Celgene: FIRST trial meets primary endpoint in patients newly diagnosed with multiple myeloma

Initial phase III trial results, presented at American Society of Hematology annual meeting, show 28% reduction in risk of progression and 22% reduction in risk of death

Celgene today announced that data from the FIRST (Frontline Investigation of lenalidomide and dexamethasone vs. standard thalidomide) trial was presented on Sunday 8 December, during the Plenary Scientific Session at the 55th American Society Hematology (ASH) annual meeting in New Orleans. FIRST (MM-020/IFM 07-01) a phase III, multi-centre study in patients newly diagnosed with multiple myeloma (ndMM) and ineligible for stem cell transplant, included 72 patients from the UK. 

After a median follow-up of 37 months, the trial met its primary endpoint (progression-free survival), demonstrating a 28% reduction in risk of progression and 22% reduction in risk of death (p=0.00006). The pre-planned interim analysis of overall survival demonstrated a 22% reduction in risk of death in favour of those patients receiving lenalidomide plus low-dose dexamethasone (LEN + LoDex) in 28-day cycles until disease progression vs. those patients receiving melphalan, prednisone and thalidomide (MPT) in 42-day cycles for 72 weeks (p=0.0168). However, the pre-specified boundary (p<0.0096) was not crossed. All other secondary endpoints – including overall response rate, time to response, duration of response, safety and quality of life – consistently showed improvement in favour of those patients receiving LEN + LoDex vs. MPT.

Professor Jamie Cavenagh, Clinical Lead in Haemato-Oncologist at St Bartholomew’s Hospital, London and UK National Coordinating Investigator for MM-020 said: “Multiple myeloma is a debilitating condition with a poor prognosis for patients and there is a need to further improve treatment and overall quality of life for patients. The initial results from FIRST are very positive, showing that patients may be able to live longer without their disease progressing and may offer a new standard of care for the treatment of multiple myeloma.”

Safety results from the FIRST trial show that grade 3/4 adverse events in patients taking LEN + LoDex vs. those taking MPT included neutropenia (28% vs. 45%), thrombocytopenia (8% vs. 11%), febrile neutropenia (1% vs. 3%), infection (29% vs. 17%), neuropathy (1% vs. 9%), and deep-vein thrombosis (8% vs. 5%). The incidence of secondary primary malignancies (SPM) was 0.4% in patients taking LEN + LoDex vs. 2.2% in those taking MPT; the overall incidence of solid tumors was identical (2.8%).

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
New armored CAR T cell therapy boosts response in Relapsed non-Hodgkin lymphoma patients