Celgene International has reported that clinical data from the Eastern Cooperative Oncology Group's large, randomized Phase III trial evaluating oral Revlimid with low-dose dexamethasone continued to demonstrate superior overall survival rates for newly diagnosed multiple myeloma patients compared to Revlimid with the standard high-dose dexamethasone.
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Revlimid was active with both dose levels of dexamethasone. The best overall response for high-dose dexamethasone (CR/VGPR/PR) was 82% compared to 71% in the low-dose dexamethasone arm, including 52% and 42% CR/VGPR. After a median 21 months follow-up, the median duration of response has not been met in either arm. While the low-dose arm had lower response rates, it was associated with superior overall survival. Additionally, time to disease progression and progression-free survival were similar in both arms of the study.
The 87% survival rate in the arm with Revlimid and low-dose dexamethasone at two years showed an advantage compared to the two-year survival rate of 75% for patients who received Revlimid and high-dose dexamethasone. Increased overall survival was seen in patients receiving Revlimid and low-dose dexamethasone regardless of age; however, patients under the age of 65 showed a two-year survival probability of 91% compared to 85% using high-dose dexamethasone at two years.
In patients who continued on treatment past six months, the 99% survival rate showed an advantage compared to a survival rate of 97% for patients who received Revlimid and high-dose dexamethasone at one year.
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