Ninety-Minute Daratumumab Infusions for Relapsed and Refractory Multiple Myeloma: Two Years of Italian Single-Center Observational Study

Attardi, Enrico; Pilerci, Sofia; Attucci, Irene; Buzzichelli, Alessandra; Messeri, Maria; Staderini, Michela; Vannucchi, Alessandro M.; Antonioli, Elisabetta

doi:10.1016/j.clml.2021.06.018

Cited by 2 publications

(3 citation statements)

References 13 publications

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“…A limitation of this study is the lack of a pharmacoeconomic analysis; however, previous studies conducted both in the US and Europe already reported a beneficial effect of the adoption of the rapid daratumumab infusion protocol also in financial terms (10,12,16).…”

Section: Discussionmentioning

confidence: 99%

Safety of Rapid Daratumumab Infusion: A Retrospective, Multicenter, Real-Life Analysis on 134 Patients With Multiple Myeloma

et al. 2022

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BackgroundThe anti-CD38 monoclonal antibody daratumumab is the backbone of most anti-multiple myeloma (MM) regimens. To mitigate the risk of infusion-related reactions (IRRs), intravenous daratumumab administration requires 7 hours for the first infusion and 3.5-4 hours thereafter, thus making daratumumab-containing regimens burdensome for patients and health care resources. Preliminary data suggest that a rapid (90-minute) infusion of daratumumab is safe and does not increase IRRs. The rapid schedule was adopted by our centers since 2019.MethodsWe conducted an observational multi-center, real-life study to assess the safety of rapid daratumumab infusion protocol from the third administration in relapsed MM patients receiving daratumumab alone or in combination with lenalidomide-dexamethasone or bortezomib-dexamethasone. The primary endpoint was the safety of the rapid infusion protocol, particularly in terms of IRRs.ResultsA total of 134 MM patients were enrolled. IRRs occurred in 7 (5%) patients and were mostly mild (6/7 of grade 1-2), with only 1 patient experiencing a grade 3 IRR. Due to the IRRs, 5 (3.7%) patients discontinued the rapid infusions and resumed daratumumab at the standard infusion rate, while 1 patient permanently discontinued daratumumab. In 4/7 patients (57%), IRRs occurred while resuming rapid daratumumab infusions after a temporary interruption (2-4 months). No other adverse event was considered related to the rapid infusion protocol.ConclusionsOur findings confirmed the safety of rapid daratumumab infusions starting from the third administration. In case of prolonged daratumumab interruption, it is advisable to resume infusions at the standard rate (3.5 hours) before switching to the rapid infusion.

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Section: Discussionmentioning

confidence: 99%

Safety of Rapid Daratumumab Infusion: A Retrospective, Multicenter, Real-Life Analysis on 134 Patients With Multiple Myeloma

et al. 2022

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Section: Fda-approved Next-generation Therapeuticsmentioning

confidence: 99%

“…To decrease infusion times, numerous trials have confirmed that rapid infusion of daratumumab 90 min and isatuximab 70 min can be initiated safely following evidence of tolerability during the first cycle (Table 3). [23][24][25][26][27][28][29] Infusion-related reactions (IRRs) are common in all formulations but more likely with IV administration and occur primarily with the first dose (Table 3). Associated symptoms are generally low grade and include chills, fever, nausea, nasal congestion, cough, and dyspnea.…”

Section: Fda-approved Next-generation Therapeuticsmentioning

confidence: 99%

Toxicity management strategies for next-generation novel therapeutics in multiple myeloma

Steinbach

Julian

McClune

et al. 2022

Therapeutic Advances in Hematology

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The therapeutic options available for patients with multiple myeloma have greatly expanded over the past decade and incorporating these novel agents into routine clinical practice has significantly improved outcomes. The next generation of therapeutics is available for relapsed and refractory patients either as standard of care or in clinical trial, and these drugs represent a generational paradigm shift. Patients now have access to a multitude of novel immunotherapeutics, including monoclonal antibodies, an antibody–drug conjugate, chimeric antigen receptor T-cells (CAR-T), and bispecific T-cell redirecting antibodies, and novel oral therapies including selinexor (selective inhibitor of nuclear export) and venetoclax (bcl-2 inhibitor). While these drugs have the potential to be highly efficacious in certain subsets of patients when used as single agents or in combination regimens, they are each associated with unique toxicity profiles. It is imperative to understand these potential adverse events to ensure patient safety. Appropriate supportive care management is paramount to maximize drug exposure and therapeutic efficacy. The following review focuses its discussion on drugs and combination regimens that are currently FDA-approved and those that continue to be investigated in clinical trials, highlights the clinically relevant toxicity profiles for each of the different agents, and provides practical considerations for the treatment team.

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Ninety-Minute Daratumumab Infusions for Relapsed and Refractory Multiple Myeloma: Two Years of Italian Single-Center Observational Study

Cited by 2 publications

References 13 publications

Safety of Rapid Daratumumab Infusion: A Retrospective, Multicenter, Real-Life Analysis on 134 Patients With Multiple Myeloma

Safety of Rapid Daratumumab Infusion: A Retrospective, Multicenter, Real-Life Analysis on 134 Patients With Multiple Myeloma

Toxicity management strategies for next-generation novel therapeutics in multiple myeloma

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