Newly Diagnosed Multiple MyelomaPhase 3iMMagine-6NCT07903506
To Evaluate Safety and Efficacy of Anitocabtagene Autoleucel Versus Autologous Stem Cell Transplant in Newly Diagnosed Multiple Myeloma
A Phase 3 study testing Anitocabtagene Autoleucel, Isatuximab and Bortezomib in people with Newly Diagnosed Multiple Myeloma, run by Kite, A Gilead Company.
Trial summary
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). 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, Isatuximab 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
- 750 participants
- Where
- No sites listed yet
- Study dates
- Feb 2027to Mar 2042
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- 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
Who cannot join
- 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
- Central nervous system (CNS) or meningeal involvement of MM
- 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.
- Prior allogeneic stem cell transplant
Show all 16Show fewer
- Any prior systemic treatment or radiotherapy treatment for any cancer other than MM within 24 months before randomization.
- Live vaccine ≤ 4 weeks before randomization
- Presence or suspicion of infection that is uncontrolled
- History or presence of intracranial or CNS disorders or malignant CNS neoplasms
- 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
- 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 Anitocabtagene Autoleucel Versus Autologous Stem Cell Transplant Following Isatuximab, Lenalidomide, Bortezomib, and Dexamethasone Induction in Participants With Newly Diagnosed Multiple Myeloma
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.
Read the detailed description
After completing quadruplet-based induction therapy followed by anitocabtagene autoleucel or autologous stem cell transplant, participants in both treatment arms will receive maintenance therapy for up to 36 cycles.
After completing the maintenance treatment period, participants will continue in a follow-up period for disease assessment and outcomes.
- Conditions
- Newly Diagnosed Multiple Myeloma
- Being tested
- Anitocabtagene Autoleucel, Isatuximab, 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
A single infusion of CAR+ transduced autologous T cells
IsatuximabDrug
Administered subcutaneously (SC)
BortezomibDrug
Administered SC
LenalidomideDrug
Administered orally (PO)
DexamethasoneDrug
Administered orally (PO)
FludarabineDrug
Administered IV
CyclophosphamideDrug
Administered IV
MelphalanDrug
Administered intravenously (IV)
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Standard of Care Therapy (SOCT) | Active comparator | Participants will receive a total of three induction therapy cycles, 42 days for each cycle, with isatuximab, bortezomib, lenalidomide and dexamethasone.
Following induction, participants will receive high dose conditioning therapy with melphalan and autologous stem cell transplantation (auto-SCT).
Following auto-SCT, participants will receive maintenance therapy with isatuximab and lenalidomide during 28-day cycles for up to 36 cycles or until unacceptable toxicity, disease progression per IMWG criteria, or withdrawal of consent, whichever occurs first. Receives: Drug: Isatuximab; Drug: Bortezomib; Drug: Lenalidomide; Drug: Dexamethasone; Drug: Melphalan |
| Arm B: Anitocabtagene Autoleucel | Experimental | Participants will receive a total of three induction therapy cycles, 42 days for each cycle, with isatuximab, bortezomib, lenalidomide and dexamethasone.
Following induction, participants will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine for 3 days, followed by a single infusion of anitocabtagene autoleucel.
Following anitocabtagene autoleucel, participants will receive maintenance therapy with isatuximab and lenalidomide during 28-day cycles for up to 36 cycles or until unacceptable toxicity, disease progression per IMWG criteria, or withdrawal of consent, whichever occurs first. Receives: Drug: Anitocabtagene Autoleucel; Drug: Isatuximab; 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: Up to 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 (21)
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)
TTR 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 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 (TTP)
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
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) Score
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 15 years
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) - Multiple Myeloma Module (EORTC QLQ-MY20) Scores
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 15 years
Change From Baseline in the European Quality of Life (EuroQoL) 5-Dimension 5-Level (EQ-5D-5L) Scale Index Score
The EQ-5D-5L includes a descriptive system that assesses health status across five dimensions that can be used to derive a single index score by applying a tariff based on health-state valuations. The index score typically ranges from 0 to 1, with higher values indicating better health status.
Measured: Baseline, up to 15 years
Change From Baseline in the EQ-5D-5L Visual Analog Scale (VAS) Score
The EQ-5D-5L includes a VAS that assesses self-rated current health status on a scale from 0 ("the worst health you can imagine") to 100 ("the best health you can imagine"), with higher scores indicating better self-rated health.
Measured: Baseline, up to 15 years
Percentages of Participants Responses for Patient Global Impression Scale - Severity (PGI-S)
The PGI-S is a single-item measure that assesses a patient's perception of disease symptom severity at a point in time using a 5-point response scale ranging from "none" to "very severe."
Measured: Up to 15 years
Percentages of Participants Responses for Patient Global Impression Scale Change (PGI-C)
The PGI-C is a single-item measure that evaluates patients' perceptions of change in their symptoms over time using a 7-point response scale ranging from "very much worse" to "very much improved."
Measured: Up to 15 years
Percentages of Participants 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 ranging from "not at all" to "very much."
Measured: Up to 15 years
Percentage of Participants With Hospitalizations
Measured: Up to 15 years
Mean Number of Inpatient Days per Hospitalizations
Measured: Up to 15 years
Mean Number of Intensive Care Unit Days per Hospitalizations
Measured: Up to 15 years
Percentage of Participants by Reason 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 posted29 Oct 2026
- Study startFeb 2027 (estimated)
- Primary completionMar 2039 (estimated)
- Study completionMar 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
- 750 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 director, Kite, A Gilead Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07903506
- Sponsor's protocol ID
- KT-US-715-0795
- Other IDs
- 2026-527841-24-00
- Acronym
- iMMagine-6
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07903506
- Acronym / sponsor ID
- iMMagine-6 / KT-US-715-0795
- Conditions
- Newly Diagnosed Multiple Myeloma
- Keywords
- Multiple Myeloma, CAR-T, ddBCMA, BCMA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Kite, A Gilead CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2027 (estimated)
- Primary completion
- Mar 2039 (estimated)
- Study completion
- Mar 2042 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
After completing quadruplet-based induction therapy followed by anitocabtagene autoleucel or autologous stem cell transplant, participants in both treatment arms will receive maintenance therapy for up to 36 cycles.
After completing the maintenance treatment period, participants will continue in a follow-up period for disease assessment and outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Standard of Care Therapy (SOCT) | Active comparator | Drug: Isatuximab, Drug: Bortezomib, Drug: Lenalidomide, Drug: Dexamethasone, Drug: MelphalanParticipants will receive a total of three induction therapy cycles, 42 days for each cycle, with isatuximab, bortezomib, lenalidomide and dexamethasone. Following induction, participants will receive high dose conditioning therapy with melphalan and autologous stem cell transplantation (auto-SCT). Following auto-SCT, participants will receive maintenance therapy with isatuximab and lenalidomide during 28-day cycles for up to 36 cycles or until unacceptable toxicity, disease progression per IMWG criteria, or withdrawal of consent, whichever occurs first. |
| Arm B: Anitocabtagene Autoleucel | Experimental | Drug: Anitocabtagene Autoleucel, Drug: Isatuximab, Drug: Bortezomib, Drug: Lenalidomide, Drug: Dexamethasone, Drug: Fludarabine, Drug: CyclophosphamideParticipants will receive a total of three induction therapy cycles, 42 days for each cycle, with isatuximab, bortezomib, lenalidomide and dexamethasone. Following induction, participants will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine for 3 days, followed by a single infusion of anitocabtagene autoleucel. Following anitocabtagene autoleucel, participants will receive maintenance therapy with isatuximab and lenalidomide during 28-day cycles for up to 36 cycles or until unacceptable toxicity, disease progression per IMWG criteria, or withdrawal of consent, whichever occurs first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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
Key exclusion criteria (16 listed)
- 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
- Central nervous system (CNS) or meningeal involvement of MM
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anitocabtagene AutoleucelA single infusion of CAR+ transduced autologous T cells | Drug | Arm B: Anitocabtagene Autoleucel |
| IsatuximabAdministered subcutaneously (SC) | Drug | Arm A: Standard of Care Therapy (SOCT), Arm B: Anitocabtagene Autoleucel |
| BortezomibAdministered SC | Drug | Arm A: Standard of Care Therapy (SOCT), Arm B: Anitocabtagene Autoleucel |
| LenalidomideAdministered orally (PO) | Drug | Arm A: Standard of Care Therapy (SOCT), Arm B: Anitocabtagene Autoleucel |
| DexamethasoneAdministered orally (PO) | Drug | Arm A: Standard of Care Therapy (SOCT), Arm B: Anitocabtagene Autoleucel |
| FludarabineAdministered IV | Drug | Arm B: Anitocabtagene Autoleucel |
| CyclophosphamideAdministered IV | Drug | Arm B: Anitocabtagene Autoleucel |
| MelphalanAdministered intravenously (IV) | Drug | Arm A: Standard of Care Therapy (SOCT) |
Primary outcome
Minimal Residual Disease (MRD)-Negative Complete Response (CR) or Stringent CR (sCR) Rate at 12 Months
Time frame: Up to 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).
Progression-Free Survival (PFS)
Time frame: Up to 15 years
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.
21 secondary outcomes
Overall survival (OS)
Time frame: Up to 15 years
Overall Response Rate (ORR)
Time frame: Up to 15 years
Rate of Very Good Partial Response or Better
Time frame: Up to 15 years
Rate of CR or Better
Time frame: Up to 15 years
Time to Response (TTR)
Time frame: Up to 15 years
Duration of response (DOR)
Time frame: Up to 15 years
Time to Progression (TTP)
Time frame: Up to 15 years
Percentage of Participants Experiencing Serious Adverse Events (SAEs)
Time frame: Enrollment up to 15 years
Percentage of Participants Experiencing Adverse Events (AEs)
Time frame: Enrollment up to 15 years
Percentage of Participants With Anti-Anitocabtagene Autoleucel Chimeric Antigen Receptor (CAR) Antibodies (Anitocabtagene Autoleucel Arm B)
Time frame: Up to 15 years
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score
Time frame: Baseline, up to 15 years
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) - Multiple Myeloma Module (EORTC QLQ-MY20) Scores
Time frame: Baseline, up to 15 years
Change From Baseline in the European Quality of Life (EuroQoL) 5-Dimension 5-Level (EQ-5D-5L) Scale Index Score
Time frame: Baseline, up to 15 years
Change From Baseline in the EQ-5D-5L Visual Analog Scale (VAS) Score
Time frame: Baseline, up to 15 years
Percentages of Participants Responses for Patient Global Impression Scale - Severity (PGI-S)
Time frame: Up to 15 years
Percentages of Participants Responses for Patient Global Impression Scale Change (PGI-C)
Time frame: Up to 15 years
Percentages of Participants Responses for Functional Assessment of Cancer Therapy Item GP5 (FACT-GP5)
Time frame: Up to 15 years
Percentage of Participants With Hospitalizations
Time frame: Up to 15 years
Mean Number of Inpatient Days per Hospitalizations
Time frame: Up to 15 years
Mean Number of Intensive Care Unit Days per Hospitalizations
Time frame: Up to 15 years
Percentage of Participants by Reason for Hospitalization
Time frame: Up to 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Newly Diagnosed Multiple Myeloma
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
RecruitingPhase 3
Belantamab Mafodotin or Daratumumab With Bortezomib, Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma
Multiple Myeloma
Not yet recruitingPhase 3
A Trial Comparing Ramantamig and Daratumumab (Ramantamig-D) Versus Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible
Multiple Myeloma
RecruitingPhase 3
A Study of Ramantamig Plus Daratumumab Versus Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd) or Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With NDMM For Whom Stem Cell Transplant is Not Planned
Multiple Myeloma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kite Study Director study director
Kite, A Gilead Company
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anitocabtagene Autoleucel, Isatuximab and Bortezomib in people with Newly Diagnosed Multiple Myeloma, run by Kite, A Gilead Company.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical Information (844-454-5483(1-844-454-KITE), medinfo@kitepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimal Residual Disease (MRD)-Negative Complete Response (CR) or Stringent CR (sCR) Rate at 12 Months (time frame: Up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.