Name of the Trial
Phase III Randomized Study of Consolidation Therapy Comprising Bortezomib and Dexamethasone with Versus without Lenalidomide in Patients with Symptomatic Multiple Myeloma Who Have Completed a Dexamethasone-Based Induction Regimen (ECOG-E1A05). See the protocol summary at http://cancer.gov/clinicaltrials/ECOG-E1A05.

Principal Investigator
Dr. Rafael Fonseca and Dr. S. Vincent Rajkumar, Eastern Cooperative Oncology Group

Why This Trial Is Important
Multiple myeloma is a type of cancer that begins in plasma cells, white blood cells that are part of the immune system. In this disease, malignant plasma cells (myeloma cells) multiply and form small lesions in the bone marrow and the solid parts of bone. Although multiple myeloma is usually not curable, advances in drug treatment and the use of stem cell transplantation have substantially increased the average survival time of patients with this disease.

Patients with multiple myeloma are often treated first with chemotherapy drugs and the steroid dexamethasone to induce remission (induction therapy). This is often followed by "consolidation therapy" with high-dose chemotherapy and stem cell transplantation. Although consolidation therapy has produced longer survival, the side effects associated with it can be severe and may dramatically affect quality of life. Doctors want to study new consolidation therapy options, using recently developed drugs, to see if they can achieve the same or better outcomes without as much risk to the patient.

In this trial, newly diagnosed patients who have undergone induction therapy will be treated with consolidation therapy consisting of dexamethasone and the drug bortezomib. Some patients will also be randomly assigned to receive a third drug called lenalidomide. Both bortezomib and lenalidomide have been approved by the FDA to treat patients with relapsed multiple myeloma, and they have shown promise in early clinical trials involving patients with newly diagnosed disease.

"One of the biggest questions in the minds of patients in this era of new drugs is, 'Do we still need to have a transplant?'" said Dr. Rajkumar. "Autologous transplants are associated with significant morbidity and can be life changing. Both of these regimens hold the promise of high response rates that may rival what we can achieve with stem cell transplantation while being easier on patients."

For More Information
See the list of entry criteria and trial contact information at http://cancer.gov/clinicaltrials/ECOG-E1A05 or call the NCI Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The toll-free call is confidential.