A recent Phase 2 study, presented at the European Hematology Association (EHA) meeting, showed that a regimen of Velcade (bortezomib), dexamethasone (Decadron), and doxorubicin (Adriamycin), or VDD, resulted in improved kidney impairment in multiple myeloma patients.

Multiple myeloma patients often face kidney complications including acute light chain induced renal failure (ARF). ARF is a serious complication that can lead to permanent kidney dysfunction and reliance on continual hemodialysis. A normal kidney produces urine for excretion but reabsorbs proteins so they do not leave the body. Anti-myeloma therapy that prevents the release of proteins in the urine can reverse acute kidney failure.

The study evaluated the effectiveness of a combination regimen, VDD, in restoring kidney function and controlling the frequency of tumors in multiple myeloma patients. The study was designed with 72 patients (median age 66 years), 81 percent of whom were newly diagnosed with multiple myeloma. Patients exhibited acute kidney failure due to the release of proteins in the urine. They were treated with VDD in 21-day cycles.

So far, 58 patients have completed at least two cycles of this regimen. Evaluation shows that 27 of those patients achieved a complete response, seven patients had a very good partial response, five had a partial response, and five had a marginal response.

The VDD regimen resulted in improved kidney function for 62 percent of patients and a complete kidney response for 31 percent. More than half of the patients showed anti-myeloma activity from the therapy. However, improved kidney function was less common in patients with severe kidney failure, even if they responded to VDD. Overall survival for patients on this regimen was 64% after two years of treatment.

Toxicity data was available for 49 of the patients. Observed severe to life threatening effects included infections (16 percent), low white blood cell count (16 percent), cardiovascular problems (10 percent), weakness (10 percent), and low blood platelet count and hearing loss (five percent). Less serious toxic effects included diarrhea and gastrointestinal bleeding. Some of these complications were due to herpes virus infections.

For more information, see abstract 0385 from the "Myeloma and other monocolonal gammopathies - Clinical I" session of the 14th Congress of the EHA.