Site Editors
Shaji K. Kumar, MD
Prashant Kapoor, MD, FACP
Shaji K. Kumar, MD
Prashant Kapoor, MD, FACP
Posted: Wednesday, October 25, 2023
The predefined final analysis of the phase II GRIFFIN trial appears to justify further evaluation of its quadruplet treatment in phase III studies, according to investigators Peter M. Voorhees, MD, of Wake Forest University School of Medicine, Charlotte, North Carolina, and colleagues. Adding the monoclonal antibody daratumumab (D) to lenalidomide, bortezomib, and dexamethasone (RVd) improved the depth of response and progression-free survival in transplantation-eligible patients with newly diagnosed multiple myeloma, they stated. This report, in The Lancet Haematology, “supports the use of D-RVd induction and consolidation and daratumumab plus lenalidomide maintenance as a new daratumumab-based quadruplet treatment option” for this population, the team continued.
Conducted in 35 U.S. research centers, GRIFFIN was an open-label, randomized, active-controlled trial. All patients, newly diagnosed, were aged 18 to 70 years and were eligible for autologous hematopoietic stem cell transplantation (HSCT). Patients were randomly assigned, on a 1:1 basis, to four D-RVd or RVd induction cycles, autologous HSCT, two D-RVd or RVd consolidation cycles, and lenalidomide with or without daratumumab maintenance therapy for 2 years. Patients could continue lenalidomide maintenance after study treatment completion.
Totals of 104 and 103 patients were assigned to the D-RVd and RVd groups, respectively; most patients were White and male. At a median follow-up of 49.6 months, D-RVd improved rates of stringent complete response compared with RVd (67% vs. 48%; P = .0079). The 4-year progression-free survival rate was 87.2% for D-RVd versus 70.0% for RVd; the hazard ratio was 0.45 (P = .032) for risk of disease progression or death with D-RVd. Median overall survival was not reached for either group (P = .84).
Among the most common grade 3 or 4 treatment-emergent adverse events in the D-RVd versus RVd groups were neutropenia (46% vs. 23%), lymphopenia (23% vs. 23%), leukopenia (17% vs. 8%), and thrombocytopenia (16% vs. 9%). “No new safety concerns occurred with maintenance therapy,” noted Dr. Voorhees and co-investigators.
Disclosure: The study authors’ disclosure information can be found at thelancet.com.
