AUTHOR=Rosiñol Laura , Hebraud Benjamin , Oriol Albert , Colin Anne-Laurène , Ríos Tamayo Rafael , Hulin Cyrille , Blanchard María Jesús , Caillot Denis , Sureda Anna , Hernández Miguel Teodoro , Arnulf Bertrand , Mateos Maria-Victoria , Macro Margaret , San-Miguel Jesús , Belhadj Karim , Lahuerta Juan José , Garelik M. Brigid , Bladé Joan , Moreau Philippe
TITLE=Integrated analysis of randomized controlled trials evaluating bortezomib + lenalidomide + dexamethasone or bortezomib + thalidomide + dexamethasone induction in transplant-eligible newly diagnosed multiple myeloma
JOURNAL=Frontiers in Oncology
VOLUME=13
YEAR=2023
URL=https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2023.1197340
DOI=10.3389/fonc.2023.1197340
ISSN=2234-943X
ABSTRACT=ObjectiveProviding the most efficacious frontline treatment for newly diagnosed multiple myeloma (NDMM) is critical for patient outcomes. No direct comparisons have been made between bortezomib + lenalidomide + dexamethasone (VRD) and bortezomib + thalidomide + dexamethasone (VTD) induction regimens in transplant-eligible NDMM.
MethodsAn integrated analysis was performed using patient data from four trials meeting prespecified eligibility criteria: two using VRD (PETHEMA GEM2012 and IFM 2009) and two using VTD (PETHEMA GEM2005 and IFM 2013-04).
ResultsThe primary endpoint was met, with VRD demonstrating a noninferior rate of at least very good partial response (≥ VGPR) after induction vs VTD. GEM comparison demonstrated improvement in the ≥ VGPR rate after induction for VRD vs VTD (66.3% vs 51.2%; P = .00281) that increased after transplant (74.4% vs 53.5%). Undetectable minimal residual disease rates post induction (46.7% vs 34.9%) and post transplant (62.4% vs 47.3%) support the benefit of VRD vs VTD. Treatment-emergent adverse events leading to study and/or treatment discontinuation were less frequent with VRD (3%, GEM2012; 6%, IFM 2009) vs VTD (11%, IFM 2013-04).
ConclusionThese results supported the benefit of VRD over VTD for induction in transplant-eligible patients with NDMM. The trials included are registered with ClinicalTrials.gov (NCT01916252, NCT01191060, NCT00461747, and NCT01971658).