Results from a recent German study suggest that a combination of Revlimid, Treanda and prednisone is active and well tolerated in patients with relapsed or refractory multiple myeloma.
Findings from the Phase 1 trial were presented at the 17th Congress of the European Hematology Association (EHA) in Amsterdam last month.
A previous Phase 1 study showed that Treanda (bendamustine), in combination with Revlimid (lenalidomide) and dexamethasone (Decadron), is well tolerated and highly active in patients with relapsed or refractory myeloma (see related Beacon news).
Treanda, which already is approved by the U.S. Food and Drug Administration for the treatment of chronic lymphocytic leukemia and certain lymphomas, is currently being investigated as a treatment for multiple myeloma. It is in the class of drugs known as alkylating agents, which also includes melphalan (Alkeran) and cyclophosphamide (Cytoxan). Treanda works by damaging the DNA of cancer cells, which in turn causes the cells to die.
In the current study, German scientists investigated the effect of Treanda, in combination with Revlimid and prednisone, in patients with refractory or relapsed (resistant) myeloma.
Prednisone, like dexamethasone, is a steroid that lowers immune function to reduce swelling and inflammation. Steroids have also been shown to kill myeloma cells.
The study included 21 myeloma patients who had previous received, and eventually relapsed after, one or two previous anti-myeloma regimens. The patients were given escalating doses of both Revlimid and Treanda. All patients received the same dose of prednisolone, an active form of prednisone that is frequently used in Europe.
Patients received the combination regimen every four weeks, for up to eight treatment cycles. Revlimid was given on days 1 through 21 of the four-week cycle, prednisone on days 1 through 4, and Treanda on days 1 and 2.
The researchers sought to estimate the maximum tolerated dose of the combination regimen during the first two treatment cycles.
Patients who responded to treatment or had stable disease following eight treatment cycles were subsequently placed on Revlimid-only maintenance therapy.
All patients completed at least two cycles of treatment.
The researchers found that 76 percent of patients responded to therapy: 9 percent achieved a stringent complete response or a near complete response, 19 percent a very good partial response, and 48 percent a partial response.
According to the researchers, the regimen was well tolerated. The maximum tolerated dose was not reached, with 19 percent of patients developing dose-limiting, blood-related side effects. Therefore, it is possible to test the combination at higher doses than used in this study.
For more information, please see abstract 848 on the EHA Meeting website.