Thalidomide-based treatment may be an option for patients with multiple myeloma (MM) who are eligible for autologous stem cell transplantation (autoSCT) and live in countries without access to proteasome inhibitors or lenalidomide, according to findings published in the Lancet Haematology.
In this open-label, phase 3, randomized, controlled trial, researchers examined the long-term effects of thalidomide in induction and maintenance therapy in 556 patients with recently diagnosed MM. Patients in the control group received 0.4 mg vincristine on days 1 to 4, 9 mg doxorubicin/m2 on days 1 to 4, and 40 mg dexamethasone on days 1 to 4, 9 to 12, and 17 to 20 for three 28-day cycles. Patients in the thalidomide group received the same amount of doxorubicin and dexamethasone along with 200 to 400 mg thalidomide daily. Patients received 200 mg melphalan/m2 with autoSCT 6 to 8 weeks after their stem cells were harvested.
Patients receiving thalidomide in conjunction with high dose melphalan and autoSCT demonstrated improved event-free survival (33 months) compared with patients receiving classical cytotoxic drugs (22 months; P <.0001).
Of the 155 patients receiving thalidomide maintenance, 65 stopped treatment due to toxicity, while 24 of the 90 patients receiving interferon alfa maintenance discontinued treatment because of toxicity. The number of second primary malignancies was similar between groups. There were 19 treatment-related deaths in the control group compared with 16 deaths in the thalidomide group.
The researchers concluded that thalidomide used during induction and maintenance therapy showed improvements in event-free and progression-free survival. However, patients must be carefully followed, and timely dose adjustments must be made to prevent thalidomide-induced neurotoxicity.
1. van de Donk NWCJ, van der Holt B, Minnema MC, et al. Thalidomide before and after autologous stem cell transplantation in recently diagnosed multiple myeloma (HOVON-50): long-term results from the phase 3, randomised controlled trial [published online October 1, 2018]. Lancet Haematol. doi: 10.1016/S2352-3026(18)30149-2