Thalidomide plus dexamethasone should be considered a standard frontline regimen for treating patients with myeloma who are candidates for autologous stem-cell transplantation, researchers have concluded.
A double-blind, placebo-controlled trial undertaken by a team led by Dr S Vincent Rajkumar of Mayo Clinic, USA, and published early online in the Journal of Clinical Oncology, examined the efficacy of thalidomide plus dexamethasone (thal/dex) as initial therapy for newly diagnosed multiple myeloma.
The study found that administering thalidomide on top of dexamethasone resulted in significantly higher response rates and prolonged time to progression in cases of newly diagnosed multiple myeloma, compared with dexamethasone alone.
However, the authors acknowledge that their results must be considered in the context of other advances in treating myeloma.
In the study, patients on combination therapy received oral thalidomide 50mg/d, increased to 100mg on day 15, and to 200mg from day 1 of cycle 2 (28-day cycles). Oral dex 40mg was administered on days 1–4, 9–12 and 17–20 during cycles 1–4 and on days 1–4 only from cycle 5 onwards. Patients in the dex arm received placebo and dex, administered as described above.
The primary endpoint was time to progression (TTP).