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Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation
, today announced that its phase III study (MM-020/IFM 07-01) of
REVLIMID^® (lenalidomide) in combination with dexamethasone in patients newly
diagnosed with multiple myeloma met its primary endpoint of progression-free
survival (PFS). In the study, a doublet regimen of continuous oral
lenalidomide in combination with low-dose dexamethasone (Rd) demonstrated a
statistically significant improvement in PFS compared to patients receiving a
comparator arm with a triplet regimen consisting of melphalan, prednisone and
thalidomide (MPT).
One of the largest phase III randomized, international studies ever conducted
in newly-diagnosed multiple myeloma, MM-020/IFM 07-01 is also known as the
FIRST^® (Front-Line Investigation of REVLIMID/Dexamethasone vs. Standard
Thalidomide) trial. The international study randomized 1,623 patients who were
ineligible for autologous stem cell transplantation to receive continuous oral
lenalidomide plus low-dose dexamethasone until disease progression;
lenalidomide plus low-dose dexamethasone for eighteen 28-day cycles (72
weeks); or melphalan, prednisone and thalidomide for up to twelve 42-day
cycles (72 weeks).
The primary endpoint for the study was PFS. Secondary endpoints include
overall survival, response rate, quality of life and safety.
The evaluation of safety and efficacy in the treatment arms is ongoing and the
results of the study are planned to be presented at an upcoming medical
meeting.
Based on the results of the FIRST^® study, the Company will commence
discussions with regulatory authorities and plans to submit dossiers for
registration in the US, Europe and other markets.
These results are from an investigational phase III study. REVLIMID is not
approved for the treatment of patients with newly-diagnosed multiple myeloma
in any country.
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