OBJECTIVETo evaluate the efficacy and safety of high-dose intravenous mecobalamin (HDIME) for the treatment of bortezomib-induced peripheral neuropathy(BIPN) in the patients with multiple myeloma (MM).

METHODSA total of 65 newly diagonsed patients with multiple myeloma receiving bortezomib in Tianjin Medical University General Hospital were enrolled in this single-centre randomized clinical trial from July 2012 to May 2016. Out of 65 patients 38 in control group received bortezomib-based chemotherapy and 27 patients in HDIME group received the additional high-dose intravenous mecobalamin.

RESULTSThe incidence of BIPN in HDIME group was lower than that in control group(29.63% vs 55.26%, χ=4.197,P<0.05). Whether the BIPN rate of Grade 2 or 3 and above in HDIME group significantly decreased as compared with control group(18.52% vs 47.37%,χ=5.746,P<0.05) (3.71% vs 21.05%, χ=3.983,P<0.05). The BIPN rate of less than 5 cycles of bortezomib was not significantly different between HDIME and control groups(χ=2.714,P>0.05). Overall effective rate of HDIME group and control group was 77.78% and 73.68%(P>0.05) respectively. Neither PFS nor OS was significantly different between HDIME group and control group(P>0.05). Treatment-related toxicity was only mild rash in 1 case. No other side-effects including nausea, abdominal pain, and hypotension occurred.

CONCLUSIONHDIME has a good efficacy for the prophylaxis BIPN and and without serious side effects.