Thalidomide and dexamethasone vs. bortezomib and dexamethasone for melphalan refractory myeloma: a randomized study

Objectives: Thalidomide and bortezomib have been frequently used for second‐line therapy in patients with myeloma relapsing after or refractory to initial melphalan‐based treatment, but no randomized trials have been published comparing these two treatment alternatives. Methods: Thalidomide‐ and bortezomib‐naïve patients with melphalan refractory myeloma were randomly assigned to low‐dose thalidomide + dexamethasone (Thal‐Dex) or bortezomib + dexamethasone (Bort‐Dex). At progression on either therapy, the patients were offered crossover to the alternative drug combination. An estimated 300 patients would be needed for the trial to detect a 50% difference in median PFS between the treatment arms. Results: After inclusion of 131 patients, the trial was prematurely closed because of low accrual. Sixty‐seven patients were randomized to Thal‐Dex and 64 to Bort‐Dex. Progression‐free survival was similar (median, 9.0 months for Thal‐Dex and 7.2 for Bort‐Dex). Response rate was similar (55% for Thal‐Dex and 63% for Bort‐Dex), but time to response was shorter (P