Research Shows Infusing Isatuximab in Just 30 Minutes Provides Same Safety

In 2024, oncologists diagnosed 180,000 new cases of multiple myeloma, and 700,000 individuals are living with the condition globally.¹ Published guidelines recommend isatuximab (Sarclisa; Sanofi), bortezomib (Velcade; Takeda), lenalidomide (Revlimid; Celgene), and dexamethasone (DexPak; Mikart) for primary therapy in both transplant and nontransplant candidates. For patients with bortezomib- or lenalidomide-refractory or relapsed disease, a regimen with isatuximab, carfilzomib (Kyprolis; Amgen), and dexamethasone may be used.²

Infusion chair-time is costly | Image credit: auremar | stock.adobe.com

Isatuximab is an FDA-approved monoclonal antibody that targets the protein CD38 within cancer cells. It plays a role in regulating and maintaining immune responses. By targeting CD38, isatuximab binds to myeloma cells, enhancing immune system activity to eliminate these cells. It also directly kills cancerous cells.³

Isatuximab is a 250 milliliters (mL) intravenous infusion administered at a maximum of 200 mL/hour and requiring at least 75 minutes of infusion time.¹ However, infusion chair-time is costly. The journal HemaSphere has published results of a study analyzing 30-minute isatuximab infusions, in which researchers concluded that 30-minute isatuximab infusions are safe and feasible.⁴

Building on previous trials, a team of researchers conducted a new study with findings published in Clinical Lymphoma Myeloma and Leukemia to further investigate the safety of 30-minute isatuximab infusions. Researchers conducted the study at the CancerCare Manitoba in Canada.The retrospective cohort study enrolled 15 patients with multiple myeloma from July 2024 to January 2025. Patients averaged 64.7 years of age and 6.9 years since diagnosis. Prior to enrollment, patients used 1 to 3 different myeloma therapies.¹

Patients’ treatment included isatuximab with carfilzomib and dexamethasone (Isa-Kd) or pomalidomide and dexamethasone (Isa-Pd). Two patients received Isa-Kd, while the remaining received Isa-Pd. Prior to the infusions, all patients received premedication with acetaminophen, famotidine, and cetirizine.¹

During the study, patients underwent 127 30-minute infusions. Nine patients began rapid infusions with their third dose, 2 during their fourth dose, and 4 after 8 or more doses of standard infusion.¹ At standard infusion rate and first exposure to isatuximab, 5 patients experienced an infusion-related reaction. The grades for these reactions ranged from 1 to 2, indicating mild severity. Patients experienced no infusion-related reactions during rapid 30-minute isatuximab infusions.¹

As of the study conclusion, 11 patients continued rapid infusions, 3 patients discontinued isatuximab due to disease progression, and 1 patient temporarily stopped therapy due to a cardiac event associated with carfilzomib.

Based on these findings, researchers concluded that 30 minute intravenous isatuximab infusions are safe. Rapid infusions also reduce costs and resource use, while enhancing patient and caregiver satisfaction and streamlining outpatient infusion scheduling. Despite the small cohort size, physicians at CancerCare Manitoba continue to use the 30-minute intravenous isatuximab infusion approach at their centers.¹

References

1. Kotb R, Geirnaert M, Rimmer E, et al. Real-world safety and tolerability of rapid, 30-minutes, intravenous isatuximab in patients with multiple myeloma. Clin Lymph Myelo Leuk. 2025. doi:10.1016/j.clml.2025.01.022

2. Kumar SK, Callander NS, Adekola K, et al. Multiple myeloma, version 2.2024, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2023;21(12):1281-1301. doi:10.6004/jnccn.2023.0061

3. Sarclisa. Prescribing information. Sanofi; updated October 2024. Accessed February 19, 2025. https://products.sanofi.us/Sarclisa/sarclisa_patient_information.pdf

4. Ocio EM, Perrot A, Moreau P, et al. 30-minute infusion of isatuximab in patients with newly diagnosed multiple myeloma: results of a phase 1b study analysis. Hemasphere. 2024;8(11):e70041. doi:10.1002/hem3.70041