Researchers from France reported that the addition of thalidomide to standard melphalan chemotherapy improves progression-free and overall survival compared to either melphalan alone or high-dose melphalan and autologous stem cell support in the treatment of newly diagnosed, elderly patients with multiple myeloma. The results from this phase III trial were presented at the 42nd annual meeting of the American Society of Clinical Oncology (ASCO) held in Atlanta, Georgia, June 2-6, 2006.
Multiple myeloma is a cancer of the blood that affects the plasma cells. Plasma cells are an important part of the immune system; they produce antibodies to help fight infection and disease. Multiple myeloma is characterized by an excess production of abnormal plasma cells. Symptoms include increased risk of bacterial infections and impaired immune responses.
Thalomide is an immunomodulatory agent that helps the immune system fight cancer. In addition, thalidomide stops or prevents blood vessels from growing and providing cancer cells with nutrients and oxygen for their spread and growth.
Melphalan/prednisone is the standard treatment for patients with newly diagnosed multiple myeloma. Autologous stem cell transplantation is also a standard treatment option for eligible patients with multiple myeloma, and with the advent of newer agents such as thalomide and Velcade® (bortezomib) emerging as effective agents in the treatment of multiple myeloma, researchers continue to directly compare treatment strategies in order to provide optimal and individualized therapeutic approaches for every patient.
The phase III trial, referred to as the IFM 99-06 trial, was initiated in May 2000 and included newly diagnosed patients between the ages of 65 and 75 years. Patients were randomly assigned to receive one of three treatments:
- Standard melphalan with prednisone
- Standard melphalan/prednisone plus thalidomide
- High-dose melphalan with autologous stem cell support
Recruitment was stopped while this trial was still in progress as the melphalan plus thalidomide treatment demonstrated clear improvements over the other two treatments.
At approximately three years after treatment, patients who were treated with melaphalan plus thalidomide experienced significantly longer progression-free and overall survival compared to patients who received the other two treatments.
- Progression free survival was 27 months for patients receiving melaphalan plus thalidomide, compared to 17 months for melaphalan and 19 months for high-dose melphalan with autologous stem cell support.
- Overall survival was 54 months for patients receiving melaphalan plus thalidomide, compared to 32 months for melaphalan and 39 months for high-dose melphalan with autologous stem cell support
Patients who received thalidomide had higher rates of low white blood cell counts (neutropenia) compared to those who received only melphalan. Other side effects of thalidomide included peripheral neuropathy (6%) and constipation (10%).
The researcher presenting these findings emphasized that melphalan plus thalidomide should now be the treatment that others are compared to in future clinical trials involving newly diagnosed, elderly patients with multiple myeloma.
Reference: Facon T, Mary J, Harousseau F, et al. Superiority of Melphalan-Prednisone (MP) + Thalidomide (THAL) over MP and Autologous Stem Cell Transplantation in the Treatment of Newly Diagnosed Elderly Patents with Multiple myeloma. Proceedings from the 42nd annual meeting of the American Society of Clinical Oncology (ASCO). Plenary Session Presented June 4, 2006. Abstract #1.