Multiple Myeloma: Evaluating Lenalidomide, Bortezomib, and Dexamethasone With Transplantation
While PFS was superior in the stem cell transplantation with RVD group vs the RVD only group, OS rates were not better, and toxicity was significantly worse.
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