Elotuzumab Meets Primary Endpoint of ORR for Newly Diagnosed Multiple Myeloma
Ninety-five percent of patients received elotuzumab at the increased rate of 5 mL/min without any incidence of IR.
|The following article features coverage from the American Society of Hematology (ASH) 2017 meeting. Click here to read more of Cancer Therapy Advisor's conference coverage.|
Elotuzumab plus lenalidomide and dexamethasone (ELd) is safe and effective among patients with newly diagnosed multiple myeloma (NDMM) and improves the overall response rate (ORR) compared with lenalidomide and dexamethasone (Ld) alone, according to an oral presentation at the 2017 American Society of Hematology (ASH) Annual Meeting in Atlanta, Georgia.1
For this open-label, phase 2 study (ClinicalTrials.gov Identifier: NCT02272803), investigators randomly assigned 82 patients with NDMM ineligible for high-dose chemotherapy plus hematopoietic cell transplantation to receive intravenous ELd or Ld alone. Patients in the ELd arm received prophylactic medication to prevent infusion reactions (IR), and in the absence of IR the infusion rate was increased from 0.5-2.0 mL/min to 5 mL/min.
At time of data analysis minimum follow-up was 6 months; 78% and 60% of patients in the ELd and Ld arms remained in the study, respectively. The investigator-assessed ORR was 88% in the ELd arm compared with 74% in the Ld arm. A very good partial response (VGPR) was observed in 45% and 29% of ELd- and Ld-treated patients, respectively.
Adverse events (AEs) were reported by 100% of patients in the ELd arm and by 98% of patients in the Ld arm. The most frequently reported AEs included constipation, pyrexia, rash, diarrhea, nasopharyngitis, dysgeusia, malaise, peripheral edema, neutropenia, leukopenia, and back pain; the most common grade 3 to 4 AEs were neutropenia and leukopenia.
Only 1 IR was reported in the ELd arm and treatment was interrupted, but the patient did not have any further IR in subsequent treatments. Ninety-five percent of patients received elotuzumab at the increased rate of 5 mL/min without any incidence of IR.
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- Takezako N, Ohta K, Handa H, et al. Elotuzumab plus lenalidomide/dexamethasone (ELd) vs Ld in patients with newly diagnosed multiple myeloma: phase 2, randomized, open-label study in Japan. Oral presentation at: American Society of Hematology 59th Annual Meeting & Exposition; December 9-12, 2017; Atlanta, GA.