Trial Description: All the drugs used in this trial have been previously approved by the US Food and Drug Administration for the treatment of myeloma, but they have not been approved in this combination. There is strong evidence that this combination is safe and effective in treating newly diagnosed myeloma. The study explores the combination alone or when combined with high-dose chemotherapy (melphalan) and autologous stem cell transplantation. Please note that bortezomib and lenalidomide are provided at no charge to patients who participate in this trial.
Trial Objectives: This study, sponsored by Dr. Paul Richardson of the Dana-Farber Cancer Institute, was designed to answer a very important question in myeloma: In the era of novel drugs, is high-dose therapy (HDT) still necessary in the initial management of multiple myeloma in younger patients? In this study, the addition of HDT to conventionaldose treatment (RVD) as compared to conventional-dose treatment (RVD) alone would be considered superior if it significantly prolongs progression-free survival by at least 9 months.