MM-053: Nursing Considerations for the Use of Isatuximab in the Treatment of Multiple Myeloma

Context: Isatuximab (Isa) is a monoclonal antibody that binds to a specific epitope on CD38 and triggers death of multiple myeloma (MM) cells. Isatuximab-irfc is FDA-approved in combination with pomalidomide and dexamethasone (Pd) to treat adults with relapsed/refractory MM (RRMM) who have received ≥2 prior therapies, including lenalidomide and a proteasome inhibitor. Objective: ICARIA-MM ( NCT02990338 ) compared efficacy and safety of Isa plus Pd (Isa-Pd) to Pd in RRMM. Design: Eligible patients had RRMM and ≥2 prior lines of therapy, including lenalidomide and a proteasome inhibitor. Setting: Prospective, randomized, open-label, active-controlled, multicenter Phase 3 study. Patients or other participants: 307 patients were randomized to receive either Isa-Pd (n=154) or Pd (n=153). Interventions: Isa was administered intravenously at 10 mg/kg weekly for 4 weeks, and every other week thereafter. Main outcome measures: Progression Free Survival (PFS). Safety assessed according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE; v4.03). Results: Median PFS, 11.5 months Isa-Pd, 6.5 months Pd; HR 0.596 (95% CI 0.44–0.81); P=0.001. ORR 60.4% Isa-Pd, 35.3% Pd (P Conclusions: The dosing regimen, clinical activity, and manageable safety profile distinguish Isa as a new treatment option for patients with RRMM. Oncology nurses will be key in the infusion process, administration of pre-medications, management of IRs, and education of patients receiving Isa treatment. Study Sponsor: Sanofi