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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06413498




Registration number
NCT06413498
Ethics application status
Date submitted
9/05/2024
Date registered
14/05/2024

Titles & IDs
Public title
A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma
Scientific title
A Phase 3, Randomized, Open-Label Study to Compare the Efficacy and Safety of Anitocabtagene Autoleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Multiple Myeloma
Secondary ID [1] 0 0
2024-511188-26
Secondary ID [2] 0 0
KT-US-679-0788
Universal Trial Number (UTN)
Trial acronym
iMMagine-3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Anitocabtagene Autoleucel
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Fludarabine
Treatment: Drugs - Pomalidomide
Treatment: Drugs - Bortezomib
Treatment: Drugs - Dexamethasone
Treatment: Drugs - Daratumumab
Treatment: Drugs - Carfilzomib

Experimental: Anitocabtagene Autoleucel - Participants with RRMM will receive lymphodepletion chemotherapy with cyclophosphamide and fludarabine for 3 days followed by single dose of anitocabtagene autoleucel chimeric antigen receptor positive (CAR+) on Day 1.

Active comparator: Standard of Care Therapy (SOCT) - Participants will receive the investigator's choice of one of the following therapies:

* pomalidomide, bortezomib, and dexamethasone (PVd) (21-day cycles)
* daratumumab, pomalidomide, and dexamethasone (DPd) (28-day cycles)
* carfilzomib, daratumumab, and dexamethasone (KDd) (28-day cycles)
* carfilzomib and dexamethasone (Kd) (28-day cycles)


Treatment: Drugs: Anitocabtagene Autoleucel
A single infusion of CAR+ transduced autologous T cells

Treatment: Drugs: Cyclophosphamide
Administered intravenously

Treatment: Drugs: Fludarabine
Administered intravenously

Treatment: Drugs: Pomalidomide
Tablet administered orally

Treatment: Drugs: Bortezomib
Administered intravenously or subcutaneously

Treatment: Drugs: Dexamethasone
Tablet administered orally

Treatment: Drugs: Daratumumab
Administered intravenously or subcutaneously

Treatment: Drugs: Carfilzomib
Administered intravenously
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
Up to 4 years
Secondary outcome [1] 0 0
Complete Response (CR) Rate (CR/ Stringent Complete Response (sCR))
Timepoint [1] 0 0
Up to 4 years
Secondary outcome [2] 0 0
Overall Minimal Residual Disease (MRD) Negativity
Timepoint [2] 0 0
Up to 7 years
Secondary outcome [3] 0 0
Overall survival (OS)
Timepoint [3] 0 0
Up to 7 years
Secondary outcome [4] 0 0
Overall Response Rate (ORR)
Timepoint [4] 0 0
Up to 7 years
Secondary outcome [5] 0 0
MRD-negative CR/sCR
Timepoint [5] 0 0
Up to 7 years
Secondary outcome [6] 0 0
MRD-negative VGPR+
Timepoint [6] 0 0
Up to 7 years
Secondary outcome [7] 0 0
Sustained MRD Negativity
Timepoint [7] 0 0
Up to 7 years
Secondary outcome [8] 0 0
Duration of Response (DOR)
Timepoint [8] 0 0
Up to 7 years
Secondary outcome [9] 0 0
Time to Progression
Timepoint [9] 0 0
Up to 7 years
Secondary outcome [10] 0 0
Time to Next Treatment
Timepoint [10] 0 0
Up to 7 years
Secondary outcome [11] 0 0
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Timepoint [11] 0 0
First dose up to 7 years
Secondary outcome [12] 0 0
Percentage of Participants With Anti-Anitocabtagene Autoleucel CAR Antibodies (Anitocabtagene Autoleucel Arm)
Timepoint [12] 0 0
Up to 7 years
Secondary outcome [13] 0 0
Percentage of Participants With Presence of Replication-Competent Lentivirus (Anitocabtagene Autoleucel Arm)
Timepoint [13] 0 0
Up to 7 years
Secondary outcome [14] 0 0
Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score
Timepoint [14] 0 0
Up to 7 years
Secondary outcome [15] 0 0
Change From Baseline in the EORTC - Multiple Myeloma Module (EORTC QLQ-MY20) Score
Timepoint [15] 0 0
Up to 7 years
Secondary outcome [16] 0 0
Change From Baseline in the European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) Score
Timepoint [16] 0 0
Up to 7 years
Secondary outcome [17] 0 0
Percentage of Participants Using Healthcare Resources
Timepoint [17] 0 0
Up to 7 years

Eligibility
Key inclusion criteria
Key

* Documented historical diagnosis of multiple myeloma (MM)
* Received 1 to 3 prior lines of antimyeloma therapy, including an immunomodulatory drug (IMiD) and an anti-cluster of differentiation 38 (CD38) monoclonal antibody (mAb). A minimum of 2 consecutive cycles of an IMiD and an anti-CD38 mAb in any prior line of therapy is required. The IMiD and anti-CD38 mAb do not need to be from the same regimen in the prior line(s) of therapy.
* Documented evidence of progressive disease by IMWG criteria based on the investigator's determination on or within 12 months of the last dose of the last regimen
* Measurable disease 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 measurable disease in the serum or urine: serum free light chain = 10 mg/dL and abnormal serum free light chain ratio
* Only individuals who are candidates to receive at least 1 of the 4 SOCT regimens (PVd, DPd, KDd, or Kd), as determined by the investigator, should be considered for this study
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Females of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior B-cell maturation antigen (BCMA)-targeted therapy
* 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
* Cardiac atrial or cardiac 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 ongoing treatment for disease control within the last 24 months. Myelodysplastic syndrome (even without ongoing treatment) is not permitted.
* Prior auto-SCT within 12 weeks before randomization
* Prior allogeneic stem cell transplant (allo-SCT)
* High-dose (eg, cumulative > 70 mg prednisone or equivalent) systemic steroid therapy or any other form of immunosuppressive therapy within 14 days before randomization
* Live vaccine = 4 weeks before randomization
* Contraindication to fludarabine or cyclophosphamide
* History of allergy or hypersensitivity to any study agent or study drug components. Individuals with a history of severe hypersensitivity reaction to dimethyl sulfoxide (DMSO) are excluded.
* Life expectancy < 12 weeks

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/08/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2031
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Epworth HealthCare - Richmond
Recruitment postcode(s) [1] 0 0
3121 - Richmond
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Kentucky
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Tennessee
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Newcastle

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Kite, A Gilead Company
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Arcellx, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kite Study Director
Address 0 0
Kite, A Gilead Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Medical Information
Address 0 0
Country 0 0
Phone 0 0
844-454-5483(1-844-454-KITE)
Fax 0 0
Email 0 0
medinfo@kitepharma.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06413498