A Trial of Single Autologous Transplant with or without Consolidation Therapy versus Tandem Autologous Transplant with Lenalidomide Maintenance for Patients with Multiple Myeloma

Multiple myeloma is difficult to treat with chemotherapy or radiation therapy alone. High doses of chemotherapy are needed, but can also lower blood counts. Using a patient’s own cells to help increase blood counts after high doses of chemotherapy is called autologous stem cell transplantation (SCT).

High-dose chemotherapy with autologous SCT has increased the length of time myeloma patients live, but it does not cure them. In most patients, the disease will come back many months or many years after the autologous SCT. The purpose of this study is to find a treatment that will prevent myeloma from returning, or delay the time to recurrence.

Patients in this study will receive one of the three possible treatments, and researchers will compare the results:

• autologous SCT followed by a second autologous SCT, and then ongoing daily oral anticancer medicine for three years (maintenance therapy)
• one autologous SCT followed by oral daily maintenance therapy for three years
• one autologous SCT followed by three anticancer medicines given together (lenalidomide, bortezomib, and dexamethasone), called “consolidation therapy,” to kill any myeloma cells remaining after the first transplant, as well as three years of oral daily maintenance therapy.