NCT07887672Not yet recruitingPhase 3
A Trial to Evaluate Safety and Efficacy of Anitocabtagene Autoleucel Versus Standard of Care in Newly Diagnosed Multiple Myeloma
A Phase 3, Randomized, Open-label, Multicenter Trial to Evaluate the Safety and Efficacy of Quadruplet Induction Followed by Anitocabtagene Autoleucel Versus Standard of Care Therapy in Participants With Newly Diagnosed Multiple Myeloma Who Are Not Eligible for Autologous Stem Cell Transplant
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Brief summary (registry, in English)
The goal of this clinical study iMMagine-4 is to compare and assess the safety and effectiveness of anitocabtagene autoleucel versus standard of care therapy (SOCT) in participants with newly diagnosed multiple myeloma (NDMM) who are not eligible for autologous stem cell transplant. The primary objective of this study is to compare the efficacy of anitocabtagene autoleucel versus quadruplet-based SOCT in participants with NDMM who are not eligible for autologous stem cell transplant (auto-SCT).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- First submitted
- 14 Oct 2026
- Start date
- Jan 2027
- Primary completion date
- Feb 2042
- Lead sponsor
- Kite, A Gilead Company
- Diseases
- Multiple myeloma
- NCT number
- NCT07887672
- EU CT number
- 2026-527198-12-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 600
- From Jan 2027 to the primary completion date, Feb 2042
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any prior anti-MM therapy (including B-cell maturation antigen (BCMA)-directed therapy, CAR T-cell therapy, or genetically modified cells), with the exception of protocol-specified anti-MM stabilizing therapy and palliative radiation
- Prior allogeneic stem cell transplant
- Any prior systemic treatment or radiotherapy treatment for any cancer other than MM within 24 months before randomization.
- Live vaccine ≤ 4 weeks before randomization
Other illness
- History of or active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, or amyloidosis
- Active malignancy (other than MM) requiring ongoing treatment for disease control within the last 24 months.
- Presence or suspicion of infection that is uncontrolled
- History or presence of intracranial or CNS disorders, or CNS neoplasms (benign and malignant)
- History of allergy or hypersensitivity to any trial agent or trial drug components
Other
- Central nervous system (CNS) or meningeal involvement of MM
- Females who are pregnant or breastfeeding
- Females of childbearing potential who are not willing to use a highly effective method of contraception from the time of informed consent through the protocol-specified duration
- Contraindication to fludarabine or cyclophosphamide
- Life expectancy \< 12 weeks
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Who the study is looking for
- Determined by the Investigator to be not eligible for auto-SCT
- Documented newly diagnosed multiple myeloma (NDMM) according to IMWG diagnostic criteria
- Measurable disease at screening per IMWG:
- Serum M-protein level ≥ 1.0 g/dL; or
- Urine M-protein level ≥ 200 mg/24 hours; or
- Serum free light chain (FLC) ≥ 10 mg/dL (100 mg/L) and abnormal serum FLC ratio
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Adequate hematological function
- Adequate renal, hepatic, pulmonary, and cardiac function
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.