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.

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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.


  1. 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.