Posted on March 10th, 2014 by
The combination of Treanda® (bendamustine), Velcade® (bortezomib) and dexamethasone produced a high response rate in patients with relapsed/refractory multiple myeloma, according to the results of a phase II study published in Blood.
Multiple myeloma is a cancer of plasma cells, which are a special type of white blood cell that are part of the body’s immune system. Patients with multiple myeloma have increased numbers of abnormal plasma cells that may produce increased quantities of dysfunctional antibodies detectable in the blood and/or urine. Patients with multiple myeloma who have become refractory—or resistant—to the drugs Revlimid® (lenalidomide) and Velcade have limited treatment options. There is no standard treatment for these patients and they typically have a poor prognosis, with a median overall survival of 9 months.
Treanda is a chemotherapy agent that combines the action of two types of agents, which attack cancerous cells through distinct pathways. It is approved for the treatment of recurrent NHL and chronic lymphocytic leukemia (CLL). Treanda has been widely used in Europe for decades, but only became available in the U.S. in 2008. It is currently being evaluated for use in other types of cancer—including multiple myeloma.
This phase II study included 79 patients from nine participating centers in Austria and the Czech Republic. The median age of all patients was 64 and most patients had stage I (34.2%) or stage II disease (39.2%). Patients had undergone a median of two prior treatment lines. Treatment consisted of Treanda (70 mg/m2) on day 1 and 4, Velcade (1.3 mg/m2) on days 1, 4, 8, 11 intravenously, and dexamethasone (20 mg) on days 1, 4, 8, and 11. Cycles were repeated every 4 weeks until a maximum of eight cycles. For patients with no response, treatment was discontinued at cycle 4.
The overall response rate to the combination was 60.9 percent—and when minor responses were included, 75.9 percent. Complete response occurred in 12 patients, very good partial response in 16 patients, partial response in 20 patients and minor response in 12 patients. The overall response rate was similar in patients who had been previously exposed to Velcade, Revlimid, or both. The median time to response was 31 days and 111 days to best response. This was notable because rapid tumor control often corresponds with rapid improvement of symptoms. Progression free survival was 9.7 months and overall survival was 25.6 months.
The treatment combination was relatively well tolerated, although 38 percent of patients experienced grade 3-4 thrombocytopenia (low platelets) and 23 percent of patients experienced grade 3 to 5 infections. Grade 2 or greater polyneuropathy increased with duration of therapy (from 19 percent at baseline to 52 percent at end of treatment). Other side effects included insomnia, fatigue, nausea, and constipation.
The researchers concluded that the combination of Treanda, Velcade, and dexamethasone is active and well tolerated in patients with relapsed/refractory multiple myeloma.
Ludwig H, Kasparu H, Leitgeb C, et al. Bendamustine-bortezomib-dexamethasone is an active and well tolerated regimen in patients with relapsed or refractory multiple myeloma. Blood. Published early online November 13, 2013. doi: 10.1182/blood-2013-08-521468
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