Modified lenalidomide, bortezomib, and dexamethasone (RVD-lite) is a highly effective and well tolerated treatment regimen among patients with multiple myeloma (MM) ineligible for transplant, according to a study published in the British Journal of Haematology.
Previous studies have shown that maximal-dose RVD leads to excellent overall response rates (ORR) and prolongs overall survival (OS) and progression-free survival (PFS) for transplant-ineligible patients with newly diagnosed MM (NDMM), but has also been associated with toxicity and frequently requires dose reductions in older patients.
For this single-arm phase 2 study, researchers enrolled 53 eligible patients and assigned them to receive RVD-lite, a reduced RVD regimen consisting of oral lenalidomide 15 mg, subcutaneous bortezomib 1.3 mg/m2, and oral dexamethasone 20 mg. Patients underwent a total of 15 treatment cycles: 9 cycles of induction therapy followed by 6 cycles of consolidation with lenalidomide and bortezomib only. The median age of study patients was 73 years.
Results showed that the ORR was 86%, with 66% of patients achieving very good partial response or better.
Patients had a median PFS of 35.1 months, and the median OS was not evaluable after 30 months of follow-up.
The most frequently observed adverse effect was peripheral neuropathy, which occurred in 31 (62%) of 53 patients. Only 1 patient reported grade 3 symptoms.
The outcomes observed with RVD-lite was not significantly different from standard dose RVD, and had comparable efficacy, improved toxicity, and may be the new treatment standard for this patient population.
The authors concluded that “an area of future exploration will be the addition of other novel therapies such as monoclonal antibodies to this regimen with the goal of creating a curative platform for the disease.”
O’Donnell EK, Laubach JP, Yee AJ, et al. A phase 2 study of modified lenalidomide, bortezomib and dexamethasone in transplant-ineligible multiple myeloma [published online May 8, 2018]. Br J Haematol. doi: 10.1111/bjh.15261