| Titre |
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) |
| Protocole ID |
EXCALIBER-Maintenance |
| ClinicalTrials.gov ID |
NCT05827016 |
| Type(s) de cancer |
Myélome |
| Phase |
Phase III |
| Type étude |
Clinique |
| Médicament |
Iberdomide en entretien versus Lenalidomide en entretien |
| 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) |
Philippe Nadeau
418-649-0252 poste 63115
|
| Statut |
 Actif en recrutement |
| Date d'activation |
01-12-2023 |
| Critètes d'éligibilité |
- 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
|
| Critètes d'exclusion |
- 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
|
Groupe d'étude en oncologie du Québec