NCT07903506Not yet recruitingPhase 3
To Evaluate Safety and Efficacy of Anitocabtagene Autoleucel Versus Autologous Stem Cell Transplant in Newly Diagnosed Multiple Myeloma
A Phase 3, Randomized, Open-Label, Multicenter Trial to Evaluate the Safety and Efficacy of Anitocabtagene Autoleucel Versus Autologous Stem Cell Transplant Following Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone Induction in Participants With Newly Diagnosed Multiple Myeloma
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
The goal of this clinical study iMMagine-6 is to compare and assess the safety and effectiveness of anitocabtagene autoleucel versus autologous stem cell transplant in participants with newly diagnosed multiple myeloma (NDMM). The primary objective of this study is to compare the efficacy of anitocabtagene autoleucel administered after quadruplet-based induction versus standard of care therapy (SOCT; quadruplet-based induction followed by autologous stem cell transplant (auto-SCT) in participants with NDMM who are eligible for auto-SCT.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 750 (estimated)
- First submitted
- 14 Oct 2026
- Start date
- Feb 2027
- Primary completion date
- Mar 2039
- Lead sponsor
- Kite, A Gilead Company
- Diseases
- Multiple myeloma
- NCT number
- NCT07903506
- EU CT number
- 2026-527841-24-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 750
- From Feb 2027 to the primary completion date, Mar 2039
- 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-multiple myeloma (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, radiotherapy for MM plasmacytoma(s), and palliative focal 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
- Cardiac atrial or 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 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 malignant CNS neoplasms
- 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, cyclophosphamide, or melphalan
- Life expectancy \< 12 weeks
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Who the study is looking for
- Documented NDMM according to IMWG diagnostic criteria
- Considered to be transplant-eligible by the investigator
- Measurable disease at screening per IMWG, defined as any of the following:
- 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 or 1
- Adequate organ function including hematological, renal, hepatic and cardiac with further details in protocol defined inclusion/exclusion criteria
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.