Behind the Phase 3 AURIGA Trial in Newly Diagnosed Multiple Myeloma
Ashraf Z. Badros, MB, ChB, discusses the background, methods, and design of the phase 3 AURIGA trial.
Ashraf Z. Badros, MB, ChB, professor of medicine, director of the Multiple Myeloma Service, and vice chair of the Clinical Research Committee for the Program in Oncology at the University of Maryland School of Medicine in Baltimore, discusses the background, methods, and design of the phase 3 AURIGA trial (NCT03901963).
The phase 3 AURIGA study evaluated daratumumab (Darzalex) and lenalidomide vs lenalidomide maintenance in patients with newly diagnosed multiple myeloma who were in very good partial response, minimal residual disease (MRD)-positive, and anti-CD38 naive post-transplant.
The primary end point was the percentage of patients with MRD-negative Status as determined by next-generation sequencing. Secondary end points included progression-free survival, percentage of patients with overall MRD-negative status, durable MRD-negative rate, percentage of patients achieving complete response (CR) or stringent CR, overall survival, duration of CR, change in health-related quality of life, safety, and tolerability.
Transcription:
0:10 | The AURIGA trial is the first trial to directly compare the addition of daratumumab to lenalidomide vs lenalidomide, which is the standard of care for maintenance after transplant and [patients with] multiple myeloma.
0:26 | The study is a randomized phase 3 trial conducted in the US and Canada. It included patients who had received a minimum of 4 cycles of induction that did not include an anti-CD38 antibody (so no daratumumab or isatuximab) followed by a transplant within 12 months. Patients should have been in [very good partial response] or better after the transplant and were MRD-positive by next-generation sequencing at the 10-5 threshold.
0:59 | Patients were stratified by cytogenetic risk and randomized within 6 months of transplant to either daratumumab and lenalidomide vs lenalidomide alone. Treatment was administered for 36 months. MRD testing was done at 12, 18, 24, and 36 months. The primary end point of the study was MRD-negative conversion rate at 10-5 after 12 months of maintenance.
