Titre A Phase 3, Two-Stage, Randomized, Multicenter, Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM)
Protocole ID EXCALIBER-RRMM (CC-220-MM-002)
ClinicalTrials.gov ID NCT04975997
Type(s) de cancer Myélome
Phase Phase III
Stade Récidivant/réfractaire (2ième ligne de traitement et plus)
Type étude Clinique
Médicament Iberdomide, daratumumab et dexaméthasone (IberDd) versus daratumumab, bortézomib et dexaméthasone (DVd)
Institution CHU DE QUEBEC – UNIVERSITE LAVAL
   HOPITAL DE L'ENFANT-JESUS
      1401 18e Rue, Québec, QC, G1J 1Z4
Ville Québec
Investigateur(trice) principal(e) Dr Marc Lalancette
Coordonnateur(trice) Patricia Chabot
 418-525-4444 poste 15769
Statut Actif en recrutement
Date d'activation 01-12-2022
Critètes d'éligibilité
  • Documented diagnosis of multiple myeloma (MM) and measurable disease
  • Received 1 to 2 prior lines of anti-myeloma therapy
  • Must have documented disease progression during or after their last anti-myeloma regimen
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2
Critètes d'exclusion
  • Any condition that confounds the ability to interpret data from the study
  • Has plasma cell leukemia, Waldenstrom's macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or clinically significant amyloidosis
  • Known central nervous system involvement with MM
  • Prior therapy with iberdomide
Other protocol-defined inclusion/exclusion criteria apply