PHASE-2 STUDY OF ORAL METHYL-CCNU AND PREDNISONE IN PREVIOUSLY TREATED ALKYLATING AGENT-RESISTANT MULTIPLE-MYELOMA

Abstract

Thirteen patients with multiple myeloma (MM) who failed to respond to or were relapsing from standard agents and who received 4 or more courses of methyl-CCNU [1-(2-chloroethyl)-3-(4-methylcyclohexyl)-1-nitrosourea] + prednisone (adequate drug trial) are reported in this paper. Methyl-CCNU was given orally before breakfast at 6 wk intervals at a starting dose of 50 mg/m2 with the intension of increasing the dose to 100, 150 and 200 mg/m2 with each subsequent course. The dose of prednisone was 75 mg/day .times. 7 with each course. The response rate was 46% (6 of 13 patients). No patient had better than a fair response. Drug toxicity, severe enough to prevent further dose escalation, was observed in every case. Prior BCNU [1,3-bis(2-chloroethyl)-1-nitrosourea] therapy or the lack of response to previous alkylating agents did not prevent a response to methyl-CCNU + prednisone. The response rate of methyl-CCNU + prednisone in MM is comparable to the results achieved with other agents in similar groups of patients.