Fully 88% of older adults with newly diagnosed multiple myeloma have at least a very good partial response when treated with low-dose autologous stem cell transplantation that is preceded by bortezomib(Drug information on bortezomib)-containing induction therapy and followed by lenalidomide-containing consolidation and maintenance therapy, according to trial results from the University of Turin in Italy.
Antonio P. Palumbo, MD, and his colleagues enrolled patients, ages 65 to 75 years, with newly diagnosed multiple myeloma or younger patients in whom full-intensity transplantation was contraindicated.
The patients were treated with a sequential strategy entailing four cycles of bortezomib, pegylated doxorubicin(Drug information on doxorubicin), and dexamethasone(Drug information on dexamethasone) (PAD) for induction; one to two cycles of peripheral blood stem cell mobilization; two cycles of low-dose melphalan(Drug information on melphalan) with autologous stem cell transplantation (MEL100); four cycles of lenalidomide and prednisone(Drug information on prednisone) (LP) for consolidation; and, finally, ongoing lenalidomide for maintenance.
The analyses presented were based on the first 86 patients. Some 62% had the 13q deletion and 21% had the 4;14 translocation (ASCO 2008 abstract 8518).
The rate of at least very good partial response increased from 59% after PAD to 88% after PAD-MEL100 and remained at 88% after PAD-MEL100-LP; however, the respective rates of complete response and near-complete response combined were 21%, 59%, and 70%. Dr. Palumbo noted that the increase in the latter rates appeared to be mainly driven by gains among patients who initially had at least a partial response. Projected 2-year event-free survival was 83% and 2-year overall survival was 92%.
The 34 trial patients who completed the regimen (PAD-MEL100-LP) had a significantly higher rate of at least very good partial response when compared with 124 historical control patients who received dexamethasone, doxorubicin, and vincristine induction followed by full-dose melphalan with autologous transplantation (DAV-MEL200) (88% vs 36%)—despite the fact that the latter group had a median age that was 10 years younger (Figure 1). Moreover, the rate of complete and near-complete response was more than twice as high with the former (70% vs 29%).
Values were also higher than those achieved historically with another regimen (Haematologica 91:1498-1505, 2006), bortezomib and dexamethasone induction with full-dose transplantation (VD-MEL200).