Combination of TRISENOX(R), Vitamin C and Low-Dose Melphalan Produces 54 Percent Objective Response Rate in Late-Stage Multiple Myeloma Patients
Monday June 14, 7:02 am ET
Preliminary Phase II TRISENOX Data Presented at International Conference
GENEVA, June 14 /PRNewswire-FirstCall/ -- At the 9th Congress of the European Hematology Association (EHA) preliminary data were presented from a multicenter, phase II study of TRISENOX® (arsenic trioxide) in a combination regimen known as MAC (melphalan, TRISENOX and vitamin C) in heavily pretreated multiple myeloma patients who had either relapsed or failed to respond to standard and/or investigational therapies. Preliminary analysis of this ongoing study, led by James Berenson, M.D. of the Institute for Myeloma & Bone Marrow Cancer Research, showed that the TRISENOX-combination produced disease responses in seven of the 13 evaluable patients (54 percent). Three additional patients achieved stable disease for an overall disease control rate of 77 percent. These patients had failed multiple prior therapies including stem cell transplant (6), bortezomib (2), thalidomide or revlimid (9) or prior melphalan (7). Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; Nuovo Mercato) markets TRISENOX in the United States and Europe.
"The preliminary results are encouraging in this group of heavily pretreated patients who have received an average of four prior regimens (range 2-8). An important component of this study will be to determine if this combination can improve kidney impairment, a common complication in multiple myeloma patients. In our previous experience this regimen improved kidney function in five of five patients," stated Berenson. "This study uses a very low dose of melphalan supporting the preclinical evidence that TRISENOX can sensitize tumors to chemotherapy. It also provides a very effective non- steroid containing regimen which spares patients the severe, often disfiguring side effects of high-dose, steroid-containing regimens."
The objectives of the study are to determine the response rate to MAC and the time to disease progression in addition to testing the safety and tolerability of the combination. Patients receive melphalan (0.1 mg/kg) daily for the first four days of each six-week cycle. TRISENOX (0.25 mg/kg) is administered in a loading dose (daily x 4), followed by vitamin C (1 gram) on a twice weekly schedule for the next four weeks of each cycle, with a maximum of six cycles of treatment. To date, the regimen has been well tolerated with mild and reversible cytopenias and fluid retention that was relieved by diuretics and/or steroids. There are currently 25 patients on the study which will continue to accrue to a target enrollment of 60 evaluable patients. |
