TITRE |
(EN) A Phase 3, Randomized, Open-Label Study to Compare the Efficacy and Safety of Anitocabtagene Autoleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Multiple Myeloma |
PROTOCOLE ID |
iMMagine-3 |
CLINICAL TRIAL.gov ID |
NCT06413498 |
TYPE(S) DE CANCER |
Myélome |
PHASE |
Phase III |
TYPE D'ÉTUDE |
Clinique |
INSTITUTION |
CUSM
1001 boul. Décarie
|
VILLE |
Montréal
|
INVESTIGATEUR(RICE) PRINCIPAL(E) |
Chaim Shustik Michael Sebag
|
COORDONATEUR(RICE) |
Nancy Renouf nancy.renouf@muhc.mcgill.ca 514-934-1934 poste 35718
|
STATUT |
Actif en recrutement
|
CRITÈRES D'ÉLIGIBILITÉ |
(EN)
|
CRITÈRES D'EXCLUSION |
(EN)
- Prior B-cell maturation antigen (BCMA)-targeted therapy
- Prior T-cell engager therapy
- Prior CAR therapy or other genetically modified T-cell therapy
- Active or prior history of central nervous system (CNS) or meningeal involvement of MM
- Cardiac atrial or cardiac ventricular MM involvement
- History of or active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis
- Active malignancy (other than MM) requiring ongoing treatment for disease control within the last 24 months. Myelodysplastic syndrome (even without ongoing treatment) is not permitted.
- Prior auto-SCT within 12 weeks before randomization
- Prior allogeneic stem cell transplant (allo-SCT)
- High-dose (eg, cumulative > 70 mg prednisone or equivalent) systemic steroid therapy or any other form of immunosuppressive therapy within 14 days before randomization
- Live vaccine ≤ 4 weeks before randomization
- Contraindication to fludarabine or cyclophosphamide
- History of allergy or hypersensitivity to any study agent or study drug components. Individuals with a history of severe hypersensitivity reaction to dimethyl sulfoxide (DMSO) are excluded.
- Life expectancy < 12 weeks
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
|