Use in patients with resistant and relapsing Multiple Myeloma. A Phase II Study

Abstract

The use of phenylalanine mustard or cyclophosphamide alone and in various combination chemotherapy programs has improved the response rate and disease-free survival in multiple myeloma. However, once those patients have become refractory or have relapsed on that therapy, subsequent salvage treatment has been very disappointing. Between 1979 and 1982 a number of preliminary studies were reported using human leukocyte interferon (Cantell) in patients with refractory or relapsing myeloma. The total number of patients reported in those studies was 25. Five of these patients had a partial response. Therefore, the present study utilizing Schering human alpha-2 interferon, was undertaken in a multi-institutional program. Thirty-eight fully evaluable patients were treated with three different alpha-2 interferon schedules. Seven of these patients had a response with one a complete remission. Of the seven responders, two were from 19 refractory patients and five from 19 relapsing patients. The complete response continues in maintained remission at 72+ weeks with the other responders lasting from 12 to 58+ weeks. In most of these patients an improvement in performance status and bone pain was noted.

Almost all patients experienced some form of fatigue and flu-like symptoms. Two-third of the patients noted anorexia and 25 to 33% of the patients experienced some degree of confusion, somnolence, dry mouth, depression and hypotension. Leukopenia was seen in half of the patients and one-third of the patients experienced thrombocytopenia and anemia. A very small number of patients had transient abnormalities in various chemistries including LDH, SGOT, SGPT, alkaline phosphatase and creatinine.

Schering human alpha-2 interferon appears effective in resistant and relapsing patients with multiple myeloma. These studies are being continued and the combination of chemotherapy plus interferon is being considered for previously untreated patients.