“The depth of response improved with the duration of treatment, achieving up to 85 percent CR or better in patients who completed induction, AHCT, and consolidation,†Dr. Mateos said. She also noted that, at 28-month follow-up, rates of progression-free survival and overall survival were 94 percent and 98 percent, respectively.
During each phase, no patients discontinued treatment because of adverse events (AEs), though four patients developed grade 3/4 neutropenia (2 during consolidation and 2 during maintenance). Treatment-related AEs included pneumonia (n=1), respiratory infection (n=1), infections (n=2), enterocolitis (n=1), cutaneous exanthema (n=1), meningitis (n=1), and massive ischemic stroke (n=1). The safety profile was acceptable, the authors wrote, adding that, “although infections are the most frequent treatment-related AEs, most were mild and manageable.â€
The lack of a comparator arm limits the study’s findings. The trial defined cure as MRD negativity sustained for at least five years, so longer-term follow-up is needed to confirm whether this approach is actually curative.
The authors report relationships with Amgen and Celgene, manufacturers of carfilzomib and lenalidomide.
Reference
Mateos MV, Lopez JM, Rodrigues-Otero P, et al. Curative strategy for high-risk smoldering myeloma (GEM-CESAR): carfilzomib, lenalidomide and dexamethasone (KRd) as induction followed by HGT-ASCT, consolidation with KRd and maintenance with Rd. Abstract #402. Presented at the 2017 American Society of Hematology Annual Meeting, December 10, 2017; Atlanta, GA.