PharmaMar commences Aplidin Phase III registration trial for multiple myeloma

PharmaMar SA (Grupo Zeltia, ZEL.MC) today announced that a registration trial in relapsed/refractory multiple myeloma patients has been initiated with Aplidin(R) (plitidepsin) in combination with dexamethasone versus dexamethasone alone.

This pivotal, international, multicenter Phase III clinical trial, called ADMYRE, will enroll 300 patients in 60 medical centers across 20 countries (including the U.S., Europe, Asia and South America), with an estimated recruitment period of 24 months. The primary objective of ADMYRE is Progression Free Survival (PFS).

Aplidin(R) is an anti-tumor agent originally isolated from the Mediterranean tunicate Aplidium albicans and currently obtained by chemical synthesis. Aplidin(R) is the second most advanced compound in clinical development at PharmaMar.

SOURCE PharmaMar