Détails de l'étude

A Phase 3, Two-stage, Randomized, Multi-center, Controlled, Open-label Study Comparing Iberdomide Maintenance to Lenalidomide Maintenance Therapy After Autologous Stem Cell Transplantation (ASCT) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) (EXCALIBER-Maintenance)

Tout stade

Type de maladie :
Traitement :
Population :
Première ligne
Thérapie ciblée
Adultes

Confirmed diagnosis of symptomatic multiple myeloma (MM)
Eastern Cooperative Oncology Group performance status (ECOG) score of 0, 1, or 2
Received 3 to 6 cycles of an induction therapy that includes a proteasome inhibitor (PI) and immunomodulatory (IMiD) [eg, bortezomib thalidomide and dexamethasone (VTd), lenalidomide, bortezomib and dexamethasone (RVd)] with or without a CD38 monoclonal antibody, or Velcade® (bortezomib), cyclophosphamide, dexamethasone (VCd), and followed by a single or tandem autologous stem cell transplantation (ASCT). Post-stem cell transplant consolidation is permitted
Participants within 12 months from initiation of induction therapy who achieved at least a partial response (PR) after autologous stem cell transplantation (ASCT) with or without consolidation, according to International Myeloma Working Group (IMWG 2016) criteria

Progressive disease or clinical relapse (as defined by IMWG response criteria) following ASCT with or without consolidation or is not responsive to primary therapy
Smoldering myeloma, solitary plasmacytoma or nonsecretory myeloma
Known central nervous system/meningeal involvement of MM
Prior history of malignancies, other than MM, unless the participant has been free of the disease for ≥ 5 years

Other protocol-defined inclusion/exclusion criteria apply

CHU de Québec – Université Laval

Investigateur(trice) principal(e)   Marc Lalancette
Autres études

MonumenTAL-6 :Étude de phase 3 avec répartition aléatoire comparant le talquétamab en association avec la pomalidomide (Tal-P), le talquétamab en association avec le téclistamab (Tal-Tec) et une association choisie par l’investigateur composée d’élotuzumab, de pomalidomide et de dexaméthasone (EPd) ou de pomalidomide, de bortézomib et de dexaméthasone (PVd), chez des participants atteints d’un myélome récidivant ou réfractaire ayant déjà reçu de 1 à 4 traitements comprenant un anticorps anti-CD38 et de la lénalidomide