TRISENOX(R) Regimen Produces High Response Rates in Patients With Relapsed Or Refractory Multiple Myeloma
Tuesday December 9, 11:45 am ET
Case Studies Evaluating Combination With Vitamin C and Low Dose Melphalan In Patients Who Failed Previous Therapy May Provide Additional Product Registration Strategy in Multiple Myeloma
SAN DIEGO, Dec. 9 /PRNewswire-FirstCall/ -- In an oral presentation at the 45th Annual Meeting of the American Society of Hematology (ASH), data were presented on a preliminary experience with an investigational regimen combining low dose chemotherapy (melphalan), TRISENOX® (arsenic trioxide), and vitamin C (MAC regimen), an investigation by James Berenson, M.D. of the Institute for Myeloma and Bone Cancer Research. The combination produced a high rate of long-lasting responses in ten heavily pretreated patients with relapsed or refractory multiple myeloma. One of the most important outcomes of this experience was the ability of the MAC regimen to improve kidney function in patients with severe myeloma kidney damage, preventing the need for those patients with kidney dysfunction to go on dialysis. In addition, the regimen was well tolerated by patients. These encouraging results served as the basis for an ongoing multicenter phase II study of this regimen. Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC - News) markets TRISENOX® in the United States and Europe for APL.
"The rapid responses and high response rates seen with the MAC regimen are impressive, particularly since several of the patients in this group were refractory to melphalan. This experience supports the preclinical findings that TRISENOX®, when used in combination, can sensitize tumor cells to other agents," said Berenson. "The ability of the MAC regimen to overcome chemotherapy-resistance in patients who have relapsed following multiagent chemotherapy regimens or treatment with agents like thalidomide and bortezomib treatment is exciting and has prompted further investigation of the MAC combination in a large multicenter study."
MAC Therapy Results, Administration and Safety
Results presented by Berenson at ASH showed that all ten of the patients responded to MAC treatment resulting in a significant reduction (29 to 90 percent) in serum myeloma protein levels. All five patients who had moderate to severe kidney dysfunction prior to treatment showed marked improvement (35 to 69 percent) in kidney function, in several cases, preventing progression to kidney dialysis. One patient with profound and refractory hypercalcemia (high blood calcium of 19.4 mg/dL) normalized this life-threatening condition within one week of initiating MAC treatment and remains normal after 50 weeks. Six of the 10 (60%) patients remain free from disease progression for a median of 10 months (range 5 to 15 months).
Overall, the combination was generally well tolerated with no reported grade 4 toxicities. Side effects were generally mild and included fatigue, marrow suppression, edema responsive to diuretics and/or steroids, rash, asymptomatic QTc prolongation, gastrointestinal complaints and headaches. TRISENOX was administered twice weekly at a dose of 0.25 mg/kg with ascorbic acid (vitamin C) at a fixed dose of 1 g. was administered intravenously over 15 minutes after each TRISENOX dose. Melphalan was administered orally daily for four days every four to six weeks at a low dose of 0.1 mg/kg.
About TRISENOX®
TRISENOX® (arsenic trioxide) is marketed by Cell Therapeutics, Inc. (CTI). TRISENOX® was approved for marketing in 2000 by the U.S. Food and Drug Administration to treat patients with relapsed or refractory Acute Promyelocytic Leukemia. (APL), a rare, life-threatening form of cancer of the blood. TRISENOX® was granted marketing authorization from the European Commission in March 2002. APL, one of eight subtypes of acute myeloid leukemia (AML), represents 10-15 percent of the more than 20,000 patients diagnosed with AML each year. TRISENOX® is currently being studied in more than 40 clinical trials in a variety of cancers. |
