Evaluating the effectiveness and safety of replacing lenalidomide with pomalidomide for the treatment of patients with multiple myeloma who are unresponsive to a lenalidomide-containing combination regimen.

This study evaluated the effectiveness and safety of replacing lenalidomide (Revlimid) with pomalidomide (Pomalyst) for the treatment of patients with relapsed or refractory (r/r) multiple myeloma (MM) who were unresponsive to a lenalidomide-containing combination regimen. The data showed that pomalidomide was a safe and effective replacement for lenalidomide in these patients.

Multiple myeloma (MM) is a type of cancer that comes from blood cells called plasma cells. Standard treatments for MM include immune modulators (IMs) such as lenalidomide. Lenalidomide is an immunotherapy drug that boosts the body’s immune system to help it attack cancer cells. A high number of patients with MM experience relapse (the tumor grows after treatment) or are refractory (not responsive to the treatment) to standard treatment.

Currently, the treatment strategies for r/r MM are based on the different combinations of conventional drugs and novel drugs. One standard treatment combination for r/r MM is pomalidomide in combination with dexamethasone. However, the effectiveness and safety of replacing lenalidomide with pomalidomide for the treatment of patients with r/r MM who are unresponsive to a lenalidomide-containing combination regimen are still unknown.

This study involved 45 patients with r/r MM who were unresponsive to a lenalidomide-containing combination regimen. All patients received pomalidomide on days 1–21 of a 28-day cycle for 8 cycles or fewer at doses of 2, 3, or 4 mg. The average follow-up period was 7 months.

The average survival without cancer worsening was 8 months. The average overall survival was 16 months.

The overall response rate (ORR; the partial or complete disappearance of the cancer) was 33%. The clinical benefit rate (CBR; ORR plus stable disease) was 44%. The ORR was 41% and the CBR was 50% in patients who received 4 mg of pomalidomide.

The most common serious side effects were low white blood cell counts (22%), low red blood cell counts (7%), and pneumonia (7%).

This study concluded that pomalidomide was a safe and effective replacement for lenalidomide in patients with r/r MM who were unresponsive to a lenalidomide-containing combination regimen.

This study was sponsored by Celgene Corporation, a Bristol-Myers Squibb Company, the manufacturer of pomalidomide. The sample size was very small and the follow-up period was short.