REVLIMID plus Dex better than Dex Alone

"The North American and International Multiple Myeloma Phase III trials reported a significant clinical benefit for patients treated with REVLIMID plus dexamethasone. In multiple myeloma patients with resistant disease, REVLIMID plus dexamethasone more than doubled the response rate compared with placebo plus dexamethasone confirming that REVLIMID has the potential to be an important new agent for multiple myeloma patients," explained Donna Weber, M.D., Associate Professor, Lymphoma/Myeloma of The University of Texas MD Anderson Cancer Center.

At the ASCO Scientific Symposium, Dr. Weber presented the results of the North American and International Multiple Myeloma Phase III trials. Dr. Weber led the North American Phase III trial ( MM-009 ), a randomized, double-blinded, placebo-controlled trial, using REVLIMID plus dexamethasone, versus placebo plus dexamethasone in pretreated relapsed or refractory multiple myeloma patients. This study enrolled 354 patients from 47 clinical sites throughout North American with data available from 171 patients randomized to REVLIMID plus dexamethasone and 171 patients randomized to placebo plus dexamethasone. The median patient age was 64 years in the REVLIMID plus dexamethasone arm, compared to 62 years in the placebo plus dexamethasone arm of the trial. An Independent Data Monitoring Committee reviewed the planned interim analysis of clinical data and determined that the North American Phase III trial overwhelmingly exceeded the pre-specified efficacy stopping rule of p <0.0015 for the primary endpoint, time-to-disease progression. Consistent with the findings of the interim analysis, available as of March 31, showed best response rates of 61.2% in patients treated with REVLIMID( R ) plus dexamethasone, compared to 22.8% of patients treated with placebo plus dexamethasone.

"Multiple myeloma is an illness with a discouraging outcome, but today, with advances such as REVLIMID, there is a prospect for myeloma to become a chronic illness for the majority of patients worldwide," explained Meletios Dimopoulos, M.D., Professor of Therapeutics at The University of Athens School of Medicine, Greece.

Dr. Dimopoulos led the International Phase III trial ( MM-010 ), a randomized, double-blinded, placebo-controlled trial, using REVLIMID plus dexamethasone, versus placebo plus dexamethasone in previously treated relapsed or refractory multiple myeloma patients. This study enrolled 351 patients from 50 clinical sites internationally with data available from 176 patients randomized to REVLIMID plus dexamethasone and 175 patients randomized to placebo plus dexamethasone. The median patient age was 63 years in the REVLIMID plus dexamethasone arm, compared to 64 years in the placebo plus dexamethasone arm of the trial. An Independent Data Monitoring Committee reviewed the planned interim analysis and determined that this International Phase III trial overwhelmingly exceeded the pre-specified efficacy stopping rule of p< 0.0015 for the primary endpoint, time-to-disease progression. Consistent with the findings of the interim analysis, the available clinical data as of March 31, showed best response rates of 58.0% in patients treated with REVLIMID plus dexamethasone, compared to 21.7% of patients treated with placebo plus dexamethasone.

In both trials, patients treated with REVLIMID and dexamethasone had an increase in side effects as compared to those patients only treated with placebo plus dexamethasone. Grade 3 / 4 toxicities included neutropenia, thrombocytopenia and anemia. Deep vein thrombosis occurred in 13.5 and 4.5% of patients treated with REVLIMID plus dexamethasone, compared to 3.5 and 3.4% of patients treated with placebo plus dexamethasone in the North American and International trials, respectively. Pulmonary embolism occurred in 2.9 and 4.0% of patients treated with REVLIMID plus dexamethasone, compared to 0.6 and 1.1% of patients treated with placebo plus dexamethasone in the North American and International trials, respectively.