Millennium study shows Velcade-based combination treatment superior to monotherapy in myeloma

By Lisa Kerner

Charlotte, N.C., June 21 - Millennium Pharmaceuticals, Inc. said results of a multicenter phase 1/ 2 study showed that Velcade in combination with melphalan and prednisone (V-MP) appeared significantly superior to melphalan and prednisone (MP) alone in treating elderly patients with newly diagnosed multiple myeloma (MM) who were ineligible for stem cell transplantation.

The study demonstrated an overall response rate of 89%, including a high complete and near complete response rate of 43%.

"Approximately half of patients presenting with multiple myeloma are elderly and not eligible for transplantation," lead investigator Jesus San Miguel said in a company news release.

"With only one cycle of V-MP, we achieved a higher response rate than our historical controls of six cycles of MP and the proportion and quality of completed responses increased with subsequent cycles," Miguel added.

In the study of 60 newly diagnosed multiple myeloma patients between ages 65 and 85, 91% were free of disease progression, with an event-free survival rate of 83%. This compares to historical control data for MP of 66% and 51%.

Millennium also sponsored an ongoing phase 3 international Vista trial of Velcade in combination with V-MP versus MP alone in patients with newly diagnosed multiple myeloma that are not transplant candidates.

Two other phase 3 multicenter trials are being conducted by international cooperative groups to evaluate Velcade-based combinations in newly diagnosed patients who are eligible for transplantation.

Located in Cambridge, Mass., Millennium develops and commercializes products for the therapeutic areas of oncology and inflammation.

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