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Lenalidomide Maintenance Therapy for Multiple Myeloma

Name of the Trial

Phase III Randomized Study of Lenalidomide as Maintenance Therapy After Autologous Stem Cell Transplantation in Patients with Multiple Myeloma (CALGB-100104). See the protocol summary.

Principal Investigators

Dr. Philip McCarthy and Dr. Kenneth Anderson, Cancer and Leukemia Group B; Dr. Edward Stadtmauer, Eastern Cooperative Oncology Group; Dr. Sergio Giralt, Blood and Marrow Transplant Clinical Trials Network

Dr. Philip McCarthy

Dr. Philip McCarthy Principal Investigator

Why This Trial Is Important

Multiple myeloma is a type of blood cancer that develops in plasma cells. Treatment for multiple myeloma is usually effective in bringing about remission or stopping disease progression, but it rarely provides a cure. Most patients will eventually have a relapse or progression and die from their disease.

Multiple myeloma treatment usually starts with chemotherapy to reduce the amount of disease. This initial treatment, called induction therapy, is often followed by consolidation therapy, which consists of high-dose chemotherapy, single or tandem autologous or allogeneic stem cell transplantation (SCT), or both. Maintenance therapy is then sometimes given in an attempt to prolong the duration of remission.

The addition of the drug lenalidomide (Revlimid; CC-5013) to induction therapy for multiple myeloma has been found to increase both the rate and the duration of remission compared to earlier regimens. In this trial, researchers are exploring whether maintenance therapy with lenalidomide following autologous SCT can slow or prevent the return of cancer. Patients who have had induction therapy will undergo single autologous SCT and then be randomly assigned to receive either maintenance lenalidomide or placebo.

"An earlier clinical trial has shown that maintenance therapy with thalidomide improves survival after autologous SCT in patients with myeloma," said Dr. McCarthy. "However, a high number of patients stopped treatment because of toxicity associated with thalidomide.

"Lenalidomide is a derivative of thalidomide that may be more potent and less toxic, so we have good reason to believe that lenalidomide maintenance therapy may help extend the length of remission in patients who respond to autologous SCT and perhaps help those with partial responses to SCT achieve complete response," Dr. McCarthy said.

"Another exciting aspect of this study is that it demonstrates an important initiative among U.S. researchers to coordinate and collaborate on multiple myeloma clinical trials," he added. "We believe this cooperative effort will improve the efficiency of multiple myeloma trials and ultimately benefit patients by speeding up the development and validation of new treatments."

For More Information

See the lists of entry criteria and trial contact information at or call the NCI's Clinical Trials Referral Office at 1-888-NCI-1937. The toll-free call is confidential.

  • Posted: February 24, 2009