Is Velcade effective in treating relapsed and/or refractory myeloma?
Velcade was initially approved by the FDA for the treatment of patients who had received at least two prior therapies. The approval was later expanded to include patients who had received at least one prior therapy. Velcade, alone (sometimes called “monotherapy” or “single-agent”) and in combination with other commonly used treatments, has been studied in patients who have previously received therapy. Data from a number of clinical trials have demonstrated Velcade’s efficacy in delaying disease progression, achieving high response rates, and improving survival in patients with relapsed and refractory myeloma. Velcade has also been shown to be highly effective in heavily-pretreated patients and in retreating patients who had previously received Velcade. Some patients may also benefit when Velcade is given at a lower dose. • Results from the Phase III APEX clinical trial comparing Velcade with high-dose dexamethasone in 669 people with relapsed/refractory myeloma showed that Velcade was