Celgene Corporation reported yesterday that a Phase 3 clinical trial of Revlimid (lenalidomide) in first-line multiple myeloma patients has produced overwhelmingly positive results. The outcome of the trial, known as MM-015, suggests that Revlimid taken in combination with melphalan (Alkeran) and prednisone, followed by continuous Revlimid, produces significant improvement in progression-free survival.

While Revlimid is already prescribed as a front-line drug for multiple myeloma, it is approved for use only in patients for whom other treatments have failed. In the United States, it is also used off-label, meaning that doctors can prescribe it in the first-line setting, though the company cannot market it for such a use. Data from this study will allow Celgene to seek formal regulatory approval in the U.S. and market Revlimid overseas as a safe first-line treatment option.

The MM-015 trial consisted of 459 patients with newly diagnosed multiple myeloma ineligible for stem cell transplantation. The results were announced along with Celgene’s second-quarter financial results, surprising investors who had not expected the trial results until later this year. The positive results of the trial prompted researchers to end the study early. Results of the study will be presented at the meeting of the American Society of Hematology in December.

For more information, see the Celgene press release.