Thalomid trial in myeloma delayed?

Celgene has announced that its Total Therapy II trial of Thalomid(thalidomide), which was initiated in October 1998 and was designed to study the drug in newly-diagnosed multiple myeloma patients as an adjunct to sequential treatment of chemotherapy and high-dose melphalan with stem cell rescue, will need to enroll a further 300 patients to "insure a thorough and meaningful analysis" between the Thalomid-treated and control groups. However, the firm stressed that the study will continue through its intended course, after interim analysis on the safety and efficacy revealed no issues leading to an early termination.

To preserve the integrity of the trial, the data safety monitoring board has elected not to allow the release of the unblinded data. Had the interim analysis demonstrated a 100% increase in the complete response rate of the Thalomid arm versus the control arm, instead of a 70% CR, the trial could have been terminated. Celgene say it is "encouraged by the overall high response rate" seen in both treatment groups, and that this continuation "should not impact our timeline for a supplemental New Drug Application" for this use of Thalomid, which has previously received US Food and Drug Administration clearance for the treatment of leprosy (Marketletter July 20, 1998).

Year-long delay?