ASCT Remains Preferred Consolidation Option In Multiple Myeloma

Multiple myeloma patients derive significant survival benefits from consolidation with high-dose melphalan plus autologous stem-cell transplantation compared with chemotherapy plus lenalidomide

medwireNews: High-dose melphalan plus autologous stem-cell transplantation (ASCT) rather than chemotherapy and lenalidomide should remain the consolidation treatment of choice in newly diagnosed multiple myeloma patients, say researchers.

They add that the transplantation-based regimen “should still be considered standard treatment, even in the era of novel agents”.

In this phase III trial, reported in The Lancet Oncology, 256 newly diagnosed patients with multiple myeloma were eligible for consolidation therapy following induction with lenalidomide and dexamethasone.

Progression-free survival (PFS) was longer for the 127 patients randomly assigned to receive high-dose melphalan plus ASCT than for the 129 given cyclophosphamide , dexamethasone and lenalidomide, at a median of 43.3 versus 28.6 months and a significant hazard radio (HR) for the initial 24 months of 2.51.

The 4-year overall survival (OS) rate was also significantly higher in the high-dose melphalan and ASCT group than in the chemotherapy plus lenalidomide group, at 86% and 73%, respectively, equating to an HR of 2.40.

Patients given high-dose melphalan plus ASCT experienced significantly more grade 3 or 4 haematological side effects compared with those treated with chemotherapy plus lenalidomide (84 vs 26%), with thrombocytopenia (82 vs 5%) and neutropenia (80 vs 24%) the most common toxicities.

Non-haematological adverse events of grade 3 or worse were also more frequent in the ASCT compared with the chemotherapy plus lenalidomide treatment arm (39 vs 23%).

But researcher Antonio Palumbo, from the University of Torino in Turin, Italy, and team note that “toxic effects were manageable and did not increase the incidence of early death or treatment discontinuation”, and they emphasise the superiority of the high-dose melphalan and ASCT combination in this patient population.

They also evaluated the effects of adding steroids to lenalidomide during the maintenance phase. Of the 223 study participants eligible for maintenance therapy, 117 were randomly allocated to receive lenalidomide plus prednisone while 106 received lenalidomide alone.

However, median PFS and the 3-year OS rate were comparable between the two groups. And although the toxicity profiles were also similar, Antonio Palumbo et al note that just over a third of patients in the steroid arm needed prednisone dose reductions, within a median of 4 months.

They conclude that “the long-term use of steroids is not well tolerated and does not provide a survival advantage compared with lenalidomide alone.”


Gay F, 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.Lancet Oncol 2015; Advance online publication 16 November. doi:

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