Background: The proteasome is a multi-enzyme complex that provides the main pathway for degradation of intracellular proteins in eukaryotic cells. Proteasome - mediated proteolysis has been shown to play a key role in the regulation of cell-cycle progression, genomic transcription, apoptosis, chemotaxis, cell adhesion and angiogenesis. Bortezomib (Velcade), a boronic acid dipeptide, is a novel, potent, selective, and reversible inhibitor of the proteasome that has been shown to have antimyeloma activity.

Methods: We enrolled 5 patients (2 female and 3 male, in age 35, 50, 64, 65, 70 years) with relapsed multiple myeloma who have failed at least two prior lines of treatment, including 2 patients treated with high dose therapy and autologous stem cell transplantation. The time since myeloma diagnosis to onset of bortezomib therapy in particular patients was 27, 27, 28, 84, 125 months. Patients received bortezomib 1.3 mg/m² as an i.v. bolus twice weekly for 2 weeks, on days 1, 4, 8 and 11 followed by 1 week without treatment, for up to six cycles (18 weeks). In 2 patients with progressive disease dexamethason was added to the regimen.

Results: In one patient a near - complete (immunofixation-positive) response was achieved. The time to response was 63 days and the duration of response was 180 days. Three patients had stable disease and 1 patient had progressive disease while receiving bortezomib. Six months after completing bortezomib therapy all 5 patients are alive, 4 with progressive disease and 1 with stable disease. The median time to progression of disease was 7 months. Adverse events: treatment with bortezomib was withheld from 2 patients (after 2 and 4 cycles, respectively) because of skin lesions (erythema multiforme) and aggravation of peripheral neuropathy. Side effects seen in the study included also pyrexia, infections, nausea, vomiting, abdominal pain, pain in limb, hypotensio, thrombocytopenia.

Conclusions: In relapsed myeloma the rate of response to bortezomib alone is 20 percent, with a duration of response of 6 months.

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1. Efficacy and safety of thalidomide in the treatment of relapsed and refractory multiple myeloma
2. Bortezomib in multiple myeloma: treatment and retreatment. A single center experience
3. INCIDENCE OF JAW OSTEONECROSIS IN MYELOMA PATIENTS TREATED WITH BISPHOSPHONATES