Newly Diagnosed Multiple MyelomaPhase 3iMMagine-4NCT07887672
A Trial to Evaluate Safety and Efficacy of Anitocabtagene Autoleucel Versus Standard of Care in Newly Diagnosed Multiple Myeloma
A Phase 3 study testing Anitocabtagene autoleucel, Daratumumab and Bortezomib in people with Newly Diagnosed Multiple Myeloma, run by Kite, A Gilead Company.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Newly Diagnosed Multiple Myeloma
- What is being tested?
- Anitocabtagene autoleucel, Daratumumab and Bortezomib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Feb 2042
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Adequate hematological function
- Adequate renal, hepatic, pulmonary, and cardiac function
Who cannot join
- 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
- Central nervous system (CNS) or meningeal involvement of MM
- 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.
- Prior allogeneic stem cell transplant
- Any prior systemic treatment or radiotherapy treatment for any cancer other than MM within 24 months before randomization.
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- Live vaccine ≤ 4 weeks before randomization
- Presence or suspicion of infection that is uncontrolled
- History or presence of intracranial or CNS disorders, or CNS neoplasms (benign and malignant)
- 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
- History of allergy or hypersensitivity to any trial agent or trial drug components
- Life expectancy < 12 weeks
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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).
Read the detailed description
After completing quadruplet-based induction therapy followed by anitocabtagene autoleucel or continuous maintenance therapy, participants will continue to be followed for disease assessments and outcomes.
- Conditions
- Newly Diagnosed Multiple Myeloma
- Being tested
- Anitocabtagene autoleucel, Daratumumab, Bortezomib, Lenalidomide, Dexamethasone
- Keywords
- Multiple Myeloma, CAR-T, ddBCMA, BCMA
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anitocabtagene autoleucelDrug
Also called CART-ddBCMA
A single infusion of CAR+ transduced autologous T cells
DaratumumabDrug
Administered subcutaneously (SC)
BortezomibDrug
Administered SC
LenalidomideDrug
Administered orally (PO)
DexamethasoneDrug
Administered PO or intravenously (IV)
FludarabineDrug
Administered IV
CyclophosphamideDrug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Standard of Care Therapy (SOCT) | Active comparator | Participants will receive a total of eight induction therapy cycles, 21-days for each cycle, with daratumumab, bortezomib, lenalidomide and dexamethasone.
Following induction, participants will receive maintenance therapy during 28-day cycles of daratumumab, lenalidomide and dexamethasone, until unacceptable toxicity, progression as per IMWG criteria, death, or participant withdrawal of consent (whichever occurs first). Receives: Drug: Daratumumab; Drug: Bortezomib; Drug: Lenalidomide; Drug: Dexamethasone |
| Arm B: Anitocabtagene Autoleucel | Experimental | Participants will receive a total of eight induction therapy cycles, 21-days for each cycle, with daratumumab, bortezomib, lenalidomide and dexamethasone.
Participants will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine for 3 days, followed by a single infusion of anitocabtagene autoleucel.
If specific criteria are met, some participants may receive maintenance therapy (at or after Month 6 post-anitocabtagene autoleucel infusion) during 28-day cycles of daratumumab, lenalidomide and dexamethasone, until unacceptable toxicity, progression as per IMWG criteria, death, or participant withdrawal of consent (whichever occurs first). Receives: Drug: Anitocabtagene autoleucel; Drug: Daratumumab; Drug: Bortezomib; Drug: Lenalidomide; Drug: Dexamethasone; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal Residual Disease (MRD)-Negative Complete Response (CR) or Stringent CR (sCR) Rate at 12 Months
Minimal residual disease (MRD)-negative CR/sCR is defined as the proportion of participants achieving CR/sCR and MRD-negative status (10^5 cutoff) at 12 months. CR/sCR per International Myeloma Working Group (IMWG) criteria is determined by the Independent Review Committee (IRC).
Measured: 12 months
Progression-Free Survival (PFS)
PFS is defined as the time from randomization to the first documented disease progression per International Myeloma Working Group (IMWG) criteria as determined by the Independent Review Committee (IRC), or death due to any cause, whichever occurs first.
Measured: Up to 15 years
Secondary outcomes (18)
Overall survival (OS)
OS is defined as the time from randomization to death due to any cause.
Measured: Up to 15 years
Overall Response Rate (ORR)
ORR is defined as the proportion of participants who achieve a best overall response of at least PR or better (sCR, CR, very good partial response (VGPR), or PR) per the 2016 IMWG criteria as determined by the IRC.
Measured: Up to 15 years
Rate of Very Good Partial Response or Better
Rate of VGPR or better is defined as the proportion of participants who achieve a best overall response of sCR, CR, or VGPR per the 2016 IMWG criteria as determined by the IRC.
Measured: Up to 15 years
Rate of CR or Better
Rate of CR or better is defined as the proportion of participants who achieve a best overall response of CR or sCR per the 2016 IMWG criteria as determined by the IRC.
Measured: Up to 15 years
Time to Response (TTR)
Time to response is defined as the time from date of randomization to the earliest date when a participant achieves a best overall response of sCR, CR, VGPR, or PR per 2016 IMWG criteria as determined by the IRC.
Measured: Up to 15 years
Duration of response (DOR)
DOR is derived only among participants who experience an overall response (sCR, CR, VGPR, or PR) per the 2016 IMWG criteria (Kumar 2016) and is defined as the time from first overall response to disease progression per the 2016 IMWG criteria as determined by the IRC, or death from any cause, whichever occurs first.
Measured: Up to 15 years
Time to Progression
Time to progression (TTP) is defined as the time from randomization to the first documented disease progression per the 2016 IMWG criteria as determined by the IRC, or death due to disease progression, whichever occurs first.
Measured: Up to 15 years
Duration of Treatment-Free Interval
Duration of treatment-free interval is defined as time from date of anitocabtagene autoleucel infusion to date of initiation of maintenance therapy.
Measured: Up to 15 years
Percentage of Participants Experiencing Serious Adverse Events (SAEs)
Measured: Enrollment up to 15 years
Percentage of Participants Experiencing Adverse Events (AEs)
Measured: Enrollment up to 15 years
Percentage of Participants With Anti-Anitocabtagene Autoleucel Chimeric Antigen Receptor (CAR) Antibodies (Anitocabtagene Autoleucel Arm B)
Measured: Up to 15 years
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores
The EORTC-QLQ-C30 is a multi-item questionnaire measuring the following content: five (5) multi-item functional scales, three (3) multi-item symptom scales, six (6) single item symptoms scales, and one combined global health status/global quality of life (QoL) scale. Each scale is measured from 0 to 100 after a linear transformation. Higher scores for functioning scales and for the Global Health Status /Global QoL scale indicate a higher level of functioning and a better QoL (ie, a better state of the participant), respectively, whereas higher scores in symptom scales represent a higher level of symptoms (ie, a worse state of the participant).
Measured: Baseline, up to 5 years
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) - Multiple Myeloma Module (EORTC QLQ-MY20) Score
The EORTC QLQ-MY20 has 20 items across 4 independent subscales; 2 functional subscales (body image, future perspective), and 2 symptoms scales (disease symptoms, and side effects of treatment) with a recall period of one week. Scores from each subscale are transformed from 0 to 100. For the functional scales, high scores represent improvement. For the symptom scales, higher scores represent worsening.
Measured: Baseline, up to 5 years
Change From Baseline in the European Quality of Life (EuroQol) 5-Dimension 5-Level (EQ-5D-5L) Scale index Score and VAS Scale Score
The EuroQol EQ-5D-5L questionnaire is a generic measure of health status with two components: the EQ-5D descriptive system and the EQ visual analog scale (VAS). The descriptive system can be used to estimate a single index value through application of a tariff of values based on direct valuations of health. The index typically ranges from 0 to 1 where a higher score indicates a better outcome. The VAS is a 20-cm VAS for recording self-rated current HRQoL state where a score of 0 represents ("the worst health you can imagine") and a score of 100 represents ("the best health you can imagine").
Measured: Baseline, up to 5 years
Percentages of Participants With Responses for Patient Global Impression Scale - Severity (PGI-S)
The PGI-S is a 5-point, single-item measure that assesses a patient's perception of disease symptom severity at a point in time.
Measured: Screening, up to 1 year
Percentages of Participants Responses for Patient Global Impression Scale Change (PGI-C)
The PGI-C is a 7-point, single-item measure that evaluates patients' perceptions of change in their symptoms over time.
Measured: Screening, up to 1 year
Percentages of Participants With Responses for Functional Assessment of Cancer Therapy Item GP5 (FACT-GP5)
The FACT-GP5 is a single-item question for assessing global treatment side effect bother from a patient's perspective.
Measured: Screening, up to 2 years
Percentage of Participants Hospitalizations, Inpatient Days, Intensive Care Unit Days, and Reasons for Hospitalization
Measured: Up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study startJan 2027 (estimated)
- Primary completionFeb 2042 (estimated)
- Study completionFeb 2042 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Kite, A Gilead CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kite, A Gilead Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kite Study Director, Study chair, Kite, A Gilead Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07887672
- Sponsor's protocol ID
- KT-US-715-0790
- Other IDs
- 2026-527198-12-00
- Acronym
- iMMagine-4
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No