MMRC and Keryx initiate Ph I KRX-0401 study

The USA-based Multiple Myeloma Research Consortium and Keryx Biopharmaceuticals have initiated a multicenter Phase I clinical program to explore the convenient all-oral combination of KRX-0401 (perifosine), Celegene's Revlimid (lenalidomide) and dexamethasone for the treatment of relapsed or refractory multiple myeloma. Under the lead of Andrzej Jakubowiak, director of the Multiple Myeloma Center of University of Michigan Comprehensive Cancer Center (Ann Arbor, Michigan), the study will also be conducted at four other of the MMRC's 13 world-renowned member academic institutions.

Entitled An Open-Label Phase I Study of the Safety of Perifosine in Combination with Lenalidomide and Dexamethasone for Patients with Relapsed or Refractory Multiple Myeloma, the clinical program represents the first time this oral triplet is being explored in the clinical setting for this incurable blood cancer, says the MMRC. The study is being conducted to determine the safety and efficacy of the drug combination in the treatment of these patients, as well as the highest dose at which KRX-0401 can be safely administered to multiple myeloma patients when combined with Revlimid and dexamethasone.