The FIRST trial, as many of you may recall, was a large trial that compared three different treatment regimens in older newly diagnosed multiple myeloma patients and patients ineligible for stem cell transplantation:
- Continuous therapy with Revlimid (lenalidomide)-dexamethasone until disease progression
- Revlimid-dexamethasone therapy for a fixed duration of 72 weeks
- Melphalan-prednisone-thalidomide (MPT) therapy for a fixed duration of 72 weeks.
We reported on the initial results from the trial when they were presented at the American Society of Hematology annual meeting last December. Here is our coverage of that presentation:
"Continuous Revlimid-Dexamethasone Therapy Delays Progression And Improves Survival In Older Newly Diagnosed Myeloma Patients (ASH 2013)," The Myeloma Beacon, February 3, 2014.
Because updated results have been published in the NEJM -- arguably the most prestigious of medical journals -- we will be publishing a new article summarizing the updated results.
In the meantime, you can view the abstract of the NEJM article here:
L Benboubker et al., "Lenalidomide and Dexamethasone in Transplant-Ineligible Patients with Myeloma," New England Journal of Medicine, September 4, 2014.
The Results section of the abstract reads as follows:
The median progression-free survival was 25.5 months with continuous lenalidomide-dexamethasone, 20.7 months with 18 cycles of lenalidomide-dexamethasone, and 21.2 months with MPT (hazard ratio for the risk of progression or death, 0.72 for continuous lenalidomide-dexamethasone vs. MPT and 0.70 for continuous lenalidomide-dexamethasone vs. 18 cycles of lenalidomide-dexamethasone; P<0.001 for both comparisons).
Continuous lenalidomide-dexamethasone was superior to MPT for all secondary efficacy end points, including overall survival (at the interim analysis). Overall survival at 4 years was 59% with continuous lenalidomide-dexamethasone, 56% with 18 cycles of lenalidomide-dexamethasone, and 51% with MPT.
Grade 3 or 4 adverse events were somewhat less frequent with continuous lenalidomide-dexamethasone than with MPT (70% vs. 78%). As compared with MPT, continuous lenalidomide-dexamethasone was associated with fewer hematologic and neurologic toxic events, a moderate increase in infections, and fewer second primary hematologic cancers.
As always, we welcome any comments or questions you may have about the study.
