Consolidation therapy with bortezomib/lenalidomide/ dexamethasone versus bortezomib/dexamethasone after a dexamethasone-based induction regimen in patients with multiple myeloma: a randomized phase III trial

Abstract

In recent years, we have seen tremendous progress in our ability to achieve durable responses in patients with multiple myeloma. At the center of this progress, we have the development of 2 unrelated classes of drugs: proteasome inhibitors such as bortezomib and immunomodulatory drugs such as thalidomide and lenalidomide. The depth and durability of responses attained with these agents in the first-line setting has raised the possibility that they may be considered primary therapy. The Eastern Cooperative Oncology Group E1A05 clinical trial addresses the potential role of bortezomib and dexamethasone (VD) or VD plus lenalidomide (VRD) as primary first-line therapy. This clinical trial enrolls patients who have completed a dexamethasone-based induction (excluding patients using bortezomib). Assuming that most patients entering this clinical trial have been previously treated with thalidomide or lenalidomide, the trial will test whether switching to a proteasome inhibitor (VD arm) versus adding a proteasome inhibitor (VRD) results in superior longterm disease control. Patients entering this clinical trial will have deferred stem cell transplantation until the time of relapse. The primary endpoint of the trial is progression-free survival. By using an alkylator-free consolidation and reserving stem cell transplantation until the time of relapse, we hope that these treatment strategies will further prolong the survival of patients with myeloma.