Combination Chemotherapy Including Velcade in Patients with Refractory or Relapsed Multiple Myeloma.

PURPOSE: Velcade, a proteasome inhibitor, is a remarkably active agent in patients with advanced relapsed or refractory multiple myeloma (MM). We report velcade combination chemotherapy in MM patients at our center.

METHODS: The trial opened in March 2006, and 9 patients who were refratory or relapsed MM have enrolled before August. The median age of the patients was 60 years (range 44 to 75). The median bone marrow plasma cell percentage was 20% (range 10.5% to 66%). The median serum ß2- microglobulin level was 3.8mg/l (range 1.2 to 8.6mg/l).5 patients committed renal disfunction. The regimens were as follows: The V-MPT regimen(4 patients) included oral melphalan (5 mg/m² on days 1-5), prednisone (50 mg/m² on days 1–5), thalidomide (100~200 mg continuously), velcade (1.3 mg/m² on days 1, 4, 15, 22). 5 patients who were renal disfunction accepted the V-VADT regimens consist of velcade (1.0mg/m² on days 1, 4, 8, 11), vincristine (0.4mg on days 1–4), pharmorubicin (10mg on days 1–4), dexamethasone (20mg/m² on days 1–4,9–12,17–20), thalidomide (200 mg continuously). The V-MPT was repeated every 5 weeks and the V-VADT every 4 weeks for a total of 6 cycles. All cycles were delivered in day hospital.

RESULTS: A median 2 cycles (range 1 to 4) were administered to the all patients. Response was defined as EBMT criteria.9 patients are presently evaluable for response after therapy.8 patients responsed to treatment: 2 complete responses (CR), 1 near CR, 3 partial responses and 2 minor responses. And one patient experienced progressive disease. Interestingly, creatinine turned to normal in 5 renal disfunction patients after 1–2 cycles therapy. Most common side-effects were nausea, vomiting, fatigue and peripheral neuropathy. Grade 3 hematological toxicities included thrombocytopenia (1 patient) and neutropenia (2 patents).

CONCLUSION: The combination therapy with velcade is safe and effective in the treatment of relapsed or refractory multiple myeloma, and well tolerated, even in renal disfunction patients.