A drug combination including Revlimid ^[1] (lenalidomide) as both an induction and maintenance therapy increases progression-free survival in newly diagnosed multiple myeloma patients over the age of 65 years, new Phase 3 research suggests. Researchers presented the preliminary results of the MM-015 clinical trial on December 7 at the 51st annual meeting of the American Society of Hematology (ASH) in New Orleans.

Currently, Revlimid is only approved in combination with dexamethasone ^[2] (Decadron) to treat relapsed multiple myeloma patients, according to the United States Food and Drug Administration ^[3]. This trial’s findings have the potential to gain Revlimid first-line treatment status, enabling its use in newly diagnosed patients.

In this study, researchers compared a combination regimen of melphalan ^[4] (Alkeran), prednisone ^[5], and Revlimid (a regimen known as MPR) with a regimen of melphalan and prednisone alone (known as MP) in elderly patients with previously untreated myeloma.

The study organizers recruited 459 myeloma patients over the age of 65 years and assigned them to three treatment groups: nine cycles of MPR induction followed by Revlimid alone as maintenance (MPR-R), nine cycles of MPR followed by a placebo (MPR-Pl), and nine cycles of MP followed by a placebo (MP-Pl). All patients took aspirin daily to counter the formation of blood clots in the body’s deep veins, a side effect of Revlimid. Researchers focused primarily on the MPR-R and MP-Pl treatment groups and evaluated the two therapies on progression-free survival.

Interim results of the MM-015 study indicated the MPR-R treatment reduced the risk of disease progression by 50 percent, in comparison to the MP-Pl treatment. However, results from the MPR-Pl treatment group were similar to the MP-Pl treatment group. In both groups, patients lived about 13 months before their disease progressed. In the MPR-R group, in contrast, patients lived considerably longer before disease progression – long enough, in fact, that the study authors are not yet able to calculate the average survival time before disease progression for the group.

These findings suggest that Revlimid works effectively as a maintenance therapy and not as well in early treatment of myeloma. However, financial analysts attribute the MPR-R and MP-Pl similarities to the incomplete nature of the data and anticipate that the final results, to be presented some time next year, will reveal significant differences between induction with Revlimid and without it.

Researchers also evaluated the treatment groups’ response to the therapy and the therapy’s safety. They concluded that MPR-R is a safe and effective therapy that should be “considered a new standard” for treating multiple myeloma in elderly patients.

For more information, see abstract 613 ^[6] at the ASH meeting Web site.