Efficacy and safety of melphalan, arsenic trioxide and ascorbic acid combination therapy in patients with relapsed or refractory multiple myeloma: a prospective, multicentre, phase II, single-arm study
Authors: Berenson, James R.; Boccia, Ralph1; Siegel, David2; Bozdech, Marek3; Bessudo, Alberto; Stadtmauer, Edward4; Talisman Pomeroy, J.5; Steis, Ronald6; Flam, Marshall7; Lutzky, Jose8; Jilani, Syed9; Volk, Joseph10; Wong, Siu-Fun11; Moss, Robert12; Patel, Ravi13; Ferretti, Delina14; Russell, Kit14; Louie, Robert; Yeh, Howard S.; Swift, Regina A.15
Source: British Journal of Haematology, Volume 135, Number 2, October 2006 , pp. 174-183(10)
Publisher: Blackwell Publishing
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Abstract:
Summary We assessed the safety and efficacy of melphalan, arsenic trioxide (ATO) and ascorbic acid (AA) (MAC) combination therapy for patients with multiple myeloma (MM) who failed more than two different prior regimens. Patients received melphalan (0·1 mg/kg p.o.), ATO (0·25 mg/kg i.v.) and AA (1 g i.v) on days 1-4 of week 1, ATO and AA twice weekly during weeks 2-5 and no treatment during week 6 of cycle 1; during cycles 2-6, the schedule remained the same except ATO and AA were given twice weekly in week 1. Objective responses occurred in 31 of 65 (48%) patients, including two complete, 15 partial and 14 minor responses. Median progression-free survival and overall survival were 7 and 19 months respectively. Twenty-two patients had elevated serum creatinine levels (SCr) at baseline, and 18 of 22 (82%) showed decreased SCr levels during treatment. Specific grade 3/4 haematological (3%) or cardiac adverse events occurred infrequently. Frequent grade 3/4 non-haematological adverse events included fever/chills (15%), pain (8%) and fatigue (6%). This steroid-free regimen was effective and well tolerated in this heavily pretreated group. These results indicate that the MAC regimen is a new therapeutic option for patients with relapsed or refractory MM.Keywords: melphalan; arsenic trioxide; ascorbic acid; multiple myeloma; phase II trial
Document Type: Research article
DOI: 10.1111/j.1365-2141.2006.06280.x
Affiliations: 1: Center for Cancer and Blood Disorders, Bethesda, MD 2: Hackensack Medical Cancer Center, Hackensack, NJ 3: Redwood Regional Oncology Center, Santa Rosa, CA 4: Department of Medicine, University of Pennsylvania, Philadelphia, PA 5: Cancer Research and Prevention Center, Soquel, CA 6: Atlanta Cancer Care, Atlanta, GA 7: Hematology-Oncology Medical Group, Fresno, CA 8: Mt Sinai Comprehensive Cancer Center, Miami Beach, FL 9: Cancer Care Associates, Torrance, CA 10: Palo Verde Hematology/Oncology Center, Glendale, AZ 11: Hematology-Oncology Medical Group, Orange, CA 12: Private practice, Fountain Valley, CA 13: Comprehensive Blood and Cancer Center, Bakersfield, CA 14: Oncotherapeutics, Inc., West Hollywood, CA 15: Institute for Myeloma and Bone Cancer Research
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