NIH logoPatients with multiple myeloma may find this piece of news interesting. A new drug for the condition has been apparently demonstrated to considerably extend disease-free survival. Scientists reveal that the initial results of a large randomized clinical trial for patients with multiple myeloma administered the oral drug lenalidomide appeared to have kept their cancer in check as against patients who were given placebo.

The oral drug lenalidomide or Revlimid also known as CC-5013 seems to have been effective in patients with multiple myeloma. Multiple myeloma is known to be a cancer of the blood and bone marrow and occurs when a kind of immune cell, called a plasma cell, increases in number to crowd out healthy blood cells in the bone marrow. The condition may cause pain, and eventually damage the bones and other body organs. Patients who were part of the current trial were supposedly given the drug after a blood stem cell transplant and seemed to have restrained their cancer.

Sponsored by the National Cancer Institute (NCI), the clinical trial comprised of patients between ages 18 to 70. A series of analysis led by the Cancer and Leukemia Group B (CALGB) in partnership with the Eastern Cooperative Oncology Group (ECOG) and the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) were conducted for the trial. The trial was overseen by the independent data and safety monitoring committee known as CALGB-100104.

The study revealed that those patients on the drug showed a much longer time before the cancer progressed after autologous blood stem cell transplantation as compared to those on placebo. This led to the trial being stopped early. In autologous blood stem cell transplantation, patients own blood stem cells are removed to then treat them with high doses of chemotherapy and or radiation therapy to kill the cancer. After this the blood stem cells are returned to the patient. The procedure is common for patients with multiple myeloma.

Between 2004 and July 2009, a total of 568 patients with multiple myeloma who had been administered no more than 12 months of earlier therapy and prior transplant before were enrolled for the study. All the subjects were known to have undergone autologous transplantation. Following this, they were given a high dose of a drug called melphalan that is commonly used to treat multiple myeloma.

Between 90 and 100 days after transplant, around 460 patients who showed adequate organ function and apparently no proof of progressive disease were finally randomized to receive lenalidomide or placebo. Patients started lenalidomide or placebo between day 100 to 110 and appeared to have continued it until they showed evidence of progressive disease.

The trial suggests that among the patients who received placebo, half seemed to have their myeloma progress or worsen within an estimated 778 days. On the contrary patients taking lenalidomide, a median time to progression could not be defined as less than half the patients appeared to have worsening of their myeloma. For the group taking Lenalidomide, it seems to have represented a 58 percent decrease in the risk of disease progression. Supposedly this difference in time to progression, scientists claim could have high statistic significance.

Apparently, this is claimed to be the first randomized phase 3 trial that exhibits a clinical benefit of lenalidomide following transplant for multiple myeloma. In this distinct trial, the kinds of side effects observed were found to be identical to the types observed in different clinical trials with Lenalidomide.

“This study answers the important question for multiple myeloma patients regarding maintenance lenalidomide therapy starting at 100 days following transplant,” mentioned Philip L. McCarthy, Jr., M.D., associate professor of medicine at Roswell Park Cancer Institute and principal investigator of this study. “We now know that prolonged maintenance therapy with lenalidomide when compared to placebo will delay disease progression. This is an exciting advance in the field of multiple myeloma therapy and occurred due to the willingness of multiple myeloma patients to participate in this study and to the cooperation of the many physicians and study groups involved.”

A derivative of thalidomide, lenalidomide has known to have been approved by the U.S FDA in 2006. It gained an approval for use in combination with dexamethasone, a steroid, for the treatment of multiple myeloma in patients who received at least one prior therapy for their disease.

The trial however does not seem to show evidence of an overall survival benefit yet. A future scientific meeting is anticipated to reveal detailed results from this trial.