KEY TAKEAWAYS
- The phase 2 study determined the efficacy and safety of D-RVD in HR-SMM.
- The trial’s primary endpoint was the MRD-negativity rate at 2 years. Secondary endpoints were PFS, ORR, and safety.
- D-RVD showed strong efficacy in HR-SMM, with high MRD-negativity rates and a toxicity profile similar to MM.
Lenalidomide has been effective in slowing disease progression in high-risk smoldering multiple myeloma (HR-SMM) patients (pts). The combination of Daratumumab, bortezomib, lenalidomide, and dexamethasone (D-RVD) has demonstrated high levels of minimal residual disease (MRD) elimination in multiple myeloma (MM).
The phase II open-label trial assessed D-RVD treatment in HR-SMM. Participants were selected based on Mayo 2018 “20-2-20” criteria, Mayo 2008 criteria, immunoparesis presence, evolving SMM, and high-risk FISH results. The treatment regimen included a two-year course of D-RVD, incorporating standard doses and schedules for all drugs.
The study’s primary endpoint was to measure MRD-negativity rates at the two-year mark, with secondary objectives including progression-free survival, overall response rate, and safety. An additional part of the study focused on pts still showing MRD after two years.
As of the last data update, 30 pts participated in the first part of the trial, with a median follow-up of 14 months. Most pts were classified as either high or intermediate risk based on Mayo 2018 criteria. No participants discontinued due to treatment toxicity.
The overall response rate stood at 87%, with different categories of response noted. MRD-negativity rate was 58% in pts with at least six months of follow-up. No progressions were observed, and stem cell collection was successful in all eligible pts. D-RVD treatment in HR-SMM showed substantial effectiveness, including high MRD-negativity rates, while maintaining a toxicity profile comparable to that in MM treatment.
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT04775550
Nadeem, O. Phase II Trial of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in High-Risk Smoldering Multiple Myeloma.
