C. Ola Landgren, MD, PhD, highlights the rationale for the phase 3 DETERMINATION trial, assessing the use of lenalidomide, bortezomib, and dexamethasone plus autologous stem cell transplant and lenalidomide maintenance in patients with newly diagnosed multiple myeloma.
In a conversation with CancerNetwork® during the 2022 American Society of Clinical Oncology Annual Meeting, C. Ola Landgren, MD, PhD, leader of both the Experimental Therapeutics and Myeloma Service as well as professor at the Sylvester Comprehensive Cancer Center, University of Miami Health System, highlighted how the phase 3 IFM/DFCI2009 trial (NCT01191060), assessing lenalidomide (Revlimid), bortezomib (Velcade), and dexamethasone (RVd) and lenalidomide maintenance for 1 year with or without autologous stem cell transplant in multiple myeloma laid the groundwork for to phase 3 DETERMINATION study (NCT01208662), which compared similar regimens but with the addition of maintenance lenalidomide until progression in newly diagnosed disease.1,2
The DETERMINATION study was developed several years back, and this is the sister or brother study to the French IFM 2009 study. The IFM study was published initially in the New England Journal of Medicine in 2017 comparing the RVd regimen to RVd with bone marrow transplant followed with lenalidomide maintenance for 1 year.
The primary end point for the IFM study was progression-free survival [PFS]. The French study reported that the addition of transplant prolonged [PFS] but they did not show any overall survival difference. They’ve also updated their results, most recently at the [2021 American Society of Hematology Annual Meeting & Exposition]. They showed at up to 8 years of follow up that there is no difference in overall survival and [PFS on second-line therapy] was identical between the 2 arms. Everyone was waiting for this DETERMINATION study to read out, the difference being that patient [were] treated the same up front but they continued lenalidomide maintenance [until progression]. The continued lenalidomide maintenance delayed the readout for this study because patients had a lower rate of progression compared to the French IFM [study] that had only 1 year of lenalidomide maintenance.