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=<sec><title>Objective</title><p>Providing 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.</p></sec><sec><title>Methods</title><p>An 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).</p></sec><sec><title>Results</title><p>The primary endpoint was met, with VRD demonstrating a noninferior rate of at least very good partial response (≥ VGPR) after induction <italic>vs</italic> VTD. GEM comparison demonstrated improvement in the ≥ VGPR rate after induction for VRD <italic>vs</italic> VTD (66.3% <italic>vs</italic> 51.2%; <italic>P</italic> = .00281) that increased after transplant (74.4% <italic>vs</italic> 53.5%). Undetectable minimal residual disease rates post induction (46.7% <italic>vs</italic> 34.9%) and post transplant (62.4% <italic>vs</italic> 47.3%) support the benefit of VRD <italic>vs</italic> VTD. Treatment-emergent adverse events leading to study and/or treatment discontinuation were less frequent with VRD (3%, GEM2012; 6%, IFM 2009) <italic>vs</italic> VTD (11%, IFM 2013-04).</p></sec><sec><title>Conclusion</title><p>These results supported the benefit of VRD over VTD for induction in transplant-eligible patients with NDMM. The trials included are registered with <uri xlink:href="https://ClinicalTrials.gov" xmlns:xlink="http://www.w3.org/1999/xlink">ClinicalTrials.gov</uri> (NCT01916252, NCT01191060, NCT00461747, and NCT01971658).</p></sec>