Protocol Now Requires Aspirin to Manage Possible Side Effects
The International Myeloma Foundation today is pleased to inform physicians, patients and their families that the clinical trial of Revlimid® plus dexamethasone in people newly diagnosed with multiple myeloma has resumed. The announcement was sent was sent to participating institutions by the Eastern Oncology Cooperative Group (ECOG), which is conducting this trial.
The ECOG study, designated E4A03, was halted at the end of September because not all study participants were taking aspirin as recommended to manage DVT's or blood clots that may occur with this regimen. The study was redesigned to make aspirin mandatory, and the participating institutions will now begin implementing the new protocol.
E4A03 is a randomized phase III study of Revlimid plus high and low-dose dexamethasone in newly diagnosed multiple myeloma.
Celgene, the company that developed Revlimid, has filed with the FDA for its approval in a malignant blood syndrome called MDS, and plans to file a supplementary new drug application to use Revlimid in multiple myeloma. In March, a trial of Revlimid with dexamethasone in relapsed myeloma did so well ("exceeded pre-specified efficacy") that all patients in the trial were offered Revlimid as part of their treatment regimen.
Patients interested in participating should contact their own physicians. More information about the study can be found on our website at (http://e4a03.myeloma.org)