Tumori, 76: 465-466, 1990 A PHASE II STUDY OF IDARUBICIN AND PREDNISONE IN MULTIPLE MYELOMA Albert S. Alberts, Geoffrey Falkson, Bernardo L. Rapoport and Almarie Uys (Department of Medical Oncology, University of Pretoria, Pretoria) Twenty-one patients with multiple myeloma were treated with idarubicin 45 mg/m 2 orally day 1 and prednisone 60 mg/m 2 day 1-4 every three weeks. Moderate to severe gastrointestinal and hematopoietic toxicity were observed. Twelve of the twenty-one patients had relapsed on prior treatment. Of these, Idarubicin (4-demethoxydaunorubicin) (IDA) is an an- thracycline analogue which has clinical activity in acute leukemia (4) and lymphoma (5). Oral IDA was shown to have activity as a single agent in advanced refractory or relapsed multiple myeloma (MM) (2). The combination of idarubicin with another active drug in multiple myeloma, prednisone, therefore seemed logical. The present phase II study was undertaken to evaluate the value of oral IDA combined with prednisone in MM. Patients and methods Twenty-one patients with MM were entered on study (Table 1). There were 7 previously untreated patients. Fourteen patients had received prior treatment. In this subset 2 patients had primary resistant disease and 12 patients had relapsed after stabilisation or response on prior treatment. All patients were on active treatment at the time of progression. Seven patients had received one prior treatment regimen, 5 patients had received 2 and 2 patients had received 3 prior treatment regimens. None of the patients had received prior anthracyclines. There were 12 males and 9 females. The median age was 56 years (range 35-79 years). Eastern Cooperative Ongology Group (ECOG) criteria for performance status was used (6). The perform- ance status was 1 in 9 patients, 2 in 9 patients and 3 in 3 patients. The Durie and Salmon staging was used (3). One patient had stage I disease, 3 patients had stage II disease and 17 patients had stage III disease. Three patients pre- sented with hypercalcemia. Fifteen patients had meas- urable bone lesions, a measurable soft tissue mass was seen in 2 patients. Six patients had IgA myeloma, 12 patients had IgG myeloma and 3 patients were non-secretors. Treatment was given as follows: IDA 45 mg/m 2 orally day 1 and prednisone 60 mg/m 2 day 1-4 every 3 weeks. Patients were treated fasting and an anti-emetic was given 2 patients responded. Two patients had primary resistant disease, neither responded. Seven patients had received no prior treatment, three responded. ldarubicin and prednisone have modest activity in refractory myeloma, with short duration of response and severe toxicity. 1 hour prior to treatment to prevent vomiting of unab- sorbed drug. Objective response was defined a 50 % or more decrease in serum and urine M-protein and bone marrow plasma cells verified on 2 consecutive determinations seperated by Table 1 - Patient characteristics. No. of patients Total 21 Median age 56 Male 12 Female 9 No prior treatment 7 Previously treated patients One regimen 7 Two regimens 5 Three regimens 2 Performance status (ECOG) PS 1 9 PS 2 9 PS 3 3 Durie and salmon stage Stage I 1 Stage II 3 Stage III 17 Myeloma type IgG 12 lg A 6 Non secretors 3 Acknowledgments: Supported in part by a grant from the National Cancer Association of South Africa. To whom correspondence should be addressed: Dr. Geoffrey Falkson, Department of Medical Oncology, University of Pretoria, P.O. Box 667, Pretoria, 0001 Rep. of South Africa. Received October 19, 1989; revised May 10, 1990. 465