12/16/2023 0 Comments Eloquent medication![]() Patients receiving elotuzumab, on a background of the combined regimen of lenalidomide plus dexamethasone, had a 30% reduction in the risk of disease progression or death. Pts continued treatment until the development of unacceptable toxicity or due to disease progression.Infusion reactions in elotuzumab group = 33 pts (10%) grade 1 or 2 in 29 patients.Grade 3 or 4 AEs were: lymphocytopenia, neutropenia, fatigue, and pneumonia.ITT population: 32% relative reduction in the risk of disease progression in the elotuzumab group (HR, 0.68 95% CI, 0.56-0.83).Safety dataset: elotuzumab = 318 pts and control = 317 pts.Pts still receiving treatment at the cut-off date for interim analysis = 35% vs 20%.Only 10% of patients that received previous lenalidomide treatment were allowed to enrol.Pre-medication (H1 blocker, H2 blocker, and acetaminophen) were administered prior to elotuzumab infusion.Control group received the same regimen, minus elotuzumab.Oral dexamethasone (40 mg) was administered during the week without elotuzumab and intravenously at a dose of 8 mg, plus 28 mg orally on the day of elotuzumab treatment (days 1, 8, 15 and 21).Oral lenalidomide (25 mg per day) was administered from day 1 –day 21 of each cycle.Intravenous elotuzumab (10 mg/kg of body weight) was administered on days 1, 8, 15 and 22, during cycle 1 and 2, then on day 1 and 15 in cycle 3. ![]() Treatment was administered in 28-day cycles.Primary endpoints were Progression Free Survival (PFS) and Overall Response Rate (ORR). Patients were randomly assigned into two treatment groups, receiving a combined regimen of lenalidomide plus dexamethasone plus elotuzumab (321 patients) or lenalidomide plus dexamethasone alone (control, 325 patients). They enrolled 646 patients (between June 2011 and November 2012 at 168 sites globally) who had received one to three prior therapies, and who had relapsed following their most recent therapy. This was the pivotal phase III study leading to approval of elotuzumab for the treatment of patients with Relapsed and/or Refractory Multiple Myeloma (RRMM). Dimopoulos and colleagues, reported results from the open-label, multi-center ELOQUENT-2 trial in The New England Journal of Medicine. In August 2015, Sagar Lonial, Meletios D.
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