Safety and Cost Benefits of the Rapid Daratumumab Infusion Protocol

Hamadeh, Issam; Reese, Emily S.; Arnall, Justin; Kachur, Ekaterina; Martin, Allison; Schneider, Meghan; Friend, Reed; Paul, Biswajit; Atrash, Shebli; Bhutani, Manisha; Voorhees, Peter M.; Usmani, Saad Z.

doi:10.1016/j.clml.2020.02.014

Cited by 16 publications

(25 citation statements)

References 13 publications

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“…The efficacy of rituximab was maintained and patients were rapidly dismissed from the clinic. Rapid Daratumumab infusion has very recently been reported in another trial (24) in which 53 MM patients received rapid infusions and no difference was seen in terms of IRRs with respect to 47 patients receiving long infusions (1.9% vs 4.3%). The latter study compared rapid infusions vs standard IV infusions: 53 patients received rapid infusions of Daratumumab, but only 18 received the rapid infusion starting from cycle 1 day 15 upfront (as in our study).…”

Section: Discussionmentioning

confidence: 94%

Long-Term Safety of Rapid Daratumumab Infusions in Multiple Myeloma Patients

et al. 2020

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Multiple myeloma survival has significantly improved in recent years, due to novel agents that are available for treatment. The anti-CD38 monoclonal antibody Daratumumab is particularly efficient for patients with relapse/refractory disease, and many studies have shown its unprecedented efficacy also as a first treatment. However, to avoid the incidence of infusion reactions, long infusion schedules of 8 h at first dose and 4 h in the following doses are required, which can reduce the compliance of patients and health care professionals. A reduced infusion time of 90 min has been reported previously, but data are missing on the prolonged safety of this over time as well as the efficacy of this approach. In this work, we investigate the safety of 484 rapid Daratumumab infusions given early after the second dose over a 22 months period in 39 myeloma patients.

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Section: Discussionmentioning

confidence: 94%

Long-Term Safety of Rapid Daratumumab Infusions in Multiple Myeloma Patients

et al. 2020

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“…Interventions outlined in Table 1 provide practical recommendations which can be implemented to meet the needs of patients during the dynamics of a pandemic. 5–50…”

Section: Altering System Cancer Regimensmentioning

confidence: 99%

“…56 Rapid infusion protocols have also been described for daratumumab administered as a 90-minute infusion and bevacizumab over 10-minutes with no added safety signals. [25][26][27][28]34,36 To further reduce infusion times, various subcutaneous options have emerged that allow administration times of a few minutes. Rituximab hyaluronidase, trastuzumab hyaluronidase, and most recently, daratumumab hyaluronidase are subcutaneous injections that can be delivered in under 10 minutes.…”

Section: Extending Therapeutic Intervals and Minimizing Chair Timementioning

confidence: 99%

Clinical strategies for optimizing infusion center care through a pandemic

Hanna

Segal

Barlow

et al. 2020

J Oncol Pharm Pract

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The national pandemic resulting from the novel coronavirus, COVID-19, has made the delivery of care for patients with cancer a challenge. There are competing risks of mortality from cancer versus serious complications and higher risk of death from COVID-19 in immunocompromised hosts. Furthermore, compounding these concerns is the inadequate supply of personal protective equipment, decreased hospital capacity, and paucity of effective treatments or vaccines to date for COVID-19. Guidance measures and recommendations have been published by national organizations aiming to facilitate the delivery of care in a safe and effective manner, many of which, are permanently adoptable interventions. Given the critical importance to continue chemotherapy, there remains additional interventions to further enhance patient safety while conserving healthcare resources such as adjustments in medication administration, reduction in laboratory or drug monitoring, and home delivery of specialty infusions. In this manuscript, we outline how to implement these actionable interventions of chemotherapy and supportive care delivery to further enhance the current precautionary measures while maintaining safe and effective patient care. Coupled with current published standards, these strategies can help alleviate the numerous challenges associated with this pandemic.

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“…The median duration of infusion is 7.0 hours for the first infusion (sometimes requiring split dosing for convenience), 4.3 hours for the second infusion, and then 3.5 hours for all subsequent infusions [37]. Recently, a rapid (90 minute) infusion protocol has proven safe and effective when used after the second infusion [40][41][42].…”

Section: Daratumumab: Clinical Development Of the IV Formulationmentioning

confidence: 99%

An evaluation of subcutaneous daratumumab for the treatment of multiple myeloma

Paul

Atrash

Bhutani

et al. 2020

Expert Review of Hematology

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Introduction: A subcutaneous formulation of daratumumab, a human immunoglobulin G1 kappa monoclonal antibody targeting CD38, recently achieved FDA approval for both newly diagnosed and relapsed refractory multiple myeloma amid promises to decrease infusion times and rates of infusion reactions in myeloma patients. Areas covered: In this article the biology behind subcutaneous administration of oncologic antibody therapies is reviewed and the subcutaneous formulation of daratumumab is covered in depth. The most recent results from the PAVO, COLUMBA, and PLEIADES clinical trials evaluating subcutaneous daratumumab as a single agent, and in combination, in both newly diagnosed, and relapsed and refractory myeloma patients are summarized. The efficacy, safety, and PK data from these trials are reviewed, and the potential of the subcutaneous formulation to improve quality of life in myeloma patients and decrease healthcare resource use is discussed. Expert opinion: Subcutaneous daratumumab is non-inferior to conventional intravenous daratumumab with lower risk of infusion-related reactions and decreased administration time. Based on these data, and the recent FDA and European Commission approvalsthe widespread use of the subcutaneous formulation for both conventional and investigational practice is supported.

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Safety and Cost Benefits of the Rapid Daratumumab Infusion Protocol

Cited by 16 publications

References 13 publications

Long-Term Safety of Rapid Daratumumab Infusions in Multiple Myeloma Patients

Long-Term Safety of Rapid Daratumumab Infusions in Multiple Myeloma Patients

Clinical strategies for optimizing infusion center care through a pandemic

An evaluation of subcutaneous daratumumab for the treatment of multiple myeloma

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