(RxWiki News) The purpose of clinical trials is to study the safety and effectiveness of a medication. Sometimes, clinical trials involving humans find that a medication does not work and the study is stopped. This just happened in a trial looking at a blood cancer medication. Celgene has stopped its phase lll trial of Revlimid, used to treat elderly patients with a blood cancer called B-cell chronic lymphocytic leukemia, or CLL.
The trial was halted because the number of deaths in the Revlimid group was higher than in the group of patients being treated with chemotherapy.
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Revlimid (lenalidomide) is currently approved by the US Food and Drug Administration (FDA) to treat several blood disorders and blood cancers as a single agent or in combination with other medications.
Revlimid is used for patients with myelodysplastic syndromes (MDS), multiple myeloma and mantle cell lymphoma (MCL).
The ORIGIN trial looking at the use of Revlimid in CLL was discontinued on July 12, 2013.
A total of 450 patients were enrolled in the trial, which was designed to extend the use of Revlimid for patients over the age of 65 with CLL.
This blood cancer is the most common type of leukemia in adults and will be diagnosed in more than 15,500 Americans this year.
The halted trial was looking at the safety and efficacy of Revlimid compared to the chemotherapy agent chlorambucil. Trial participants had other conditions (comorbidities) in addition to CLL, such as diabetes, congestive heart failure and kidney problems.
What the FDA calls an “imbalance of deaths” occurred when 34 of the 210 patients in the Revlimid group died, compared to 18 deaths among the 211 patients receiving cholorambucile.
The specific reason for this imbalance is not clear. Celgene will be conducting a data analysis to determine what factors may have led to this imbalance.
Two other trials evaluating Revlimid as a treatment for CLL will continue, according to the company.