Détails de l'étude

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

Phase III

Type de maladie :
Traitement :
Population :
Rechute et réfractaire
Thérapie ciblée
Adultes
  • Documented multiple myeloma with mesurable disease.
  • Relapsed or refractory disease
  • Documented evidence of PD or failure to achieve a minimal response to the last line of therapy based on investigator’s determination of response by IMWG criteria on or after their last regimen
  • ECOG of 0, 1, or
  • A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6months after the last dose of study treatment
  • Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients
  • Stroke, transient ischemic attack, or seizure within 6 months prior to signing informed consent form (ICF)
  • Major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment
  • A maximum cumulative dose of corticosteroids of >=140 mg of prednisone or equivalent within 14-day period before the first dose of study drug
  • Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. If either is suspected, negative whole brain magnetic resonance imaging (MRI) and lumbar cytology are required

CIUSSS de l’Est-de-l’Ile-de-Montreal – HMR

  • Nom de chercheur / email Dr Jean-Sébastien Claveau / jean-sebastien.claveau.med@ssss.gouv.qc.ca
  • Nom infirmière de recherche : – Marie-Pier Lecours-Cyr / mplecours-cyr.hmr@ssss.gouv.qc.ca
Autres études