iMMagine-3
Research type
Research Study
Full 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
IRAS ID
1010356
Contact name
Enrique Granados
Contact email
Sponsor organisation
Kite Pharma, Inc.
Clinicaltrials.gov Identifier
Research summary
Multiple myeloma is a cancer that forms in a type of white blood cell called a plasma cell. In multiple myeloma, cancerous plasma cells build up in bone marrow. This can affect multiple areas of the body including the spine, pelvis and ribs. Symptoms include bone pain, tiredness and kidney problems.
This study is for relapsed or refractory multiple myeloma, which means that the cancer has returned or is non-responsive to current treatment.
The aim of this study is to find out if the experimental treatment, anitocabtagene autoleucel (anito-cel), is safe and effective in treating relapsed or refractory multiple myeloma compared to standard of care treatment (SOCT).
Anito-cel is made by using a type of the participant’s own white blood cells, called T-cells. The cells are collected, changed to target the participant’s cancer cells, and given back to them.
The study will involve approximately 450 participants globally. It has 2 treatment groups:
• Anito-cel - involves collection of white blood cells to manufacture anito-cel, 3 days of lymphodepleting chemotherapy to prepare for receiving of anito-cel, and then a single infusion of anito-cel.
• SOCT – involves receiving 1 of 4 chemo-immunotherapy based therapies available to treat multiple myeloma.Participants will be randomly assigned to one of the treatment groups by a process called randomisation and they will have a 50% chance of being in the Anito-cel Group. Both the participant and their doctor will know which group they have been assigned to.
The duration of the study may be different for each participant as it will depend on things like which treatment group they are assigned to and the response to the therapy. Participants from both groups will be followed on the study for approximately 4 years. Participants will attend their study site for visits over this period. These visits will involve procedures such as physical exams, blood samples, biopsies and scans.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
24/SC/0270
Date of REC Opinion
16 Oct 2024
REC opinion
Further Information Favourable Opinion