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)
  • 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)
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.