Updated results from Celgene’s FIRST Study of REVLIMID presented at European Haematology Association congress

12 June 2015  •  Author:

Celgene International has announced updated results of its pivotal Phase III FIRST trial.


The trial compared continuous REVLIMID® (lenalidomide) plus low-dose dexamethasone (continuous Rd) to a fixed duration of 18 cycles of Rd (72 weeks) (Rd18) or 12 cycles of melphalan, prednisone and thalidomide (MPT) for the treatment of transplant ineligible patients with newly diagnosed multiple myeloma. The results were presented during the European Haematology Association annual congress.

In the study, the primary endpoint was progression-free survival (PFS) and the primary analysis was between continuous Rd and MPT. Overall survival (OS) was a secondary endpoint, along with response rate, duration of response, time to response, safety, time to second-line anti-myeloma treatment and best response achieved to second-line anti-myeloma treatment.

An updated analysis of progression-free survival (PFS) demonstrated a median of 26.0 months for patients treated with continuous Rd compared with 21.9 months for MPT. The median PFS for Rd18 was 21.0 months.

Continuous Rd treatment (doublet regimen) continued to show an OS advantage, with a 25% reduction in risk of death versus the triple-agent MPT regimen in this updated survival analysis, translating into a median OS improvement of 10.4 months.

Updated results reinforce the survival advantage for continued REVLIMID therapy in patients with multiple myeloma

“The updated results of the FIRST study reinforce the survival advantage for continuous REVLIMID therapy in patients newly diagnosed with multiple myeloma,” said Prof. Thierry Facon, MD, University of Lille and primary investigator of the study.

In the United States, REVLIMID is approved in combination with dexamethasone for the treatment of patients with multiple myeloma. In the European Union, REVLIMID is approved for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. REVLIMID is also approved in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy in nearly 70 countries, encompassing Europe, the Americas, the Middle East and Asia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy in Australia and New Zealand.

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