Lenalidomide, bortezomib, and dexamethasone (RVD) combination therapy with stem cell transplantation results in longer progression-free survival (PFS), but not overall survival (OS), than RVD alone among patients with newly diagnosed multiple myeloma, according to a study published in The New England Journal of Medicine.1
For newly diagnosed patients aged less than 65 years, high-dose chemotherapy followed by transplantation is a standard treatment regime. New data about treatment with RVD suggest, however, that transplantation-use should be re-evaluated in this setting.
For this randomized, phase 3 trial (ClinicalTrials.gov Identifier: NCT01191060), researchers enrolled 700 of 764 screened patients to receive 3 cycles of RVD alone followed by either 5 additional RVD cycles or high-dose chemotherapy and transplantation followed by 2 additional cycles of RVD; 350 patients were assigned to each group.
The complete response rate was better in the transplantation group (205 patients vs 169 in the RVD only group); the very good partial response rate was, however, similar (102 in the transplantation group vs 101 in the RVD only group). Seventy-nine percent of patients in the transplantation group vs 65% of patients in the RVD only group had no detectable minimal residual disease during the study.
PFS was superior in the transplantation group (50 vs 36 months), though 4-year OS rates were similar (81% in the transplantation group vs 82%).
The rates of grade 3-4 neutropenia, gastrointestinal disorders, and infection were all significantly higher in the transplantation group.
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The authors concluded that while PFS was superior in the transplantation group, OS rates were not better, and toxicity was significantly worse.
- Attal M, Lauwers-Cances V, Hulin C, et al. Lenalidomide, bortezomib, and dexamethasone with transplantation for myeloma. N Engl J Med. 2017;376:1311-20. doi: 10.1056/NEJMoa1611750