Celgene International's Phase III study (MM-020/IFM 07-01) of oral Revlimid (Lenalidomide) in combination with low-dose dexamethasone (Rd) has met its primary endpoint of progression-free survival (PFS) in patients newly diagnosed with multiple myeloma.
According to the data, the combination demonstrated a statistically significant improvement in PFS against a comparator arm with a triplet regimen consisting of melphalan, prednisone and thalidomide (MPT).
A total of 1,623 patients ineligible for autologous stem cell transplantation have been randomised in the study with continuous oral lenalidomide plus low-dose dexamethasone until disease progression.
In addition, patients were randomised with lenalidomide plus low-dose dexamethasone for eighteen 28-day cycles; or melphalan, prednisone and thalidomide for up to twelve 42-day cycles (72 weeks).
Overall survival, response rate, quality of life and safety were the secondary endpoints of the Phase III randomised, international study, MM-020/IFM 07-01, also known as the 'Front-Line Investigation of REVLIMID/Dexamethasone vs. Standard Thalidomide' (FIRST) trial.
The company is currently evaluating the safety and efficacy in the treatment arms and expects to begin discussions with regulatory authorities based on the results to submit dossiers for registration in the US, Europe and other markets.
Revlimid is not approved for the treatment of patients with newly diagnosed multiple myeloma anywhere worldwide.
Image: Micrograph of a plasmacytoma, the histologic correlate of multiple myeloma. H&E stain. Photo: courtesy of Nephron.