Results from a recent phase III trial demonstrate that the addition of Thalomid® (thalidomide) to the steroid dexamethasone improves progression-free survival in patients with newly diagnosed multiple myeloma. The trial was stopped when the addition of Thalomid had clearly demonstrated superiority over dexamethasone alone.
Multiple myeloma is a cancer of the blood that affects the plasma cells. Plasma cells, which produce antibodies to help fight infection and disease, are a vital part of the immune system. In multiple myeloma an excess of abnormal plasma cells is produced. This produces symptoms such as increased risk for bacterial infections or impaired immune responses. Other effects of myeloma may include damage to the kidneys, osteoporosis, anemia, and an elevated blood calcium level.
Often, patients with multiple myeloma are elderly and unable to tolerate aggressive therapy. This has led to the development of novel agents that are easily administered and tolerated while producing anticancer activity in patients with multiple myeloma.
Thalomid is an oral agent that is still in clinical trials for the treatment of various cancers. It stimulates the immune system to help fight the cancer. It also reduces the development of new arteries (anti-angiogenesis) that supply cancer cells with nutrients and oxygen that enable them to grow and replicate.
Researchers recently conducted a phase III trial (the last phase prior to FDA review) to directly compare Thalomid plus dexamethasone (a steroid commonly used in the treatment of multiple myeloma) to dexamethasone alone. The trial included 270 patients with newly diagnosed multiple myeloma.
Patients treated with Thalomid/dexamethasone had significantly improved outcomes compared to those treated with dexamethasone alone:
- Time to cancer progression was 75.7 weeks for patients treated with Thalomid/dexamethasone, compared with 27.9 weeks for those treated with dexamethasone only.
- Progression-free survival was 55.7 weeks for patients treated with Thalomid/dexamethasone, compared with 24.3 weeks for those treated with dexamethasone only.
- Side effects attributed to Thalomid included insomnia, tremors, dizziness, constipation, and changes in numbness/tingling/burning of the hands and feet.
The researchers concluded that the addition of Thalomid to dexamethasone significantly improves progression-free survival in patients with newly diagnosed multiple myeloma. Patients with newly diagnosed multiple myeloma may wish to speak with their physician regarding their risks and benefits of participation in a clinical trial further evaluating Thalomid or other novel therapeutic agents.
Reference: Celgene. THALOMID Pivotal Phase III Multiple Myeloma Trial Reaches Pre-Specified Interim Endpoint. Accessed http://ir.celgene.com/phoenix.zhtml?c=111960&p=irol-newsArticle&t=Regular&id=801802&. Accessed January 2006.