Consolidation with high-dose melphalan and autologous stem-cell transplantation (ASCT) remains the preferred option in transplant-eligible patients with multiple myeloma, even though chemotherapy plus lenalidomide has a better safety profile, a new study published online ahead of print in the journal The Lancet Oncology has shown.1
Currently, high-dose melphalan plus ASCT is the standard treatment strategy in transplant-eligible patients with newly diagnosed multiple myeloma.
For the open-label, multicenter, phase 3 study, researchers enrolled 389 transplant-eligible patients with newly diagnosed multiple myeloma 65 years or younger. All patients received induction with 4 28-day cycles of lenalidomide, dexamethasone, and cyclophosphamide, followed by granulocyte colony-stimulating factor (GCSF) for stem-cell mobilization and collection.
Of the 389 participants, 256 were eligible for consolidation. Patients were randomly assigned to receive 6 cycles of cyclophosphamide 300 mg/m2 on days 1, 8, and 15, dexamethasone 40 mg on days 1, 8, 15, and 22, and lenalidomide 25 mg on days 1-21, or 2 courses of high-dose melphalan 200 mg/m2 plus ASCT.
There were also 223 patients eligible for maintenance therapy. Those patients were randomly assigned to receive maintenance lenalidomide 10 mg on days 1-21 plus prednisone 50 mg every other day or lenalidomide alone.
Results showed that median progression-free survival during consolidation was 28.6 months (95% CI, 20.6 – 36.7) with chemotherapy plus lenalidomide and 43.3 months (95% CI, 33.2 – 52.2) with high-dose melphalan and ASCT (HR for the first 24 months, 2.51; 95% CI, 1.60 – 3.94; P < .0001). Researchers found no significant difference in progression-free survival between maintenance groups (HR, 0.84; 95% CI, 0.59 – 1.20; P = .34).
In regard to safety, there were fewer grade 3 or 4 adverse events reported in the chemotherapy plus lenalidomide treatment arm than in the melphalan plus ASCT arm.
- Gay G, Oliva S, Petrucci MT, et al. Chemotherapy plus lenalidomide versus autologous transplantation, followed by lenalidomide plus prednisone versus lenalidomide maintenance, in patients with multiple myeloma: a randomised, multicentre, phase 3 trial [published online ahead of print on November 16, 2015]. Lancet Oncol. doi: 10.1016/S1470-2045(15)00389-7.