Newly diagnosed multiple myeloma patients respond better to treatment when Empliciti (elotuzumab) is added to a combination of Revlimid (lenalidomide) and dexamethasone, a study from Japan demonstrates.
The treatment was also well-tolerated, researchers said during a presentation at the American Society of Hematology (ASH) 59th Annual Meeting in December 2017.
Empliciti is approved in this combination for patients with relapsed or refractory myeloma — both in Japan and the U.S. But its impact on disease in newly diagnosed myeloma patients has not been studied, said Mitsuo Hori, MD and PhD, from the Ibaraki Prefectural Central Hospital, who presented the research.
The study was led by researchers at the National Hospital Organization Disaster Medical Center in Japan and supported by Bristol-Myers Squibb, which manufactures Empliciti.
His presentation, “Elotuzumab Plus Lenalidomide/Dexamethasone (ELd) Vs Ld in Patients with Newly Diagnosed Multiple Myeloma: Phase 2, Randomized, Open-Label Study in Japan,” described data from a Phase 2 clinical trial (NCT02272803).
The study, performed at several clinics across Japan, treated 82 newly diagnosed patients who were not eligible for chemotherapy and blood stem cell transplant.
Participants were randomly assigned treatment with either the triple combination — Empliciti, Revlimid, and dexamethasone — or Revlimid and dexamethasone alone. Patients and study staff were aware of which treatment each patient received — a study approach called open-label.
In March 2017, 78% of patients on the triple-combination regimen remained in the study. Of those who stopped, most quit the study because of disease progression. Meanwhile, only 60% percent of the double-combination-treated patients remained in the trial. Patients in this group quit because of drug toxicities, adverse events unrelated to treatment, or simply wished to stop participating.
Among those receiving all three drugs, 88% responded to the treatment, compared to only 74% in the double-combination group.
Forty-five percent of patients in the triple-combination group had at least a very good partial response. Among those receiving only two medications, the number was 29%.
All patients in the triple, and 98% in the double-combination group reported adverse events. Most adverse events were more common in the triple combination group, including constipation, fever, diarrhea, malaise, and swelling. Reduced blood cell counts were also more common in this group.
Severe adverse events — mainly reduced numbers of certain blood cells — were also more common in the triple-combination group.
The study also demonstrated that it was possible to speed up infusion rates of the treatments without triggering more infusion reactions.
The study is still ongoing, and researchers will test, in future analyses, if the treatment improves the time patients live without disease progression.