ALCYONE — A Study of Daratumumab Plus Bortezomib, Melphalan, and Prednisone (D-VMP) Versus Bortezomib, Melphalan, and Prednisone in Newly Diagnosed Multiple Myeloma

Phase 3 · 2018 · Multiple Myeloma

Design

Open-label randomized trial of daratumumab added to bortezomib-melphalan-prednisone (D-VMP) versus VMP alone.

Population

Newly diagnosed multiple myeloma patients ineligible for autologous stem-cell transplant.

Primary Endpoint

progression-free survival (PFS)

Key Result

18-month PFS 71.6% vs 50.2% (HR 0.50); overall survival benefit maintained at long-term follow-up (HR ~0.60).

Guideline Impact

NCCN-recommended frontline option for transplant-ineligible myeloma