Patients with newly diagnosed and relapsed or refractory multiple myeloma (MM) often experience relapse when treated with bortezomib and dexamethasone. A team of researchers, led by Andrzej Jakubowiak, sought to determine if the addition of elotuzumab to the commonly used bortezomib and dexamethasone combination therapy would favorably impact patient survival.
Eligible patients were adults with a diagnosis of multiple myeloma and recoded progression following one or more lines of therapy. (Patients with significant cardiac disease, grade 2+ neuropathy, or concurrent malignancies were excluded.) The 152 patients who participated in the phase 2 study were randomized to receive either elotuzumab with bortezomib and dexamethasone (EBd; 77 patients) or bortezomib and dexamethasone (Bd; 75 patients) alone. Progression-free survival (defined as time from randomization to the date of the first documented tumor progression or death) was the primary end point.
Progression-free survival at 1 year was 39% (95% CI, 28%-50%) with EBd vs 33% (95% CI, 22%-44%) with Bd. At the 2-year mark, the recorded survival rate was 18% (95% CI, 10%-28%) with EBd, vs 11% (95% CI, 5%-20%) with Bd. Some patient subgroups, particularly patients older than 65 years or patients who had received prior immunomodulatory therapy, demonstrated a trend toward increased progression-free survival when treated with EBd.
The researchers concluded that elotuzumab appears to provide clinical benefit without added clinically significant toxicity when combined with dexamethasone.
1. Jakubowiak A, Offidani M, Pégourie B, et al. Randomized phase 2 study: elotuzumab plus bortezomib/dexamethasone vs bortezomib/dexamethasone for relapsed/refractory MM. Blood. 2016;127(23):2833-2840. doi: 10.1182/blood-2016-01-694604.