TRISENOX Combination Regimen Induces High Rate of Responses in Patients With Late-stage, Relapsed or Refractory Multiple Myeloma
Monday April 11, 7:00 am ET
- Objective Responses Observed in 59 Percent of Evaluable Patients Including Many Refractory to Nearly All Other Major Classes of Therapeutics
SEATTLE, April 11 /PRNewswire-FirstCall/ -- At the 10th International Myeloma Workshop, James Berenson, M.D., Medical & Scientific Director of the Institute for Myeloma & Bone Cancer Research presented data from a multicenter, phase II trial of a TRISENOX combination regimen, known as MAC (melphalan, TRISENOX and vitamin C), in relapsed or refractory multiple myeloma patients. The data showed that 22 of the 37 patients evaluated (60 percent) achieved an objective response, with eight patients experiencing a decrease in serum M-protein of 50 percent or more and 14 patients experiencing a decrease in serum M-protein of between 25 to 49 percent. Of the twenty-nine patients who had failed prior thalidomide or lenolinamide therapy, 14 patients responded to the TRISENOX regimen. In addition, seven out of 10 patients who had failed bortezomib therapy responded and 10 out of 16 patients who had received prior melphalan therapy responded. The regimen was well tolerated. The few significant adverse events included mild cytopenias, fluid retention, and neuropathy. TRISENOX (arsenic trioxide) is marketed in the United States and Europe by Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; Nuovo Mercato).
"In addition to the impressive response rates reported in this group of heavily pretreated patients, who had received an average of approximately four prior regimens (range of one to eight) prior treatments, the MAC regimen resulted in a marked improvement in the serum creatinine levels in patients with renal insufficiency," stated Berenson. "The regimen is very well tolerated and gives patients another option besides high-dose dexamethasone which can have severe side effects. The median duration of response has not been reached, but responses have been durable with."
This study will continue to accrue to a target enrollment of 60 evaluable patients. For more information about this presentation, please visit the CTI website at the following link cticseattle.com. |
