Researchers at Moffitt Cancer Center and colleagues have investigated the safety, efficacy and the maximum tolerated dose of pomalidomide for patients with multiple myeloma who have disease relapsed after treatments with other drugs, such as bortezomib and lenalidomide. This phase I clinical trial enrolled 38 patients, and pomalidomide provided a minimal or better response for 42 percent of the patients, a partial response or better for 21 percent, and a complete response for 3 percent.
The study, a collaborative effort among researchers from Moffitt, Dana-Farber Cancer Institute, Hackensack University Medical Center, Multiple Myeloma Research Consortium, and Celgene Corporation, appeared in the Dec. 14 issue of Blood, the journal of the American Society of Hematology.
According to the authors, almost all multiple myeloma patients treated with bortezomib, lenalidomide or thalidomide relapse, and survival times shorten progressively with each subsequent relapse. Effective new treatments that re-establish tumor response are urgently required to improve outcomes for these patients.
"This open-label, phase I, dose-escalation study was primarily conducted to evaluate the maximum tolerated dose of pomalidomide," said study co-author Daniel Sullivan, M.D., associate center director for clinical investigations at Moffitt. "The secondary objective was to assess safety of pomalidomide when given with or without dexamethasone."