Bortezomib in combination with thalidomide-dexamethasone for previously untreated multiple myeloma.

In a previous trial among 137 previously untreated patients with multiple myeloma, the combination of thalidomide-dexamethasone induced remission in 66% of patients, including complete remission in 13%. In an attempt to induce more frequent remissions, we added bortezomib to this program. Between 7/03 and 3/06, 38 newly diagnosed patients with multiple myeloma received at least one, but no more than 3, courses of bortezomib in a dose of 1.3 mg/m(2) IV x 4; dexamethasone 20 mg/m(2) PO for 4 days beginning on days 1, 9, 17; thalidomide 100 mg PO daily increasing to a maximum of 200 mg. There was rapid onset of remission in 33 patients (87%) including 6 patients with complete remission (16%). Most side effects were preventable, but otherwise were usually mild and reversible. After a median of 4 months, 25 eligible patients received intensive therapy with high-dose melphalan supported by autologous blood stem cells, so that the myeloma was in complete remission in 14 patients (37% of all patients). The combination of bortezomib-thalidomide-dexamethasone was a highly effective primary treatment for newly diagnosed patients with multiple myeloma.