| Titre |
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 |
| ClinicalTrials.gov ID |
NCT06413498 |
| Type(s) de cancer |
Myélome |
| Phase |
Phase III |
| Stade |
Récidivant/réfractaire (2ième ligne de traitement et plus) |
| Type étude |
Clinique |
| Médicament |
Anitocabtagene Autoleucel Versus traitement standard |
| Institution |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
 SITE GLEN
1001 boul. Décarie , Montréal, QC, H4A 3J1
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Chaim Shustik
Dr Michael Sebag
|
| Coordonnateur(trice) |
Nancy Renouf
514-934-1934 poste 35718
|
| Statut |
 Actif en recrutement |
| Critètes d'éligibilité |
- Documented historical diagnosis of multiple myeloma (MM)
- Received 1 to 3 prior lines of antimyeloma therapy, including an immunomodulatory drug (IMiD) and an anti-cluster of differentiation 38 (CD38) monoclonal antibody (mAb). A minimum of 2 consecutive cycles of an IMiD and an anti-CD38 mAb in any prior line of therapy is required. The IMiD and anti-CD38 mAb do not need to be from the same regimen in the prior line(s) of therapy.
- Documented evidence of progressive disease by IMWG criteria based on the investigator's determination on or within 12 months of the last dose of the last regimen
-
Measurable disease at screening per IMWG, defined as any of the following:
- Serum M-protein level ≥ 0.5 g/dL or urine M-protein level ≥ 200 mg/24 hours; or
- Light chain MM without measurable disease in the serum or urine: serum free light chain ≥ 10 mg/dL and abnormal serum free light chain ratio
- Only individuals who are candidates to receive at least 1 of the 4 SOCT regimens (PVd, DPd, KDd, or Kd), as determined by the investigator, should be considered for this study
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Females of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)
|
| Critètes d'exclusion |
- 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.
|
Groupe d'étude en oncologie du Québec