At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Anitocabtagene Autoleucel (drug), Cyclophosphamide (drug), Fludarabine (drug), Pomalidomide (drug)
- How long the study runs
- Study runs about 83 months (dates as stated)
- About the drug or intervention
- Anitocabtagene Autoleucel — drug: A single infusion of CAR+ transduced autologous T cells · Cyclophosphamide — drug: Administered intravenously · Fludarabine — drug: Administered intravenously · Pomalidomide — drug: Tablet administered orally · Bortezomib — drug: Administered intravenously or subcutaneously · Dexamethasone — drug: Tablet administered orally · Daratumumab — drug: Administered intravenously or subcutaneously · Carfilzomib — drug: Administered intravenously
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 452
- Started
- 2024-08-23
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for multiple myeloma
- • Phase3 - 452 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with multiple myeloma
Where?
- • Bristol - University Hospitals Bristol NHS Foundation Trust, Bristol Haematology and Oncology Centre
- • Cardiff - University Hospital of Wales
- • Leeds - Leeds Teaching Hospitals NHS Trust, St James's University Hospital
- • London - King's College Hospital
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ of therapy is required
What the study is looking for
- ✓Documented historical diagnosis of multiple myeloma (MM)
- ✓Documented evidence of progressive disease by IMWG criteria based on the investigator's determination on or within...
- ✓cancer that can be measured on scans 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 cancer that can be measured on scans in the serum or urine: serum free light chain ≥ 10 mg/dL and abnormal...
Who cannot take part
- ✗Prior B-cell maturation antigen (BCMA)-treatment that targets specific changes in the cancer
- ✗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
- ✗heart atrial or heart ventricular MM involvement
See the full criteria
Where Is This Study? (6 UK sites)
University Hospitals Bristol NHS Foundation Trust, Bristol Haematology and Oncology Centre
Bristol BS2 8ED, United Kingdom
University Hospital of Wales
Cardiff CF14 4XW, United Kingdom
Leeds Teaching Hospitals NHS Trust, St James's University Hospital
Leeds LS9 7TF, United Kingdom
King's College Hospital
London SE5 9NU, United Kingdom
University College London Hospital
London WC1E 6JN, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825Newcastle Hospitals NHS Foundation Trust, Freeman Hospital
Newcastle NE7 7DN, United Kingdom
