The myeloma expert discussed the randomized, open label study measuring the safety and efficacy of daratumumab (Darzalex) plus RVd for patients with newly diagnosed multiple myeloma.
In an interview with CancerNetwork®, Peter Voorhees, MD, of the Levine Cancer Institute, discussed the design of the phase 2 GRIFFIN study (NCT02874742) investigating the safety and efficacy of adding daratumumab (Darzalex) to the combination of lenalidomide, bortezomib, and dexamethasone (RVd) for patients with newly diagnosed multiple myeloma.
GRIFFIN is a randomized phase 2 study, which is evaluating the safety and efficacy of incorporating the CD38 monoclonal antibody daratumumab into the lenalidomide, bortezomib and dexamethasone, or RVd, backbone in newly diagnosed, transplant eligible, multiple myeloma patients. So, the way that this study was designed is that patients that were assigned to the control arm received four 3-week cycles of RVd induction therapy, followed by an autologous stem cell transplant with high dose melphalan chemotherapy. On recovery, those patients receive 2 consolidation cycles of RVd followed by lenalidomide (Revlimid) maintenance therapy – what we would argue is the current standard of care for transplant eligible myeloma patients. For the experimental arm, daratumumab was incorporated into the RVd backbone with induction therapy on a weekly basis. After transplant with consolidation, daratumumab was given on day 1 of each of the 2 consolidation cycles. In the maintenance phase, daratumumab was given once every 4 weeks up to 2 years in combination with lenalidomide. After completion of 2 years of study maintenance therapy, both the control and experimental arms were encouraged to remain on lenalidomide maintenance therapy until disease progression, or the emergence of unacceptable side effects. The primary outcome of the study, which has since been published in Blood earlier this year, was achievement of stringent complete response by the end of consolidation therapy. Other important secondary end points included MRD negativity, progression-free and overall survival, as well as safety.