Dr. Voorhees Discusses Safety Run-in of Daratumumab in Myeloma

Peter Voorhees, MD, professor of medicine, UNC Lineberger Comprehensive Cancer Center, discusses the safety run-in of the Griffin study looking at daratumumab (Darzalex) in the treatment of patients with myeloma.

The addition of the monoclonal antibody daratumumab to the standard triplet of bortezomib (Velcade), lenalidomide (Lenvima), and dexamethasone (VRd) was evaluated in the Griffin trial. Sixteen patients were enrolled into a safety run-in, Voorhees says, in which researchers set out to ensure that there were no severe adverse events (AEs) with the first cycle of therapy. In results presented at the 2017 ASH Annual Meeting, only 3 patients out of the 16 were reported to have demonstrated dose-limiting toxicities, he says. Although their events were grade 3 in severity, all 3 of the patients were able to resume treatment and continue on the trial.

In the randomized phase II portion of the Griffin trial, patients received 4 cycles of daratumumab with VRd induction. They then went on to stem cell transplantation. When they were done, they received 3 cycles of daratumumab/VRd consolidation, followed by daratumumab and lenalidomide maintenance therapy for 2 years and were allowed to continue lenalidomide until disease progression.

As far as the AEs are concerned, they were largely what one would expect when daratumumab is added to RVd, Voorhees says. Neutropenia was noted in 75% of the patients; however, none of the neutropenia cases were grade 4 in severity.