| TITRE |
(EN) 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 |
| CLINICAL TRIAL.gov ID |
NCT05827016 |
| TYPE(S) DE CANCER |
Myélome |
| PHASE |
Phase III |
| TYPE D'ÉTUDE |
Clinique |
| INSTITUTION |
CHU DE QUEBEC
1401 18e Rue
(418) 525-4444
|
| VILLE |
Québec
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Marc Lalancette
|
| COORDONATEUR(RICE) |
Philippe Nadeau
philippe.nadeau@chudequebec.ca
418-649-0252 poste 63115
|
| STATUT |
Actif en recrutement
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- 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
|
| CRITÈRES D'EXCLUSION |
(EN)
- 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
|
