"Multiple myeloma is an illness with a discouraging outcome, but, today, with advances such as REVLIMID(R), 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. Revlimid(R) (Lenalidomide) Clinical Data From Interim Analysis of Pivotal Phase III Special Protocol Assessment Trials in Previously Treated Myeloma Presented at the 10th International Multiple Myeloma Workshop | |
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Celgene Corporation (Nasdaq: CELG) announced initial clinical results from its Pivotal Phase III Special Protocol Assessment (SPA) trials using REVLIMID (lenalidomide) as a new approach in the treatment of heavily pretreated patients with relapsed or refractory multiple myeloma. The studies reported an overwhelming statistically significant difference (p is less-than 0.00001) in time-to-progression (TTP) rate -- the primary endpoint of the two trials -- had not yet been reached for the combination therapy arms. At the time of the interim analysis, the median TTP for the U.S. trial (MM-009) was at least fifteen months (MM-009) and for the international trial (MM-010) more than eleven months. This is in contrast to the TTP for the dexamethasone only treated arms of both trials in which the median TTP was five months. These clinical data were presented at the 10th International Multiple Myeloma Workshop, one of the largest blood cancer meetings in the world, in Sydney, Australia, April 10-14, 2005.
Multiple myeloma is the second most common cancer of the blood, representing approximately one percent of all cancers and two percent of all cancer deaths with a worldwide prevalence of approximately 200,000 cases. In the year 2004, there were an estimated 74,000 new cases of multiple myeloma worldwide. The estimated number of deaths from multiple myeloma in 2005 was about 60,000 worldwide.
"The North American and International Multiple Myeloma Phase III trials confirm 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 dexamethasone alone confirming that REVLIMID has the potential to be an important new agent for multiple myeloma," explained Donna Weber, M.D., Associate Professor, Lymphoma/Myeloma of The University of Texas MD Anderson Cancer Center.
Dr. Weber led the U.S. Phase III trial (MM-009), a randomized, double-blinded, placebo-controlled trial, using REVLIMID plus dexamethasone, versus dexamethasone alone in heavily pretreated relapsed or refractory multiple myeloma patients. This study enrolled 354 patients from 47 clinical sites throughout the U.S. with data available from 170 patients randomized to REVLIMID plus dexamethasone and 170 patients randomized to dexamethasone alone. The median patient age was 63 years. An Independent Data Monitoring Committee (IDMC) reviewed the planned interim analysis and determined that the U.S. Phase III trial overwhelmingly exceeded the pre-established efficacy stopping rule of p is less-than 0.0015 for the primary endpoint, time-to- disease progression. The response data in MM-009 were available on 340 of the 354 eligible patients that confirmed the findings of the interim analysis, with responses occurring in 51.3% of patients treated with REVLIMID plus dexamethasone, compared to 22.9% of patients treated with dexamethasone alone (p is equal-to 0.001; one-sided Fisher's exact test).
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