Study Comparing Anitocabtagene Autoleucel to Standard Therapy in Patients with Relapsed or Refractory Multiple Myeloma
Sponsor: Kite, A Gilead Company
ClinicalTrials ID:NCT06413498
This clinical trial is comparing a new treatment, anitocabtagene autoleucel, to standard therapy in patients with multiple myeloma that has returned or not responded to previous treatments. The study aims to see which treatment is more effective in delaying the progression of the disease.
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Program Overview
The iMMagine-3 study is designed to compare the effectiveness of a new treatment called anitocabtagene autoleucel with standard therapy in patients with multiple myeloma that has come back or not responded to previous treatments. Participants in the study will have received 1 to 3 prior treatments, including specific drugs like an anti-CD38 antibody and an immunomodulatory drug. The main goal is to see which treatment helps patients live longer without their disease getting worse.
Description
After receiving the treatment, participants who are given anitocabtagene autoleucel will be monitored during a follow-up period. After this, they will join a separate long-term follow-up study to continue monitoring their health for up to 15 years.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of multiple myeloma.
- Have received 1 to 3 previous treatments for multiple myeloma, including specific drugs like an immunomodulatory drug and an anti-CD38 antibody.
- Show evidence of disease progression within 12 months of the last treatment.
- Have measurable disease at the time of screening, as defined by specific medical criteria.
- Be eligible to receive at least one of the standard therapy regimens specified in the study.
- Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Women of childbearing potential must have a negative pregnancy test before starting the study.
Exclusion Criteria
- Have received prior treatment targeting BCMA, T-cell engager therapy, or CAR T-cell therapy.
- Have a history of cancer affecting the central nervous system or meninges.
- Have heart involvement from multiple myeloma.
- Have a history of certain other blood disorders or active cancers requiring treatment within the last 24 months.
- Have had a stem cell transplant within 12 weeks before joining the study.
- Have received high-dose steroid therapy or other immunosuppressive treatments recently.
- Have received a live vaccine within 4 weeks before joining the study.
- Have allergies to any study drugs or components.
- Have a life expectancy of less than 12 weeks.
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