Phase 3 study of carfilzomib for the treatment of relapsed multiple myeloma

Onyx Pharmaceuticals announced that it has begun enrollment in a Phase 3 trial evaluating carfilzomib in combination with Revlimid (lenalidomide) and low dose dexamethasone in patients with relapsed multiple myeloma. This international trial, known as the ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) trial, is evaluating carfilzomib in combination with lenalidomide and low dose dexamethasone, versus lenalidomide and low dose dexamethasone alone, in 700 patients with relapsed multiple myeloma following treatment with one to three prior regimens.

The primary endpoint of the trial is progression-free survival. Secondary endpoints include overall survival, overall response rate, duration of response, disease control rate, safety, time-to-progression and time-to-next treatment. Patients will be randomized to receive carfilzomib (20mg/m2 on days 1 and 2 of cycle 1 only, then 27mg/m2 subsequently), in addition to a standard dosing schedule of lenalidomide (25mg per day for 21 days on, 7 days off) and low-dose dexamethasone (40mg per week in 4 week cycles), versus lenalidomide and low-dose dexamethasone alone.

Carfilzomib is a selective, next-generation proteasome inhibitor that is being investigated in a broad clinical trial program for multiple myeloma.

For more information call (510) 597-6500 or visit www.onyx-pharm.com.