Related Pages Search for Clinical Trials 1 NCI's PDQ® Cancer Clinical Trials Registry. Multiple Myeloma/Other Plasma Cell Neoplasms 2 NCI's gateway for information about multiple myeloma and other plasma cell neoplasms.

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 ³.

Principal Investigators

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 ⁴. Some patients will also be randomly assigned to receive a third drug called lenalidomide ⁵. 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 ³ or call the NCI Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The toll-free call is confidential.

Glossary Terms

Taken from an individual's own tissues, cells, or DNA.

The soft, sponge-like tissue in the center of most bones. It produces white blood cells, red blood cells, and platelets.

A synthetic steroid (similar to steroid hormones produced naturally in the adrenal gland). Dexamethasone is used to treat leukemia and lymphoma and may be used to treat some of the problems caused by other cancers and their treatment.

An agency in the U.S. federal government whose mission is to protect public health by making sure that food, cosmetics, and nutritional supplements are safe to use and truthfully labeled. The FDA also makes sure that drugs, medical devices, and equipment are safe and effective, and that blood for transfusions and transplant tissue are safe. Also called Food and Drug Administration.

The complex group of organs and cells that defends the body against infections and other diseases.

A disease or the incidence of disease within a population. Morbidity also refers to adverse effects caused by a treatment.

A method of replacing immature blood-forming cells that were destroyed by cancer treatment. The stem cells are given to the person after treatment to help the bone marrow recover and continue producing healthy blood cells.