Maintenance therapy with bortezomib plus thalidomide significantly prolonged progression-free survival compared with thalidomide or interferon alfa-2b in patients with newly diagnosed symptomatic multiple myeloma, a study published in the journal Leukemia has shown.1
For the multicenter, open-label, phase 3 GEM05MENOS65 trial (clinicalTrials.gov Identifier: NCT00461747), investigators enrolled 390 patients aged 65 years or younger with newly diagnosed symptomatic multiple myeloma.
Participants were randomly assigned to receive induction therapy with thalidomide plus dexamethasone, bortezomib plus thalidomide and dexamethasone, or 4 alternating cycles of VBMCP (vincristine, BCNU, cyclophosphamide, melphalan, prednisone) and VBAD (vincristine, BCNU, doxorubicin, dexamethasone) followed by 2 cycles of bortezomib alone. Patients then underwent autologous hematopoietic cell transplantation with melphalan.
Investigators then randomly assigned 271 patients a second time to receive maintenance therapy with thalidomide plus bortezomib, thalidomide alone, or interferon alfa-2b alone.
Results showed no significant difference in the complete response rate between maintenance therapy arms, with 21% of patients who received thalidomide plus bortezomib maintenance achieving a complete response compared with 11% with thalidomide alone and 17% with inferferon alfa-2b.
However, researchers found that median progression-free survival was significantly longer with thalidomide plus bortezomib vs thalidomide alone and interferon alfa-2b alone after a median follow-up of 58.6 months (P =.03). There was no significant difference in overall survival between the 3 maintenance arms.
Nearly half of patients treated with thalidomide and bortezomib experienced grade 2 to 3 peripheral neuropathy vs 34.4% of patients treated with thalidomide only and 1% of those given interferon alfa-2b.
1. Rosinol L, Oriol A, Teruel AI, et al. Bortezomib and thalidomide maintenance after stem-cell transplantation for multiple myeloma: A PETHEMA/GEM trial. Leukemia. In press.