A combination therapy of weekly Velcade (bortezomib), Doxil (pegylated liposomal doxorubicin), and dexamethasone (Decadron) led to a high response rate and moderate side effects in elderly patients with relapsed or refractory myeloma, according to a study published in the journal Clinical Lymphoma, Myeloma & Leukemia.

Previous studies have shown a complementary, additive relationship between Velcade and other drugs, such as Doxil and dexamethasone. However, a three-fold combination has never been evaluated in patients over the age of 70, even though 70 is the median age at diagnosis of multiple myeloma.

In this study, doctors examined the effectiveness and safety of Velcade in combination with Doxil and dexamethasone (VDD) in elderly myeloma patients. Researchers recruited 25 patients over the age of 70 with relapsed or refractory myeloma. The patients had received a median number of two prior treatments.

For treatment, patients received Velcade (1.3 mg/m²  intravenously on days 1, 4, 8 and 11 every 21 days during cycles 1 and 2 and on days 1, 8, 15 and 22 every 32 days from cycle 3 on), Doxil (30 mg/m² intravenously on day 4 during cycles 1 and 2 and on day 8 from cycle 3 on), and dexamethasone (40 mg intravenously on days 1 to 4 during cycles 1 and 2 and 20 mg intravenously on days 1, 8, 15 and 22 from cycle 3 on). Patients underwent three to six cycles, depending on their responses. They also took a preventative antiviral medication twice each day. Doctors followed up with patients for a median of 12 months.

Of the 25 study participants, eight (32 percent) achieved complete response, eight (32 percent) reached very good partial response, one (4 percent) experienced partial response, and three (12 percent) had minor response. This added up to an overall response rate of 80 percent.

Overall, patients experienced a median progression-free survival of eight months. Researchers observed a difference between patients who had very good partial response (VGPR) or better and those who did not. Patients who had VGPR or better remained in remission for a median of 12 months, whereas patients who had less than VGPR experienced a median progression-free survival of four months. Eight of the 25 patients died due to disease progression. A median overall survival was not reached.

The treatment resulted in some severe side effects, including peripheral nerve damage (12 percent), low platelet count (12 percent), low white blood cell count (12 percent), and low red blood cell count (8 percent). More patients experienced the same side effects to a milder degree and others such as fatigue (20 percent) and diarrhea (16 percent).

Researchers concluded that the combination of Velcade, Doxil, and dexamethasone proved effective and safe in multiple myeloma patients over the age of 70 when administered weekly.

For more information, please see the journal Clinical Lymphoma, Myeloma & Leukemia (abstract).