A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma
a study on Multiple Myeloma
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UC Davis UCLA UCSD UCSF
- Dates
- study startedstudy ends around
Description
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.
Official Title
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
Details
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.
Keywords
Multiple Myeloma, CAR-T, ddBCMA, BCMA, Cyclophosphamide, fludarabine, pomalidomide, Bortezomib, Dexamethasone, daratumumab, carfilzomib, Anitocabtagene Autoleucel
Eligibility
You can join if…
Open to people ages 18 years and up
- 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)
You CAN'T join if...
- 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.
Locations
- University of California, Davis Comprehensive Cancer Center
accepting new patients
Sacramento 5389489 California 5332921 95817 United States - UC San Diego Moores Cancer Center
accepting new patients
San Diego 5391811 California 5332921 92037 United States - University of California San Francisco Medical Center
withdrawn
San Francisco 5391959 California 5332921 94143 United States - UCLA Department of Medicine-Hematology/Oncology
accepting new patients
Santa Monica 5393212 California 5332921 90404 United States - USC/Norris Comprehensive Cancer Center
accepting new patients
Los Angeles 5368361 California 5332921 90033 United States - Stanford Cancer Institute
accepting new patients
Stanford 5398563 California 5332921 94305 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Kite, A Gilead Company
- Links
- Gilead Clinical Trials Website
- ID
- NCT06413498
- Phase
- Phase 3 Multiple Myeloma Research Study
- Study Type
- Interventional
- Participants
- Expecting 450 study participants
- Last Updated