RecruitingPHASE3INTERVENTIONAL

A Study Comparing Anitocabtagene Autoleucel to Standard of Care Therapy in Participants With Relapsed/ Refractory Multiple Myeloma

This important study, named iMMagine-3, is looking for people with a type of blood cancer called multiple myeloma. Specifically, it's for those whose cancer has returned after treatment or hasn't responded to their existing medicines. Participants would have already tried 1 to 3 different treatments, including specific types of drugs (an anti-CD38 antibody and an immunomodulatory drug). The main goal is to compare a new experimental treatment, called anitocabtagene autoleucel, with standard care options. Doctors want to find out if this new treatment is more effective at controlling the cancer. If you join, you will be carefully monitored not just during the treatment period, but for up to 15 years afterwards to understand the long-term effects.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Kite, A Gilead Company

Enrolment target

450

Start

23 Aug 2024

Estimated completion

01 Jul 2031

Multiple Myeloma

What is this study about?

This study is about a type of cancer called multiple myeloma. This cancer affects certain cells in your bone marrow. Sometimes, despite treatment, the cancer can come back (this is called 'relapsed') or it might not respond to treatments (which is called 'refractory'). If this has happened to you after trying one to three different treatments, including specific types of drugs (an anti-CD38 antibody and an immunomodulatory drug), then this study might be for you.

The main purpose of this study is to compare a new experimental treatment, called anitocabtagene autoleucel, with treatments that doctors currently use (these are called 'standard of care'). Researchers want to find out if this new treatment works better and is safer than the current standard options for people whose multiple myeloma has relapsed or didn't respond to previous treatments.

Taking part would mean being closely monitored during the treatment phase. After that, you would continue to be followed up for a very long time – up to 15 years. This long-term follow-up is important because it helps doctors understand the long-term effects of the new treatment and how it impacts people's health over many years.

Key takeaways

This study is for people with multiple myeloma that has come back or not responded to previous treatments.
It compares a new treatment called anitocabtagene autoleucel with standard care.
You would have already tried 1 to 3 prior treatments, including specific types of drugs.
If you join, you will be followed closely for up to 15 years.
The aim is to find out if the new treatment is more effective.
Both new and standard treatments have potential risks and benefits.

Who may be eligible?

To be part of this study, you need to have a confirmed diagnosis of multiple myeloma and your cancer must have either come back or not responded to previous treatments. You should have already received between one and three different types of treatment, including particular medications like an immunomodulatory drug and an anti-CD38 drug. Your cancer must also be measurable when doctors check, which means they can see signs of it in your blood or urine.

You also need to be well enough to receive at least one of the standard treatments offered in the study, and your general health, as measured by a simple score (ECOG 0 or 1), should be good.

There are also some reasons why you might not be able to join. For example, if you've had certain types of previous treatments for myeloma, or if your cancer has spread to your brain or spinal cord, or if you have certain other serious health conditions like plasma cell leukaemia. If you are female and could become pregnant, you would need to have a negative pregnancy test.

Quick self-check

I have been diagnosed with multiple myeloma.
My myeloma has either come back or not responded to treatments.
I have had 1 to 3 prior treatments, including specific types of medicines (an immunomodulatory drug and an anti-CD38 drug).
Doctors can measure my myeloma in my blood or urine.
I am generally well and fit enough for treatment.
I have not had certain previous cancer treatments, like CAR T-cell therapy.

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will either receive the new experimental treatment, anitocabtagene autoleucel, or one of the standard treatments for multiple myeloma. The study will involve regular visits to the clinic for assessments, which will include blood tests, urine tests, and other checks to see how you are doing and how the treatment is working. The specific medicines you receive will depend on which group you are in.

After you finish the main treatment period, the study team will continue to follow your health very closely. This means you’ll have check-ups for a long time, potentially up to 15 years. The total time you'll be involved in the study, from treatment to long-term follow-up, could be quite extensive, but this is important for understanding the full impact of the new treatment.

Potential risks and benefits

This study offers the potential benefit of trying a new treatment that might be more effective than current standard options for your multiple myeloma. However, like all medical treatments, both the new drug and standard therapies carry potential risks and side effects, which the study team will explain fully. You will be closely monitored for any reactions or complications, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (124)

Banner MD Anderson Cancer Center
Gilbert, United States· Active not recruiting
Mayo Clinic Hospital
Gilbert, United States· Active not recruiting
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, United States· Active not recruiting
USC/Norris Comprehensive Cancer Center
Los Angeles, United States· Active not recruiting
University of California Davis Comprehensive Cancer Center
Sacramento, United States· Active not recruiting
UC San Diego Moores Cancer Center
San Diego, United States· Active not recruiting
University of California San Francisco Medical Center
San Francisco, United States· Withdrawn
UCLA Hematology/Oncology (Bowyer Infusion Clinic)
Santa Monica, United States· Active not recruiting
Stanford Cancer Institute
Stanford, United States· Active not recruiting
Colorado Blood Cancer Institute
Denver, United States· Active not recruiting
Sylvester Comprehensive Cancer Center
Coral Gables, United States· Active not recruiting
Mayo Clinic
Jacksonville, United States· Active not recruiting

+112 more sites — see the official record for the full list.

Common questions

What is multiple myeloma?

Multiple myeloma is a type of cancer that affects plasma cells, which are a type of white blood cell found in the bone marrow.

What does 'relapsed/refractory' mean?

It means your cancer has either come back after treatment (relapsed) or it hasn't responded to previous treatments (refractory).

What is anitocabtagene autoleucel?

It's the name of the new, experimental treatment being tested in this study for multiple myeloma.

How long will I be followed up after treatment?

You will be followed up for a long time, potentially for up to 15 years, to monitor the long-term effects of the treatment.

Can I choose which treatment I receive?

The study aims to compare treatments, so you would be assigned to either the new treatment or a standard treatment, like a lottery system.

How to find out more

Medical Information

medinfo@kitepharma.com 844-454-5483(1-844-454-KITE) Official trial record

Always speak to your GP or specialist before deciding to take part in a study.