100 patients who received denosumab with severe renal impairment and we’ve seen that first of all the efficacy is exactly the same but we have one side effect that needs to be given special attention and this is hypocalcemia. Patients with severe renal impairment with a standard dose of denosumab of 120 mg have severe hypocalcemia, and some of these patients need to be hospitalized in order to receive calcium because of hypocalcemia grade 3 and 4. So for some reasons, because this is a real-world study, it was not a prospective study, it was a retrospective analysis, we’ve seen that some patients receive 60 mg instead of 120 every month because the physicians believe that probably 60 mg monthly is better for renal impairment and we’ve seen that these patients had very good efficacy again with no skeletal-related events during the follow-up of the study which is around two years but also these patients had low levels of hypocalcemia. So we believe that for patients with severe renal impairment we need to further evaluate a lower dose of denosumab in order to reduce the level of hypocalcemia that these patients develop.
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Disclosures
Amgen: Honoraria, Other: Travel expenses, Research Funding; AstraZeneca: Honoraria, Other: Travel expenses; BMS: Honoraria; EUSA Pharma: Honoraria, Other: Travel expenses; Janssen: Honoraria, Research Funding; GSK: Honoraria, Research Funding; Menarini/Stemline: Honoraria; Pfizer: Honoraria; Sanofi: Honoraria, Other: Travel expenses, Research Funding; Takeda: Honoraria, Other: Travel expenses, Research Funding; Novartis: Honoraria; Antengene: Honoraria, Research Funding; Swixx: Honoraria.
