A recent study of newly diagnosed multiple myeloma patients found that Revlimid ^[1] (lenalidomide) and low-dose dexamethasone ^[2] (Decadron) resulted in better short-term overall survival and fewer severe side effects than Revlimid and high-dose dexamethasone.  Results were so convincing after one year that the trial was stopped early.

For years, Revlimid plus high-dose dexamethasone has been a standard treatment for multiple myeloma.

“The results of the study have already changed practice worldwide,” said Dr. S. Vincent Rajkumar of the Mayo Clinic and lead author of the study.

In this study, 445 patients were randomly assigned to receive either a high- or low-dose treatment over four 28-day cycles.  After the four cycles, a complete or partial response was seen in 169 of the eligible 214 high-dose patients (79 percent) and in 142 of the eligible 205 low-dose patients (68 percent).

After one year, overall survival was 96 percent in the low-dose group and 87 percent in the high-dose group.  As a result, the trial was prematurely terminated and patients in the high-dose group were switched to the low-dose treatment.

Within the first four cycles, 117 high-dose patients (52 percent) experienced severe side effects compared to only 76 low-dose patients (35 percent).

The most common severe side effects were deep vein thrombosis, pneumonia, and fatigue.  Deep vein thrombosis, or blood clotting in veins located deep in the body, was reported in 26 percent of high-dose patients and 12 percent of low-dose patients; pneumonia was seen in 16 percent and 9 percent, respectively; and fatigue was experienced by 15 percent and 9 percent, respectively.

According to Dr. Rajkumar, not only does low-dose dexamethasone result in fewer side effects, but it likely allows patients to be treated for longer, which translates into a beneficial clinical effect.

Greater survival with low-dose dexamethasone might also be due to high-dose dexamethasone countering some of the favorable effects of Revlimid, he said.

The study has had a significant impact on the multiple myeloma community. “Very few patients receive high-dose dexamethasone anymore, particularly in the newly diagnosed setting, and most if not all currently ongoing Phase 3 trials are using low-dose dexamethasone,” said Dr. Rajkumar.

“I believe that the results of the study have already made life easier and more tolerable for patients and also lowered early mortality significantly.”

For more information, please see the study in The Lancet Oncology ^[3] (abstract).