Posted: Thursday, July 7, 2022
The quadruplet regimen of the monoclonal antibody daratumumab, ixazomib, pomalidomide, and dexamethasone was reported to be a well-tolerated and effective combination as salvage therapy for patients with early relapsed or refractory multiple myeloma, including those with high-risk genetic abnormalities, according to the stage 2 interim results of a phase II multicenter trial presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 8041). Anupama Deepa Kumar, MD, of the University of California, San Diego, La Jolla, and colleagues reported an objective response rate to date of 84%.
This study included patients with early relapsed or refractory multiple myeloma who had no previous exposure to daratumumab or ixazomib, no disease progression with pomalidomide, and who had received between one and three prior lines of therapy. A Simon’s optimal two-stage design was used, with 14 patients in stage 1 to assess response and 32 patients in stage 2. To date, 18 patients have been treated in stage 2.
The patient population was divided evenly between men and women; most had received one prior line of therapy. All patients were lenalidomide-exposed, and nearly half (47%) had high-risk cytogenetic features.
The best responses included five stringent complete responses (21%), four very good partial responses (21%), and seven partial responses (37%). The median overall survival was 39 months, and progression-free survival was 9.5 months. The median time on treatment was 4 months, with 11 patients remaining on the quadruplet regimen. Five deaths occurred—four due to progressive disease and one due to sepsis. The most common grade 3 or 4 treatment-emergent adverse events included neutropenia (78%), infection (30%), leukopenia (11%), respiratory conditions (7%), psychiatric disturbance (4%), and thrombosis (4%).
Disclosure: For full disclosures of the study authors, visit coi.asco.org.