Aniline mustard, an alkylating agent effective in plasma cell tumors in BALB/c mice, was used in a prospective randomized study of 44 patients with multiple myeloma. None of the patients had received prior chemotherapy, and only three had had radiation. The patients were randomized between two regimens, one consisting of aniline mustard, 1 mg/kg, and the other of aniline mustard, 1 mg/kg, plus prednisone, 1.2 mg/kg in decreasing dosage. Thirty-three patients were treated for 30 days or more and were eligible for evaluation of response. Nine patients responded in two or more parameters. Myeloma progressed during the study in all but three patients. Twenty-two of the 31 responses occurred in patients who received prednisone in addition to aniline mustard. Approximately two-thirds of the responses occurred in the first 60 days of therapy. Toxicity consisted mainly of leukopenia. Infections occurred in 10 patients, and a skin rash was noted in 2 others. Aniline mustard possesses some activity in multiple myeloma but is inferior to melphalan.

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This investigation was supported in part by Research Grant CA-4646 from the NIH, USPHS. Additional grant support was from Roswell Park Memorial Institute (CA-2599), Bowman Gray School of Medicine (CA-3927), Dartmouth Medical School (CA-4326), New York Hospital (CA-7968), and Acute Leukemia Group B Operations Office (CA-10456).

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