A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma
18 Years and older, Male and Female
KT-US-679-0788 (primary)
NCI-2024-05712
2024-511188-26
Summary
The goal of this study (iMMagine-3) is to compare the study drug, anitocabtagene
autoleucel to standard of care therapy (SOCT) in participants with relapsed/refractory
multiple myeloma who have received 1 to 3 prior lines of therapy, including an anti-CD38
monoclonal antibody and an immunomodulatory drug.
The primary objective of this study is to compare the efficacy of anitocabtagene
autoleucel versus SOCT in participants with RRMM as measured by progression-free survival
(PFS) per blinded independent review committee (IRC).
Objectives
After completing the treatment period, all participants who will receive anitocabtagene
autoleucel, will be followed in the post-treatment follow-up period. Thereafter,
participants will transition to a separate long-term follow-up study (KT-US-982-5968) to
continue follow-up out to 15 years.
Eligibility
- 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) Key
Treatment Sites in Georgia
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